[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorder-asd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorder-asd":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,61,86,107,143,170,198,229,255,287,316,341,364,390,410,474,497,523,549,580,599,623,643,667,688],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100616348","phase-1-adia-med-of-winter-park-llc-autism-spectrum-disorder-research-study-100616348",false,"NCT07304440","Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study","Inclusion Criteria:\n\n* Age 3-12 years\n* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2)\n* Parent\u002Fguardian willingness to consider experimental treatments and comply with study requirements\n* Ability to attend all scheduled visits\n* Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent\n\nExclusion Criteria:\n\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days\n* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening","ALL","3 Years","12 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.",[28,29,30,31],"Autism Spectrum Disorder","Autism","ASD","Autism Spectrum Disorder (ASD)",[33,34,35,36,37,38,39,29,28,30,40,41,42,43,44,45,46,47],"Glutathione","Intravenous glutathione","Glutathione therapy","Antioxidant therapy","Oxidative stress","Immune modulation","Anti-inflammatory therapy","Autism symptoms","Stem cell therapy","MSCs","Mesenchymal stem cells","Regenerative medicine","Cellular therapy","Hematopoietic stem cells (HSCs)","Allogeneic stem cells","RECRUITING","2026-06-16",{"date":51,"type":52},"2026-06-17","ACTUAL",{"date":54,"type":52},"2026-05-01",{"date":56,"type":21},"2028-06-15",{"name":58,"class":59},"Adia Med of Winter Park LLC","OTHER",1,{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":16,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":60},"100643518","how-trunk-control-links-autism-severity-to-functional-exercise-capacity-in-children-with-asd-100643518","NCT07634107","How Trunk Control Links Autism Severity to Functional Exercise Capacity in Children With ASD","Trunk Control Mediates the Association Between Autism Severity and Functional Exercise Capacity in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Children aged 4-12 years (inclusive) at the time of assessment\n* Confirmed diagnosis of ASD according to DSM-5 criteria, documented in the hospital record by a licensed clinical psychologist or developmental paediatrician\n* Classified at DSM-5 severity Level 1, 2, or 3 in the existing clinical file\n* Currently attending physiotherapy or developmental rehabilitation outpatient services at the hospital\n* Able to attempt the Six-Minute Walk Test (6MWT) with or without verbal prompting\n* Written informed consent from parent or legal guardian; verbal assent from child where developmentally appropriate (aged 7 years and above)\n\nExclusion Criteria:\n\n* Co-existing neurological condition independently affecting gait (e.g., cerebral palsy, uncontrolled epilepsy)\n* Orthopaedic condition precluding walking or safe execution of the Trunk Impairment Scale\n* Acute illness, fever, or significant behavioural crisis at the time of the scheduled assessment session\n* Current enrolment in a structured physiotherapy or physical activity intervention programme\n* Caregiver refusal of consent or participant non-cooperation with either assessment tool at the time of the visit",true,"4 Years",{"count":71,"type":21},200,"1 Day","OBSERVATIONAL","The goal of this observational study is to learn if trunk control (the ability to balance and stabilize the upper body while sitting or moving) links autism severity to functional exercise capacity in children aged 4-12 years with Autism Spectrum Disorder (ASD). The main questions it aims to answer are:\n\n1. Does trunk control explain why children with more severe ASD have lower functional exercise capacity?\n2. Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)?\n\nParticipants will complete two assessments in a single 30-40 minute session during their routine clinic visit:\n\n1. A trunk control test, where a trained physiotherapist observes seated balance and movement.\n2. A 6-Minute Walk Test (6MWT), where the child moves along a flat hospital corridor for 6 minutes and the total distance covered is recorded as a measure of functional exercise capacity.\n\nNo treatment or intervention is involved. All assessments are safe, non-invasive, and conducted at a tertiary care children's hospital in Pakistan.",[31],"NOT_YET_RECRUITING","2026-06-06",{"date":79,"type":52},"2026-06-10",{"date":81,"type":21},"2026-06",{"date":83,"type":21},"2026-07",{"name":85,"class":59},"Dr. Mehak Naeem",{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100637682","phase-1-gaip-asd-research-study-100637682","NCT07622316","GAIP ASD Research Study","Greater Atlanta Integrative Pediatrics Autism Spectrum Disorder Research Study","Inclusion Criteria:\n\n* Age 3 years and up\n* Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent)\n* Parent\u002Fguardian willingness to consider experimental treatments and comply with study requirements\n* Ability to obtain required bloodwork\n* Ability to attend all scheduled visits\n\nExclusion Criteria:\n\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Immunocompromised\n* Malignancy history\n* Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days",{"count":20,"type":21},[24],"This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.",[28,29,30,31],[33,34,35,36,37,38,39,29,28,30,40,41,44,47,45],"2026-06-01",{"date":100,"type":52},"2026-06-03",{"date":98,"type":21},{"date":103,"type":21},"2027-06-30",{"name":105,"class":59},"Greater Atlanta Integrative Pediatrics",2,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":68,"sex":16,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":60},"100639915","online-evaluation-of-the-diagnostic-accuracy-of-blinklabs-digital-assessments-for-autism-100639915","NCT07590973","Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism","Inclusion Criteria:\n\n1. Age: Children between 2 to 11 years old\n2. Parent\u002FCaregiver\u002FHealthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.\n3. Language Proficiency: Parents and subjects must have functional English capability in the home environment.\n4. Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).\n5. Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.\n\nExclusion Criteria:\n\n1. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.\n2. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.\n3. Location of at home testing: Not being able to complete all remote at-home study sessions within the US.\n4. History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.","2 Years","11 Years",{"count":116,"type":21},1000,"This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.\n\nIn this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.\n\nThe study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.\n\nThis study does not involve any treatment or medical intervention.",[29,28,31,119],"Neurodevelopmental Conditions",[28,29,121,119,122,123,124,125,126,127,128,129,130,131,132],"Autism Diagnosis","Pediatric Assessment","Digital Assessment","Mobile Application","Smartphone-based Assessment","Digital Health","Remote Study","Observational Study","Eye Movements","Repetitive Behavior","Reflexive Sensorimotor Behavior","Machine Learning","2026-05-11",{"date":135,"type":52},"2026-05-15",{"date":137,"type":52},"2025-02-15",{"date":139,"type":21},"2026-12-01",{"name":141,"class":142},"Blinklab Limited","INDUSTRY",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":16,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":60},"100618288","an-examination-of-the-performance-of-qbmobile-in-differential-diagnosis-associated-with-adhd-symptoms-100618288","NCT07329673","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms","An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.","Inclusion Criteria:\n\n* Provide written informed consent (including parent\u002Flegal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;\n* Aged \\> 6 years and \\\u003C 60 years old;\n* Referred for an initial assessment for ASD, MDD, Bipolar Disorder or Anxiety Disorder (Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)) or has a prior diagnosis of one of the included disorders but is not currently receiving treatment;\n* Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ASD, MDD, Bipolar Disorder or Anxiety Disorder per sites standard clinical procedures;\n* Have adequate sensory and physical ability to complete QbMobile;\n* Possess or have access to an iPhone model that supports QbMobile.\n\nExclusion Criteria:\n\n* Intellectual disability designated by IQ\\\u003C70;\n* Has a DSM-5 or ICD-11 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder;\n* Has a primary diagnosis of ADHD (combined, inattentive, or hyperactivity\u002Fimpulsive presentation);\n* Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease, etc);\n* Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);\n* Use of prescription medications (e.g., anxiolytics, sedative medications) taken on the day before completing QbMobile that could significantly affect performance;\n* Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.","6 Years","60 Years",{"count":153,"type":21},300,"The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.",[156,31,157,158,159,160],"Bi-Polar Disorder","Major Depression Disorders","Separation Anxiety Disorder","Social Anxiety Disorder","Generalized Anxiety Disorder (GAD)","2026-05-04",{"date":163,"type":52},"2026-05-06",{"date":165,"type":52},"2026-01-01",{"date":167,"type":21},"2026-11",{"name":169,"class":142},"Qbtech AB",{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":68,"sex":16,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":60},"100636799","biomarkers-of-asdadhd-and-factors-affecting-anxiety-and-depression-in-children-and-young-adults-100636799","NCT07570381","Biomarkers of ASD\u002FADHD and Factors Affecting Anxiety and Depression in Children and Young Adults","Biomarker Discovery for Predicting Autism Spectrum Disorder and Attention\u002FHyperactivity Disorders, and Identification of Environmental Factors Influencing Anxiety and Depression in Children, Adolescents, and Young Adults","PUREMIND-OS","OS1 Inclusion Criteria:\n\n* Infants born very preterm (\\\u003C32 weeks) or extremely preterm (\\\u003C28 weeks); or\n* Term-born infants with documented perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE); or\n* Term-born infants with no risk factors (comparison group).\n* Must be ≤12 months corrected age at enrolment.\n\nOS1 Exclusion Criteria:\n\n* Syndromic, chromosomal, or known genetic conditions.\n* Motor impairments that would prevent participation in psychometric or neurophysiology assessments.\n\nOS2 Inclusion Criteria:\n\n* Individuals aged 5-25 years.\n* Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD).\n* Able to participate in scheduled assessments.\n\nOS2 Exclusion Criteria:\n\n* Severe motor impairments that limit psychometric assessment.\n* Diagnosis of schizophrenia, due to confounding neurocognitive effects.","6 Months","25 Years",{"count":181,"type":21},800,"The PUREMIND OS1\u002FOS2 study is a multinational, prospective, longitudinal observational study designed to identify early neurophysiological, biological, environmental, and psychosocial markers associated with neurodevelopmental and mental health conditions from infancy through young adulthood.\n\nObservational Study 1 (OS1) follows infants and toddlers at high risk for Autism Spectrum Disorder (ASD) and Attention-Deficit\u002FHyperactivity Disorder (ADHD) to discover biomarkers predictive of later clinical diagnosis, using EEG, fNIRS, psychometric assessments, and biological samples.\n\nObservational Study 2 (OS2) includes children, adolescents, and young adults with ASD, ADHD, or Developmental Coordination Disorder (DCD) to identify environmental and biological factors causally linked to anxiety and depression symptoms, and to support the development of personalised criteria for evidence-based interventions.\n\nApproximately 800 participants will be recruited across 10 international clinical sites. The study aims to generate multi-domain data to support predictive modelling and inform future personalised mental-health prevention strategies across childhood and young adulthood.",[184,31,185],"ADHD - Attention Deficit Disorder With Hyperactivity","Developmental Coordination Disorder (DCD)",[187,188,189],"Attention Deficit Disorder with Hyperactivity","Autism spectrum disorder","Developmental Coordination Disorder","2026-04-29",{"date":163,"type":52},{"date":193,"type":21},"2026-08-01",{"date":195,"type":21},"2028-12-31",{"name":197,"class":59},"University of Exeter",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":16,"minAge":113,"maxAge":69,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":60},"100633092","trial-of-center-based-early-start-denver-model-vs-pivotal-response-treatment-in-children-with-autism-100633092","NCT07522190","Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism","Randomized Controlled Trial of Center-Based Early Start Denver Model (ESDM) vs. Pivotal Response Treatment (PRT) in Children With Autism","Inclusion Criteria:\n\n* Children must be between 2 and 4 years, 11 months of age at enrollment\n* Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment\n* Demonstrated significant language delay as determined by standardized language measures\n* Ability to participate in study assessments and intervention procedures\n* At least one English-speaking parent or caregiver available to participate in parent training and research measures\n* Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder)\n* Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease)\n* Child's primary language is not English\n* Prior adequate trial of PRT or ESDM\n* Receipt of more than 15 hours per week of in-home applied behavior analysis services\n* Inability to complete study assessments or procedures to obtain valid data",{"count":206,"type":21},140,[208],"NA","The goal of this study is to compare two well-established early autism interventions, Early Start Denver Model (ESDM) and Pivotal Response Treatment (PRT), to better understand which approach is most effective for improving communication skills in young children with autism and which children may benefit most from each treatment. Additionally, after completing either the ESDM or PRT, some participants who meet specific clinical criteria may be offered home-based Developmental Reciprocity Treatment (DRT). The study will include boys and girls 2 to 4 years 11 months old diagnosed with ASD. The main questions this study aims to answer are whether center-based ESDM and center-based PRT improve communication skills in young children with autism, and whether certain children respond better to one treatment approach than the other. Participants will be randomly assigned to either ESDM or PRT for 24 weeks in a center-based program, attend treatment session 4 days per week (\\~3 hours\u002Fday), complete developmental and autism assessments at baseline, 12 weeks, and 24 weeks, have a parent participate in weekly parent training sessions, and complete follow-up assessments at weeks 36 and 48.",[31,29],[29,28,212,213,214,215,216,217,218,219],"Early Start Denver Model (ESDM)","Pivotal Response Treatment (PRT)","Early Intervention","Naturalistic Developmental Behavioral Intervention (NDBI)","Communication","Early Development","Parents","Language","2026-04-14",{"date":222,"type":52},"2026-04-17",{"date":224,"type":21},"2027-01",{"date":226,"type":21},"2037-01",{"name":228,"class":59},"Stanford University",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":60},"100611667","phase-1-prospective-clinical-study-on-human-umbilical-cord-mesenchymal-stem-cell-derived-exosomes-for-the-treatment-of-childhood-autism-100611667","NCT07243561","Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism","EXO-ASD","Inclusion Criteria:\n\n* Diagnosis meets the ICD-11 ASD criteria or DSM-5 ASD clinical diagnostic standards.\n* No significant improvement in core symptoms was observed after ≥3 months of standardized behavioral intervention.\n* Score ≥30 on the CARS2, indicating mild-to-moderate or more severe autism.\n* Aged 3 (inclusive) to 7 (inclusive) years, regardless of gender\n* Voluntary participation in this clinical study, with written informed consent provided by the patient's legal guardian, and willingness to undergo examinations, treatment, and cooperate with follow-up visits.\n* In the investigator's judgment, the patient is capable of understanding and complying with study requirements.\n\nExclusion Criteria:\n\n* History of severe allergic reactions.\n* Any severe mental disorder or other types of autism spectrum disorders.\n* History of epileptic seizures within the past six months.\n* Autism secondary to epilepsy, cerebrovascular disease, or traumatic brain injury.\n* Disease severity rated as normal, borderline mental disorder, or mild mental disorder on the Clinical Global Impression scale.\n* Moderate or severe extrapyramidal symptoms or tardive dyskinesia.\n* Severe self-injurious behavior.\n* Active systemic or severe localized infections, including human immunodeficiency virus, syphilis, and hepatitis.\n* Autoimmune diseases.\n* Major organ impairment.\n* Severe pulmonary or hematological diseases, malignancies, or immunodeficiency.\n* Concurrent treatments that may interfere with the safety and efficacy evaluation of stem cell therapy.\n* Participation in other clinical trials within the past three months.\n* Other clinical conditions deemed by investigators as unsuitable for study inclusion.","7 Years",{"count":238,"type":21},40,[24,25],"This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, randomized, controlled, open-label trial. Forty pediatric patients with ASD will be randomly assigned at a 1:1 ratio to two groups: an active exosome nasal spray treatment group and a no-intervention control group. The treatment group will receive the nasal spray every other day, totaling 10 administrations throughout the study. The no-intervention control group will receive no experimental treatment but will undergo the same assessments and safety checks concurrently with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.",[242,243],"Autism Spectrum Disorder (ASD","Prospective Study",[28,245,246],"umbilical cord mesenchymal stem cells","exosome","2026-04-12",{"date":220,"type":52},{"date":250,"type":52},"2025-09-01",{"date":252,"type":21},"2026-07-30",{"name":254,"class":59},"Dongfang People's Hospital",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":16,"minAge":150,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":283,"leadSponsor":285,"locationsCount":4},"100618026","school-based-sensory-processing-and-daily-living-skills-focused-occupational-therapy-program-100618026","NCT07326267","School-Based Sensory Processing and Daily Living Skills-Focused Occupational Therapy Program","Development and Evaluation of a School-Based Occupational Therapy Program Focused on Sensory Processing and Activities of Daily Living: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Regular school attendance (Anticipated ability to attend at least 70% of the planned intervention sessions during the study period);\n* Written informed consent obtained from the family;\n* Formal diagnosis of Autism Spectrum Disorder or Intellectual Disability, documented by an official disability report;\n* Presence of observable difficulties in sensory processing and activities of daily living (ADL), verified through the student's Individualized Education Program (IEP) records;\n* Ability to partially follow single-step basic instructions, as documented in the IEP records;\n* Willingness of families and teachers to participate in follow-up assessments (T2 and beyond).\n\nExclusion Criteria:\n\n* Uncontrolled epilepsy or other medical conditions that may interfere with participation or safety during sessions.\n* Medical contraindications to modalities such as swinging or deep pressure or severe musculoskeletal limitations preventing participation in task-oriented ADL practice.\n* Being in a period of severe acute behavioral crisis;\n* Concurrent participation in occupational therapy or special education programs for ≥2 hours per week that would compromise data interpretation;\n* Presence of severe visual or hearing impairments that would substantially limit the child's ability to perceive sensory stimuli, follow task instructions, or validly engage in assessment procedures;\n* Inability to maintain family and\u002For teacher collaboration throughout the intervention period;\n* Inconsistent school attendance during the intervention period (e.g., prolonged absenteeism);\n* Insufficient language comprehension to engage with basic task instructions even with support.","14 Years",{"count":238,"type":21},[208],"This study aims to develop and evaluate a school-based occupational therapy program focused on sensory processing and activities of daily living for children with Autism Spectrum Disorder and Intellectual Disability. Sensory processing difficulties often affect school participation, behavior regulation, and independence in daily tasks. Although occupational therapy interventions have shown benefits in clinical settings, evidence for their use in schools is limited.\n\nThe trial will take place at Vali Ayhan Çevik Special Education School and will enroll students aged 6 to 14 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive weekly 50-minute occupational therapy sessions for 10 to 12 weeks, including sensory preparation, task-oriented practice, and strategies to support everyday skills. The control group will receive family education, a written home program, and routine school observation.\n\nOutcomes will be assessed at baseline, after the intervention, and at 4 to 6-week follow-up. The main outcome is change in Goal Attainment Scaling scores, which reflect progress toward individualized goals. Additional measures include functional ability, sensory processing, and demographic and clinical information. The study will also monitor feasibility and how closely the program is delivered as planned.\n\nThis research is expected to provide evidence on the feasibility and effects of a standardized occupational therapy program in a school setting and to support the use of similar approaches in educational contexts.",[267,31],"Intellectual Disability, Variable",[269,270,271,272,273,274,275,276,277,278],"School-Based Occupational Therapy","Sensory Processing Intervention","Activities of Daily Living (ADL)","Intellectual Disability (ID)","Randomized Controlled Trial","Feasibility Trial","Goal Attainment Scaling (GAS)","Special Education School","Independence","Sensory Integration","2026-04-08",{"date":281,"type":52},"2026-04-09",{"date":161,"type":21},{"date":284,"type":21},"2027-03-01",{"name":286,"class":59},"Çankırı Karatekin University",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":68,"sex":16,"minAge":294,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":60},"100625376","an-empowering-parent-training-intervention-to-increase-physical-activity-in-preschool-aged-children-with-autism-100625376","NCT07421830","An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism","An Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism: A Randomized Control Trial","Inclusion Criteria:\n\n* Parents or caregivers (who are at least 18 years of age) of children with a diagnosis of autism.\n* The autism diagnosis for the child can be from a school or medical setting.\n* The parent or caregiver's child with autism must be between 2 years 11 months and 5 years, 11 months of age.\n* Parent or caregivers must be able to read and write in English.\n\nExclusion Criteria:\n\n* Parents or caregivers who do not have a child with autism.\n* Adults who do not have children.\n* Parents or caregivers who cannot read and write in English.","18 Years",{"count":296,"type":21},114,[208],"The goal of this clinical trial is to learn if WE PLAY for Parents can improve caregivers' knowledge, attitudes, confidence, and skills promoting physical activity with their young child with autism. The main questions it aims to answer are: (1) Do participants who complete WE PLAY for Parents improve their knowledge, behavior intentions, perceived behavior control, self-efficacy, and parenting practices related to physical activity promotion with their child (Primary Hypotheses); and (2) Do participants view WE PLAY for Parents as acceptable, understandable, and feasible \\[secondary hypothesis)?\n\nResearchers will compare the WE PLAY for Parents group \\[experimental arm\\] to a Waitlist Control group to see if there are differences in the variables listed in the primary hypothesis.\n\nParticipants will: (1) Complete a set of questionnaires at three timepoints: pre-training, post-training, and 3-month follow-up that each take between 10-15 minutes; (2) be randomly assigned to take the training over the next two weeks or be offered the training after 3 months.\n\nThe online training takes about 90 minutes. It includes watching informational videos, viewing video clips of adults helping children be active, reading handouts on behavior management tips and social stories, participating in an anonymous discussion board with other parents, and completing a self-assessment.",[31],[301,302,303,304,305,306,307],"parents","autism","physical activity","preschoolers","health promotion","active play","caregivers","2026-04-06",{"date":279,"type":52},{"date":311,"type":52},"2026-02-20",{"date":313,"type":21},"2026-12-31",{"name":315,"class":59},"Northeastern University",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":68,"sex":16,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":60},"100614219","coaching-and-leadership-in-autism-support-settings-100614219","NCT07276750","Coaching and Leadership in Autism Support Settings","CLASS","Inclusion Criteria:\n\n* Special or general education teachers, paraeducators, and other staff who provide direct instruction and\u002For behavioral support to autistic children during the school day (e.g., speech therapist, school psychologist).\n* Autistic children with:\n* a documented autism spectrum disorder diagnosis via school records (i.e., Individualized Education Program; IEP)\n* are enrolled with a participating educator\n* are in grades K-5\n* ages 5-12\n* Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) total score \\>=101\n* EDI sum score of \\>=8 at baseline\n\nExclusion Criteria:\n\n* SESBI-R total score \\\u003C101 (i.e. T score 51+)\n* EDI sum score \\\u003C8","5 Years",{"count":325,"type":21},373,[208],"Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time. To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM). Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes. The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services. If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.",[31],[330,331,302,332],"implementation","schools","behavior management",{"date":334,"type":52},"2026-04-07",{"date":336,"type":52},"2026-02-01",{"date":338,"type":21},"2030-08-31",{"name":340,"class":59},"University of California, Los Angeles",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":68,"sex":16,"minAge":113,"maxAge":294,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":60},"100632875","monitoring-daily-mobility-in-children-with-autism-100632875","NCT07519369","Monitoring Daily Mobility in Children With Autism","Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism","SIMBA","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria\n* Age between 2 and 18 years\n* Ability to walk independently\n* Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring\n* Willingness to undergo one night of home polysomnography with video-EEG\u002Fpolygraphy during the wearable monitoring period\n* Informed consent signed by both parents\u002Flegal guardian; assent from the minor when applicable\n\nExclusion Criteria:\n\n* Skin contraindications to the wristband\u002Ffixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)\n* Severe motor impairments\n* Recent orthopedic surgery (\\\u003C6 months)\n* Use of orthoses or assistive devices during walking\n* Severe behavioral disorder making device use impracticable despite acclimatization strategies",{"count":350,"type":21},80,[208],"Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.",[242],[28,30,355,356],"sleep","movement disorders","2026-04-02",{"date":281,"type":52},{"date":360,"type":52},"2026-02-18",{"date":81,"type":21},{"name":363,"class":59},"IRCCS San Raffaele Roma",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":16,"minAge":294,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":60},"100631060","prospective-study-to-determine-the-prevalence-of-signs-of-central-sensitization-in-adults-with-asd-without-intellectual-developmental-disorders-100631060","NCT07495761","Prospective Study to Determine the Prevalence of Signs of Central Sensitization in Adults With ASD Without Intellectual Developmental Disorders","Presca : Prospective Study to Determine the Prevalence of Signs of Central Sensitization in Adults With ASD Without Intellectual Developmental Disorders","Presca","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Medical diagnosis of ASD without established intellectual developmental disorder\n3. Patient affiliated with a social security system or beneficiary of such a system\n4. Understanding of written French (good comprehension of self-questionnaire questions)\n5. No objection from the patient to participate in the study\n\nExclusion Criteria:\n\n1. Intellectual developmental disorder that prevents understanding of self-administered questionnaires\n2. Individuals subject to legal or judicial protection measures or unable to express their consent",{"count":20,"type":21},"Autism is a neurodevelopmental disorder (NDD) characterized by two key features: persistent deficits in communication and social interaction, and restricted, repetitive patterns of behavior, interests, and activities. Ninety-five percent of children aged 3 to 6 with autism spectrum disorder (ASD) have sensory peculiarities. In adulthood, this figure remains at 90%. This atypical sensory processing has been part of the DSM diagnostic criteria since 2013.\n\nEach sense can be affected by hypo- or hypersensitivity. In the continuum of this particular sensory processing, pain, which is defined as an unpleasant sensory and emotional experience, can be very present but also difficult to detect and manage. It is now established that there are other characteristics that impact pain in ASD: information processing time may be longer, referred to as \"latency time,\" but there are also difficulties in representing the body schema and difficulties in identifying and\u002For interpreting perceptions. Expression may be atypical, and there may be an apparent lack of reaction to pain due to a lack of flexibility.\n\nAll of these characteristics themselves vary over time (with age, the menstrual cycle, lack of sleep, fatigue, etc.), to the point that even pain specialists in pain clinics may not recognize them.\n\nIt is therefore essential to carry out appropriate, individualized assessments.\n\nThe scientific literature refers to the high frequency of painful events in ASD. For example, the prevalence of gastrointestinal disorders with their associated abdominal pain is significantly higher. Recent research has revealed that 82.4% of children and adolescents with ASD have at least one gastrointestinal symptom. Researchers have found that children with ASD are almost eight times more likely to have one or more chronic gastrointestinal symptoms than typically developing children. There are also more common comorbidities that facilitate or maintain chronic pain: Ehler Danlos syndrome and hypermobility spectrum disorders, IBD, ADHD, post-traumatic stress disorder, depression, migraines and tension headaches, anxiety disorders, epilepsy, small fiber pathologies, nutritional deficiencies, musculoskeletal disorders, etc.\n\nMutations in certain genes involved in ASD (such as SCN9A, SHANK3, and CNTNAP2) lead to impaired neuronal function, producing different responses to pain, as demonstrated in both mouse and human models. The links between ASD and chronic pain are therefore complex. Sometimes it is the unusual characteristics of the pain that could lead to a diagnosis of ASD.\n\nThe concept of central sensitization (CS), which underlies the type of pain known as \"nociplastic,\" helps explain the state of pain hypersensitivity and pathologies such as fibromyalgia and irritable bowel syndrome. In 2022, Grant et al. found that 21% of adults with ASD surveyed in the cohort reported having a diagnosis of central sensitization syndrome (CSS), but 60% scored at or above the cut-off. This suggests that CS symptoms such as pain and fatigue are very common in people with autism, and perhaps more prevalent than in the general population. For example, three-quarters of women diagnosed with ASD and\u002For ADHD in childhood report chronic pain in adulthood.\n\nThe issue is the disability associated with this chronic pain and the impairment of quality of life.",[375,31],"Pain Management",[377,378,379,380],"autism spectrum disorder","chronic pain","signs of central sensitization","ASD r without intellectual developmental disorder","2026-03-24",{"date":383,"type":52},"2026-03-27",{"date":385,"type":52},"2026-02-04",{"date":387,"type":21},"2027-07-29",{"name":389,"class":59},"Groupe Hospitalier Mutualiste de Grenoble",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":68,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":406,"leadSponsor":408,"locationsCount":60},"100630950","exploring-the-physiological-mechanisms-of-austism-through-organoids-100630950","NCT07494331","Exploring the Physiological Mechanisms of Austism Through Organoids","Exploring the Physiologicla Mechainisms of Austism Through Organoids Derived Differentiated Cells of Individuals With Autism","EXPECT HYPE","Inclusion Criteria:\n\n* A child diagnosed with an autism spectrum disorder in accordance with clinical practice guidelines\n\n  * A sibling without an autism spectrum disorder (SRS \\\u003C 65)\n  * Biological parents\n  * Children and parents must be enrolled in a social security program, Universal Health Coverage (CMU), or an equivalent program.\n\nExclusion Criteria:\n\n* Refusal to undergo a blood test\n* Uncontrolled (unstabilized) medical condition (including psychiatric conditions) that precludes participation in the study\n* Sibling with an SRS score \\> 65 at screening or under 2 years old",{"count":350,"type":21},"Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder affecting approximately 1% of the population, characterized by difficulties with social interaction and communication. Studies have identified more than 200 genes linked to ASD, particularly those involved in chromatin remodeling and synaptic neuronal connectivity (CHD8, SCN2A, NLGN3-4X, SHANK1-3). The goal of the project is to decipher the biological mechanisms underlying ASD in order to develop therapeutic strategies, using innovative preclinical models such as organoids.",[242],[30,402],"organoid","2026-03-20",{"date":383,"type":52},{"date":54,"type":21},{"date":407,"type":21},"2028-05-01",{"name":409,"class":59},"Assistance Publique - Hôpitaux de Paris",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":16,"minAge":69,"maxAge":18,"enrollmentInfo":418,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":419,"conditions":420,"keywords":442,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":60},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.",{"count":20,"type":21},"This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[421,422,423,424,425,426,427,428,429,28,242,430,431,432,433,434,435,436,437,438,439,440,441],"Neurodevelopmental Disorders","Neurodevelopmental Disorders (NDD)","Neurodevelopmental Disorders and Developmental Abnormalities","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Infantile","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Hypoxic Ischemic Encephalopathy","Hypoxic Ischemic Encephalopathy (HIE)","Traumatic Brain Injury (TBI)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","22q11.2 Deletion Syndrome","Sensorimotor Integration",[443,444,445,446,447,448,449,450,451,452,278,453,454,455,456,457,458,459,421,460,461,462,463,214,464],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Cognitive Therapy","2026-03-19",{"date":467,"type":52},"2026-03-25",{"date":469,"type":52},"2026-03-01",{"date":471,"type":21},"2036-12-30",{"name":473,"class":59},"Healing Hope International",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":68,"sex":16,"minAge":480,"maxAge":481,"enrollmentInfo":482,"targetDuration":484,"studyType":73,"phases":4,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100629296","research-on-speech-development-trajectories-and-predictive-models-in-children-with-autism-spectrum-disorder-100629296","NCT07472829","Research on Speech Development Trajectories and Predictive Models in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Diagnosed as typically developing children by two or more associate chief physicians.\n* Gender- and age-matched to the ASD group.\n* Participants whose native language is Chinese.\n\nExclusion Criteria:\n\n* Participants not meeting the age requirement.\n* Presence of orofacial motor and swallowing dysfunction.\n* Hearing impairment.\n* Participants whose native language isn't Chinese.\n* Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders.","18 Months","60 Months",{"count":483,"type":21},120,"3 Months","Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.",[487,31],"Speech","2026-03-14",{"date":490,"type":52},"2026-03-17",{"date":492,"type":21},"2026-03-10",{"date":494,"type":21},"2027-12-31",{"name":496,"class":59},"Children's Hospital of Chongqing Medical University",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":30,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":294,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":60},"100586562","modified-and-context-focused-sports-intervention-in-adolescents-with-autism-study-protocol-100586562","NCT06916988","Modified and Context-Focused Sports Intervention in Adolescents With Autism: Study Protocol","Modified Sports Intervention Combined With Context-Focused Intervention in Adolescents With Autism Spectrum Disorder: Protocol for a Mixed Methods Study","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD).\n* Level I of functioning (able to maintain interaction and adapt to changes).\n* Level II of functioning (able to communicate with others but faces difficulties when changes occur) according to the Autism Spectrum Disorder Social Communication Functioning Classification System.\n\nExclusion Criteria:\n\n* Cognitive limitations\n* Behavioral limitations\n* Clinical limitations (e.g., severe cardiorespiratory disease)",{"count":505,"type":21},52,[208],"Adolescents with Autism Spectrum Disorder (ASD) typically engage less in physical activities than their typically developing peers, influenced by intrinsic and extrinsic factors. Modified sports interventions, like Sports Stars Brazil, can improve motor skills and promote lifelong participation in sports by enhancing physical, social, and cognitive abilities. However, adolescents often face barriers to engaging in community sports and recreational activities after completing the program. PREP is an approach designed to address these barriers by modifying environments and empowering families. To date, no study has explored this combination in adolescents with ASD. Objective: This protocol assesses the effectiveness of combining Sports Stars Brazil with PREP to enhance participation and physical literacy in adolescents with ASD and explores participant and family perceptions. Method: A mixed-methods study with two phases: 1) a randomized controlled trial to investigate combined intervention's effects; and 2) evaluation of participant and family perceptions.",[31],[510,511,512,513,28],"Context-centered intervention","Participation","Adolescents","Modified Sports","2026-03-12",{"date":516,"type":52},"2026-03-13",{"date":518,"type":52},"2025-06-01",{"date":520,"type":21},"2027-06-01",{"name":522,"class":59},"Federal University of Minas Gerais",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":16,"minAge":323,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":106},"100629047","characterization-of-the-natural-history-of-microduplication-syndrome-7q1123-100629047","NCT07469566","Characterization of the Natural History of Microduplication Syndrome 7q11.23","Characterization of the Natural History of Microduplication Syndrome","HINADU7","Inclusion Criteria:\n\n* Diagnosis of 7q11.23 microduplication confirmed by Chromosomal Microarray Analysis or qPCR.\n* Aged \\> 5 to \\\u003C 50 years\n* Whose maternal language is French\n* Having signed the informed consent and\u002For for whom parents\u002Flegal guardian have signed the informed consent.\n* Affiliated to national Health Insurance system (sécurité sociale) or parents\u002Flegal guardian affiliated to national health insurance system Each 7DUP patient will be matched to a sex- and chronological age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519). Each 7DUP patient will be matched to a sex- and mental age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519).\n\nExclusion Criteria:\n\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to sign the informed consent\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.\n\nRegarding specifically the neuroimaging data (MRI):\n\n* Having a contraindication to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip, and claustrophobic subjects).\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected by MRI.","50 Years",{"count":533,"type":21},15,[208],"7q11.23 duplication syndrome (7q duplication syndrome\u002F7DUP) is caused by a microduplication of the 7q11.23 chromosomal region, encompassing 26-28 genes, including the GTF2I gene. This syndrome, often considered as a \"mirror\" phenotype of Williams-Beuren syndrome (WBS), is characterized by a wide range of neurodevelopmental impairments, including a neurodevelopmental disorder (NDD), autism spectrum disorders (ASD), selective mutism, mild dysmorphic features, and aortic dilation. Notably, one of the core clinical features of 7DUP is socialization impairment, which varies in severity across individuals.\n\nThe GTF2I gene, identified as critical in the pathogenesis of both WBS and 7DUP, exhibits opposite expression patterns in the two syndromes, with reduced expression in WBS and overexpression in 7DUP. The gene's dysregulation in 7DUP plays a pivotal role in the pathogenesis of the associated NDD and social deficits. Despite progress in characterizing the genetic underpinnings of 7DUP, there remains a critical gap in understanding the developmental trajectory of socialization impairments in affected individuals, especially during their transition through different developmental stages, from early childhood to adulthood.\n\nRecent advancements in the study of neuronal models derived from induced pluripotent stem cells (iPSCs) and brain organoids have shed light on the molecular mechanisms driving 7DUP-related NDDs. Histone deacetylase inhibitors (HDAC inhibitors), which have been widely used in oncology, have shown promising preliminary results in reducing abnormal GTF2I expression in glutamatergic neurons differentiated from 7DUP patient-derived iPSCs. Preclinical studies in mouse models further demonstrated that these drugs can ameliorate socialization deficits, highlighting their therapeutic potential in addressing the core neurodevelopmental challenges in 7DUP.\n\nHowever, despite these advancements, no longitudinal clinical studies have characterized the developmental trajectory of socialization impairments in 7DUP patients. Understanding this trajectory is critical, as it can inform the timing and potential impact of therapeutic interventions, such as HDAC inhibitors. Given the complexity and variability of the 7DUP phenotype, a comprehensive clinical characterization of socialization impairments across the lifespan is essential to improve diagnostic accuracy, optimize intervention strategies, and ultimately improve patient outcomes.\n\nThe aim of this research is to characterize the developmental trajectory of socialization impairments in patients with 7DUP, from early childhood through adulthood. By identifying patterns of socialization difficulties, this innovative study will allow to efficiently prepare future therapeutic trials, by specifying the phenotype of the patients, and by determining the most relevant outcome measures, taking into account, on one hand, their neurodevelopmental involvement and, on the other hand, the type of experimental design to be used in the context of rare diseases.",[537,31,422],"7q11.23 Microduplication Syndrome (7DUP)",[539,540,541,377,30],"7q11.23 microduplication","7DUP syndrome","neurodevelopmental disorders",{"date":516,"type":52},{"date":544,"type":21},"2026-03-15",{"date":546,"type":21},"2027-07-15",{"name":548,"class":59},"Hospices Civils de Lyon",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":68,"sex":16,"minAge":17,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":106},"100627577","phase-2-role-of-the-gut-vascular-barrier-and-microbiota-in-autism-spectrum-disorders-100627577","NCT07450443","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders","Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment","DSA\u002FGVB","Inclusion Criteria:\n\n* Group 1 and 2:\n\nInclusion criteria\n\n* Diagnosis of ASD according to DSM-5 diagnostic criteria;\n* Clinical neurological evaluation by child neurologist and neuropsychologist with administration of standardized instruments such as Autism Diagnostic Observation Schedule-2 (ADOS-2) and\u002For Autism Diagnostic Interview-Revised (ADI-R) to support diagnosis;\n* Assessment of psychomotor or intellectual development (Griffiths Scales, Wechsler Scales, Leiter Scale)\n* Assessment of the following symptoms in the past three months: constipation, diarrhea, abnormal stool consistency, abnormal stool smell, flatulence, abdominal pain, unexplained daytime irritability, and nighttime awakening, and abdominal tenderness. The degree of gastrointestinal disturbances will be quantified before recruitment using an Italian version of the GI Severity Index. A score of at least 2 in a single item of gastrointestinal symptoms (item 1-6) was required for entry into the symptomatic group.\n* Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®.\n\nGroup 3 Inclusion criteria\n\n* Males or females aged between 3 and 8 years whit typical development and absence of gastrointestinal symtomps\n* Signed informed consent for analysis of intestinal microbiota and metabolome\n\nExclusion Criteria:\n\nGroup 1 and 2\n\n* Exclusion Criteria\n* Children with syndromic ASD or defined genetic diseases;\n* Subjects with significant health problems requiring surgical treatment or continuous medical; treatment;\n* Severe gastrointestinal problems requiring immediate (life-threatening) treatment;\n* Severely underweight\u002Fmalnourished children;\n* Use of medications that may affect biomarkers assessed, for example: antibiotics and\u002For pre-, probiotics within 1 month prior to enrollment.\n\nGroup 3 exclusion criteria\n\n\\- Participants with gastrointestinal problems requiring immediate (life-threatening) treatment, or with gastrointestinal symptoms such as chronic irregular bowel movements (constipation, diarrhea), encopresis, recurrent abdominal bloating and pain, gastroesophageal reflux and vomiting, or food aversion.","8 Years",{"count":559,"type":21},90,[25,561],"PHASE3","Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.",[29,564,31],"Autism Disorder",[566,567,568,569,570],"Autism Spectrum Disorders (ASD)","Microbiota","Gastrointestinal symptoms","Behaviour regulation","Sensory profile","2026-02-27",{"date":573,"type":52},"2026-03-04",{"date":575,"type":52},"2023-03-21",{"date":577,"type":21},"2027-12",{"name":579,"class":59},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":16,"minAge":69,"maxAge":294,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":596,"leadSponsor":597,"locationsCount":60},"100626397","phase-1-xenon-therapy-for-children-with-autism-spectrum-disorder-100626397","NCT07435103","Xenon Therapy for Children With Autism Spectrum Disorder","Efficacy of Xenon in Children With Autism Spectrum Disorder: a Multicenter, Randomized, Controlled Study","ASD; Xe","Inclusion Criteria:\n\n* Aged 4-18 years, with no gender restriction.\n* Meeting the diagnostic criteria for Autism Spectrum Disorder (ASD) as specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with the diagnosis confirmed by assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).\n* The total T-score on the Social Responsiveness Scale, Second Edition (SRS-2) is ≥90.\n* No treatment such as neuromodulation (transcranial magnetic stimulation, transcranial electrical stimulation) has been received for at least 1 month prior to randomization.\n* For participants who have previously taken psychotropic medications prior to randomization, it is required that the medications have been discontinued for a minimum of 5 half-lives or 4 weeks, whichever is longer.\n* The participants and their legal guardians confirm that they will not add new or alter the existing established treatment regimens such as behavioral rehabilitation during the study period.\n* The legal guardians of the participants have a full understanding of the study content, participate voluntarily, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Having other major neurological diseases (e.g., epilepsy, cerebral palsy), severe physical illnesses, or genetic syndromes.\n* Having severe auditory or visual impairments that prevent the completion of assessments with cooperation.\n* A history of anaphylaxis or adverse reactions to Xenon.\n* Currently participating in or having participated in other interventional clinical trials within the recent 3 months.\n* The investigator judges that there is any condition that may increase the risk to the participant or interfere with the conduct of the trial and the assessment of its results.",{"count":589,"type":21},72,[24,25],"This study aims to evaluate the efficacy and safety of inhaled xenon for the treatment of children with autism spectrum disorder (ASD). The primary objective is to determine whether short-term inhalational xenon therapy can improve social functioning in children with ASD, as measured by changes in the Social Responsiveness Scale (SRS). Safety and tolerability of xenon inhalation in the pediatric population will also be assessed.\n\nIn this randomized, placebo-controlled trial, participants will receive either inhaled xenon or a placebo gas (medical air without xenon) to compare treatment effects.\n\nParticipants will:\n\nInhale 25% xenon or placebo for 10 minutes per day for 10 consecutive days Attend two clinical visits: one immediately after completion of the intervention and one at 3 months post-intervention for follow-up assessments and safety evaluations",[31,29],"2026-02-24",{"date":571,"type":52},{"date":469,"type":21},{"date":103,"type":21},{"name":598,"class":59},"The Children's Hospital of Zhejiang University School of Medicine",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":606,"minAge":4,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":621,"locationsCount":60},"100607506","l-theanine-and-paraxanthine-for-cognitive-improvement-in-adults-with-adhd-and-asd-100607506","NCT07189442","L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD","Combining L-theanine and Paraxanthine for Transient Improvement of Cognitive Deficits Among Patients With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder: A Series of Translational Pilot Neuroimaging Studies","Inclusion Criteria:\n\nAdults (18+ years) diagnosed by a physician (per self-report) with ADHD or ASD\n\n\\* Participants with a dual diagnosis and ASD and ADHD will be recruited but will only be included in the ASD group - their concurrent ADHD diagnosis will be included as an additional variable in exploratory analyses\n\nExclusion Criteria:\n\n1. Subjects with gross visual or auditory impairments that might limit their ability to perform neuropsychological tasks\n2. Inability to read and follow written instructions\n3. Physical, neurological, intellectual, or psychiatric impairments (except ADHD or ASD) that could affect cognitive and motor functions\n4. Subjects on medications including antidepressants and antipsychotics that may affect performance in the tasks\n5. Subjects on medications that are likely to interact with the administered substances, including regular intake of medication that could alter visual, auditory, cognitive, or motor functions (except stimulants)\n6. History of head injury resulting in loss of consciousness\u002Fhistory of brain surgery\n7. Subjects who have developed adverse effects when caffeine\u002Fparaxanthine \u002FL-theanine\u002Fcorn starch (will be in placebo) containing products were consumed\n8. Subjects who are unwilling or unable to refrain from intake of L-theanine\u002F caffeine\u002F paraxanthine containing food or beverages within the 24 hours prior to each study visit\n9. Intake of drugs containing caffeine, other phosphodiesterase inhibitors, or adenosine receptor blockers within the past 3 months\n10. Intake of medications known to have pharmacological interactions with paraxanthine within the past 3 months\n11. Current\u002Fpast diagnosis of tics or other forms of dyskinesia\n12. History of headache, drowsiness, anxiety, insomnia, or nausea following intake of caffeine or caffeine-containing beverages\n13. Current\u002Fpast history of smoking and\u002For alcohol or drug abuse\n14. Subjects with absolute contraindications to undergo MRI after being screened by the TTNI safety screening sheet (Appendix)\n15. Unwillingness or inability to entirely refrain from the use of electronic devices during study visits\n16. Unwillingness or inability to follow written, on-screen, and verbal instructions given by the study team.","MALE",{"count":608,"type":21},24,[208],"This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.",[612,31],"Attention Deficit Hyperactivity Disorder (ADHD)",[614,615,30,188,29],"ADHD","Attention Deficit Hyperactivity Disorder",{"date":617,"type":52},"2026-02-05",{"date":619,"type":52},"2025-10-01",{"date":98,"type":21},{"name":622,"class":59},"Texas Tech University Health Sciences Center",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":16,"minAge":557,"maxAge":18,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":60},"100583733","transcranial-direct-current-stimulation-in-children-with-autism-spectrum-disorder-100583733","NCT06880159","Transcranial Direct Current Stimulation in Children With Autism Spectrum Disorder","Effects of Transcranial Direct Current Stimulation (tDCS) for Enhancing Cognitive Function in Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n* being 8-12 years old\n* diagnosed with ASD given by registered psychiatrists or clinical psychologists according to the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) criteria of ASD\n* IQ score above 60\n* able to communicate in Chinese\n\nExclusion Criteria:\n\n* with severe motor dysfunctions\n* history of other neurological and psychiatric disorders or head trauma",{"count":559,"type":21},[208],"Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD).\n\nObjective: (1) To assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in children with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on children with ASD.\n\nMethods: To assess the therapeutic effects of tDCS, 90 adolescents with ASD (age 6-12 years) will be randomly assigned to active- (n=45), or sham- (n=45) tDCS groups. Twenty-minute sessions of tDCS stimulation to the left dorsolateral prefrontal cortex (DLPRC) will be provided on 10 consecutive weekdays, in conjunction with cognitive training exercises. Participants with a head circumference of less than 53 cm will receive 1.0 mA of stimulation, while those with a circumference of 53 cm or greater will receive 1.5 mA. EEG, fNIRS and neuropsychological tests will be administered before, immediately after, and 2 months after the series of tDCS sessions.\n\nHypothesis: The investigators hypothesize that children with ASD who are randomly assigned to receive a montage of prefrontal tDCS, with cathode (inhibitory) placed over left DLPFC and anode (excitatory) over right supraorbital region) will evidence greater improvement in executive function (primary outcome) than children with ASD who are randomly assigned to receive sham-tDCS.\n\nIn addition to testing the primary clinical outcome, stated above, in planned exploratory analyses, the investigators will also examine the effects of tDCS on secondary outcome measures of cognitive function, including information processing speed, working memory, inhibitory control, and cognitive flexibility; and conduct exploratory mediation analyses to better understand the potential neurophysiological factors underlying the therapeutic effects of tDCS. This will include E\u002FI ratio as exploratory mediator variables. As these secondary analyses are exploratory, the investigators will report them as such in presentations and published papers, and the investigators will not draw definitive conclusions from them. Rather, they will be used to better understand the potential impact of tDCS and the mechanisms underlying impact, and to inform future research.",[31,634,635],"Transcranial Direct Current Stimulation (tDCS)","Electroencephalography",{"date":637,"type":52},"2026-02-06",{"date":250,"type":52},{"date":640,"type":21},"2028-06",{"name":642,"class":59},"The Hong Kong Polytechnic University",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":16,"minAge":150,"maxAge":18,"enrollmentInfo":650,"targetDuration":4,"studyType":22,"phases":652,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":665,"locationsCount":60},"100623557","sleep-intervention-in-children-with-asd-100623557","NCT07398183","Sleep Intervention in Children With ASD","Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial","Inclusion Criteria:\n\n* (1) Parents\u002Fcaregivers with a child aged 6 to 12 years old, and attending a local mainstream primary school at the time of recruitment;\n* (2) The child is diagnosed to have ASD, which will be based on the assessment conducted by a psychiatrist or a clinical psychologist that incorporates the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) assessment criteria, with corroboration by the Autism Diagnostic Interview - Revised (ADI-R);\n* (3) The child is reported by the parent\u002Fcaregiver to have insomnia symptoms, typically a difficulty in falling asleep with or without bedtime resistance, which is operationally defined as sleep onset latency exceeding 25 minutes and occurring three or more times per week. The child's sleep problems have lasted for a minimum of three months and have led to an impairment in the daily functioning of the child and\u002For parents. Such inclusion criteria are based on the DSM-V criteria for insomnia, with the choice of a 25-minute sleep onset latency criteria based on the normative values reported by Scholle et al.;\n* (4) Parent owns and knows how to use smartphones and can comprehend Chinese language;\n* (5) The child's parent or guardian gives written informed consent of participation into the study;\n* (6) Being able to comply with the study protocol.\n\nExclusion Criteria:\n\n* (1) Children with diagnosed intellectual disability;\n* (2) Children with any diagnosed co-morbid neurological or medical conditions which could have affected their sleep, such as blindness, traumatic brain injury, epilepsy and poorly controlled eczema;\n* (3) Children with diagnosed sleep disorders other than insomnia or with suspected sleep apnoea (as assessed by the Children's Sleep Habits Questionnaire (CSHQ): obtaining a score of 4 or above on the sleep-disordered breathing subscale on the CSHQ) that may potentially contribute to a disruption in sleep continuity and quality. Children who are currently receiving regular melatonin treatment, as well as other medications such as Selective Serotonin Reuptake Inhibitors (SSRIs), will be considered for inclusion in the trial if they continue to meet the eligibility criteria.",{"count":651,"type":21},195,[208],"The goal of this randomised controlled trial is to examine the following research questions: 1) whether digitally delivered parent-based behavioural sleep intervention with or without personalised support is effective in improving sleep, clinical and daytime symptoms, and 2) whether such interventions can also improve parental sleep, mental health, and parenting stress in children with ASD and insomnia.",[655,31],"Insomnia",[657,188,30,658],"insomnia","behavioral sleep intervention","2026-02-02",{"date":661,"type":52},"2026-02-09",{"date":663,"type":52},"2025-01-01",{"date":494,"type":21},{"name":666,"class":59},"The University of Hong Kong",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":68,"sex":16,"minAge":18,"maxAge":673,"enrollmentInfo":674,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":676,"conditions":677,"keywords":678,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":684,"leadSponsor":686,"locationsCount":4},"100620638","internalized-symptoms-in-adolescents-with-autism-spectrum-disorder-asd-and-typically-developing-adolescents--gaining-insight-into-coping-strategies-and-the-psychological-processes-involved-100620638","NCT07360223","Internalized Symptoms in Adolescents With Autism Spectrum Disorder (ASD) and Typically Developing Adolescents : Gaining Insight Into Coping Strategies and the Psychological Processes Involved","Inclusion Criteria:\n\n* 12-17 years\n* speak french fluently\n\nExclusion Criteria:\n\n* Intellectual disability","17 Years",{"count":675,"type":21},252,"Introduction: Adolescents with autism spectrum disorder (ASD) have more mental health problems than typically developping adolescents (without ASD). Coping strategies are a key concern for adolescents with ASD in managing depressive and anxiety symptoms. Currently, few studies have examined the coping strategies used by adolescents with ASD. The methodological considerations underscore the need for an assessment method tailored to adolescents with ASD. Finally, although current data are still limited, the results suggest that there may be differences between the coping strategies used by adolescents with ASD and typically developing adolescents, thus calling for more in-depth comparative research.\n\nObjectives: This study aims to validate a coping strategies assessment method adapted for adolescents with ASD (1) and to examine coping strategies associated with internalizing symptoms (2)\n\nPopulation: 252 participants: 84 adolescents with ASD (1), 84 adolescents with autistic traits but no clinical diagnosis of ASD (2), and 84 typically developing adolescents (3). The age range is 12-17 years.\n\nStudy design: The study is divided into two parts: a cross-sectional part (T) and a longitudinal part (L).\n\n* The cross-sectional part will include three meetings spread over a period of approximately three months (approximately one meeting per month).\n* The longitudinal part will consist of a meeting scheduled one year after the last meeting of the cross-sectional part.",[31],[679],"ASD coping","2026-01-27",{"date":682,"type":52},"2026-01-29",{"date":336,"type":21},{"date":685,"type":21},"2031-12-31",{"name":687,"class":59},"Université Catholique de Louvain",{"id":689,"slug":690,"hasResults":12,"nctId":691,"briefTitle":692,"officialTitle":693,"acronym":694,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":16,"minAge":150,"maxAge":294,"enrollmentInfo":696,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":698,"conditions":699,"keywords":701,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":714,"locationsCount":60},"100621161","portable-sleep-monitors-in-children-with-autism-spectrum-disorder-100621161","NCT07367022","Portable Sleep Monitors in Children With Autism Spectrum Disorder","The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder","PrSM","Inclusion Criteria:\n\n1. Children between 6 to 18 years of age, AND;\n2. Children diagnosed with autism spectrum disorder, AND;\n3. Children who will be undergoing a polysomnogram (PSG) for the first time, AND;\n4. Caregiver willing to complete questionnaires about child's sleep and behavior\n\nExclusion Criteria:\n\n1. Children who are currently using respiratory therapy\n2. Children who have previously completed a PSG\n3. Caregiver unwilling to complete questionnaires about child's sleep and behavior",{"count":697,"type":21},20,"The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to:\n\n1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG);\n2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA);\n3. Evaluate patient and family preferences for sleep testing.",[31,700],"Obstructive Sleep Apnea (OSA)",[702,703,704,705,706,707],"Portable Sleep Monitor","Polysomnogram","Children with ASD","Nox T3s","Sleep Disordered Breathing","Sleep disorder","2026-01-16",{"date":710,"type":52},"2026-01-26",{"date":712,"type":52},"2025-08-12",{"date":313,"type":21},{"name":715,"class":59},"Lena Xiao"]