[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,117,0,25,[9,50,79,113,142,168,195,214,294,333,362,388,418,446,473,491,511,529,555,581,607,628,650,684,714],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100629612","differences-in-rest-emotion-and-arousal-modulation-in-youth-100629612",false,"NCT07476937","Differences in Rest, Emotion, and Arousal Modulation in Youth","Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth","DREAMY-Autism","Inclusion Criteria:\n\n1. Youth between the ages of 6 and 10 years old\n2. Caregiver-reported autism diagnosis and \\>11 on Social Communication Questionnaire\n3. Caregiver-reported bedtime resistance (\\>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)\n4. Caregiver willing to participate in all bedtimes during study\n5. Stable medication use (e.g., no changes within 2 weeks)\n\nExclusion Criteria:\n\n1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).\n2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).\n3. Unstable medication use (dose or timing).\n4. Current behavioral treatment for sleep disorder","ALL","6 Years","10 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.",[29,30,31],"Autism","Sleep Disturbances in Children","Sleep",[33,34,35,31,36],"Sleep disturbances","Emotion Dysregulation","Sensory Processing","autism","RECRUITING","2026-06-30",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2026-06-01",{"date":45,"type":23},"2030-08",{"name":47,"class":48},"University of Pittsburgh","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100631414","improving-caregiver-engagement-in-early-interventions-100631414","NCT07500363","Improving Caregiver Engagement in Early Interventions","Improving Caregiver Engagement in Early Interventions for Autistic Children Using a Mobile Health Approach","Providers' eligibility criteria\n\n1. currently providing early intervention services, including a caregiver-coaching component\n2. having at least 1 child in the autism service classification on their caseload.\n\nCaregiver\u002FChild Dyads eligibility criteria\n\n1. child is 12-60 months of age at the time of enrollment\n2. child has a diagnosis or high likelihood of autism\n3. a family\u002Ffriend supporter of the caregiver is willing to be part of the study\n4. caregivers and supporters speak English","12 Months",{"count":59,"type":23},28,[26],"The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).",[29],[64,65,66,67,68],"Early Intervention","Caregiver Mediated Interventions","caregiver engagement","mobile health","social support","NOT_YET_RECRUITING","2026-06-26",{"date":72,"type":41},"2026-06-29",{"date":74,"type":23},"2026-07",{"date":76,"type":23},"2028-12",{"name":78,"class":48},"University of California, Davis",{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":4,"leadSponsor":110,"locationsCount":49},"100078073","the-neurodevelopmental-and-behavioral-phenotyping-screening-protocol-100078073","NCT00271622","The Neurodevelopmental and Behavioral Phenotyping Screening Protocol","Neurodevelopmental and Behavioral Phenotyping Screening Protocol","* INCLUSION CRITERIA:\n* Subjects must be at least 6 weeks of age.\n* Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents\u002Fguardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.\n* Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).\n\nEXCLUSION CRITERIA:\n\n-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians\u002Fcaretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.",true,"6 Weeks",{"count":89,"type":23},5000,"OBSERVATIONAL","The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.",[93,29,94,95],"Neurologic Disorders","Neurodegenerative Disease","Neurobehavioral Manifestation",[97,98,99,100,101,102,103,104],"Developmental Delay","Pediatric","Pervasive Developmental Disorder","Early Development","Healthy Control Subjects","Autism Spectrum Disorders","Healthy Volunteer","HV","2026-06-24",{"date":107,"type":41},"2026-06-25",{"date":109,"type":41},"2006-02-27",{"name":111,"class":112},"National Institute of Mental Health (NIMH)","NIH",{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":24,"phases":124,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":4},"100644755","a-two-part-intervention-to-target-cardiovascular-health-100644755","NCT07673172","A Two-Part Intervention to Target Cardiovascular Health","Autism Research Consortium on Physical Health: A Two-Part Intervention to Target Cardiovascular Health","Inclusion Criteria:\n\n* • Have a diagnosis of autism or be told by a healthcare provider that you have autism\n\n  * Be between the ages of 9 and 26\n  * Have a BMI greater than the 84th percentile\n  * English speaking\n\nExclusion Criteria:\n\n* • Children younger than 9 years of age\n\n  * Adults older than 26 years of age\n  * Individuals without a diagnosis of autism\n  * Individuals with a BMI less than the 84th percentile","9 Years","26 Years",{"count":123,"type":23},130,[26],"Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress.\n\nThis study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.",[29,127,128,129],"Adverse Childhood Experience","Stress","Cardiovascular (CV) Risk",[36,131,132,133],"adverse childhood experiences","stress","cardiovascular risk","2026-06-22",{"date":72,"type":41},{"date":137,"type":23},"2026-07-01",{"date":139,"type":23},"2028-08-31",{"name":141,"class":48},"University of California, Los Angeles",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":86,"sex":18,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":24,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":49},"100543965","modified-pivotal-response-treatment-for-insistence-on-sameness-in-autistic-youth-100543965","NCT06362733","Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth","M-PRT-IS","Participants will include children with:\n\n1. parent\u002Fguardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;\n2. diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);\n3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;\n4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;\n5. English-speaking parent and youth able to consistently participate in study procedures;\n6. family resides in United States.","4 Years","17 Years",{"count":152,"type":23},44,[26],"The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour\u002Fweek) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.",[156,157,29],"Autism Spectrum Disorder","Restricted Behavior",[159,160],"Intervention","Pivotal Response Treatment",{"date":107,"type":41},{"date":163,"type":41},"2024-07-11",{"date":165,"type":23},"2028-07-01",{"name":167,"class":48},"Stanford University",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":49},"100431550","trial-of-center-based-vs-in-home-pivotal-response-treatment-prt-in-autism-100431550","NCT04899544","Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","PRT-HvC","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;\n* Boys and girls between 2.0 and 5.11 years;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;\n* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;\n* Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;\n* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);\n* No more than 60 minutes of individual 1:1 speech therapy per week;\n* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Receiving ABA of 15 hours or more;\n* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);\n* Previous adequate Pivotal Response Treatment (PRT) trial;\n* Participants living more than 30 miles from Stanford University;\n* Child's primary language other than English.","2 Years","5 Years",{"count":179,"type":23},120,[26],"The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).",[29,156,183],"ASD",[185,186,187,188],"pivotal response treatment","PRT","center based","social and communication",{"date":105,"type":41},{"date":191,"type":41},"2022-10-18",{"date":193,"type":23},"2028-09-15",{"name":167,"class":48},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":19,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":203,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":49},"100352269","phase-2-a-study-of-esomeprazole-in-children-with-autism-100352269","NCT03866668","A Study of Esomeprazole in Children With Autism","An Open-Label Pilot Study of Esomeprazole in Children With Autism","Inclusion Criteria:\n\n* outpatients 2 to 6 years of age;\n* males and females who are physically healthy;\n* diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)\n* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;\n* ability of subject to swallow the compound;\n* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);\n* no planned changes in psychosocial interventions during the open-label trial.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;\n* prior adequate trial of Esomeprazole;\n* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).",{"count":7,"type":23},[204],"PHASE2","Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive\u002Fstereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.",[29,156],[208],"Esomeprazole",{"date":107,"type":41},{"date":211,"type":41},"2019-05-29",{"date":76,"type":23},{"name":167,"class":48},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":86,"sex":18,"minAge":150,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":270,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":49},"100641475","qaiax-aihealth4u---ai-public-health-central-microcity-a-re-quantum-ai-agency-aka-ai-city-hall-project-upsto-app-nos-64074526-64063557-63903181-63729428-100641475","NCT07661823","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428: A Quantum AI Public Health Agency That Provides Free Public Health Services to Registered and Sponsored Visitors\u002FOccupants for RDT&E Under 28 U.S. Code 1498 (Classified as a PPA Under 10 U.S. Code 129a)","QAIAx","Inclusion Criteria:\n\n* Individuals aged 17 to 99 years old.\n* Referral by a licensed health services professional (e.g., R.N., N.P., Ph.D., M.D.).\n* Referral by a non-profit organization (e.g., 501c3, university, church).\n* Referral by a public agency (e.g., case manager, social worker, parole\u002Fprobation\u002FPTS officer, judge).\n\nExclusion Criteria:\n\n\\* Individuals under 17 or over 99 years of age.","99 Years",{"count":224,"type":23},1000000,[26],"BRIEF SUMMARY\n\nA. \"What is the purpose of this study?\"\n\nThis study will test whether the \"AI City Hall Project\" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called \"Microcities\". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance.\n\nB. \"What conditions does the study focus on?\"\n\nThe study focuses on adults with:\n\n* Autism spectrum disorders (Asperger's, autism, ADHD, ASD)\n* Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA\u002Fecstasy, tobacco\u002Fnicotine)\n* Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders)\n* Behavioral addictions (gambling, sex addiction) and related issues (sex offence history).\n\nC. \"What does the study involve?\"\n\nEligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital \"attitude inoculation\" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic.\n\n\\*\\*Who can participate?\\*\\*\n\nYou may be able to join if you:\n\n* Are an adult (18 years or older)\n* Have a diagnosis of one of the listed mental-health or addiction disorders\n* Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole\u002Fprobation officer, judge)\n* Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses.\n\nParticipants who are veterans, receive public assistance (e.g., VA disability, SSDI\u002FSSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised.\n\n\\*\\*Where is the study taking place?\\*\\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones.\n\n\\*\\*Who is sponsoring the study?\\*\\* The study is sponsored by \\*\\*Veterans Recovery Network Inc.\\*\\*, a non-profit organization, in collaboration with \\*\\*AI-119 Vulcan Project Research \\& Educational Technology Co. (PRETCO)\\*\\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM).\n\nThis summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.",[228,229,230,29,231,232,183,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269],"Asperger's Disorder","Asperger Disorder","Autism Disorder","ADHD - Attention Deficit Disorder With Hyperactivity","ADHD","Alcohol Abuse\u002FDependence","Alcohol Addiction","Alcohol and Other Drug Use Disorders","Alcohol and Other Substance Use Prevention","Gambling Addiction","Gambling Disorder","Sex Abuse","Sex Behavior","Sex Crimes","Sex Disorder","Sex Disorders","Gender Dysphoria, Adult","Eating Behavior Disorders","Narcotic-Related Disorders","Narcotic Addiction","Narcissism","Psychiatric Disorder","Psychedelic Effects in Healthy Volunteers","Psychedelic Experiences","Psychedelic Drug Dependence","Marijuana Use Disorder","Marijuana Abuse and Dependence","Smoking (Tobacco) Addiction","Smoking Among Youth","Smoking Abstinence","Abstinence, Sex","Opiate Substitution Treatment","Opioid Abuse (Disorder)","Opioid Abuse and Addiction","Cocaine Abuse","MDMA ('Ecstasy')","Addiction Disorders","Homeless and Low Incomes People, Refugees","Homelessness","Reliability and Validity","Anger Problems","Child Abuse, Sexual",[271,272,273,274,275,276,277,278,279,280,281,282,283,284,285],"ai city hall project","ai 119","ai119","qaia","qaiax","ai wat","veterans recovery network","veterans","addiction disorder","vulcan","artificial intelligence","agi","military","sex addiction","mental health treatment","2026-06-16",{"date":134,"type":41},{"date":289,"type":23},"2026-08-01",{"date":291,"type":23},"2028-12-31",{"name":293,"class":48},"Veterans Recovery Network Inc.",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":300,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":24,"phases":304,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":49},"100616348","phase-1-adia-med-of-winter-park-llc-autism-spectrum-disorder-research-study-100616348","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","3 Years","12 Years",{"count":303,"type":23},100,[305,204],"PHASE1","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.",[156,29,183,308],"Autism Spectrum Disorder (ASD)",[310,311,312,313,314,315,316,29,156,183,317,318,319,320,321,322,323,324],"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",{"date":326,"type":41},"2026-06-17",{"date":328,"type":41},"2026-05-01",{"date":330,"type":23},"2028-06-15",{"name":332,"class":48},"Adia Med of Winter Park LLC",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":149,"maxAge":19,"enrollmentInfo":340,"targetDuration":4,"studyType":24,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":49},"100642616","cognitive-training-in-virtual-reality-for-autism-100642616","NCT07643649","Cognitive Training in Virtual Reality for Autism","Mind in Motion: Assessing the Efficacy of Virtual Reality Cognitive Training in Neurodivergent Children With Autism","Inclusion Criteria:\n\n* Diagnosis of Autism\n* QI \\> 70\n\nExclusion Criteria:\n\n* Severe neurological or sensory comorbidities",{"count":341,"type":23},30,[26],"The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory.\n\nThis randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ \\>70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches.\n\nIt is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.",[29,156],[36,346,347,348,349,350,351,156,352],"children","Virtual Reality Rehabilitation System","Cognitive Training","Executive Functions","Visual Attention","Visuo-Spatial Memory","Autism Spectrum Condition","2026-06-09",{"date":355,"type":41},"2026-06-11",{"date":357,"type":23},"2026-09-01",{"date":359,"type":23},"2027-03-31",{"name":361,"class":48},"Istituto per la Ricerca e l'Innovazione Biomedica",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":49},"100471516","early-diagnostic-response-model-edrm-100471516","NCT05419895","Early Diagnostic Response Model (EDRM)","Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts","Inclusion Criteria:\n\n* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.\n* Referring BCW provider must be one of the participating BCW health districts in this pilot study.\n* Parent\u002FGuardian needs to have basic English proficiency\n* Parent\u002FGuardian needs to have internet access\n* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).\n* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.\n* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.\n* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.","16 Months","36 Months",{"count":372,"type":23},300,[26],"Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.",[156,29],[29,64,377,378],"Telehealth","Assessment","2026-06-08",{"date":381,"type":41},"2026-06-10",{"date":383,"type":41},"2022-06-16",{"date":385,"type":23},"2028-07",{"name":387,"class":48},"Emory University",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":395,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":24,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100572462","meeting-the-needs-of-young-hispanic-autistic-children-100572462","NCT06733584","Meeting the Needs of Young Hispanic Autistic Children","Meeting the Needs of Young Hispanic Autistic Children: Developing a Culturally and Linguistically Sensitive Intervention to Alleviate Core Social Challenges","Inclusion Criteria:\n\n* Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of \\\u003C 320% of the federal poverty level, determined by their household size\n* Children must be between 18-42 months old at the start of the study\n* Children must have no other known neurological or genetic concerns or disorders determined by parent report\n* Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate\n* Families must have a primary home language of English and\u002For Spanish\n\nExclusion Criteria:\n\n* Children who are from a family that is not Hispanic and\u002For does not have an income-to-needs ratio of \\\u003C 320% of the federal poverty level, determined by their household size\n* Children younger than 18 months or older than 42 months at the start of the study\n* Children whose parents report they have any other known neurological or genetic concerns or disorders\n* Children who receive a Calibrated Severity Score (CSS) lower than 4 on the ADOS-2\n* Families who do not have English or Spanish as a primary home language","18 Months","42 Months",{"count":398,"type":23},200,[26],"Purpose of the Study: The goal of this clinical trial is to find out if a technique called the \"mutual gaze procedure\" used in a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income.\n\nWhat Will Happen: Researchers will compare two versions of CLR-Pathways.\n\n* Version 1: Includes mutual gaze strategies.\n* Version 2: Does not include mutual gaze strategies.\n\nWhat to Expect: Participants will:\n\n* Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours.\n* Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.",[29],[403,404,405,406,407],"Autism Intervention","Cultural and Linguistic Responsivity","Social development","Social communication","Hispanic","2026-06-04",{"date":410,"type":41},"2026-06-05",{"date":412,"type":41},"2025-09-22",{"date":414,"type":23},"2028-01",{"name":416,"class":48},"The University of Texas at Dallas",3,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":426,"maxAge":301,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":430,"conditions":431,"keywords":434,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":49},"100638999","regulating-together-for-intellectual-disability-and-autism-a-group-behavioral-therapy-for-for-emotion-dysregulation-100638999","NCT07624448","Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation","Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability","RT-ID","Child Participant Inclusion Criteria:\n\n* Males, females, or non-binary youth between 8 and 12 years of age\n* Confirmed diagnosis of Autism Spectrum Disorder (ASD)\n* Confirmed diagnosis of Intellectual Disability\n* Fluent in spoken English.\n* Use of flexible phrase speech or greater\n* Meeting clinically significant emotion dysregulation criteria\n* Willing to participate in twice weekly 90-minute sessions\n* Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable\n* Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant\n\nChild Participant Exclusion Criteria:\n\n* Initiation of new psychosocial intervention within 30 days prior to first day of treatment\n* Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.\n* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches\n* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss\n\nCaregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Lives and cares for their child with ASD+ID for \\> 50% of the year\n* Fluent in spoken English.\n* Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly\n\nCaregiver Exclusion Criteria:\n\n-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss","8 Years",{"count":428,"type":23},10,[26],"The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:\n\nTo adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.",[29,432,433],"Intellectual Disabilities With Other Behavioral Symptoms","Intellectual Disability",[29,435,436,437],"intellectual disability","emotion dysregulation","aggression","2026-06-03",{"date":410,"type":41},{"date":441,"type":23},"2026-10",{"date":443,"type":23},"2027-12",{"name":445,"class":48},"Children's Mercy Hospital Kansas City",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":86,"sex":18,"minAge":453,"maxAge":454,"enrollmentInfo":455,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":472},"100509669","screening-for-autism-in-9-month-olds-by-measuring-social-visual-engagement-100509669","NCT05916430","Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement","Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement","Inclusion Criteria:\n\n* Infants between the chronological ages of 8-10 months\n* Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision)\n* Participants' parents\u002Fcaregivers must be able to understand and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n\\- Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).","8 Months","10 Months",{"count":456,"type":23},2120,"The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.",[29,459],"Infant Development",[461,462,463,464,465,102],"Screening","well-baby visits","Social Development","Communicative Development","Development Disabilities","2026-06-02",{"date":408,"type":41},{"date":469,"type":41},"2023-02-02",{"date":443,"type":23},{"name":387,"class":48},2,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":300,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":24,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":472},"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":303,"type":23},[305],"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.",[156,29,183,308],[310,311,312,313,314,315,316,29,156,183,317,318,321,324,322],{"date":438,"type":41},{"date":43,"type":23},{"date":488,"type":23},"2027-06-30",{"name":490,"class":48},"Greater Atlanta Integrative Pediatrics",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":18,"minAge":498,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":24,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":49},"100640041","evaluating-a-workbook-to-promote-autistic-wellbeing-100640041","NCT07630376","Evaluating a Workbook to Promote Autistic Wellbeing","Evaluating the Use of a Guided Self-help Workbook to Promote Wellbeing for Autistic Adults: A Mixed-methods Multiple Single-case Study","Inclusion Criteria:\n\n* A pre-existing diagnosis of autism OR on a waiting list for autism assessment OR self-identified as autistic and scoring above cut-off on the autism quotient (AQ-50) screening questionnaire.\n* Aged 18 years or over and able to give informed consent to participate.\n* Under the care of a community-based mental health team in Kent and Medway Mental Health NHS Trust and not due for discharge during the study period.\n* Have already completed assessment processes (including risk assessment) during intake by the clinical team and a management plan is in place.\n* The named clinician assesses that the individual is in sufficiently stable condition to participate in the study, and is likely to remain engaged in the intervention.\n* Proficiency in reading and writing English.\n* If on medication for mental health, the dose is stable (minimum of 3 months) with no planned changes during the study.\n\nExclusion Criteria:\n\n* Presence of a moderate to severe learning disability that would limit independent engagement with self-help materials.\n* Engaged in another psychological therapy or psychologically-informed intervention, or due to begin another during the study.\n* Current acute mental health crisis or elevated risk to self\u002Fothers requiring intensive intervention (assessed via clinical team judgement).\n* Insufficient capacity to engage with the study protocol or complete measures (as determined by the care team).","18 Years",{"count":428,"type":23},[26],"The goal of this clinical trial is to examine the feasibility and acceptability of a brief guided self-help wellbeing intervention for autistic adults accessing UK secondary mental health services. The study also aims to begin to evaluate whether use of the workbook is associated with any changes in wellbeing. The main questions it aims to answer are:\n\n1. Is it feasible to recruit and retain autistic adults to participate in the study?\n2. Do participants find the workbook acceptable and relevant?\n3. Are there measurable improvements in wellbeing following workbook use?\n4. What changes, if any, do participants recommend for future versions of the intervention?\n\nParticipants will:\n\n* Take part in 4-6 sessions of 30-60 minutes using the guided self-help workbook with the support of a trained National Health Service support worker, assistant psychologist, or mental health professional\n* Complete wellbeing questionnaires before, during, and after using the workbook\n* Complete brief daily wellbeing ratings throughout the study\n* Take part in a 1:1 semi-structured interview of up to an hour to discuss their experience of the workbook",[29,503],"Wellbeing",{"date":410,"type":41},{"date":506,"type":23},"2026-06",{"date":508,"type":23},"2027-04",{"name":510,"class":48},"Canterbury Christ Church University",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":370,"enrollmentInfo":518,"targetDuration":4,"studyType":24,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":526,"leadSponsor":528,"locationsCount":49},"100639392","early-diagnostic-telehealth-pilot-for-moderate--and-high-risk-children-evaluating-assessment-protocols-and-efficiency-in-georgias-early-intervention-program-100639392","NCT07623759","Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program","Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program","Inclusion Criteria:\n\n* Child is enrolled in a participating BCW district.\n* Child is 16-36 months of age at the time of referral.\n* Child is identified as moderate- or high-risk on the M-CHAT-R\u002FF\n* BCW provider submits a referral to the EDRM-E pilot by 33 months of age.\n* Parent\u002Fguardian has basic English proficiency in order to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care.\n* Documentation of the M-CHAT-R\u002FF screening results and parental consent to refer is completed and submitted.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referred from non-onboarded BCW districts.\n* Child is older than 33 months at referral.\n* Non-English speaking families due to staffing and resource limitations as the consent, parent interview and child assessment would need to be done and accessible in other languages and are not available within this study scope at this time. .",{"count":303,"type":23},[26],"This pilot study includes children identified as moderate- as well as high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. The project will evaluate the feasibility, acceptability, and implementation of a diagnostic protocol, including optional measures, through measures of recruitment, retention, adherence, provider confidence, and time from referral to report completion. It will also examine which child diagnostic measures are essential and needed to improve psychologists' diagnostic confidence. Caregiver, early intervention provider, and clinician experiences and satisfaction before, during, and after assessment will be assessed to evaluate protocol acceptability, knowledge, and access to services. Outcomes will be analyzed using the RE-AIM Framework (reach, effectiveness, adoption, implementation, maintenance) and compared across BCW districts and child characteristics, including changes in autism screening, referral, and evaluation rates over time.",[156,29],[29,64],"2026-05-29",{"date":438,"type":41},{"date":506,"type":23},{"date":527,"type":23},"2027-06",{"name":387,"class":48},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":86,"sex":18,"minAge":536,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":24,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":49},"100570121","the-alama-project-autism-outcomes-and-neurobehavioral-markers-in-young-children-born-to-mothers-with-hiv-in-kenya-100570121","NCT06703125","The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya","Alama","Inclusion Criteria:\n\n* Children enrolled in the Tabiri study (R01HD104552)\n* CHEU or CHUU\n* Children ages 24-72 months\n* Caregivers of children must speak Kiswahili (local language) or English.\n\nExclusion Criteria:\n\n* There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.","24 Months","72 Months",{"count":539,"type":23},850,[26],"The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).",[29],[29,544,545],"HIV","Eye tracker","2026-05-21",{"date":548,"type":41},"2026-05-26",{"date":550,"type":41},"2025-02-11",{"date":552,"type":23},"2029-02-28",{"name":554,"class":48},"Indiana University",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":395,"maxAge":370,"enrollmentInfo":562,"targetDuration":4,"studyType":24,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":49},"100506887","reciprocal-imitation-training-and-musical-rhythm-sensitivity-in-autistic-toddlers-100506887","NCT05880225","Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers","Musical Rhythm Sensitivity to Scaffold Social Engagement in Autism Spectrum Disorder","Inclusion Criteria:\n\n* diagnosis of autism \u002F autism spectrum disorder\n* 18-36 months of age\n\nExclusion Criteria:\n\n* Major hearing or visual impairment (e.g., congenital nystagmus), seizure disorder, genetic syndromes, or gestational age \\\u003C=34 weeks.",{"count":563,"type":23},40,[26],"The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.",[29,156],[36,568,569,570,571],"imitation","social communication","rhythm","music","2026-05-18",{"date":574,"type":41},"2026-05-20",{"date":576,"type":41},"2023-07-03",{"date":578,"type":23},"2027-04-30",{"name":580,"class":48},"Vanderbilt University Medical Center",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":86,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":49},"100604341","evaluating-georgia-part-c-implementation-outcomes-100604341","NCT07148258","Evaluating Georgia Part C Implementation Outcomes","Inclusion Criteria for Providers:\n\n* Currently employed or contracted by Georgia's EI system\n* Maintain an active therapy caseload\n* Fluent in English.\n\nInclusion Criteria for Caregivers:\n\n* Have a child under 36 months currently enrolled in services through Georgia's Early Intervention system\n* Are being seen by a provider participating in Project ImPACT training and research\n* Fluent in English.\n\nExclusion Criteria for both Providers and Caregivers:\n\n* Not meeting the eligibility criteria.",{"count":588,"type":23},20,[26],"This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism?\n\nThe primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism intervention that is delivered as part of routine training within Georgia's EI system. Providers in the study will receive one of two Project ImPACT training models to help us understand which training model helps providers learn Project ImPACT better. Specifically, this study will examine the: 1) the process and quality by which Project ImPACT is implemented and adapted by EI providers across the two training conditions; 2) factors that impact how well Project ImPACT is implemented; and 3) the child (i.e., social communication) and family (i.e., parent empowerment and fidelity) outcomes associated with receiving Project ImPACT.",[592,29],"Communication Disorder, Childhood",[594,595,596,597,598],"Caregivers","Early Intervention (EI) Providers","Early Intervention System","Project ImPACT","Social communication delays","2026-05-15",{"date":601,"type":41},"2026-05-19",{"date":603,"type":41},"2025-09-03",{"date":605,"type":23},"2028-09",{"name":387,"class":48},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":86,"sex":18,"minAge":176,"maxAge":177,"enrollmentInfo":615,"targetDuration":4,"studyType":24,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":49},"100556306","online-pivotal-response-treatment-training-in-autism-spectrum-disorder-100556306","NCT06523387","Online Pivotal Response Treatment Training in Autism Spectrum Disorder","Randomized Controlled Trial of an Online Pivotal Response Treatment Training in Autism Spectrum Disorder","PRT-O","Inclusion Criteria:\n\n* 2:0 to 5:11 years at the time of consent,\n* diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),\n* with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),\n* an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,\n* stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,\n* stable treatment (ABA, Floortime, or other interventions), speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,\n* no more than 60 minutes of 1:1 speech therapy per week\n\nExclusion Criteria:\n\n* Children who have a primary language other than English\n* parent or child diagnosed with severe psychiatric disorder or unstable medical problem\n* previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline\n* Receiving more than 15 hours of in home 1:1 ABA per week\n* living within 100 miles of Stanford University.",{"count":152,"type":23},[26],"This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.",[156,29],[160,620,621],"Parent Training","Online Course",{"date":601,"type":41},{"date":624,"type":41},"2026-01-30",{"date":626,"type":23},"2028-12-30",{"name":167,"class":48},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":86,"sex":18,"minAge":498,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":24,"phases":637,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":49},"100636932","project-independence-100636932","NCT07572110","Project Independence","The Development and Evaluation of an Online, Caregiver-Directed Single Session Intervention for Building Independence in Daily Living Skills in Autistic Youth","Inclusion Criteria:\n\n* Any adult (age 18+) who is a parent, family member, or legal caregiver and is one of the main adults responsible for the daily care of an autistic youth in the targeted age range for at least half of the time.\n* Those that currently reside in the United States\n* Those that have a mobile device (e.g., laptop, tablet, smartphone) or desktop computer and internet access sufficient for the delivery of the study assessments and online intervention\n* Those who may or may not report current clinically significant psychopathological symptoms (e.g., anxiety, depression, parental stress).\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (i.e., infants, children, teenagers).",{"count":636,"type":23},70,[26],"This project aims to develop and test the feasibility, acceptability, and preliminary impact of a brief, online single-session intervention (SSI) for caregivers of autistic youth ages 10 to 14. The SSI, called Project Independence, is designed to give caregivers practical tools to support greater independence in daily living routines. To test the SSI, participants will be randomly assigned to either complete Project Independence or watch a time-matched, series of educational video with unrelated content.",[640,641,642,29],"Accommodation","Daily Activities","Independence","2026-05-14",{"date":601,"type":41},{"date":646,"type":41},"2026-05-08",{"date":443,"type":23},{"name":649,"class":48},"University of Miami",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":86,"sex":18,"minAge":176,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":49},"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.","11 Years",{"count":658,"type":23},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.",[29,156,308,661],"Neurodevelopmental Conditions",[156,29,663,661,664,665,666,667,668,669,670,671,672,673,674],"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":599,"type":41},{"date":678,"type":41},"2025-02-15",{"date":680,"type":23},"2026-12-01",{"name":682,"class":683},"Blinklab Limited","INDUSTRY",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":24,"phases":693,"briefSummary":694,"conditions":695,"keywords":699,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":706,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":49},"100625272","tf-cbt-for-autistic-youth-pilot-implementation---open-pilot-100625272","NCT07420478","TF-CBT for Autistic Youth Pilot Implementation - Open Pilot","Implementation Science-Guided Pilot Study of Trauma-Focused Cognitive Behavioral Therapy for Autistic Youth in Community Mental Health Settings","Inclusion Criteria for Therapists\n\n1. Employed as a clinician at a participating Community Mental Health Center (CMHC; publicly-funded mental health program) for at least 6 months.\n2. Trained in TF-CBT.\n3. Has an eligible autistic youth on current caseload (see below).\n\nInclusion Criteria for Child Participants\n\n1. Between 6 and 18 years old (up to 17 years, 11 months).\n2. Current medical diagnosis of autism.\n3. Has a non-offending caregiver who is able to participate in treatment (i.e., caregiver who is not the perpetrator of the abuse\u002Fother trauma).\n4. Initiated outpatient psychotherapy services from participating therapist within enrolled CMHC.\n5. A moderate level of trauma-related distress as measured by the Child and Adolescent Trauma Screen-2 (CATS-2).\n\nExclusion Criteria for Child Participants\n\n1\\. Does not present with trauma-related distress (score falls within the \"Normal\" range as measured by the Child and Adolescent Trauma Screen-2 Self- and Parent-Report).",{"count":692,"type":23},24,[26],"Compared to the general population, autistic youth are at increased risk for both exposure to potentially traumatic events and trauma-related symptoms following trauma exposure. Autistic people identify approaches to effectively addressing trauma as a top mental health research priority, yet providers in community settings often report inadequate training in trauma treatment. The purpose of this study is to conduct an open pilot to evaluate the feasibility and acceptability of an evidence-based intervention for youth affected by trauma, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), that has been modified for autistic youth served in Community Mental Health Centers.",[156,696,29,697,698],"PTSD and Trauma-related Symptoms","Trauma and Stressor Related Disorders","Mental Health Services",[29,700,701,702,703,704,705],"Trauma","PTSD","Mental health symptoms","TF-CBT","Implementation science","Trauma-Focused Cognitive Behavioral Therapy",{"date":707,"type":41},"2026-05-13",{"date":709,"type":41},"2026-05-05",{"date":711,"type":23},"2027-02-28",{"name":713,"class":48},"Dartmouth-Hitchcock Medical Center",{"id":715,"slug":716,"hasResults":12,"nctId":717,"briefTitle":718,"officialTitle":719,"acronym":720,"eligibilityCriteria":721,"healthyVolunteers":12,"sex":722,"minAge":498,"maxAge":723,"enrollmentInfo":724,"targetDuration":4,"studyType":24,"phases":726,"briefSummary":728,"conditions":729,"keywords":731,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":740,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":49},"100587940","early-phase-1-prednisone-in-adults-with-an-immune-mediated-subtype-of-autism-spectrum-disorder-100587940","NCT06934915","Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups Trial of Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder","PREDICT","Inclusion Criteria:\n\n1. 18 to 50 years of age (inclusive) and assigned male at birth.\n2. Diagnostic Statistical Manual of Mental Disorders (DSM), Fourth Edition, Text Revision (DSM-IV-TR) diagnosed autistic disorder, and DSM, Fifth Edition, Text Revision (DSM-5-TR) diagnosed autism spectrum disorder (ASD), level 2 or 3. A qualified (board-eligible or board-certified) psychiatrist or psychologist, with experience in diagnostic determinations of ASD, will make a final diagnostic determination based on clinical history, clinical observations, medical records, mental status exams, and screening measures.\n3. A Clinical Global Impression-Severity (CGI-S) rating ≥ 4 (\"Moderate\") at screening (and baseline).\n4. A non-verbal IQ in the range of moderate intellectual disability or higher (≥ 35), as measured by the non-verbal Abbreviated IQ (ABIQ) score of the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), or mental age of at least 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the Developmental Profile (DP-4) Parent\u002FCaregiver Interview form.\n5. Participation of a study partner who has consistent contact with the participant and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments.\n6. Participant reports ≥ 1 of the following:\n\n   * A diagnosed comorbid autoimmune disease (e.g., Crohn's disease, Graves' disease, Hashimoto's disease, psoriasis, rheumatoid arthritis, ulcerative colitis, type 1 diabetes mellitus, etc.).\n   * Current biomarker evidence of critical indicators of inflammation\u002Fautoimmunity, such as elevated levels of C-reactive protein (CRP) or abnormal value of antinuclear antibodies (ANA).\n   * A significant family history of autoimmunity, defined as having ≥ 1 first-degree relative or ≥ 2 second-degree relatives with autoimmune diseases. The Principal Investigator (PI) will make the final determination on this criterion.\n7. Any concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have been stable for at least 4 weeks prior to the screening visit and the participant\u002Fstudy partner intend to maintain a stable regimen throughout the trial.\n8. Participant can tolerate swallowing large capsules.\n9. Participant is willing and able, in the investigator's opinion, to comply with all study procedures.\n\nIndividuals must satisfy the following criteria to be enrolled as study partners:\n\n1. The study partner is fluent in English.\n2. The study partner is a caregiver or an individual who has consistent contact with the participant, knows the participant well, and is willing and able to attend visits, oversee the participant's compliance with the protocol and study medication, and report on the participant's status through study assessments. The PI will make the final determination on this criterion.\n\nExclusion Criteria:\n\n1. DSM-5-TR diagnosed ASD, level 1, or presence of another DSM-IV-TR diagnosed pervasive developmental disorder, such as Asperger's disorder, childhood disintegrative disorder, Rett syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). A qualified psychiatrist or psychologist will make a diagnostic determination after reviewing clinical history, clinical observations, medical records, mental status exams, and screening measures.\n2. A CGI-S rating \\\u003C 4 at screening (or baseline).\n3. A non-verbal IQ in the range of severe or profound intellectual disability (\\\u003C 35), as measured by the non-verbal ABIQ score of the SB-5, or mental age below 18 months, as measured by the Cognitive and Adaptive Behavior subscales of the DP-4 Parent\u002FCaregiver Interview form. Individuals testing below 18 months may be enrolled after a case review by the PI and study psychologist, especially if testing scores were likely underestimated due to uncooperative behavior.\n4. Previous documentation of a prolonged electroencephalogram (EEG) suggestive of Landau-Kleffner syndrome or continuous spike and wave during sleep (CSWS) syndrome.\n5. Presence of a defined genetic disorder, such as Angelman syndrome, Fragile X syndrome, Noonan syndrome, Tuberous sclerosis, Williams syndrome, or any documented chromosomal or genetic abnormality with proven clinical significance in the etiology of ASD.\n6. Documented significant pre- or post-natal central nervous system insult, such as an in-utero cerebral vascular accident, that is believed to have significantly contributed to the development of the individual's ASD.\n7. Mitochondrial disorder verified by skin and\u002For muscle biopsy.\n8. History of bipolar disorder or psychotic disorder, including major depressive disorder with psychotic features, schizoaffective disorder, or schizophrenia. History of a significant and interfering comorbid major psychiatric disorder, including obsessive-compulsive disorder, post-traumatic stress disorder, or substance use disorder requiring \\> 1 psychiatric hospitalization for treatment of specific comorbid psychiatric disorders above and beyond target symptoms associated with ASD, such as aggression, irritability, self-injury, property destruction, mood swings, or severe tantrums. Minor psychiatric disorders, such as adjustment disorder, attention-deficit hyperactivity disorder, generalized anxiety disorder, major depressive disorder, persistent depressive disorder, or social anxiety disorder, may not exclude participation. The PI will make the final determination on this exclusion criterion.\n9. Concomitant medications or interventions for ASD-related symptoms (e.g., alpha-2 agonists, anticonvulsants, antidepressants, antipsychotics, anxiolytics, gastrointestinal medications, medications for sleep disorders, probiotics, stimulants, behavioral therapies, psychosocial interventions, speech therapy, etc.) have not been stable for at least 4 weeks prior to the screening visit.\n10. An active bacterial, fungal, helminthic, protozoan, or viral infection that could be exacerbated by a course of prednisone, as determined by the PI.\n11. Significant medical findings from history, physical examination, or laboratory testing that may be incompatible with prednisone use (e.g., participants with chronic infectious conditions or unstable diabetes mellitus).\n12. Individuals with a history of seizures being treated with an anticonvulsant may be eligible if seizure-free for at least 6 months and the anticonvulsant dose has been stable for at least 4 weeks prior to the screening visit.\n13. Use of immunosuppressive agents within the 6 months prior to the screening visit or concurrent use of immunosuppressive agents that, in the judgment of the PI, would interfere with study outcomes or pose unreasonable risk with prednisone administration.\n14. A known hypersensitivity to prednisone or any other component of the study product.\n15. The participant is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.\n\nIndividuals may be excluded from enrollment as study partners if either of the following criteria are met:\n\n1. The study partner is not fluent in English.\n2. The study partner is deemed unsuitable for any reason by the PI, including an inability to complete or comply with study requirements.","MALE","50 Years",{"count":725,"type":23},32,[727],"EARLY_PHASE1","The goal of this clinical trial is to learn how prednisone affects adults with autism spectrum disorder (ASD). It will also learn about the safety of prednisone. The main questions it aims to answer are:\n\n* How does prednisone affect the core features and associated target symptoms of ASD in adults with an immune-mediated subtype of ASD?\n* Is prednisone safe for autistic adults without causing too many side effects?\n* Does this study warrant larger trials studying anti-inflammatory drugs in this subject population?\n\nResearchers will compare the drug prednisone to a placebo (a look-alike substance that contains no drug) to see how prednisone affects autistic adult males.\n\nParticipants will:\n\n* Visit the clinic 2 times for a screening and baseline visit.\n* Take prednisone or a placebo every day for 16 weeks.\n* Visit the clinic 2 times for checkups, tests, questionnaires, and dose changes, and 1 time for a follow-up visit 4 weeks after stopping the study drug.\n* Provide blood and urine samples for testing up to 4 times.\n* Complete 8 remote calls every 1-2 weeks for checkups and dose changes.\n* Keep a diary of the dose and times they take the study drug every day and any symptoms or side effects they experience.",[156,102,730,29],"Autistic Disorder",[156,730,29,732,733,734,735,736,737,738,739],"Autoimmunity","Autoimmune Disorders","Inflammation","Neuroinflammation","Anti-Inflammatory Agents","Corticosteroids","Glucocorticoids","Prednisone",{"date":741,"type":41},"2026-05-12",{"date":743,"type":23},"2026-11",{"date":745,"type":23},"2029-02",{"name":747,"class":48},"Christopher John McDougle, M.D."]