[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-in-children":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,83,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100643483","phase-2-clinical-trial-evaluating-the-effects-of-ganaxolone-in-children-with-autism-100643483",false,"NCT07635862","Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism","A Randomized Controlled Trial of Ganaxolone for Children With Autism Spectrum Disorder","Inclusion Criteria:\n\n1. children between the ages of 5 years and 17 years old at enrollment\n2. diagnosis of autism spectrum disorder based on DSM-5 criteria and confirmed with the Autism Diagnostic Inventory - Revised (ADI-R) and Autism Diagnostic Observation Schedule 2nd edition (ADOS-2), or Childhood Autism Rating Scales (CARS)\n3. medical stability based on clinical interview\n4. stable medication regimens (2 weeks, with the exception of fluoxetine for 4 weeks)\n5. stable psychosocial therapies (4 weeks) prior to randomization and no plans to change treatments or intensity during the trial\n6. high rates of irritability defined as the Aberrant Behavior Checklist irritability subscale score \\> 18\n7. for participants who are sexually active, use of an effective contraceptive (e.g., birth control medications for female participants and condoms for male participants) and no plans for pregnancy throughout the trial\n8. for females, negative urine pregnancy test at baseline\n9. no planned changes in school placement\n10. for participants living within 150 miles of Stanford University, have the ability to attend site visits and attempt EEG and MRI procedures before and after the trial\n11. availability of a reliable informant who interacts with the participant regularly and can reliably complete assessments in English regarding their behaviors throughout the trial\n12. ability to participate in the testing administered in English to the extent that valid standard scores and biological samples can be obtained.\n\nExclusion Criteria:\n\n1. any unstable medical condition, such as unstable seizure disorder or heart disease\n2. any lifetime diagnosis of severe psychiatric (e.g., schizophrenia) or neurodegenerative conditions\n3. concomitant use of any neuroactive steroids or corticosteroids.\n4. history of substance abuse or active\u002Fplanned use of alcohol, opioids, or cannabinoids\n5. recent history or current suicidal ideation assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS) and by clinical interview with the study physician\n6. pregnancy and mothers who are breastfeeding\n7. prior participation in any clinical trial in the 30 days prior to study entry\n8. known intolerance or hypersensitivity to ganaxolone or similar analogs\n9. Concomitant use of medications that are inducers of CYP450 3A4\u002F5, such as rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's wort","ALL","5 Years","17 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberrant Behavior Checklist (ABC) because it is a common symptom of emotion dysregulation in ASD that impacts quality of life, including mental health, independence, educational opportunities, and integration into the community. The secondary domains of interest for this trial are restricted and repetitive behaviors (RRB), specifically insistence on sameness (IS), a subdomain of RRB characterized by inflexibility and a strong preference for predictable routines and familiar environments. Secondary outcome measures include the IS subscale from the Dimensional Assessment of Repetitive Behaviors (DARB) and subscales of the Clinical Global Impressions Scale for irritability (CGI-IR) and IS (CGI-IS). For participants living within 150 miles of Stanford University, we require participants to attend site visits and attempt EEG and MRI procedures before and after the trial, though we are recruiting nationally and the study can be completed without site vists.",[27,28,29],"Autism in Children","Autistic Disorder in Children and Adolescents","Autism Spectrum Disorder",[31,32,33,34,35,36,37,38],"Autism","Ganaxolone","Autism disorder in children and adolescents","Ztalmy","GABA","Insistance on Sameness","Emotional Regulation Difficulties","Irritability","NOT_YET_RECRUITING","2026-06-03",{"date":42,"type":43},"2026-06-09","ACTUAL",{"date":45,"type":21},"2027-01-01",{"date":47,"type":21},"2030-01-01",{"name":49,"class":50},"Stanford University","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":16,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":51},"100631236","cft-guided-self-help-intervention-parents-of-autistic-children-100631236","NCT07498049","CFT Guided Self-help Intervention: Parents of Autistic Children","Testing a Compassion-focused Guided Self-help Intervention for Parents of Autistic Children - Single Case Series Design","CFT-GSH-PAC","Inclusion Criteria:\n\n* Participants must be a parent who lives with their autistic child. The parent must be aged 18 years and above and their child must be aged between 6 and 17 years old. The parent participant must have good use of the English language to provide informed consent, access the workbook material, listen to the audio tracks, engage verbally in the support telephone calls and change interviews and complete outcome measures. The child must have a formal diagnosis of autism spectrum disorder as confirmed following assessment by a doctor or practitioner psychologist. Participants must be technology-literate and have access to technology to access video calls for screening and check-in calls as needed.\n\nExclusion Criteria:\n\n* Those who are currently receiving psychological or mental health input from professionals, those experiencing thoughts related to self-harm and\u002For suicide and those who are dependent on alcohol or drugs, those with a learning disability or other cognitive impairment will be excluded from this research.",true,"18 Years",{"count":63,"type":21},8,[65],"NA","This research will aim to test how practical, achievable and effective a brief, guided, self-help compassion focused intervention is for parents of autistic children aged 6-17 years old.\n\nThe demands of parenting can be rewarding but also challenging, and it is known that parents of autistic children experience additional pressures. As a result of this, parents of autistic children may be more likely to experience increased stress, anxiety, low mood and lower quality of life, compared to those parenting children who are not autistic.\n\nThere has been only a small amount of research so far regarding whether interventions that focus on building compassion, would be beneficial to parents of autistic children. The purpose of this study is to test whether a short, self-guided compassion-focused intervention is practical, achievable and effective for parents of autistic children. The intervention is based on Compassion Focused Therapy (CFT) and involves reading workbook material and listening to audio tracks. There will also be some questionnaires to complete and 30-minute weekly support calls with the lead researcher.\n\nThis intervention was adapted previously, from an intervention for parents in general, to be more suitable and focused on the needs of parents of autistic children. This study will be the first time the adapted intervention has been used by parents.\n\nThe intervention will be tested by 6-8 parents and will be about 13 weeks long. We will collect some demographic data at the start of the study, and there will be the opportunity to complete an evaluation questionnaire.",[68,31,69,29,27,70,71,72,73],"Autism Disorders and Maternal Stress","Autism Disorder","Parent","Parent Mental Health","Parent Stress","Parent Support","2026-03-23",{"date":76,"type":43},"2026-03-27",{"date":78,"type":21},"2026-04",{"date":80,"type":21},"2027-09",{"name":82,"class":50},"University of Nottingham",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":60,"sex":16,"minAge":4,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":104,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":51},"100618256","investigating-phenotypic-epigenetic-and-neurogenetic-traits-in-rare-and-ultra-rare-neurodevelopmental-disorders-project-penguin-100618256","NCT07329257","Investigating Phenotypic, Epigenetic, and NeuroGenetic Traits in Rare and Ultra-rare Neurodevelopmental Disorders (Project PENGUIN)","Investigating Phenotypic, Epigenetic, and NeuroGenetic Traits in Rare and Ultra-rare Neurodevelopmental Disorders","For those with a rare condition:\n\nInclusion Criteria:\n\n* Diagnosed or suspected neurogenetic disorder\n* Individuals 0-99\n\nExclusion Criteria:\n\n* Individuals unwilling or unable to complete visits with the study team.\n\nFor control parents\u002Fcaregivers of those with a rare condition:\n\nInclusion Criteria:\n\n* No history of a neurological disorder.\n* \\>18 years.\n* Legal caregiver of the patient diagnosed with a rare neurodevelopmental disorder.\n\nExclusion Criteria:\n\n* Individuals unwilling or unable to complete the visit with the study team.\n* Individuals who have a history of neurological disorders.\n* \\\u003C 18 years old\n\nFor all individuals who participate in the skin biopsy:\n\n* Individuals with disease that is known to be associated with poor wound healing.\n* Individuals with a history of allergic reaction to lidocaine.\n* Medical History of cellulitis, diabetes mellitus, poor extremity circulation, deep vein thrombosis, or a history of non-traumatic amputation.\n* Currently taking anticoagulation or have taken with last 6 months","99 Years",{"count":92,"type":21},100,"OBSERVATIONAL","Rare genetic neurodevelopmental disorders, such as Syt-1 or Baker Gordon Syndrome (BAGOS) arise from mutations in genes essential for brain development and function, often disrupting neurotransmission and neuronal connectivity. These conditions present with a wide range of symptoms including developmental delays, seizures, motor and behavioral challenges, and vary widely in severity. These disorders are complex, and they remain poorly understood and lack effective treatments.\n\nNatural history and clinical genetic studies are crucial for mapping how these disorders progress, improving diagnostic accuracy, and guiding therapy development. A major focus is identifying reliable biomarkers (genetic, imaging, and physiological) to track disease severity and support clinical trials. This study will securely collect and analyze data to better understand disease impact, develop patient-derived model systems, and build resources to support future treatments.",[96,97,98,99,100,101,102,27,103],"Baker Gordon Syndrome","Rare Neurodevelopmental Conditions","Rare Neurogenetic Conditions","Syt-1 Disorder","Epilepsy","Seizure","Genetic Mutations","Developmental Delay (Disorder)",[96,105,106,107,108,109,110,111,31],"BAGOS","Rare Conditions","Rare","Neurogenetic","Neurodevelopmental","Ultra-rare","Genetic mutation","RECRUITING","2025-12-28",{"date":115,"type":43},"2026-01-09",{"date":117,"type":43},"2025-12-04",{"date":119,"type":21},"2028-12",{"name":121,"class":50},"University of Missouri-Columbia",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100574742","abdominal-transcutaneous-electrical-acupoint-stimulation-on-children-with-autism-spectrum-disorder-100574742","NCT06763237","Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder","Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder: A Randomized Clinical Trial","TEAS\u002FASD","Inclusion Criteria:\n\n* Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)\n* Aged 3 to 6 years\n\nExclusion Criteria:\n\n* Diagnosed with other organic diseases (such as severe hearing and visual impairment, brain trauma) and neurological disease (e.g., epilepsy, Rett syndrome), or psychiatric disorder (schizophrenia, bipolar affective disorder, etc)\n* Oral or injected antibiotics within 30 days before screening\n* History of acupuncture, electroacupuncture, TEAS treatment before screening\n* Taking antipsychotic drugs and psychobiotic supplements within 30 days before screening","3 Years","6 Years",{"count":133,"type":21},42,[65],"The goal of this clinical trial is to learn if abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) works to treat autism spectrum disorder (ASD) in children. It will also learn about the safety of abdominal TEAS. The main questions it aims to answer are:\n\nDoes abdominal TEAS a safe and effective treatment for children with autism spectrum disorder and gastrointestinal symptoms? Researchers will compare abdominal TEAS to a placebo (a sham abdominal TEAS without stimulation) to see if abdominal TEAS works to treat ASD.\n\nParticipants will:\n\nTake abdominal TEAS or sham abdominal TEAS 5 days a week for 8 weeks. Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms.",[29,27],[138,139,140,141],"Transcutaneous electrical acupoint stimulation","Gastrointestinal symptoms","Children","Autism spectrum disorder","2025-01-02",{"date":144,"type":43},"2025-01-08",{"date":146,"type":21},"2025-01-10",{"date":148,"type":21},"2026-01-10",{"name":150,"class":50},"First Affiliated Hospital Xi'an Jiaotong University",2]