[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626446":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":40,"locations":49,"responsibleParty":81,"collaborators":84,"id":91,"slug":26,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":92,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleep Parent Treatment (SPT)","EXPERIMENTAL","Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks.",[13],"Behavioral: Sleep Parent Training (SPT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleep Parent Education (SPE)","ACTIVE_COMPARATOR","Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks.",[19],"Behavioral: Sleep Parent Education (SPE)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Sleep Parent Training (SPT)","Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occur to ensure implementation fidelity. A sleep plan for the child is developed with the parent and is revised, as needed, at each session.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments.",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Luc Lecavalier, PhD","Ohio State University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Cynthia R Johnson","Cleveland Clinic Center for Autism",{"name":39,"affiliation":5,"role":34},"Lawrence Scahill, MSN, PhD",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Cynthia Johnson, PhD","CONTACT","(216) 448-6440","johnsoc@ccf.org",{"name":32,"role":43,"phone":47,"phoneExt":26,"email":48},"(614) 685-8722","luc.lecavalier@osumc.edu",[50,63,73],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":26},"Emory School Of Medicine","RECRUITING","Atlanta","Georgia","30322","United States",{"type":58,"coordinates":59},"Point",[60,61],-84.38798,33.749,{"lat":61,"lon":60},{"facility":64,"status":52,"city":65,"state":66,"zip":67,"country":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":26},"Case Western Reserve University","Cleveland","Ohio","44106",{"type":58,"coordinates":69},[70,71],-81.69541,41.4995,{"lat":71,"lon":70},{"facility":33,"status":52,"city":74,"state":66,"zip":75,"country":56,"cosmosGeoPoint":76,"geoPoint":80,"contacts":26},"Columbus","43210",{"type":58,"coordinates":77},[78,79],-82.99879,39.96118,{"lat":79,"lon":78},{"type":34,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lawrence Scahill","Professor",[85,88,90],{"name":86,"class":87},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":89,"class":6},"The Cleveland Clinic",{"name":33,"class":6},"100626446",false,"NCT07435740","Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children","Inclusion Criteria:\n\n* Age \\>3 to 7 years 11 months\n* Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)\n* Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)\n* Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)\n* Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English\n\nExclusion Criteria:\n\n* Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)\n* Children with a psychiatric disorder or serious behavioral problem requiring a different treatment\n* Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)\n* Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English","ALL","3 Years","7 Years",{"count":100,"type":101},130,"ESTIMATED","INTERVENTIONAL",[104],"NA","This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.",[107],"Insomnia",[109],"autism","2026-06-16",{"date":112,"type":113},"2026-06-18","ACTUAL",{"date":115,"type":113},"2026-06-05",{"date":117,"type":101},"2031-01",{"name":5,"class":6},3]