[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626446":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":40,"locations":49,"responsibleParty":82,"collaborators":85,"id":92,"slug":26,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":26,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"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",[50,64,74],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":26},"Emory School Of Medicine","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-84.38798,33.749,{"lat":62,"lon":61},{"facility":65,"status":52,"city":66,"state":67,"zip":68,"country":56,"countryCode":57,"cosmosGeoPoint":69,"geoPoint":73,"contacts":26},"Case Western Reserve University","Cleveland","Ohio","44106",{"type":59,"coordinates":70},[71,72],-81.69541,41.4995,{"lat":72,"lon":71},{"facility":33,"status":52,"city":75,"state":67,"zip":76,"country":56,"countryCode":57,"cosmosGeoPoint":77,"geoPoint":81,"contacts":26},"Columbus","43210",{"type":59,"coordinates":78},[79,80],-82.99879,39.96118,{"lat":80,"lon":79},{"type":34,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lawrence Scahill","Professor",[86,89,91],{"name":87,"class":88},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":90,"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":101,"type":102},130,"ESTIMATED","INTERVENTIONAL",[105],"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.",[108],"Insomnia",[110],"autism","2026-06-16",{"date":113,"type":114},"2026-06-18","ACTUAL",{"date":116,"type":114},"2026-06-05",{"date":118,"type":102},"2031-01",{"name":5,"class":6},3]