Online sleep program for parents of young autistic children with insomnia
Tests two parent-led sleep programs delivered online for young autistic children with insomnia.
Plain-language title generated from the registry record
Registry title: Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Key facts
- Where
- Cleveland and Columbus, United StatesSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 7 years old?
Source: NCT07435740, who can take part
Where in United States
- Case Western Reserve UniversityCleveland, United StatesTaking people
- Cleveland Clinic Children's Center for AutismCleveland, United StatesTaking people
- Ohio State UniversityColumbus, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Cleveland Clinic
- Trial code
- NCT07435740
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
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.
Inclusion: Age >3 to 7 years 11 months; Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R); 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); 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); Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English.
Exclusion: 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); Children with a psychiatric disorder or serious behavioral problem requiring a different treatment; 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); 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.