Parent-led sleep program for insomnia in young autistic children
Official title: Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Run by The Cleveland Clinic · NCT07435740 · Data updated 2026-11-12
This trial tests whether a parent-delivered Sleep Parent Treatment (SPT) helps improve sleep for autistic kids aged 3 to almost 8 years, compared with Sleep Parent Education (SPE), over 10 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 7 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Cleveland, Ohio and 2 other locations) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | January 2031 |
| Study ends | January 2031 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07435740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 years to 7 years 11 months with a clinical ASD diagnosis, significant insomnia symptoms, and fluent in English.
✕Probably not a fit
Children with serious medical conditions, other sleep disorders, or concurrent psychiatric issues may be less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, telehealth trial compares two parent-mediated behavioral approaches for insomnia in children with autism aged 3 years to 7 years 11 months. Families are assigned to SPT or SPE for a 10-week period to see if the structured parent-led program improves sleep initiation and maintenance. Insomnia in autistic children is common and can affect daytime behavior, learning, and caregiver stress, making effective home-based strategies important. The study builds on prior telehealth work suggesting that parent-directed treatments can be beneficial. Outcomes focus on sleep parameters and caregiver impact, using validated parent-reported measures and clinical ratings.
Why it matters
Potential benefit: If successful, the intervention could provide a practical, home-based approach to reduce insomnia symptoms and improve daytime functioning for autistic children and relief for families.
How similar studies have gone: Past telehealth trials found that parent-mediated approaches can help, with some evidence favoring structured programs like SPT.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Cleveland Clinic Children's Center for Autism
Cleveland, Ohio, United States Recruiting -
Case Western Reserve University
Cleveland, Ohio, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Luc Lecavalier, PhD — Ohio State University
- Study coordinator: Cynthia Johnson, PhD
- Email: johnsoc@ccf.org
- Phone: (216) 448-6440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.