NCT07435740Recruiting
Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 5 Jun 2026
- Primary completion date
- Jan 2031
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Autism
- NCT number
- NCT07435740
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 5 Jun 2026 to the primary completion date, Jan 2031
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Children's Center for Autism Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.