Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Recruiting now · Not applicable
Conditions studied: Insomnia
In brief
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.
Key facts
- Study ID
- NCT07435740
- Run by
- Emory University
- People needed
- 130
- Starts
- 2026-06-05
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Emory School Of Medicine — Atlanta, Georgia, United States (enrolling)
- Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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