RecruitingInsomnia
Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
Eligible age
3–7 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Emory University
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's recruiting
Source: ClinicalTrials.gov · NCT07435740 · last updated 2026-06-18