Clinical Trial

Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Recruiting
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Summary
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-19
notable Enrollment reduced: 180 -> 130 participants 2026-05-15
Trial Details
NCT Number NCT07435740
Lead Sponsor Emory University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Cleveland Clinic, Ohio State University
Conditions Insomnia
Enrollment 130 participants
Start Date 2026-06-05
Primary Completion 2031-01 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-18