Clinical Trial

Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder

Enrolling by Invitation
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Record status
This record was last updated December 22, 2025 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Therefore, multiple sleep dimensions (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration) are appropriate therapeutic targets to improve daytime behavioral functioning and other psychosocial outcomes. The primary objective is to evaluate the implementation of a modification of a behavioral sleep and circadian intervention to improve multiple sleep dimension in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted to assess the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention with up to 50 school-age children with ASD, to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy. This modified intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-28; most recent amendment 2025-12-18.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-09-03
Trial Details
NCT Number NCT07007819
Lead Sponsor Case Western Reserve University
Collaborators: American Academy of Sleep Medicine, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), University Hospitals Cleveland Medical Center
Conditions Sleep Disturbance, Autism Spectrum Disorder
Enrollment 50 participants
Start Date 2025-08-27
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-22