NCT07007819

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Study Overview: The overall goals are to adapt and evaluate the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention for school-age children with autism spectrum disorder (ASD). Initial modifications were based on individual qualitative interviews with parents and feedback from a community advisory board to revise the existing intervention. A qualitative descriptive approach guided the modification of the intervention's content, format, delivery, and identification of barriers and facilitators. End-user feedback and debriefing were conducted with parents who participated in the qualitative interviews. The final phase of the study involves conducting a randomized pilot study to assess the feasibility, acceptability, and preliminary efficacy of this intervention prototype. Our primary objective is to evaluate the implementation of a modified sleep and circadian intervention to improve multiple sleep dimensions in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted with up to 50 school-age children with ASD to assess the feasibility, acceptability, and preliminary efficacy of the intervention. The study aims 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. 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). Study Design: A two-arm, RCT will be used to evaluate the preliminary efficacy, feasibility, and acceptability of the modified behavioral sleep intervention compared to a time-balanced attention control condition (enhanced usual care). Data collection will include T0 baseline measures (parent ratings and 7 nights of actigraphy sleep monitoring). After completing the baseline measures, participants will be allocated to either the experimental condition or the enhanced usual care control condition. T1 will include immediate post-intervention measures at 3 months (parent ratings and 7 nights of actigraphy sleep monitoring). T2 will include repeating measures at 6 months post-intervention (parent ratings only).

Conditions

• Sleep Disturbance
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Modified Sleep and Circadian Intervention	The modified sleep and circadian intervention has 5 individual sessions that will be delivered via Zoom to parents over 12 weeks and consists of 4 cross-cutting modules (functional analysis, goal setting, motivational interviewing, sleep education), 5 core sessions, and 7 optional modules that are delivered based on personalized treatment goals. The intervention format is as follows: (1) 60-minute session with consultation on setting goals and developing an action plan to improve sleep timing, quantity, and regularity; (2) 5-minute weekly follow-ups and a 3-night sleep diary; and (3) four 30-45-minute booster sessions every 3 weeks. Child attendance is optional.
BEHAVIORAL	Enhanced Usual Care	Enhanced Usual Care (EUC) is an active comparison treatment balanced for time and attention. Participants will be asked to maintain their typical sleep schedules. EUC sessions will review the interrelationships between stress, diet, health, exercise, and behavior, with a sleep education portion \< 10 minutes and no encouragement to change behavior. EUC sessions will be used to establish rapport and promote study retention. EUC participants will not complete weekly sleep diaries. At the end of Week 12, EUC participants will receive a 1-hour optional Zoom session with the PI on sleep education.

Timeline

• Start date: 2025-08-27
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-06-06
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States