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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07007819
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified Sleep and Circadian Intervention — BEHAVIORAL
    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.
  • Enhanced Usual Care — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Aug 27, 2025
Status verified
Dec 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Modified Sleep and Circadian Intervention
    Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.
  • Active Comparator: Enhanced Usual Care Control Condition
    Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.

Primary Outcome Measure

The Improvement Scale of the Clinical Global Impressions Scale (CGI-I) [ Time Frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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