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

NCT07007819 | Enrolling By Invitation DMC

• 1 other identifier: STUDY20240404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sleep Disturbance; Autism Spectrum Disorder

Keywords

Sleep and Circadian Intervention; Autism Spectrum Disorder; Pediatrics; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)

  The improvement scale of Clinical Global Impression (CGI-I) Scale will be used to evaluate treatment-related improvement. The CGI-Improvement scale is rated by a clinician on a scale of 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse." The CGI-Improvement scale (Scores 1 "very much improved" or 2 "much improved") will be used to identify a positive response to treatment.

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

• Change in the Pediatric Autism Insomnia Rating Scale (PAIRS)

  The PAIRS is a parent rating of insomnia and sleep-related impairments over the past two weeks in children with ASD age 3 to 12 years. The PAIRS is a single-factor measure comprising 21 items that assess difficulties with falling and/or staying asleep, as well as the impact of sleep problems on the child and the family. Items are scored: 0 (mild = not present, not a problem) to 3 (severe = frequent and a major problem). Higher scores indicate greater severity.

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

Secondary Outcomes (6)

• Change in Child Sleep Dimensions Composite Score

  Baseline, Post-Intervention (Week 12)

• Change in Child Daytime Behavior

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

• Change in Child Health-Related Quality of Life

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

• Change in Parental Stress

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

• Change in Parental Sense of Competence

  Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

Study Arms (2)

Modified Sleep and Circadian Intervention

EXPERIMENTAL

Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.

Behavioral: Modified Sleep and Circadian Intervention

Enhanced Usual Care Control Condition

ACTIVE COMPARATOR

Up to 50 children will be randomly assigned (1:1) to the modified sleep and circadian intervention or enhanced usual care for 12 weeks.

Behavioral: Enhanced Usual Care

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.

Modified Sleep and Circadian Intervention

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.

Enhanced Usual Care Control Condition

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-12 years with a clinical diagnosis of ASD defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition and corroborated by the Social Communication Questionnaire-lifetime score of ≥ 15.
• Child must have ≥ 1 poor sleep health dimensions (B-SATED).
• Child is not currently participating in any sleep-related interventions.
• Child has not had any medication changes within the past month that interfere with sleep.
• If present, the child must have a treated OSA (mild or less) diagnosis and willingness to continue treatment (≥80% adherence).
• Parent must be an adult legal guardian proficient in English.

You may not qualify if:

• Children with an untreated complex medical condition that interferes with sleep (e.g., epilepsy, nocturnal seizures).
• Children with moderate to severe OSA.
• Unable to complete protocol (e.g., serious behavioral concerns, bereavement, currently homeless).

Sponsors & Collaborators

• Case Western Reserve University: lead
• American Academy of Sleep Medicine: collaborator
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Parasomnias; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Megan L Wenzell, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A trained researcher, masked to group assignment, will administer the primary outcome as an independent evaluator. Since this is a pilot study, the PI will deliver the intervention to allow for real-time adjustments and optimal quality control.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The sleep and circadian 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.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 6, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)