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

NCT ID: NCT07007819

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2026-08-01

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).

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified Sleep and Circadian Intervention

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Child must have ≥ 1 poor sleep health dimensions (B-SATED).

3. Child is not currently participating in any sleep-related interventions.

4. Child has not had any medication changes within the past month that interfere with sleep.

5. If present, the child must have a treated OSA (mild or less) diagnosis and willingness to continue treatment (≥80% adherence).

6. Parent must be an adult legal guardian proficient in English.

Exclusion Criteria

1. Children with an untreated complex medical condition that interferes with sleep (e.g., epilepsy, nocturnal seizures).

2. Children with moderate to severe OSA.

3. Unable to complete protocol (e.g., serious behavioral concerns, bereavement, currently homeless).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Megan Wenzell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan L Wenzell, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

STUDY20240404

Identifier Type: -

Identifier Source: org_study_id