Clinical trial NCT07007819: Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder
Official title: Community-Engaged Behavioral Sleep and Circadian Intervention for School-Aged Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavioral Sleep and Circadian Intervention
Sleep Disturbance
Autism Spectrum Disorder
Keywords: Sleep and Circadian Intervention
Autism Spectrum Disorder
Pediatrics
Sleep Disturbance
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
name: University Hospitals Cleveland Medical Center
First posted: 2025-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).

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).

Primary outcomes:
measure: The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
measure: Change in the Pediatric Autism Insomnia Rating Scale (PAIRS)
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Secondary outcomes:
measure: Change in Child Sleep Dimensions Composite Score
timeFrame: Baseline, Post-Intervention (Week 12)
measure: Change in Child Daytime Behavior
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
measure: Change in Child Health-Related Quality of Life
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
measure: Change in Parental Stress
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
measure: Change in Parental Sense of Competence
timeFrame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
measure: Change in Parental Sleep Quality
timeFrame: Baseline and Post-Intervention (Week 12)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Megan L Wenzell, PhD
role: PRINCIPAL_INVESTIGATOR
References: