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

Launched by CASE WESTERN RESERVE UNIVERSITY · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a special program designed to help improve sleep for school-aged children with Autism Spectrum Disorder (ASD). Many children with ASD have trouble sleeping, which can lead to behavioral issues and stress for both the children and their parents. The study will involve up to 50 children aged 6 to 12 who have a diagnosis of ASD and are experiencing sleep problems. The goal is to see if a modified behavioral sleep intervention can help these children sleep better and improve their daytime behavior, quality of life, and reduce parental stress over a 12-week period.

To be eligible for the trial, children must have a confirmed diagnosis of ASD and show at least one issue with their sleep. They should not be part of any other sleep programs or have had recent medication changes that affect sleep. Parents must be the legal guardians and fluent in English. Throughout the study, families can expect to participate in activities aimed at improving various aspects of sleep, which researchers will measure to see how well the program works. The study is not yet recruiting participants, but it aims to provide valuable insights into helping children with ASD achieve better sleep.

Gender

ALL

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).