Sleep Program for School-Aged Children With Autism and Sleep Problems
Tests a modified behavioral sleep program for children with autism and sleep problems.
Plain-language title generated from the registry record
Registry title: Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder
Key facts
- Where
- Cleveland, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 12 years old?
Source: NCT07007819, who can take part
Where in United States
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Case Western Reserve University
- Trial code
- NCT07007819
- Record updated
- 1 September 2026
- Original description
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.Read full original descriptionShow less
Community-Engaged Behavioral Sleep and Circadian Intervention for School-Aged Children With Autism Spectrum Disorder
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).
Inclusion: 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.
Exclusion: 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).