An interventional study of Modified Sleep and Circadian Intervention and Enhanced Usual Care in Sleep Disturbance and Autism Spectrum Disorder, sponsored by Case Western Reserve University. Enrolling by invitation at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Supportive care
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).
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).
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 (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.
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.
Time frame: 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.
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Child Sleep Dimensions Composite Score
Behaviors, Satisfaction, Alertness, Timing, Efficiency, Duration (B-SATED) sleep dimensions is a composite score that will be measured by the Modified Children's Sleep Habits Questionnaire (M-CSHQ), sleep diaries, and/or actigraphy \[Poor sleep dimensions = Behaviors-M-CSHQ and sleep diary items related to bedtime routine consistency, sleep onset associations, co-sleeping, caffeine intake, and bedtime media use-endorsement of any of these items indicates poor sleep behaviors; Satisfaction-M-CSHQ total ≥ 33; Alertness/Sleepiness-M-CSHQ alertness score ≥ 10; Timing/Regularity-variability in bed/waketimes ≥ 1 hour; sleep Efficiency \< 85%; sleep Duration \< 9 hours per 24-hour period\]. One overall score is derived from the six dimensions. Each dimension will be dichotomized as "1=good" or "0=poor" with scores ranging from 0-6, with a higher score indicating better sleep. Cutoffs are based on pediatric sleep recommendations.
Time frame: Baseline, Post-Intervention (Week 12)
Change in Child Daytime Behavior
The Aberrant Behavior Checklist (ABC) is a parent rating of child behavior with five subscales: Irritability (15 items), Lethargy/Social Withdrawal (16 items), Stereotypic Behavior (7 items), Hyperactivity/ Noncompliance (16 items), and Inappropriate Speech (4 items). The ABC consists of 58-items scored: 0 (never a problem) to 3 (severe problem). Higher scores indicate greater severity.
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Child Health-Related Quality of Life
The PedsQL 4.0 will be used to measure pediatric health-related quality of life (HRQoL). The 23-item PedsQL Generic Core Scale is used to measure pediatric HRQoL and covers four domains related to functioning: Physical (8 items), Emotional (5 items), Social (5 items), and School (5 items for children). Items are scored on a 5-point Likert-type scale (range, 0 = never a problem; 4 = almost always a problem). To compute summary scores, items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate better pediatric HRQoL.
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Stress
The Parenting Stress Index-Short Form (PSI-SF) is a 36-item tool specifically designed to measure parenting stress. Items are scored on a 5-point likert scale with 1 = strongly disagree and 5 = strongly agree. There are three subscales of the PSI-SF, each containing 12 items: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores can range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sense of Competence
The Parenting Sense of Competence Scale (PSOC) consists of 17-items that are designed to measure parental satisfaction and self-efficacy. Items are scored on a 6-point scale with scores ranging from "strongly agree" = 6 to "strongly disagree" = 1. Higher scores reflect greater parental competence.
Time frame: Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
Change in Parental Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item questionnaire designed to assess sleep quality and disturbances. It evaluates seven components of sleep, which are combined to produce a global score ranging from 0 to 21. A total score of 5 or higher indicates clinically significant sleep difficulties, with higher scores reflecting poorer sleep quality.
Time frame: Baseline and Post-Intervention (Week 12)
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
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