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Enrolling by invitation Not applicable Interventional

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

ClinicalTrials.gov ID: NCT07007819

Public ClinicalTrials.gov record NCT07007819. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07007819
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Not applicable
Enrollment
50 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 12 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2025
Primary completion
Dec 8, 2026
Completion
Dec 8, 2026
Last update posted
Aug 31, 2026

2025 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University Hospitals Cleveland Medical Center Cleveland Ohio 44106

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07007819, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07007819 live on ClinicalTrials.gov.

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