NCT07007819

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

Enrolling by Invitation
NAAges 6–12InterventionalSupportive care
Case Western Reserve University
~50 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Modified Sleep and Circadian InterventionEnhanced Usual Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)
Measured over Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)
+1 more outcome measured
Sleep Disturbance
Autism Spectrum Disorder
1 sites across 1 states
Ohio1
  • Megan L Wenzell, PhD · PRINCIPAL_INVESTIGATOR · Case Western Reserve University

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • The Improvement Scale of the Clinical Global Impressions Scale (CGI-I)Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

    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.

  • Change in the Pediatric Autism Insomnia Rating Scale (PAIRS)Baseline, Post-Intervention (Week 12), and Follow Up (Week 24)

    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.