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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 27, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Sleep DisturbanceAutism Spectrum Disorder
Interventions
BEHAVIORAL

Modified Sleep and Circadian Intervention

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.

BEHAVIORAL

Enhanced Usual Care

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.

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
collaborator

American Academy of Sleep Medicine

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

University Hospitals Cleveland Medical Center

OTHER

lead

Case Western Reserve University

OTHER

NCT07007819 - Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder | Biotech Hunter | Biotech Hunter