Clinical Trial

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Study acronym: RECHArge

Recruiting

Record status

This record was last updated March 15, 2024 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.

Summary

Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2020-09-09; most recent amendment 2024-03-12.

Status change: Not Yet Recruiting → Recruiting 2020-11-03

Trial Details

NCT Number	NCT04545606
Lead Sponsor	University of Missouri-Columbia Collaborators: United States Department of Defense
Conditions	Insomnia Chronic, Autism Spectrum Disorder
Enrollment	180 participants
Start Date	2020-09-15
Primary Completion	2025-08 (estimated)
Study Completion	2030-08 (estimated)
Updated on ClinicalTrials.gov	2024-03-15