Clinical Trial

SLEEP-COPE: Sleep Intervention for Oppositional Children

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 28, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-01; most recent amendment 2025-03-24.
Status change: Not Yet Recruiting → Recruiting 2024-05-07
Trial Details
NCT Number NCT06350292
Lead Sponsor University of South Florida
Conditions Insomnia Chronic, Oppositional Defiant Disorder
Enrollment 25 participants
Start Date 2024-04-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-28