Viewing Study NCT06350292



Ignite Creation Date: 2024-05-06 @ 8:22 PM
Last Modification Date: 2024-10-26 @ 3:26 PM
Study NCT ID: NCT06350292
Status: RECRUITING
Last Update Posted: 2024-05-09
First Post: 2024-03-25

Brief Title: SLEEP-COPE Sleep Intervention for Oppositional Children
Sponsor: University of South Florida
Organization: University of South Florida

Study Overview

Official Title: SLEEP-COPE Sleep Enhancement and Effective Parenting for Children With Oppositional and Problematic Expressions
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None