๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-03-24

SLEEP-COPE: Sleep Intervention for Oppositional Children (NCT06350292)

SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: University of South Florida

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of South Florida โ€” Tampa, Florida

Age range: 8 Years to 12 Years

๐Ÿงช Interventions in This Study

  • SLEEP: COPE (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of South Florida โ€” Tampa, Florida

๐Ÿ“ž Contact the Study Coordinator

Phone: (813) 974-8110

Email: mstearns@usf.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—