Last reviewed · How we verify
NCT06350292
SLEEP-COPE: Sleep Intervention for Oppositional Children
NA trial testing SLEEP: COPE in Insomnia Chronic in 25 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | University of South Florida |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 April 2024 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SLEEP: COPE
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Oppositional Defiant Disorder — all drugs for Oppositional Defiant Disorder →
Sponsor
University of South Florida
Who can join
Adults 8 to 12, any sex, with Insomnia Chronic or Oppositional Defiant Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06350292
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06350292 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Florida
- Last refreshed: 28 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06350292.
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