Who is eligible for clinical trial NCT06350292?

Participants must meet protocol criteria for Insomnia Chronic. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06350292 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-03-24

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

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: University of South Florida

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (10 items).

Location: University of South Florida — Tampa, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Child ages 8-12 with ODD (prior diagnosis) and insomnia
Child and parent English proficiency. Insomnia:
complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
daytime dysfunction (mood, cognitive, social, academic) due to insomnia
baseline diaries and actigraphy indicate \>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights

Usually NOT eligible if any of the following apply:

Exclusion criteria:
Parent unable to provide informed consent or child unable to provide assent
Family unwilling to accept random assignment
Child/parent participation in another randomized research project
Parent unable to complete forms or implement treatment procedures due to cognitive impairment
Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
Other conditions adversely affecting trial participation

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of South Florida — Tampa, Florida

💰 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 § 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.

🏛️ View Official NIH Record ↗