SLEEP-COPE: Sleep Intervention for Oppositional Children

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06350292
Status
Recruiting
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Conditions

  • Insomnia Chronic
  • Oppositional Defiant Disorder

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • SLEEP: COPE — BEHAVIORAL
    Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2025
Primary completion
Aug 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SLEEP: COPE
    Content includes both standard CBT-I techniques \[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.

Primary Outcome Measure

Child Daily Sleep Diaries [ Time Frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33620-8100
Melanie Stearns, PhD
[email protected]

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By research site
University of South Florida· Tampa, FL

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