Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06410495
Status
Recruiting
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Conditions

  • Insomnia Chronic
  • Oppositional Defiant Disorder

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.

Key Dates

Start date
May 1, 2024
Status verified
Mar 2025
Primary completion
Aug 1, 2025
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: NiteCAPP SINCC
    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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