SLEEP-COPE: Sleep Intervention for Oppositional Children

NCT06350292 | Recruiting DMC

• 1 other identifier: 0161464
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia Chronic; Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (2)

• Child Daily Sleep Diaries

  Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.

  Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks

• Parent Daily Sleep Diaries

  Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.

  Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks

Secondary Outcomes (14)

• Child Actigraphy

  24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks

• Parent Actigraphy

  24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks

• Child Salivary Cortisol

  before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

• Child Hair Cortisol

  0 weeks, 6 weeks, 10 weeks

• The Revised Childhood Anxiety and Depression Scale

  0 weeks, 6 weeks, 10 weeks

Study Arms (1)

SLEEP: COPE

EXPERIMENTAL

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.

Behavioral: SLEEP: COPE

Interventions

SLEEP: COPE BEHAVIORAL

Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

SLEEP: COPE

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620-8100, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Central Study Contacts

Melanie A Stearns, PhD

CONTACT

8139748110; mstearns@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)