SLEEP-COPE: Sleep Intervention for Oppositional Children

NCT ID: NCT06350292

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SLEEP: COPE

Intervention Type: BEHAVIORAL

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

Interventions

SLEEP: COPE

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Child ages 8-12 with ODD (prior diagnosis) and insomnia

2. Child and parent English proficiency.

Insomnia:

1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos

2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia

3. 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

Exclusion Criteria

1. Parent unable to provide informed consent or child unable to provide assent

2. Family unwilling to accept random assignment

3. Child/parent participation in another randomized research project

4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment

5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)

6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin

7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial

8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)

9. Other conditions adversely affecting trial participation

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Melanie Stearns

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melanie A Stearns, PhD

Role: CONTACT

mstearns@usf.edu

8139748110

Facility Contacts

Melanie Stearns, PhD

Role: primary

mstearns@usf.edu

Other Identifiers

0161464

Identifier Type: -

Identifier Source: org_study_id