Recruiting

Sleep Intervention

Sponsor:

University of South Florida

Code:

NCT06350292

Conditions

Insomnia Chronic

Oppositional Defiant Disorder

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

SLEEP: COPE

Study Details

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 ID

NCT06350292

Start date

Apr 1, 2024

Status verified date

Mar, 2025

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SLEEP: COPE

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melanie A Stearns, PhD

8139748110mstearns@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33620-8100

Contacts

Melanie Stearns, PhD

mstearns@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2025-03-28.