SLEEP-COPE: Sleep Intervention for Oppositional Children

SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions

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.

Study Overview

• Status: Recruiting
• Conditions: Oppositional Defiant Disorder; Insomnia Chronic
• Intervention / Treatment: Behavioral: SLEEP: COPE

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie A Stearns, PhD; Phone Number: 8139748110; Email: mstearns@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620-8100
      • Recruiting
      • University of South Florida
      • Contact: Melanie Stearns, PhD; Email: mstearns@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: SLEEP: COPE; Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Actigraphy	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Parent Actigraphy	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Child Salivary Cortisol	Salivary cortisol collected in the morning before and after cold-pressor task and immediately frozen. Saliva samples (25 µL) assayed in duplicate. At rest children will undergo the following: 1) baseline saliva collection, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) post assessment saliva collection.	before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Child Hair Cortisol	Hair collected (15-50 mg) will be cut into 1 cm segments and ground into a fine powder before extracted with methanol for 16-18 hours while shaking. Cortisol then is quantified by liquid chromatography - tandem mass spectrometry (LC-MS/MS) (Salimetrics LLC, State College PA).	0 weeks, 6 weeks, 10 weeks
The Revised Childhood Anxiety and Depression Scale	Measures child anxiety and depression	0 weeks, 6 weeks, 10 weeks
PROMIS Child Sleep Disturbance	Measures child sleep	0 weeks, 6 weeks, 10 weeks
Alabama Parenting Questionnaire	Measures parenting behaviors	0 weeks, 6 weeks, 10 weeks
Perceived Stress Scale	Measures parent stress	0 weeks, 6 weeks, 10 weeks
Child Disruptive Behavior Disorders Checklist	Measures child disruptive behaviors	0 weeks, 6 weeks, 10 weeks
Beck Depression Inventory-II	Measures parent depression	0 weeks, 6 weeks, 10 weeks
State-Trait Anxiety Inventory	Measures parent anxiety	0 weeks, 6 weeks, 10 weeks
PROMIS Adult Sleep Disturbance	Measures parent sleep	0 weeks, 6 weeks, 10 weeks
Pediatric Sleep Questionnaire	Measures child sleep apnea risk	0 weeks, 6 weeks, 10 weeks
Epworth Sleepiness Scale	Measures parent sleep apnea risk	0 weeks, 6 weeks, 10 weeks

Collaborators and Investigators

• Sponsor: University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder
• Other Study ID Numbers: 0161464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No