SLEEP-COPE: Sleep Intervention for Oppositional Children

Not Applicable

Recruiting

• Conditions: Oppositional Defiant Disorder; Insomnia Chronic

• Registration Number: NCT06350292
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Study Start: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Parent Daily Sleep Diaries	Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks	Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
Child Daily Sleep Diaries	Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Child Actigraphy	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
The Revised Childhood Anxiety and Depression Scale	0 weeks, 6 weeks, 10 weeks	Measures child anxiety and depression
PROMIS Child Sleep Disturbance	0 weeks, 6 weeks, 10 weeks	Measures child sleep
Alabama Parenting Questionnaire	0 weeks, 6 weeks, 10 weeks	Measures parenting behaviors
Parent Actigraphy	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.
Child Disruptive Behavior Disorders Checklist	0 weeks, 6 weeks, 10 weeks	Measures child disruptive behaviors
Epworth Sleepiness Scale	0 weeks, 6 weeks, 10 weeks	Measures parent sleep apnea risk
Child Salivary Cortisol	before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks	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.
Child Hair Cortisol	0 weeks, 6 weeks, 10 weeks	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).
Perceived Stress Scale	0 weeks, 6 weeks, 10 weeks	Measures parent stress
Beck Depression Inventory-II	0 weeks, 6 weeks, 10 weeks	Measures parent depression
PROMIS Adult Sleep Disturbance	0 weeks, 6 weeks, 10 weeks	Measures parent sleep
State-Trait Anxiety Inventory	0 weeks, 6 weeks, 10 weeks	Measures parent anxiety
Pediatric Sleep Questionnaire	0 weeks, 6 weeks, 10 weeks	Measures child sleep apnea risk

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States