SLEEP-COPE: Sleep Intervention for Oppositional Children

Oppositional Defiant Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350292
• Other study ID #: 0161464
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: University of South Florida
• Contact: Melanie A Stearns, PhD
• Phone: 8139748110
• Email: mstearns[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Chronic
• Oppositional Defiant Disorder

Intervention

Behavioral:
• SLEEP: COPE
Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The Revised Childhood Anxiety and Depression Scale	Measures child anxiety and depression	0 weeks, 6 weeks, 10 weeks
Secondary	PROMIS Child Sleep Disturbance	Measures child sleep	0 weeks, 6 weeks, 10 weeks
Secondary	Alabama Parenting Questionnaire	Measures parenting behaviors	0 weeks, 6 weeks, 10 weeks
Secondary	Perceived Stress Scale	Measures parent stress	0 weeks, 6 weeks, 10 weeks
Secondary	Child Disruptive Behavior Disorders Checklist	Measures child disruptive behaviors	0 weeks, 6 weeks, 10 weeks
Secondary	Beck Depression Inventory-II	Measures parent depression	0 weeks, 6 weeks, 10 weeks
Secondary	State-Trait Anxiety Inventory	Measures parent anxiety	0 weeks, 6 weeks, 10 weeks
Secondary	PROMIS Adult Sleep Disturbance	Measures parent sleep	0 weeks, 6 weeks, 10 weeks
Secondary	Pediatric Sleep Questionnaire	Measures child sleep apnea risk	0 weeks, 6 weeks, 10 weeks
Secondary	Epworth Sleepiness Scale	Measures parent sleep apnea risk	0 weeks, 6 weeks, 10 weeks