SLEEP-COPE: Sleep Intervention for Oppositional Children

University of South Florida25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia Chronic Oppositional Defiant Disorder

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks

Secondary Outcomes

Child Actigraphy

Physiological measure of sleep efficiency, sleep onset latency, and total sleep time.

Time frame: 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.

Time frame: 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.

Time frame: 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).