Clinical trial NCT06350292: SLEEP-COPE: Sleep Intervention for Oppositional Children
Official title: SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Oppositional Defiant Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child Daily Sleep Diaries
timeFrame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
measure: Parent Daily Sleep Diaries
timeFrame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Secondary outcomes:
measure: Child Actigraphy
timeFrame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
measure: Parent Actigraphy
timeFrame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
measure: Child Salivary Cortisol
timeFrame: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
measure: Child Hair Cortisol
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: The Revised Childhood Anxiety and Depression Scale
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: PROMIS Child Sleep Disturbance
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Alabama Parenting Questionnaire
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Perceived Stress Scale
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Child Disruptive Behavior Disorders Checklist
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Beck Depression Inventory-II
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: State-Trait Anxiety Inventory
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: PROMIS Adult Sleep Disturbance
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Pediatric Sleep Questionnaire
timeFrame: 0 weeks, 6 weeks, 10 weeks
measure: Epworth Sleepiness Scale
timeFrame: 0 weeks, 6 weeks, 10 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: