SLEEP-COPE: Sleep Intervention for Oppositional Children
Eligible age
8–12 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of South Florida
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Tampa
Source: ClinicalTrials.gov · NCT06350292 · last updated 2025-03-28