SLEEP-COPE: Sleep Intervention for Oppositional Children
Recruiting · NCT06350292 · Interventional (participants receive a specific treatment) · Lead sponsor: University of South Florida
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Child ages 8-12 with ODD (prior diagnosis) and insomnia
- Child and parent English proficiency.
- Insomnia:
- complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
- daytime dysfunction (mood, cognitive, social, academic) due to insomnia
- 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
- Parent unable to provide informed consent or child unable to provide assent
- Family unwilling to accept random assignment
- Child/parent participation in another randomized research project
- Parent unable to complete forms or implement treatment procedures due to cognitive impairment
- Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
- Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
- Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- Other conditions adversely affecting trial participation
Where it is running
1 location listed across 1 US state.
- University of South Florida - Tampa, Florida, United States