SLEEP-COPE: Sleep Intervention for Oppositional Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity of South Florida
About this trial
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
Qualifiers
Child ages 8-12 with ODD (prior diagnosis) and insomnia
Child and parent English proficiency.
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SLEEP: COPE
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov