Actively Recruiting
SLEEP-COPE: Sleep Intervention for Oppositional Children
Led by University of South Florida · Updated on 2025-03-28
25
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
SLEEP-COPE: Sleep Intervention for Oppositional Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 8 to 12 years with a prior diagnosis of Oppositional Defiant Disorder (ODD) and insomnia
- Child and parent must be proficient in English
- Child has complaints of difficulty falling asleep, staying asleep, or early morning awakening lasting 3 or more months
- Child experiences daytime problems in mood, thinking, social, or academic areas due to insomnia
- Sleep diaries and actigraphy show over 30 minutes of delayed sleep onset, waking after sleep onset, or early awakening on at least 6 nights
You will not qualify if you...
- Parent unable to provide informed consent or child unable to provide assent
- Family unwilling to accept random assignment
- Child or parent currently participating in another randomized research project
- Parent unable to complete forms or carry out treatment due to cognitive impairment
- Child has untreated medical conditions including other sleep disorders like apnea, epilepsy, psychotic disorders, suicidal thoughts, or frequent parasomnias
- Child uses psychotropic or other medications affecting sleep, except stimulants, sleep medications, or melatonin
- Child is receiving other non-drug sleep treatments such as CBT outside this trial
- Parent reports inability to wear Holter Monitoring or actigraphy devices due to sensitivity or behavior
- Any other conditions that would negatively impact participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of South Florida
Tampa, Florida, United States, 33620-8100
Actively Recruiting
Research Team
M
Melanie A Stearns, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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