Actively Recruiting
SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
Led by University of South Florida · Updated on 2025-03-28
25
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Children diagnosed with Oppositional Defiant Disorder (ODD) often face problems such as insomnia, mood difficulties, and challenges with compliance. Researchers are evaluating a telehealth-delivered cognitive behavioral treatment for insomnia (CBT-I) called SLEEP-COPE, designed specifically for children with ODD and their parents. This trial aims to develop and test this brief dyadic therapy to improve sleep and related issues, especially in areas with limited mental healthcare access. The study uses the SLEEP-COPE program, which combines standard CBT-I methods like sleep hygiene, stimulus control, sleep restriction, and cognitive therapy with strategies tailored to children with ODD and their parents. The treatment involves active participation from both children and parents, with parents helping implement behavioral strategies. The intervention is delivered remotely via telehealth to reduce the burden of in-person visits. Participants will complete daily sleep diaries for both children and parents over 14-day periods at baseline, 6 weeks, and 10 weeks. They will also wear actigraphy devices continuously during these 2-week assessment periods to monitor sleep patterns. Additional assessments include child salivary and hair cortisol, anxiety and depression scales, parenting questionnaires, stress scales, and behavioral checklists at the same time points. The study monitors multiple outcomes related to sleep, mood, behavior, and parenting over approximately 10 weeks.
CONDITIONS
Brief 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 prior diagnosis of Oppositional Defiant Disorder 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 related to insomnia such as mood, cognitive, social, or academic difficulties
- Sleep diaries and actigraphy show more than 30 minutes of sleep onset latency, wake after sleep onset, or early morning awakening on 6 or more nights at baseline
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 study
- Parent unable to complete study 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 non-drug treatment for sleep outside this trial
- Parent reports inability to undergo Holter monitoring or actigraphy due to sensitivity or behavioral issues
- Other conditions that would negatively affect participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive a sleep intervention using CBT-I techniques and behavioral strategies targeting children with oppositional defiant disorder and their parents.
Regular visits during the 10-week treatment period
Duration - Up to 10 weeks
Participants complete follow-up assessments including sleep diaries, actigraphy, and behavioral questionnaires at 6 and 10 weeks.
Assessments at 6 weeks and 10 weeks
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
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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