Actively Recruiting
Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
Led by University of South Florida · Updated on 2025-03-28
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a brief web-based cognitive behavioral treatment for insomnia (CBT-I) designed for children aged 8 to 17 with oppositional defiant disorder (ODD) and their parents. This pilot study aims to adapt and test the treatment for acceptability, feasibility, and early signs of effectiveness in improving sleep problems in this group. The intervention, called NiteCAPP SINCC, combines standard CBT-I methods such as sleep hygiene, stimulus control, sleep restriction, and cognitive therapy with specific modules addressing challenges faced by children with ODD and their parents. The treatment encourages active child participation as much as possible, with parents supporting the implementation of behavioral strategies. The study involves only this experimental behavioral intervention. Participants and their parents will complete daily sleep diaries each morning for 14 days at the start, 6 weeks, and 10 weeks into the study. They will also wear actigraphy devices continuously during these 2-week assessment periods to monitor sleep patterns. Additional measurements include heart rate variability during a stress task and various questionnaires assessing anxiety, depression, sleep disturbance, parenting, stress, and child behavior at the same time points. The study monitors changes in sleep and related symptoms over about 10 weeks.
CONDITIONS
Brief Title
Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child ages 8 to 17 years with a prior diagnosis of oppositional defiant disorder and insomnia
- Child and parent must be proficient in English
- Child has had difficulties falling asleep, staying asleep, or early morning awakening for 3 or more months
- Child experiences daytime problems (mood, cognitive, social, academic) due to insomnia
- Sleep diaries and actigraphy show more than 30 minutes of sleep onset delay, wake after sleep onset, or early morning 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 (e.g., apnea, epilepsy, psychotic disorders, suicidal thoughts, frequent parasomnias)
- Child uses psychotropic or other medications that affect sleep except stimulants, sleep medications, or melatonin
- Child is receiving non-drug treatment for sleep outside this trial
- Parent reports inability to tolerate Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral issues)
- Other conditions that may 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.
Duration - Approximately 10 weeks
Participants engage in a digital family-based behavioral intervention focusing on improving sleep in children with ODD and their parents using CBT-I techniques and modules targeting noncompliance. Parents work with children to implement behavioral strategies.
Assessments at baseline, 6 weeks, and 10 weeks including daily sleep diaries for 14 days, actigraphy monitoring for 2 weeks, and various behavioral and physiological assessments
Trial Site Locations
Total: 1 location
1
University of South Florida
Tampa, Florida, United States, 33620-8100
Actively Recruiting
Research Team
M
Melanie 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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