University of South Florida
Tampa, Florida, 33620-8100, United States
Location status: Recruiting
NCT Number: NCT06410495
In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.
Interested in participating?
Request Info8 year–17 year
All sexes
Interventional
Not applicable
Tampa, Florida, 33620-8100, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Insomnia:
Exclusion criteria
Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.
Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by parent that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time
Time frame: 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Physiological measure of sleep efficiency, sleep onset latency, and total sleep time
Time frame: during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Child heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state
Time frame: during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Parent heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures child anxiety and depression
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures child sleep
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parenting behaviors
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parent stress
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures child disruptive behaviors
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parent depression
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parent anxiety
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parent sleep
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures child sleep apnea risk
Time frame: 0 weeks, 6 weeks, 10 weeks
Measures parent sleep apnea risk
Contact information is provided by the study sponsor or research team.
University of South Florida
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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