University of South Florida
Tampa, Florida, 33620-8100, United States
Location status: Recruiting
NCT Number: NCT06350292
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.
Interested in participating?
Request Info8 year–12 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 parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
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: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Salivary cortisol collected in the morning before and after cold-pressor task and immediately frozen. Saliva samples (25 µL) assayed in duplicate. At rest children will undergo the following: 1) baseline saliva collection, 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) post assessment saliva collection.
Time frame: 0 weeks, 6 weeks, 10 weeks
Hair collected (15-50 mg) will be cut into 1 cm segments and ground into a fine powder before extracted with methanol for 16-18 hours while shaking. Cortisol then is quantified by liquid chromatography - tandem mass spectrometry (LC-MS/MS) (Salimetrics LLC, State College PA).
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
SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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