An interventional study of SLEEP: COPE in Insomnia Chronic and Oppositional Defiant Disorder, sponsored by University of South Florida. Recruiting at 1 site in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 25 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Insomnia:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Content includes both standard CBT-I techniques \[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.
Behavioral: SLEEP: COPE
Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.
Child Daily Sleep Diaries
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
Parent Daily Sleep Diaries
Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
Time frame: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Child Actigraphy
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
Parent Actigraphy
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
Child Salivary Cortisol
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: before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Child Hair Cortisol
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
The Revised Childhood Anxiety and Depression Scale
Measures child anxiety and depression
Time frame: 0 weeks, 6 weeks, 10 weeks
PROMIS Child Sleep Disturbance
Measures child sleep
Time frame: 0 weeks, 6 weeks, 10 weeks
Alabama Parenting Questionnaire
Measures parenting behaviors
Time frame: 0 weeks, 6 weeks, 10 weeks
Perceived Stress Scale
Measures parent stress
Time frame: 0 weeks, 6 weeks, 10 weeks
Child Disruptive Behavior Disorders Checklist
Measures child disruptive behaviors
Time frame: 0 weeks, 6 weeks, 10 weeks
Beck Depression Inventory-II
Measures parent depression
Time frame: 0 weeks, 6 weeks, 10 weeks
State-Trait Anxiety Inventory
Measures parent anxiety
Time frame: 0 weeks, 6 weeks, 10 weeks
PROMIS Adult Sleep Disturbance
Measures parent sleep
Time frame: 0 weeks, 6 weeks, 10 weeks
Pediatric Sleep Questionnaire
Measures child sleep apnea risk
Time frame: 0 weeks, 6 weeks, 10 weeks
Epworth Sleepiness Scale
Measures parent sleep apnea risk
Time frame: 0 weeks, 6 weeks, 10 weeks
Plan to share: No
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