An interventional study of NiteCAPP SINCC in Oppositional Defiant Disorder and Insomnia Chronic, sponsored by University of South Florida. Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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.
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder 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: NiteCAPP SINCC
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 parent 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
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 Heartrate Variability
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
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: during a cold-pressor task at 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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Oppositional Defiant Disorder →