Digital Dyadic Family Based Intervention to Improve Sleep in Children With ODD and Their Parents: NiteCAPP SINCC (Pilot)
- Conditions
- Insomnia ChronicOppositional Defiant Disorder
- Interventions
- Behavioral: NiteCAPP SINCC
- Registration Number
- NCT06410495
- Lead Sponsor
- University of South Florida
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NiteCAPP SINCC NiteCAPP SINCC 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.
- Primary Outcome Measures
Name Time Method Parent Daily Sleep Diaries 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.
Child Daily Sleep Diaries 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.
- Secondary Outcome Measures
Name Time Method PROMIS Adult Sleep Disturbance 0 weeks, 6 weeks, 10 weeks Measures parent sleep
Alabama Parenting Questionnaire 0 weeks, 6 weeks, 10 weeks Measures parenting behaviors
Perceived Stress Scale 0 weeks, 6 weeks, 10 weeks Measures parent stress
Pediatric Sleep Questionnaire 0 weeks, 6 weeks, 10 weeks Measures child sleep apnea risk
Child Disruptive Behavior Disorders Checklist 0 weeks, 6 weeks, 10 weeks Measures child disruptive behaviors
Child Actigraphy 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
Parent Actigraphy 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
Child Heartrate Variability 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
PROMIS Child Sleep Disturbance 0 weeks, 6 weeks, 10 weeks Measures child sleep
Beck Depression Inventory-II 0 weeks, 6 weeks, 10 weeks Measures parent depression
State-Trait Anxiety Inventory 0 weeks, 6 weeks, 10 weeks Measures parent anxiety
Epworth Sleepiness Scale 0 weeks, 6 weeks, 10 weeks Measures parent sleep apnea risk
Parent Heartrate Variability 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
The Revised Childhood Anxiety and Depression Scale 0 weeks, 6 weeks, 10 weeks Measures child anxiety and depression
Trial Locations
- Locations (1)
University of South Florida
🇺🇸Tampa, Florida, United States