Oppositional Defiant Disorder Clinical Trial
Official title:
Digital Dyadic Family Based Intervention to Improve Sleep in Children With ODD and Their Parents: NiteCAPP SINCC (Pilot)
NCT number | NCT06410495 |
Other study ID # | 6595 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | December 1, 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | Inclusion criteria: 1. Child ages 8-12 with ODD (prior diagnosis) and insomnia 2. Child and parent English proficiency. Insomnia: 1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos 2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia 3. baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights Exclusion criteria: 1. Parent unable to provide informed consent or child unable to provide assent 2. Family unwilling to accept random assignment 3. Child/parent participation in another randomized research project 4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment 5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias) 6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin 7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial 8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts) 9. Other conditions adversely affecting trial participation |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks | |
Primary | 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. | Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Child Actigraphy | Physiological measure of sleep efficiency, sleep onset latency, and total sleep time | 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Parent Actigraphy | Physiological measure of sleep efficiency, sleep onset latency, and total sleep time | 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks | |
Secondary | 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 | during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks | |
Secondary | 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 | during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks | |
Secondary | The Revised Childhood Anxiety and Depression Scale | Measures child anxiety and depression | 0 weeks, 6 weeks, 10 weeks | |
Secondary | PROMIS Child Sleep Disturbance | Measures child sleep | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Alabama Parenting Questionnaire | Measures parenting behaviors | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Perceived Stress Scale | Measures parent stress | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Child Disruptive Behavior Disorders Checklist | Measures child disruptive behaviors | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Beck Depression Inventory-II | Measures parent depression | 0 weeks, 6 weeks, 10 weeks | |
Secondary | State-Trait Anxiety Inventory | Measures parent anxiety | 0 weeks, 6 weeks, 10 weeks | |
Secondary | PROMIS Adult Sleep Disturbance | Measures parent sleep | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Pediatric Sleep Questionnaire | Measures child sleep apnea risk | 0 weeks, 6 weeks, 10 weeks | |
Secondary | Epworth Sleepiness Scale | Measures parent sleep apnea risk | 0 weeks, 6 weeks, 10 weeks |
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