Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents:… (NCT06410495) | Clinical Trial Compass
RecruitingNot Applicable
Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
United States30 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range8 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Child ages 8-17 with ODD (prior diagnosis) and insomnia
✓. Child and parent English proficiency.
✓. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
✓. daytime dysfunction (mood, cognitive, social, academic) due to insomnia
✓. 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
✕. Parent unable to provide informed consent or child unable to provide assent
✕. Family unwilling to accept random assignment
✕. Child/parent participation in another randomized research project
✕. Parent unable to complete forms or implement treatment procedures due to cognitive impairment
✕. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
✕. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
✕. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
What they're measuring
1
Child Daily Sleep Diaries
Timeframe: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
2
Parent Daily Sleep Diaries
Timeframe: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks