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RecruitingOppositional Defiant DisorderInsomnia Chronic

Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)

Eligible age

8–17 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: University of South Florida

You may qualify if…

  • ✓ 1. Child ages 8-17 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

You may not qualify if…

  • ✕ 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)

Where it's recruiting

Florida

Tampa

Source: ClinicalTrials.gov · NCT06410495 · last updated 2025-03-28