💬In plain words
What the trial is, and whether it could suit you
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.
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📋 Eligibility rules (as published)
Inclusion criteria:
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
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
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