RecruitingNot ApplicableNCT06410495

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

Sponsor

University of South Florida

Enrollment

30 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Insomnia Chronic Oppositional Defiant Disorder

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.

Eligibility

Min Age: 8 YearsMax Age: 17 Years

Inclusion Criteria6

Child ages 8-17 with ODD (prior diagnosis) and insomnia
Child and parent English proficiency.
Insomnia:
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 Criteria9

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
Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
Other conditions adversely affecting trial participation

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