Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
Recruiting · NCT06410495 · Interventional (participants receive a specific treatment) · Lead sponsor: University of South Florida
View the official record on ClinicalTrials.gov →Interventions studied
NiteCAPP SINCC
What this trial is about
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 take part
Age range
8 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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
- Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- Other conditions adversely affecting trial participation
Where it is running
1 location listed across 1 US state.
- University of South Florida - Tampa, Florida, United States