Web-based intervention to improve sleep in children with behavioral issues and their parents
Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
This study is testing a web-based program to help children with behavioral issues and their parents improve sleep and family dynamics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06410495 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on a brief web-based cognitive behavioral treatment for insomnia (CBT-I) tailored for children aged 8-17 diagnosed with oppositional defiant disorder (ODD) and their parents. The program is designed to be iteratively adapted and tested for its acceptability, feasibility, and preliminary efficacy in addressing sleep issues. Participants will engage in a structured treatment approach that aims to improve sleep patterns and overall family dynamics. The study will assess the impact of the intervention on both the child and parent experiences related to sleep disturbances.
Who should consider this trial
Good fit: Ideal candidates include children aged 8-17 with a prior diagnosis of ODD and chronic insomnia, along with their parents who are proficient in English.
Not a fit: Patients who have untreated medical comorbidities or other sleep disorders may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and behavioral outcomes for children with ODD and their families.
How similar studies have performed: While there is limited information on similar studies, the use of web-based CBT-I has shown promise in other populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida
- University of South Florida — Tampa, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Melanie Stearns, PhD
- Email: mstearns@usf.edu
- Phone: 8123828872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.