Telehealth sleep intervention for children with oppositional defiant disorder
SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
This study tests a new online sleep program for children with Oppositional Defiant Disorder and insomnia to see if it can help them sleep better and feel more focused during the day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06350292 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on children aged 8-12 diagnosed with Oppositional Defiant Disorder (ODD) who also experience insomnia. It aims to evaluate the effectiveness of a brief telehealth cognitive behavioral treatment for insomnia (CBT-I) called SLEEP-COPE, which involves both the child and their parent. The intervention seeks to improve sleep quality and related issues by utilizing telehealth to make treatment more accessible, especially in areas with limited mental healthcare resources. The study will assess the impact of this intervention on insomnia symptoms and daytime functioning.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-12 with a prior diagnosis of ODD and insomnia.
Not a fit: Patients with untreated medical comorbidities or other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall functioning in children with ODD.
How similar studies have performed: While telehealth CBT-I has shown efficacy in adults and children, this specific application for children with ODD is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Child ages 8-12 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 A Stearns, PhD
- Email: mstearns@usf.edu
- Phone: 8139748110
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.