NCT06410495 Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
| NCT ID | NCT06410495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South Florida |
| Condition | Oppositional Defiant Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-05-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06410495 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Oppositional Defiant Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06410495 currently recruiting?
Yes, NCT06410495 is actively recruiting participants. Contact the research team at mstearns@usf.edu for enrollment information.
Where is the NCT06410495 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06410495 clinical trial?
NCT06410495 is sponsored by University of South Florida. The trial plans to enroll 30 participants.