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Behavioral Intervention

Sleep Intervention for Oppositional Defiant Disorder

N/A
Recruiting
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Awards & highlights

Summary

This trial aims to test a new telehealth program called SLEEP-COPE, which is a form of cognitive behavioral therapy for insomnia (CBT-I) designed for children with Oppositional Defiant

Who is the study for?
This trial is for children aged 8-12 with Oppositional Defiant Disorder (ODD) and chronic insomnia. They must have had sleep difficulties for over three months, affecting their mood or daily functioning. Both child and parent need to speak English. Children who don't meet the specific sleep problem criteria or have other conditions that could interfere are not eligible.
What is being tested?
SLEEP-COPE is being tested in this trial; it's a telehealth Cognitive Behavioral Treatment for Insomnia (CBT-I) designed specifically for kids with ODD and their parents. The treatment aims to improve sleep issues through online sessions, making it accessible even in areas with limited mental health services.
What are the potential side effects?
Since SLEEP-COPE involves behavioral therapy delivered via telehealth without medication, there may be minimal side effects compared to drug treatments. However, specifics on side effects will depend on individual experiences throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child Daily Sleep Diaries
Parent Daily Sleep Diaries
Secondary outcome measures
Alabama Parenting Questionnaire
Beck Depression Inventory-II
Child Actigraphy
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SLEEP: COPEExperimental Treatment1 Intervention
Content includes both standard CBT-I techniques \[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.

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Who is running the clinical trial?

University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,202 Total Patients Enrolled
~8 spots leftby Jan 2025
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