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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child Daily Sleep Diaries

Parent Daily Sleep Diaries

Secondary study objectives

Alabama Parenting Questionnaire

Beck Depression Inventory-II

Child Actigraphy

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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