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Behavioral Intervention

Digital Therapy for Children With ODD and Sleep Issues

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

Insomnia criteria: complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ months, daytime dysfunction due to insomnia, baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening on 6+ nights

Be younger than 18 years old

Must not have

Family unwilling to accept random assignment

Parent unable to complete forms or implement treatment procedures due to cognitive impairment

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 tests a short online therapy for children with behavior problems and sleep issues, and their parents.

Who is the study for?

This trial is for children aged 8-12 with Oppositional Defiant Disorder (ODD) and chronic insomnia, lasting over 3 months. Both child and parent must speak English. Kids on certain medications or undergoing other sleep treatments, or those with untreated medical issues like psychotic disorders are excluded.

What is being tested?

The NiteCAPP SINCC program, a web-based cognitive behavioral therapy for insomnia tailored to kids with ODD and their parents, is being tested for its usability and initial effectiveness in improving sleep patterns.

What are the potential side effects?

Since this intervention involves behavioral therapy rather than medication, typical drug side effects aren't expected. However, participants may experience stress or anxiety related to new routines or changes in behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child or I have had trouble sleeping for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My family and I are not open to being randomly assigned in the trial.

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My parent cannot complete forms or follow treatment due to cognitive issues.

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My child has no untreated major health issues or severe mental health conditions.

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I am unable to give consent or my child cannot agree to participate.

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: NiteCAPP SINCCExperimental 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.

0 / 5Eligibility criteria met