Telehealth sleep intervention for children with oppositional defiant disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Melanie A Stearns, PhD
• Email: mstearns@usf.edu
• Phone: 8139748110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.