SLEEP-COPE: Sleep Intervention for Oppositional Children

Launched by UNIVERSITY OF SOUTH FLORIDA · Apr 1, 2024

Keywords

ClinConnect Summary

The SLEEP-COPE study is researching a new way to help children aged 8 to 12 who have Oppositional Defiant Disorder (ODD) and are struggling with insomnia. Insomnia can make it hard for children to fall asleep, stay asleep, or wake up too early, which can affect their mood and daily activities. This study is testing a brief online therapy called Cognitive Behavioral Treatment for Insomnia (CBT-I) that parents and children can do together from home. This approach could be especially helpful for families in areas where it’s difficult to access mental health care.

To participate in this study, children must have a prior diagnosis of ODD and be experiencing sleep problems for more than three months. Parents and children should be comfortable communicating in English. If you think your child might be eligible or if you have questions, this trial could offer a practical way to address sleep difficulties while also helping with related issues like behavior and mood. Participants will receive support and guidance throughout the process, and the goal is to find effective ways to improve sleep and overall well-being for children with ODD.

Gender

ALL

Eligibility criteria

• 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