Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)

Launched by UNIVERSITY OF SOUTH FLORIDA · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial, called NiteCAPP SINCC, is exploring a new online program designed to help children aged 8-12 who have Oppositional Defiant Disorder (ODD) and trouble sleeping (insomnia). The program uses a type of therapy called cognitive behavioral therapy for insomnia (CBT-I), which focuses on changing thoughts and behaviors that affect sleep. The goal of the trial is to see if this web-based treatment is acceptable to families, if they can easily participate, and if it helps improve sleep for both children and their parents.

To be eligible for the study, children must be diagnosed with ODD and have been experiencing sleep problems for at least three months. Parents and children need to be comfortable communicating in English. Participants will be randomly assigned to either the treatment group or a control group, and both the child and parent will need to commit to completing the program. Throughout the trial, families will track sleep patterns and any changes in mood or behavior. This is a great opportunity for families struggling with sleep issues related to ODD to find support and possibly improve their situation together.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Child ages 8-17 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