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

NCT06410495 | Recruiting

• 1 other identifier: 6595
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.

Conditions

Oppositional Defiant Disorder; Insomnia Chronic

Outcome Measures

Primary Outcomes (2)

• Child Daily Sleep Diaries

  Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.

  Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks

• Parent Daily Sleep Diaries

  Daily diaries filled out by parent that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.

  Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks

Secondary Outcomes (14)

• Child Actigraphy

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

• Parent Actigraphy

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

• Child Heartrate Variability

  during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

• Parent Heartrate Variability

  during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

• The Revised Childhood Anxiety and Depression Scale

  0 weeks, 6 weeks, 10 weeks

Study Arms (1)

NiteCAPP SINCC

EXPERIMENTAL

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.

Behavioral: NiteCAPP SINCC

Interventions

NiteCAPP SINCC BEHAVIORAL

Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

NiteCAPP SINCC

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child ages 8-17 with ODD (prior diagnosis) and insomnia
• Child and parent English proficiency.
• Insomnia:
• complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
• daytime dysfunction (mood, cognitive, social, academic) due to insomnia
• 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

You may not qualify if:

• Parent unable to provide informed consent or child unable to provide assent
• Family unwilling to accept random assignment
• Child/parent participation in another randomized research project
• Parent unable to complete forms or implement treatment procedures due to cognitive impairment
• Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, \[frequent\] parasomnias)
• Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
• Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
• Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
• Other conditions adversely affecting trial participation

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620-8100, United States

RECRUITING

MeSH Terms

Conditions

Oppositional Defiant Disorder; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Melanie Stearns, PhD

CONTACT

8123828872; mstearns@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)