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

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.

Study Overview

• Status: Recruiting
• Conditions: Oppositional Defiant Disorder; Insomnia Chronic
• Intervention / Treatment: Behavioral: NiteCAPP SINCC

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Stearns, PhD; Phone Number: 8123828872; Email: mstearns@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620-8100
      • Recruiting
      • University of South Florida
      • Contact: Melanie Stearns, PhD; Email: mstearns@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NiteCAPP SINCC; 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; Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Revised Childhood Anxiety and Depression Scale	Measures child anxiety and depression	0 weeks, 6 weeks, 10 weeks
PROMIS Child Sleep Disturbance	Measures child sleep	0 weeks, 6 weeks, 10 weeks
Alabama Parenting Questionnaire	Measures parenting behaviors	0 weeks, 6 weeks, 10 weeks
Perceived Stress Scale	Measures parent stress	0 weeks, 6 weeks, 10 weeks
Child Disruptive Behavior Disorders Checklist	Measures child disruptive behaviors	0 weeks, 6 weeks, 10 weeks
Beck Depression Inventory-II	Measures parent depression	0 weeks, 6 weeks, 10 weeks
State-Trait Anxiety Inventory	Measures parent anxiety	0 weeks, 6 weeks, 10 weeks
PROMIS Adult Sleep Disturbance	Measures parent sleep	0 weeks, 6 weeks, 10 weeks
Pediatric Sleep Questionnaire	Measures child sleep apnea risk	0 weeks, 6 weeks, 10 weeks
Epworth Sleepiness Scale	Measures parent sleep apnea risk	0 weeks, 6 weeks, 10 weeks
Child Actigraphy	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Parent Actigraphy	Physiological measure of sleep efficiency, sleep onset latency, and total sleep time	24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks
Child Heartrate Variability	Child heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state	during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks
Parent Heartrate Variability	Parent heartrate variability will be measured during the following: 1) resting state, 2) cold pressor stimulation to hand (place hand to bottom of 4° Celsius ice water) for 30 secs, 3) 3 min recovery, 4) cold pressor stimulation to other hand for 30secs, 5) resting state	during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks

Collaborators and Investigators

• Sponsor: University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Oppositional Defiant Disorder
• Other Study ID Numbers: 6595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No