Behavioral Sleep Intervention in Children With Disruptive Behaviors

NCT02783560 | Completed

• 2 other identifiers: 2286108UL1TR001108
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite the high prevalence of sleep difficulties in children with disruptive behavior disorders, little is known about the role of sleep in treating disruptive behavior. The current study evaluates the addition of a sleep intervention to an existing parent-training program for caregivers of children ages 3-8 with disruptive behaviors. Objectives are to examine the impact of a novel sleep treatment program on sleep, disruptive behavior, and other measures of family functioning, utilizing a variety of self-report and objective measures (e.g. actigraphy, electrodermal activity). The investigators hypothesize that sleep intervention will result in improvements in sleep and disruptive behavior compared to control group receiving a highly plausible addition to the standard parent training intervention, and that sleep outcomes will moderate overall treatment success.

Conditions

Insomnia; Disruptive Behavior Disorder; Oppositional Defiant Disorder

Keywords

Sleep; Electrodermal Activity; Mealtimes

Outcome Measures

Primary Outcomes (1)

• Child Externalizing Symptoms (after sleep or control/mealtime intervention)

  Eyberg Child Behavior Inventory, Intensity Score

  Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).

Secondary Outcomes (9)

• Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention)

  Change from baseline (first visit) to midpoint 1 (after sleep or mealtime intervention, approximately 6 weeks after visit 1).

• Objective Estimate of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)

  Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)

• Objective Estimate of Child Sleep Patterns (before and after sleep intervention; pre/post)

  Change from baseline (first visit) to midpoint 1 (after sleep, approximately six weeks after visit 1) for the sleep condition and midpoint 2 to final (approximately six week after midpoint 2) for the mealtime condition.

• Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention)

  Change from baseline (first visit) to midpoint 1 (after sleep/mealtime intervention, approximately 6 weeks after visit 1).

• Subjective Report of Child Sleep Patterns (after sleep or control/mealtime intervention + parent training)

  Change from baseline (first visit) to midpoint 2 (after parent training but before crossover, approximately 12-14 weeks after baseline)

Study Arms (2)

Sleep First

EXPERIMENTAL

Families in this condition will receive a behavioral sleep intervention program (The Sleep Train Program) first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive the mealtime intervention (The Family Mealtimes Program).

Behavioral: The Sleep Train Program; Behavioral: The Family Mealtimes Program

Mealtimes First

ACTIVE COMPARATOR

Families in this active comparison condition will receive a behavioral treatment to promote positive family mealtimes first, prior to a parent training intervention for disruptive behavior. After the completion of the parent training program and several assessment periods, families will receive a behavioral sleep intervention (The Sleep Train Program).

Behavioral: The Sleep Train Program; Behavioral: The Family Mealtimes Program

Interventions

The Sleep Train Program BEHAVIORAL

This modular behavioral sleep intervention includes required modules on sleep routines and sleep habits, and optional modules on bedtime problems, fears, anxiety, and independent sleep.

Mealtimes First; Sleep First

The Family Mealtimes Program BEHAVIORAL

This modular behavioral mealtime intervention includes required modules on mealtime routines and healthy mealtime habits, and optional modules on picky eating and mealtime behavior difficulties.

Mealtimes First; Sleep First

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver participating in treatment lives at home with the child at least 50% of the time
• Child has an Eyberg Problem or Intensity T score of 60 or greater OR an Achenbach score of 60 or greater on the Externalizing scale

You may not qualify if:

• Child is working with another therapist or provider to address either sleep or disruptive behaviors
• Child is taking medications known to impact sleep
• Child has symptoms of obstructive sleep apnea (OSA) and OSA has not been ruled out via a sleep study
• Child has a sibling who is already participating in the study
• Child has been diagnosed with an autism spectrum disorder

Sponsors & Collaborators

• Indiana University: lead
• Indiana University School of Medicine: collaborator

Related Publications (1)

• McQuillan ME, Bates JE, Hoyniak CP, Staples AD, Honaker SM. Children's Sleep and Externalizing Problems: A Day-to-day Multilevel Modeling Approach. Behav Sleep Med. 2023 Nov 2;21(6):712-726. doi: 10.1080/15402002.2022.2156510. Epub 2022 Dec 13.

  PMID: 36514294 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Sarah M Honaker, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share