Behavioral Sleep Intervention in Children With Disruptive Behaviors

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Brief Title

Behavioral Sleep Intervention in Children With Disruptive Behaviors

Official Title

The Role of Sleep in Addressing Disruptive Behavior in Children

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.
    

Detailed Description

      Overview: The current study, which is a collaboration between Indiana University at
      Bloomington (PI: Bates) and Indiana University School of Medicine (PI: Honaker), seeks to
      evaluate the impact of adding a sleep component to a parenting intervention that has been
      shown to effectively treat disruptive behavior in children. A mealtime intervention will
      serve as an active control for the sleep treatment component, as the mealtime intervention
      targets changes in a family routine but is unlikely to significantly impact sleep.
      Participants who receive the sleep component are expected to show significant improvements in
      sleep compared to the mealtime group. The investigators further hypothesize that children
      receiving the sleep intervention will have reduced presleep arousal levels compared to
      baseline, and will show greater reduction in presleep arousal levels than the
      mealtime/control group. Finally, because of the documented links between poor sleep and
      externalizing behavior problems and theoretical arguments about sleep mechanisms supporting
      emotional and behavioral self-regulation, the investigators hypothesize that the participants
      who receive the sleep component will show greater reductions in disruptive behavior compared
      to the mealtime/control group.

      Participants and Design: Participants are 3-8-year-old children who exhibit disruptive
      behaviors and their parents. Participants meeting criteria for the parent-training program
      offered as part of the general clinic practice would be approached by the therapist to
      discuss participation in the study. Following the consent procedure, they would be randomly
      assigned to one of two groups. The sleep intervention group would receive a brief, novel
      sleep intervention (The Sleep Train Program) in the context of the parenting program's
      Setting Up for Success segment, which focuses on positive routines. Sleep would be addressed
      briefly as needed in subsequent sessions. The mealtime/control group would not receive any
      particular intervention or guidance regarding sleep, but would instead focus on the routine
      of mealtimes. All families would then receive the same core intervention for disruptive
      behavior. Following the completion of the data collection, families who received the sleep
      component would receive the mealtime component, and vice versa.

      Interventions: The existing parenting skills intervention is largely built on Troubled
      Families: A Treatment Program, a manualized treatment approach with extensive empirical
      support, selected as it is currently delivered by clinical psychology trainees at the
      Psychological Clinic at Indiana University in Bloomington. The sleep intervention and control
      intervention focusing on mealtime structure have been designed to be parallel in terms of
      structure and length. Though neither intervention has been evaluated (both were developed for
      this study), both incorporate treatment strategies with an empirical basis. The sleep
      intervention focuses on sufficient sleep, healthy sleep habits, and a positive bedtime
      routine, with optional modules to help address bedtime problems, night wakings, fears,
      anxiety, and independent sleep. The mealtime intervention focuses on healthy mealtime habits
      and mealtime routines, with optional modules to address picky eating and disruptive mealtime
      behaviors.

      Data collection and measures: Some data will be recorded daily throughout the study,
      including parent diary measures of child sleep and the main child misbehaviors
      (noncompliance, tantrums, aggression). Other data will be collected in 4 major assessments
      periods. The baseline assessment will occur at the end of the initial assessment with the
      family and prior to the first treatment session. The midpoint assessment will occur prior to
      the start of the discipline intervention, approximately six week after the start of
      treatment. This assessment period allows for evaluation of disruptive behavior and sleep
      following the sleep component and an introductory segment (Setting Up for Success), but prior
      to the initiation of the core disruptive behavior / parenting intervention. In other words,
      any improvements in disruptive behavior could be attributed largely to the sleep or mealtime
      addition rather than the core parenting intervention. The second midpoint assessment will
      occur following the core intervention, but prior to initiating the sleep/mealtime component
      not previously covered. This allows for the evaluation of the combined sleep and disruptive
      behavior interventions, as well as a comparison in treatment outcomes for those who received
      the sleep component and those who received the mealtime/control component. A final assessment
      will occur following the conclusion of treatment. Survey data will be collected using on-line
      forms created in REDCap, and completed on a tablet that will be loaned to the family.

      Measures were selected to assess sleep, disruptive behavior, child daytime functioning more
      generally, and family functioning. An actigraph is worn by the child for one week during each
      of the four assessment periods, with interpretation aided by the accompanying sleep diary. An
      Empatica E3 device will be used to assess electro dermal activity (EDA) as a measure of
      presleep arousal. The child will be asked to wear this device each evening from the start of
      the bedtime routine through sleep onset, at which point the parent is asked to remove the
      device.

      Individuals collaborating on this study include: John Bates PhD (co-PI), Indiana University
      at Bloomington; Amy Williams PhD, Indiana University School of Medicine, and several graduate
      students at Indiana University in Bloomington, specifically Maureen McQuillan, Caroline
      Hoyniak, Brittany Rudd, and Kyle Gerst.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Insomnia

Intervention

The Sleep Train Program

Study Arms / Comparison Groups

 Sleep First
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

24

Start Date

May 2016

Completion Date

December 2019

Primary Completion Date

June 2019

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

3 Years - 8 Years

Accepts Healthy Volunteers

No

Contacts

Sarah M Honaker, PhD, , 



Administrative Informations


NCT ID

NCT02783560

Organization ID

2286108

Secondary IDs

UL1TR001108

Responsible Party

Principal Investigator

Study Sponsor

Indiana University

Collaborators

 Indiana University School of Medicine

Study Sponsor

Sarah M Honaker, PhD, Principal Investigator, Indiana University School of Medicine


Verification Date

April 2019