Behavioral Sleep Intervention in Children With Disruptive Behaviors
Condition: Insomnia; Disruptive Behavior Disorder; Oppositional Defiant Disorder
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

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.
    

Intervention name(s): The Sleep Train Program; The Family Mealtimes Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep; Electrodermal Activity; Mealtimes