Treatment of Sleep Disturbances in School-age Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Dyssomnias; Parasomnias; Syndrome
Study type: Interventional

Summary: 
      The investigators long-term goal is to improve outcomes for children with Down syndrome (DS)
      and their caregivers. Towards that goal, the investigators propose a randomized clinical
      trial of a behavioral sleep treatment designed specifically for children with DS, documenting
      the impact not only on sleep, but also on the child's daytime inhibitory control and behavior
      problems, and the caregiver's sleep and stress levels. The investigators will randomize 80
      families of children with DS ages 6-17 to receive either a 5-session behavioral sleep
      treatment (BST; targeting sleep education, behavioral principles and visual supports) or a
      general-education control condition (CON). The BST will cater to the unique needs of children
      with DS, adapting an intervention that successfully treats behavioral sleep disturbances in
      children with autism1. Pre- and post-intervention, children will undergo comprehensive
      assessments of cognitive, behavioral, and adaptive functioning involving direct testing and
      input from parents and teachers. Child and parent sleep will be monitored via actigraphy and
      parent-completed sleep diaries, and parents will report on their stress levels and mood.
    

Detailed description: 
      The investigators long-term goal is to improve outcomes for children with DS and their
      caregivers. Towards that goal, the investigators propose a randomized clinical trial of a
      behavioral sleep treatment designed specifically for children with DS, documenting the impact
      not only on sleep, but also on the child's daytime inhibitory control and behavior problems,
      and the caregiver's sleep and stress levels. The investigators will randomize 80 families of
      children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST;
      targeting sleep education, behavioral principles and visual supports) or a general-education
      control condition (CON). The BST will catered to the unique needs of children with DS,
      adapting an intervention developed by a member of the investigators research team with NIH
      support (R34 MH082882) that successfully treats behavioral sleep disturbances in children
      with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of
      cognitive, behavioral, and adaptive functioning involving direct testing and input from
      parents and teachers. Child and parent sleep will be monitored via actigraphy and
      parent-completed sleep diaries, and parents will report on their stress levels and mood. As a
      critical first step towards an effective treatment, this initial efficacy study will address
      3 aims:

      Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.

      Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON
      condition.

      Aim #2: Test the impact of the BST on the daytime functioning of children with DS.

      Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general
      behavior problems and other measures of executive dysfunction than in the CON condition.

      Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers'
      sleep and stress.

      Hypothesis 3: Parents of children receiving BST will have improved sleep duration and
      decreased stress.
    

Intervention name(s): Behavioral Sleep Treatment; Standard of care sleep treatment enhanced with psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems
Information on healthy sleep hygiene, preventative techniques, and use of visual supports
Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking
Information on procedures for delayed sleep onset and problematic sleep associations
Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future; Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome
Introduction to understanding and interpreting results from clinical evaluations
Introduction to educational planning, expectations, and transition planning
Introduction to lifespan development and advocacy and support services available
Feedback on current concerns and methods for obtaining services to manage concerns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Behavior; Sleep; Problems; Intervention