<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996175</url>
  </required_header>
  <id_info>
    <org_study_id>1R21HD082307-01A1</org_study_id>
    <nct_id>NCT02996175</nct_id>
  </id_info>
  <brief_title>Treatment of Sleep Disturbances in School-age Children With Down Syndrome</brief_title>
  <official_title>Treatment of Sleep Disturbances in School-age Children With Down Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators long-term goal is to improve outcomes for children with Down syndrome (DS)&#xD;
      and their caregivers. Towards that goal, the investigators propose a randomized clinical&#xD;
      trial of a behavioral sleep treatment designed specifically for children with DS, documenting&#xD;
      the impact not only on sleep, but also on the child's daytime inhibitory control and behavior&#xD;
      problems, and the caregiver's sleep and stress levels. The investigators will randomize 80&#xD;
      families of children with DS ages 6-17 to receive either a 5-session behavioral sleep&#xD;
      treatment (BST; targeting sleep education, behavioral principles and visual supports) or a&#xD;
      general-education control condition (CON). The BST will cater to the unique needs of children&#xD;
      with DS, adapting an intervention that successfully treats behavioral sleep disturbances in&#xD;
      children with autism1. Pre- and post-intervention, children will undergo comprehensive&#xD;
      assessments of cognitive, behavioral, and adaptive functioning involving direct testing and&#xD;
      input from parents and teachers. Child and parent sleep will be monitored via actigraphy and&#xD;
      parent-completed sleep diaries, and parents will report on their stress levels and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators long-term goal is to improve outcomes for children with DS and their&#xD;
      caregivers. Towards that goal, the investigators propose a randomized clinical trial of a&#xD;
      behavioral sleep treatment designed specifically for children with DS, documenting the impact&#xD;
      not only on sleep, but also on the child's daytime inhibitory control and behavior problems,&#xD;
      and the caregiver's sleep and stress levels. The investigators will randomize 80 families of&#xD;
      children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST;&#xD;
      targeting sleep education, behavioral principles and visual supports) or a general-education&#xD;
      control condition (CON). The BST will catered to the unique needs of children with DS,&#xD;
      adapting an intervention developed by a member of the investigators research team with NIH&#xD;
      support (R34 MH082882) that successfully treats behavioral sleep disturbances in children&#xD;
      with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of&#xD;
      cognitive, behavioral, and adaptive functioning involving direct testing and input from&#xD;
      parents and teachers. Child and parent sleep will be monitored via actigraphy and&#xD;
      parent-completed sleep diaries, and parents will report on their stress levels and mood. As a&#xD;
      critical first step towards an effective treatment, this initial efficacy study will address&#xD;
      3 aims:&#xD;
&#xD;
      Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.&#xD;
&#xD;
      Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON&#xD;
      condition.&#xD;
&#xD;
      Aim #2: Test the impact of the BST on the daytime functioning of children with DS.&#xD;
&#xD;
      Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general&#xD;
      behavior problems and other measures of executive dysfunction than in the CON condition.&#xD;
&#xD;
      Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers'&#xD;
      sleep and stress.&#xD;
&#xD;
      Hypothesis 3: Parents of children receiving BST will have improved sleep duration and&#xD;
      decreased stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)</measure>
    <time_frame>Baseline, 6 Weeks, 19 Weeks</time_frame>
    <description>33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99.&#xD;
This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)</measure>
    <time_frame>Baseline, 6 Weeks, 19 Weeks</time_frame>
    <description>113-Item parent report measure for child behavior now. Each item is scored 0-2 (0 = Not True (as far as you know); 1 = Somewhat or Sometimes True; 2 = Very True or Often True. Scoring is done through software giving T-scores for 8 subscales with borderline and clinical ranges identified. SPSS will be used for analysis to compare to parent report data from a daily behavior journal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).</measure>
    <time_frame>Baseline, 6 Weeks, 19 Weeks</time_frame>
    <description>50-item parent report measure rating child's impact on family and different areas of family functioning. Each of the first 48 items are scored 1-4 (1 = Not at all; 2 = Somewhat; 3 = Much; 4 = Very Much) and items 48 &amp; 49 scored 1-7 (1 = Much Easier; 2 = Easier; 3 = Slightly Easier; 4 = About the Same; 5 = Slightly More Difficult; 6 = More Difficult; 7 = Much More Difficult). There are 5 items that are reverse scored. Scoring yields T-scores for 7 subscales.Data will be entered into SPSS and used as a parental stress scale for social impact.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>SMART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group targeting behavioral sleep problems for 5 weeks.&#xD;
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&#xD;
Information on healthy sleep hygiene, preventative techniques, and use of visual supports&#xD;
Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking&#xD;
Information on procedures for delayed sleep onset and problematic sleep associations&#xD;
Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WISE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Sleep Treatment</intervention_name>
    <description>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&#xD;
Information on healthy sleep hygiene, preventative techniques, and use of visual supports&#xD;
Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking&#xD;
Information on procedures for delayed sleep onset and problematic sleep associations&#xD;
Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future</description>
    <arm_group_label>SMART</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care sleep treatment enhanced with psychoeducation</intervention_name>
    <description>Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome&#xD;
Introduction to understanding and interpreting results from clinical evaluations&#xD;
Introduction to educational planning, expectations, and transition planning&#xD;
Introduction to lifespan development and advocacy and support services available&#xD;
Feedback on current concerns and methods for obtaining services to manage concerns</description>
    <arm_group_label>WISE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Down Syndrome&#xD;
&#xD;
          -  6-17 years of age&#xD;
&#xD;
          -  behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance,&#xD;
             delayed sleep onset, problematic sleep associations, nighttime awakenings or morning&#xD;
             awakenings)&#xD;
&#xD;
          -  English as primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism&#xD;
             Spectrum Disorder&#xD;
&#xD;
          -  History of blindness,deafness,motor impairment&#xD;
&#xD;
          -  nonverbal mental age below 36 months&#xD;
&#xD;
          -  any medication change w/in past 2 months affecting sleep&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 30, 2015</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>June 1, 2018</last_update_submitted>
  <last_update_submitted_qc>June 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Behavior</keyword>
  <keyword>Sleep</keyword>
  <keyword>Problems</keyword>
  <keyword>Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996175
org study id: 1R21HD082307-01A1
nct id: NCT02996175
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
time frame: Baseline, 6 Weeks, 19 Weeks
description: 33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99.
This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.
measure: Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)
time frame: Baseline, 6 Weeks, 19 Weeks
description: 113-Item parent report measure for child behavior now. Each item is scored 0-2 (0 = Not True (as far as you know); 1 = Somewhat or Sometimes True; 2 = Very True or Often True. Scoring is done through software giving T-scores for 8 subscales with borderline and clinical ranges identified. SPSS will be used for analysis to compare to parent report data from a daily behavior journal.
measure: Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).
time frame: Baseline, 6 Weeks, 19 Weeks
description: 50-item parent report measure rating child's impact on family and different areas of family functioning. Each of the first 48 items are scored 1-4 (1 = Not at all; 2 = Somewhat; 3 = Much; 4 = Very Much) and items 48 & 49 scored 1-7 (1 = Much Easier; 2 = Easier; 3 = Slightly Easier; 4 = About the Same; 5 = Slightly More Difficult; 6 = More Difficult; 7 = Much More Difficult). There are 5 items that are reverse scored. Scoring yields T-scores for 7 subscales.Data will be entered into SPSS and used as a parental stress scale for social impact.
arm group label: SMART
arm group type: Experimental
description: Treatment group targeting behavioral sleep problems for 5 weeks.
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
arm group label: WISE
arm group type: Active Comparator
description: Standard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns
intervention type: Behavioral
intervention name: Behavioral Sleep Treatment
description: 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
arm group label: SMART
intervention type: Behavioral
intervention name: Standard of care sleep treatment enhanced with psychoeducation
description: 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
arm group label: WISE
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Down Syndrome
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Syndrome