<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/NCT02255721</url>
  </required_header>
  <id_info>
    <org_study_id>416530030101</org_study_id>
    <secondary_id>R01HD071937</secondary_id>
    <nct_id>NCT02255721</nct_id>
  </id_info>
  <brief_title>Sleep Health in Preschoolers: a Randomized Controlled Trial</brief_title>
  <acronym>SHIP</acronym>
  <official_title>Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SHIP study is a randomized controlled trial of an intervention for preschool children&#xD;
      with sleep problems, in which we aim to give parents the knowledge, motivation, and skills&#xD;
      necessary to set goals, problem-solve, and improve their child's sleep. In collecting three&#xD;
      years of follow-up data, we will be able to determine the impact of the SHIP intervention on&#xD;
      childhood sleep problems, obesity, academic achievement, and emotional and behavioral&#xD;
      problems, as well as parental stress and daytime tiredness. This study has the dual potential&#xD;
      to expand treatment resources for young children with behavioral sleep problems and to&#xD;
      increase our scientific understanding of the long-term consequences of early childhood sleep&#xD;
      problems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in actigraphic and diary measured sleep quantity and quality measures</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and diary measured sleep quantity and quality measures</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and diary measured sleep quantity and quality measures</measure>
    <time_frame>Baseline, 24-month follow-up</time_frame>
    <description>Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and diary measured sleep quantity and quality measures</measure>
    <time_frame>Baseline, 36-month follow-up</time_frame>
    <description>Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and parent report measures of sleep onset difficulties</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and parent report measures of sleep onset difficulties</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and parent report measures of sleep onset difficulties</measure>
    <time_frame>Baseline, 24-month follow-up</time_frame>
    <description>Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in actigraphic and parent report measures of sleep onset difficulties</measure>
    <time_frame>Baseline, 36-month follow-up</time_frame>
    <description>Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in child anthropometric measures</measure>
    <time_frame>Baseline, 24-month follow-up</time_frame>
    <description>Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child anthropometric measures</measure>
    <time_frame>Baseline, 36-month follow-up</time_frame>
    <description>Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory in child anthropometric measures</measure>
    <time_frame>Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up</time_frame>
    <description>Trajectory in child anthropometric measures (BMI z-score for age and gender, waist circumference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent-reported child behavioral and emotional symptoms and executive function</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent-reported child behavioral and emotional symptoms and executive function</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent &amp; teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)</measure>
    <time_frame>Baseline, 24-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent &amp; teacher-reported child behavioral and emotional symptoms and executive function</measure>
    <time_frame>Baseline, 36-month follow-up</time_frame>
    <description>Change in parent &amp; teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in directly assessed performance on WJIII NU achievement battery and executive function</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language and basic reading skills) and executive function (iPad-based testing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in directly assessed performance on WJIII NU achievement battery and executive function</measure>
    <time_frame>Baseline, 24-month follow-up</time_frame>
    <description>Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in directly assessed performance on WJIII NU achievement battery and executive function</measure>
    <time_frame>Baseline, 36-month follow-up</time_frame>
    <description>Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory in actigraphic and diary measured sleep quantity and quality measures</measure>
    <time_frame>Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up</time_frame>
    <description>Trajectory in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trajectory in actigraphic and parent report measures of sleep onset difficulties</measure>
    <time_frame>Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up</time_frame>
    <description>Trajectory in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in parent-reported and actigraphic sleep hygiene behaviors</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in parent-reported and actigraphic sleep hygiene behaviors (Child Sleep Hygiene Scale total score and subscales, % of diary nights with parent in bedroom at sleep onset, mean diary-reported screen time during two hours prior to bedtime, mean actigraphic physical activity during two hours prior to bedtime, mean actigraphic light exposure during two hours prior to bedtime, mean actigraphic light exposure at nocturnal sleep midpoint)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in parent-reported and actigraphic sleep hygiene behaviors</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in parent-reported and actigraphic sleep hygiene behaviors (Child Sleep Hygiene Scale total score and subscales, % of diary nights with parent in bedroom at sleep onset, mean diary-reported screen time during two hours prior to bedtime, mean actigraphic physical activity during two hours prior to bedtime, mean actigraphic light exposure during two hours prior to bedtime, mean actigraphic light exposure at nocturnal sleep midpoint)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in survey-reported parent sleep-related beliefs and attitudes</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in survey-reported parent sleep-related beliefs and attitudes (modified MCISQ, plus outcomes expectations and self-efficacy on sleep)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in parent sleep and functioning via diary and survey self-report</measure>
    <time_frame>Baseline, 3-month follow-up</time_frame>
    <description>Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in parent sleep and functioning via diary and survey self-report</measure>
    <time_frame>Baseline, 12-month follow-up</time_frame>
    <description>Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in parent sleep and functioning via diary and survey self-report</measure>
    <time_frame>Baseline,24-month follow-up</time_frame>
    <description>Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>SHIP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SHIP is a health behavior change intervention to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SHIP Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SHIP (Sleep Health in Preschoolers)</intervention_name>
    <description>SHIP (Sleep Health in Preschoolers) is a family-centered health behavior change intervention for child behavioral sleep problems delivered 1:1 to parents via a home visit and follow-up phone calls.</description>
    <arm_group_label>SHIP Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SHIP Control Arm</intervention_name>
    <description>Families will receive a family-centered health behavior change intervention for child health topics unrelated to sleep or outcome measures, delivered 1:1 to parents via a home visit and follow-up phone calls.</description>
    <arm_group_label>SHIP Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 30-71 months&#xD;
&#xD;
          -  Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep&#xD;
             Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight&#xD;
             sleep of 9hrs or less per night&#xD;
&#xD;
          -  English speaking parent or guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5&#xD;
&#xD;
          -  Currently taking prescribed sleep medications, psychostimulants, and/or systemic&#xD;
             corticosteroids&#xD;
&#xD;
          -  Serious medical conditions likely to affect sleep, including diabetes or cancer&#xD;
&#xD;
          -  Major cognitive or developmental disorder, including autism spectrum disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Garrison, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98145-5005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Michelle Garrison</investigator_full_name>
    <investigator_title>Research Assistant Professor, University of Washington</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT02255721
org study id: 416530030101
secondary id: R01HD071937
nct id: NCT02255721
lead sponsor: 
collaborator: 
has dmc: No
The SHIP study is a randomized controlled trial of an intervention for preschool children
      with sleep problems, in which we aim to give parents the knowledge, motivation, and skills
      necessary to set goals, problem-solve, and improve their child's sleep. In collecting three
      years of follow-up data, we will be able to determine the impact of the SHIP intervention on
      childhood sleep problems, obesity, academic achievement, and emotional and behavioral
      problems, as well as parental stress and daytime tiredness. This study has the dual potential
      to expand treatment resources for young children with behavioral sleep problems and to
      increase our scientific understanding of the long-term consequences of early childhood sleep
      problems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in actigraphic and diary measured sleep quantity and quality measures
time frame: Baseline, 3-month follow-up
description: Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
measure: Change in actigraphic and diary measured sleep quantity and quality measures
time frame: Baseline, 12-month follow-up
description: Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
measure: Change in actigraphic and diary measured sleep quantity and quality measures
time frame: Baseline, 24-month follow-up
description: Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measure
measure: Change in actigraphic and diary measured sleep quantity and quality measures
time frame: Baseline, 36-month follow-up
description: Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
measure: Change in actigraphic and parent report measures of sleep onset difficulties
time frame: Baseline, 3-month follow-up
description: Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
measure: Change in actigraphic and parent report measures of sleep onset difficulties
time frame: Baseline, 12-month follow-up
description: Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
measure: Change in actigraphic and parent report measures of sleep onset difficulties
time frame: Baseline, 24-month follow-up
description: Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
measure: Change in actigraphic and parent report measures of sleep onset difficulties
time frame: Baseline, 36-month follow-up
description: Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
measure: Change in child anthropometric measures
time frame: Baseline, 24-month follow-up
description: Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
measure: Change in child anthropometric measures
time frame: Baseline, 36-month follow-up
description: Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
measure: Trajectory in child anthropometric measures
time frame: Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up
description: Trajectory in child anthropometric measures (BMI z-score for age and gender, waist circumference)
measure: Change in parent-reported child behavioral and emotional symptoms and executive function
time frame: Baseline, 3-month follow-up
description: Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
measure: Change in parent-reported child behavioral and emotional symptoms and executive function
time frame: Baseline, 12-month follow-up
description: Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
measure: Change in parent & teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
time frame: Baseline, 24-month follow-up
measure: Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
time frame: Baseline, 36-month follow-up
description: Change in parent & teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
time frame: Baseline, 12-month follow-up
description: Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language and basic reading skills) and executive function (iPad-based testing).
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
time frame: Baseline, 24-month follow-up
description: Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
time frame: Baseline, 36-month follow-up
description: Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)
measure: Trajectory in actigraphic and diary measured sleep quantity and quality measures
time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
description: Trajectory in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
measure: Trajectory in actigraphic and parent report measures of sleep onset difficulties
time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
description: Trajectory in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
measure: Change in parent-reported and actigraphic sleep hygiene behaviors
time frame: Baseline, 3-month follow-up
description: Change in parent-reported and actigraphic sleep hygiene behaviors (Child Sleep Hygiene Scale total score and subscales, % of diary nights with parent in bedroom at sleep onset, mean diary-reported screen time during two hours prior to bedtime, mean actigraphic physical activity during two hours prior to bedtime, mean actigraphic light exposure during two hours prior to bedtime, mean actigraphic light exposure at nocturnal sleep midpoint)
measure: Change in parent-reported and actigraphic sleep hygiene behaviors
time frame: Baseline, 12-month follow-up
description: Change in parent-reported and actigraphic sleep hygiene behaviors (Child Sleep Hygiene Scale total score and subscales, % of diary nights with parent in bedroom at sleep onset, mean diary-reported screen time during two hours prior to bedtime, mean actigraphic physical activity during two hours prior to bedtime, mean actigraphic light exposure during two hours prior to bedtime, mean actigraphic light exposure at nocturnal sleep midpoint)
measure: Change in survey-reported parent sleep-related beliefs and attitudes
time frame: Baseline, 3-month follow-up
description: Change in survey-reported parent sleep-related beliefs and attitudes (modified MCISQ, plus outcomes expectations and self-efficacy on sleep)
measure: Change in parent sleep and functioning via diary and survey self-report
time frame: Baseline, 3-month follow-up
description: Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)
measure: Change in parent sleep and functioning via diary and survey self-report
time frame: Baseline, 12-month follow-up
description: Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)
measure: Change in parent sleep and functioning via diary and survey self-report
time frame: Baseline,24-month follow-up
description: Change in parent sleep and functioning via diary and survey self-report (parent nocturnal sleep time and sleep onset latency, parent PROMIS scores for sleep disturbance, PedsQL family impact score and subscales, missed work days, productivity)
arm group label: SHIP Intervention
arm group type: Experimental
description: SHIP is a health behavior change intervention to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep.
arm group label: SHIP Control Arm
arm group type: Active Comparator
description: The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.
intervention type: Behavioral
intervention name: SHIP (Sleep Health in Preschoolers)
description: SHIP (Sleep Health in Preschoolers) is a family-centered health behavior change intervention for child behavioral sleep problems delivered 1:1 to parents via a home visit and follow-up phone calls.
arm group label: SHIP Intervention
intervention type: Behavioral
intervention name: SHIP Control Arm
description: Families will receive a family-centered health behavior change intervention for child health topics unrelated to sleep or outcome measures, delivered 1:1 to parents via a home visit and follow-up phone calls.
arm group label: SHIP Control Arm
criteria: 
gender: All
minimum age: 30 Months
maximum age: 71 Months
healthy volunteers: No
last name: Michelle Garrison, PhD
role: Principal Investigator
affiliation: Seattle Children's Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Michelle Garrison
investigator title: Research Assistant Professor, University of Washington
mesh term: Sleep Initiation and Maintenance Disorders