Sleep Health in Preschoolers: a Randomized Controlled Trial

Overview

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.

Full Title of Study: “Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • Behavioral: SHIP (Sleep Health in Preschoolers)
    • 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.
  • Behavioral: SHIP Control Arm
    • 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.

Arms, Groups and Cohorts

  • Experimental: SHIP Intervention
    • 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.
  • Active Comparator: SHIP Control Arm
    • The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.

Clinical Trial Outcome Measures

Primary Measures

  • Change in actigraphic and diary measured sleep quantity and quality measures
    • Time Frame: Baseline, 3-month follow-up
    • Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
  • Change in actigraphic and diary measured sleep quantity and quality measures
    • Time Frame: Baseline, 12-month follow-up
    • Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
  • Change in actigraphic and diary measured sleep quantity and quality measures
    • Time Frame: Baseline, 24-month follow-up
    • Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measure
  • Change in actigraphic and diary measured sleep quantity and quality measures
    • Time Frame: Baseline, 36-month follow-up
    • Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
  • Change in actigraphic and parent report measures of sleep onset difficulties
    • Time Frame: Baseline, 3-month follow-up
    • 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)
  • Change in actigraphic and parent report measures of sleep onset difficulties
    • Time Frame: Baseline, 12-month follow-up
    • 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)
  • Change in actigraphic and parent report measures of sleep onset difficulties
    • Time Frame: Baseline, 24-month follow-up
    • 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)
  • Change in actigraphic and parent report measures of sleep onset difficulties
    • Time Frame: Baseline, 36-month follow-up
    • 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)

Secondary Measures

  • Change in child anthropometric measures
    • Time Frame: Baseline, 24-month follow-up
    • Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
  • Change in child anthropometric measures
    • Time Frame: Baseline, 36-month follow-up
    • Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
  • Trajectory in child anthropometric measures
    • Time Frame: Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up
    • Trajectory in child anthropometric measures (BMI z-score for age and gender, waist circumference)
  • Change in parent-reported child behavioral and emotional symptoms and executive function
    • Time Frame: Baseline, 3-month follow-up
    • 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)
  • Change in parent-reported child behavioral and emotional symptoms and executive function
    • Time Frame: Baseline, 12-month follow-up
    • 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)
  • 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
  • Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
    • Time Frame: Baseline, 36-month follow-up
    • 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)
  • Change in directly assessed performance on WJIII NU achievement battery and executive function
    • Time Frame: Baseline, 12-month follow-up
    • 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).
  • Change in directly assessed performance on WJIII NU achievement battery and executive function
    • Time Frame: Baseline, 24-month follow-up
    • 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)
  • Change in directly assessed performance on WJIII NU achievement battery and executive function
    • Time Frame: Baseline, 36-month follow-up
    • 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)
  • 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
    • Trajectory in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
  • 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
    • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • Age 30-71 months – Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night – English speaking parent or guardian Exclusion Criteria:

  • Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5 – Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids – Serious medical conditions likely to affect sleep, including diabetes or cancer – Major cognitive or developmental disorder, including autism spectrum disorder

Gender Eligibility: All

Minimum Age: 30 Months

Maximum Age: 71 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seattle Children’s Hospital
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michelle Garrison, Research Assistant Professor, University of Washington – Seattle Children’s Hospital
  • Overall Official(s)
    • Michelle Garrison, PhD, Principal Investigator, Seattle Children’s Research Institute

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