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Sleep Health in Preschoolers: a Randomized Controlled Trial (SHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255721
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Michelle Garrison, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 30, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date August 12, 2020
Actual Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 30, 2014)
  • Change in parent-reported and actigraphic sleep hygiene behaviors [ Time Frame: Baseline, 3-month follow-up ]
    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)
  • Change in parent-reported and actigraphic sleep hygiene behaviors [ Time Frame: Baseline, 12-month follow-up ]
    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)
  • Change in survey-reported parent sleep-related beliefs and attitudes [ Time Frame: Baseline, 3-month follow-up ]
    Change in survey-reported parent sleep-related beliefs and attitudes (modified MCISQ, plus outcomes expectations and self-efficacy on sleep)
  • Change in parent sleep and functioning via diary and survey self-report [ Time Frame: Baseline, 3-month follow-up ]
    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)
  • Change in parent sleep and functioning via diary and survey self-report [ Time Frame: Baseline, 12-month follow-up ]
    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)
  • Change in parent sleep and functioning via diary and survey self-report [ Time Frame: Baseline,24-month follow-up ]
    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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Sleep Health in Preschoolers: a Randomized Controlled Trial
Official Title  ICMJE Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: SHIP (Sleep Health in Preschoolers)
  • 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.
    Intervention: Behavioral: SHIP Control Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2014)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 71 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255721
Other Study ID Numbers  ICMJE 416530030101
R01HD071937 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle Garrison, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Michelle Garrison, PhD Seattle Children's Research Institute
PRS Account Seattle Children's Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP