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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

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Behavioral: SHIP (Sleep Health in Preschoolers) Behavioral: SHIP Control Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
Actual Study Start Date : November 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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 ]
  7. 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)

  8. 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).

  9. 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)

  10. 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)

  11. 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

  12. 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)


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255721


Locations
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United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98145-5005
Sponsors and Collaborators
Seattle Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Michelle Garrison, PhD Seattle Children's Research Institute
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Responsible Party: Michelle Garrison, Research Assistant Professor, University of Washington, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02255721    
Other Study ID Numbers: 416530030101
R01HD071937 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders