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

Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Behavioral: SHIP (Sleep Health in Preschoolers); Behavioral: SHIP Control Arm

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145-5005
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent-reported and actigraphic sleep hygiene behaviors	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)	Baseline, 3-month follow-up
Change in parent-reported and actigraphic sleep hygiene behaviors	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)	Baseline, 12-month follow-up
Change in survey-reported parent sleep-related beliefs and attitudes	Change in survey-reported parent sleep-related beliefs and attitudes (modified MCISQ, plus outcomes expectations and self-efficacy on sleep)	Baseline, 3-month follow-up
Change in parent sleep and functioning via diary and survey self-report	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)	Baseline, 3-month follow-up
Change in parent sleep and functioning via diary and survey self-report	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)	Baseline, 12-month follow-up
Change in parent sleep and functioning via diary and survey self-report	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)	Baseline,24-month follow-up

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Michelle Garrison, PhD, Seattle Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 416530030101; R01HD071937 (U.S. NIH Grant/Contract)