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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
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.
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.
Seattle Children's Research Institute
Seattle, Washington, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 36-month follow-up
Change in child anthropometric measures
Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Time frame: Baseline, 24-month follow-up
Change in child anthropometric measures
Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Time frame: Baseline, 36-month follow-up
Trajectory in child anthropometric measures
Trajectory in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
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
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)
Time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up