An interventional study of SHIP (Sleep Health in Preschoolers) and SHIP Control Arm in Sleep Initiation and Maintenance Disorders, sponsored by Seattle Children's Hospital. Status unknown at 1 site in United States. Open to participants aged 30 Months to 71 Months. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 500 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Seattle Children's Hospital is the lead sponsor of 211 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
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.
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)
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline,24-month follow-up
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Sleep Initiation and Maintenance Disorders→
Seattle Children's Hospital