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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD071937 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHIP Intervention | Experimental | 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. |
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| SHIP Control Arm | Active Comparator | The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHIP (Sleep Health in Preschoolers) | Behavioral | 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. |
| 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) |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Garrison, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Research Institute | Seattle | Washington | 98145-5005 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012767 | Ships |
| ID | Term |
|---|---|
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
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| SHIP Control Arm | Behavioral | 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. |
|
| 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 |
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 |
| 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 |
| D001523 |
| Mental Disorders |