Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
BEHAVIORALSHIP (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.
BEHAVIORALSHIP 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 71 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in actigraphic and diary measured sleep quantity and quality measures | 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 |
| Change in actigraphic and parent report measures of sleep onset difficulties | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trajectory in child anthropometric measures | 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) |
| Change in parent-reported child behavioral and emotional symptoms and executive function | 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) |
| 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 child anthropometric measures | Baseline, 24-month follow-up | Change in child anthropometric measures (BMI z-score for age and gender, waist circumference) |
| Change in directly assessed performance on WJIII NU achievement battery and executive function | 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). |
| Trajectory in actigraphic and diary measured sleep quantity and quality measures | 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 |
| Trajectory in actigraphic and parent report measures of sleep onset difficulties | 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) |
| Change in parent & teacher-reported child behavioral and emotional symptoms and executive function | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in parent-reported and actigraphic sleep hygiene behaviors | 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) |
| Change in parent sleep and functioning via diary and survey self-report | 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) |
| Change in survey-reported parent sleep-related beliefs and attitudes | 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) |
Countries
United States
Outcome results
None listed