Sleep Health in Preschoolers: a Randomized Controlled Trial

Study Overview
=================
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.

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

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Behavioral: SHIP (Sleep Health in Preschoolers)
* Behavioral: SHIP Control Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 71 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHIP Intervention<br>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)<br>* 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.<br>|
| Active Comparator: SHIP Control Arm<br>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<br>* 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.<br>|

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 |