Sleep Health in Preschoolers: a Randomized Controlled Trial

Not Applicable

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: SHIP (Sleep Health in Preschoolers); Behavioral: SHIP Control Arm

• Registration Number: NCT02255721
• Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHIP Intervention	SHIP (Sleep Health in Preschoolers)	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.
SHIP Control Arm	SHIP Control Arm	The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.

Primary Outcome Measures

Name	Time	Method
Change in actigraphic and diary measured sleep quantity and quality measures	Baseline, 36-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, 36-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 Outcome Measures

Name	Time	Method
Change in child anthropometric measures	Baseline, 36-month follow-up	Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
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, 12-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 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)
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 directly assessed performance on WJIII NU achievement battery and executive function	Baseline, 36-month follow-up	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)
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)

Trial Locations

Locations (1)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States