Sleep Health in Preschoolers: a Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SHIP Intervention

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.

Group Type EXPERIMENTAL

SHIP (Sleep Health in Preschoolers)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

SHIP Control Arm

Intervention Type 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.

Interventions

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SHIP (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.

Intervention Type BEHAVIORAL

SHIP 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No