Sleep Health in Preschoolers: a Randomized Controlled Trial (SHIP)

Seattle Children's Healthcare System

Status: Unknown

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Behavioral: SHIP (Sleep Health in Preschoolers); Behavioral: SHIP Control Arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02255721

R01HD071937 (U.S. NIH Grant/Contract)

416530030101

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 30 to 71 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

SHIP Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: SHIP (Sleep Health in Preschoolers)

SHIP Control Arm

Active Comparator group

Description:

The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.

Treatment:

Behavioral: SHIP Control Arm