Sleep Health in Preschoolers: a Randomized Controlled Trial

NCT02255721 | Unknown

• 2 other identifiers: 416530030101R01HD071937
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• Change in child anthropometric measures

  Baseline, 24-month follow-up

• Change in child anthropometric measures

  Baseline, 36-month follow-up

• Trajectory in child anthropometric measures

  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

  Baseline, 3-month follow-up

• Change in parent-reported child behavioral and emotional symptoms and executive function

  Baseline, 12-month follow-up

Other Outcomes (6)

• Change in parent-reported and actigraphic sleep hygiene behaviors

  Baseline, 3-month follow-up

• Change in parent-reported and actigraphic sleep hygiene behaviors

  Baseline, 12-month follow-up

• Change in survey-reported parent sleep-related beliefs and attitudes

  Baseline, 3-month follow-up

Study Arms (2)

SHIP Intervention

EXPERIMENTAL

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)

SHIP Control Arm

ACTIVE COMPARATOR

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

Interventions

SHIP (Sleep Health in Preschoolers) 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 Intervention

SHIP Control Arm 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.

SHIP Control Arm

Eligibility Criteria

• Age: 30 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145-5005, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ships

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Transportation; Technology, Industry, and Agriculture

Study Officials

• Michelle Garrison, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor, University of Washington

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (1)