Clinical trial NCT02255721: Sleep Health in Preschoolers: a Randomized Controlled Trial
Official title: Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-10-02
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in actigraphic and diary measured sleep quantity and quality measures
timeFrame: Baseline, 3-month follow-up
measure: Change in actigraphic and diary measured sleep quantity and quality measures
timeFrame: Baseline, 12-month follow-up
measure: Change in actigraphic and diary measured sleep quantity and quality measures
timeFrame: Baseline, 24-month follow-up
measure: Change in actigraphic and diary measured sleep quantity and quality measures
timeFrame: Baseline, 36-month follow-up
measure: Change in actigraphic and parent report measures of sleep onset difficulties
timeFrame: Baseline, 3-month follow-up
measure: Change in actigraphic and parent report measures of sleep onset difficulties
timeFrame: Baseline, 12-month follow-up
measure: Change in actigraphic and parent report measures of sleep onset difficulties
timeFrame: Baseline, 24-month follow-up
measure: Change in actigraphic and parent report measures of sleep onset difficulties
timeFrame: Baseline, 36-month follow-up
Secondary outcomes:
measure: Change in child anthropometric measures
timeFrame: Baseline, 24-month follow-up
measure: Change in child anthropometric measures
timeFrame: Baseline, 36-month follow-up
measure: Trajectory in child anthropometric measures
timeFrame: Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up
measure: Change in parent-reported child behavioral and emotional symptoms and executive function
timeFrame: Baseline, 3-month follow-up
measure: Change in parent-reported child behavioral and emotional symptoms and executive function
timeFrame: Baseline, 12-month follow-up
measure: 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)
timeFrame: Baseline, 24-month follow-up
measure: Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
timeFrame: Baseline, 36-month follow-up
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
timeFrame: Baseline, 12-month follow-up
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
timeFrame: Baseline, 24-month follow-up
measure: Change in directly assessed performance on WJIII NU achievement battery and executive function
timeFrame: Baseline, 36-month follow-up
measure: Trajectory in actigraphic and diary measured sleep quantity and quality measures
timeFrame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
measure: Trajectory in actigraphic and parent report measures of sleep onset difficulties
timeFrame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
Other outcomes:
measure: Change in parent-reported and actigraphic sleep hygiene behaviors
timeFrame: Baseline, 3-month follow-up
measure: Change in parent-reported and actigraphic sleep hygiene behaviors
timeFrame: Baseline, 12-month follow-up
measure: Change in survey-reported parent sleep-related beliefs and attitudes
timeFrame: Baseline, 3-month follow-up
measure: Change in parent sleep and functioning via diary and survey self-report
timeFrame: Baseline, 3-month follow-up
measure: Change in parent sleep and functioning via diary and survey self-report
timeFrame: Baseline, 12-month follow-up
measure: Change in parent sleep and functioning via diary and survey self-report
timeFrame: Baseline,24-month follow-up
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Michelle Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References: