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SHIP Intervention for Insomnia (SHIP Trial)

N/A
Waitlist Available
Led By Michelle Garrison, PhD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Insomnia
  • Sleep Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in actigraphic and diary measured sleep quantity and quality measures
Change in actigraphic and parent report measures of sleep onset difficulties
Secondary study objectives
Change in child anthropometric measures
Change in directly assessed performance on WJIII NU achievement battery and executive function
Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
+4 more
Other study objectives
Change in parent sleep and functioning via diary and survey self-report
Change in parent-reported and actigraphic sleep hygiene behaviors
Change in survey-reported parent sleep-related beliefs and attitudes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SHIP InterventionExperimental Treatment1 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 II: SHIP Control ArmActive Control1 Intervention
The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,230,594 Total Patients Enrolled
2 Trials studying Insomnia
245 Patients Enrolled for Insomnia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,045 Previous Clinical Trials
2,730,453 Total Patients Enrolled
4 Trials studying Insomnia
8,600 Patients Enrolled for Insomnia
Michelle Garrison, PhDPrincipal InvestigatorSeattle Children's Research Institute
~42 spots leftby Nov 2025