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SHS Low-Income for Injury
N/A
Recruiting
Led By Amy Damashek
Research Sponsored by Western Michigan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Caregivers will be eligible to participate if they are the primary caregiver (male or female) for at least one child in the target age range (3-4 years-of-age), the caregiver can speak and read English, and the caregiver did not participate in the focus group study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights
Study Summary
This trial will test whether a caregiver supervision intervention can reduce injury frequency in children. 100 caregivers will be randomly assigned to either the intervention or control group. The intervention group will receive the usual care plus the supervision intervention while the control group will only receive the usual care. The results of the trial will be used to support a larger study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Supervision levels
Secondary outcome measures
Injury Frequency
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Supervising for Home Safety modifiedExperimental Treatment1 Intervention
We will train caregivers to provide adequate levels of supervision to the 3-4 year-old children.
Group II: Services as UsualPlacebo Group1 Intervention
Clients will receive home visiting services from Head Start
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Who is running the clinical trial?
Western Michigan UniversityLead Sponsor
16 Previous Clinical Trials
2,778 Total Patients Enrolled
University of GuelphOTHER
80 Previous Clinical Trials
10,078 Total Patients Enrolled
Amy DamashekPrincipal InvestigatorWestern Michigan University
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