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Home Supervision for Preventing Injuries
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
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.
Who is the study for?
This trial is for primary caregivers, regardless of gender, who have a child aged 3-4 years. They must be able to speak and read English and should not have participated in the related focus group study. It excludes families with children diagnosed with pervasive developmental disorders or those who are blind or deaf.
What is being tested?
The study tests a supervision intervention aimed at reducing injury frequency in children. Caregivers will either receive standard services (control) or standard services plus the tailored home supervision program (treatment). The effectiveness will be measured to plan for a larger-scale test.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medical treatments, there are no typical side effects like you would expect from drugs; however, participants may experience changes in their routine due to new supervision practices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
83 Previous Clinical Trials
14,898 Total Patients Enrolled
Amy DamashekPrincipal InvestigatorWestern Michigan University
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