~42 spots leftby Apr 2026

Cincinnati Home Injury Prevention Study

(CHIP Trial)

Recruiting in Palo Alto (17 mi)
Overseen byKieran Phelan, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo Group

Trial Summary

What is the purpose of this trial?

One aim of this study is to test the efficacy of the installation of multiple, passive measures to reduce exposure to injury hazards in the homes of young children of first-time mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers and children who benefit most from the intervention and examine the potential moderating effect of maternal depressive symptoms, the intensity of supervisory behavior, and child temperament and activity, on the intervention and subsequent injury outcomes. Specific Aim 1 Hypotheses: H1.1: The housing units randomly assigned to the intervention group will have a significant decrease in the number and density (number per area) of residential injury-related hazards compared with control group units. H1.2: Children who are randomized to the intervention group (e.g. installation of multiple, passive measures to reduce exposure to residential injury hazards) will have a 50% reduction in modifiable and medically-attended injuries compared with children in the control group followed-up for 24-months in intention-to-treat analyses. Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the effects of the intervention on childhood injury in the home; households and children of mothers with higher levels of symptoms will have more hazards and injuries. H2.2: Children of mothers with less intense maternal supervisory behavior over the course of the intervention follow-up will have higher rates of injury. H2.3: Children scoring high in activity on the Carey Temperament Scale will experience reduced benefits of the intervention on childhood injury in the home.

Eligibility Criteria

Inclusion Criteria

Mothers enrolled in the ECS program who have completed at least one ECS home visit
Have a child greater than 5 months of age
Are non-English speaking
See 4 more

Treatment Details

Interventions

  • Injury Intervention Group (Behavioural Intervention)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Injury Intervention GroupExperimental Treatment1 Intervention
Injury Intervention Group: In homes of children who are randomized to the injury intervention arm of the trial, a comprehensive survey of injury hazards in living spaces will be undertaken. In addition to quantifying hazards, the area of living spaces will be obtained to allow the determination of both the number and density (number of hazards per 100 sq ft) of injury hazards. If one or more injury hazards are identified, they will be removed and/or modified to reduce exposure and injury risk. The intervention is focused on areas in living spaces below 1 meter (\~39 inches) in height from (the 75th percentile in height or eye-level for a 3-year old US male toddler) which might be easily reached or climbed on by children less than 4 years
Group II: Literacy GroupActive Control1 Intervention
Families in the Literacy Group (control group)will receive a program which seeks to promote literacy by providing developmentally appropriate books and other reading-related materials to children and encouraging mothers to develop an interest in reading with their child. After enrollment and randomization, CHIP staff will visit these control group homes, assess the mother's interest in and barriers to reading with her child, council mothers about the importance of literacy and reading books to their child, and children will be given age appropriate books and other materials to promote literacy.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

References