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Injury in the Home | Cincinnati Home Injury Prevention Study

Injury in the Home research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion: - Mothers enrolled in the ECS program who have completed at least one ECS home visit Exclusion- Mothers who: - Have a child greater than 5 months of age - Are non-English speaking - Live beyond a 3-hr driving radius - Have plans to relocate outside of a 3-hour driving radius from Cincinnati Children's Hospital in the next 12 months at the time of screening - Mothers with ECS accounts marked as \"Other\" such as HMG Part C (having a chronic illness, congenital disorder or developmental delay), HMG At-Risk, first time fathers in Kentucky, etc. - index child is a twin

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Injury in the Home

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Injury Intervention GroupThe hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Literacy GroupFamilies 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.

Injury Intervention GroupInjury 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

Study Status

Unknown status

Start Date: September 2010

Completed Date: July 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Any modifiable and medically-attended injury in enrolled children

Secondary Outcome: Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children.

Study sponsors, principal investigator, and references

Principal Investigator: Kieran Phelan, MD

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01327092

Phelan KJ, Khoury J, Xu Y, Lanphear B. Validation of a HOME Injury Survey. Inj Prev. 2009 Oct;15(5):300-6. doi: 10.1136/ip.2008.020958.

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