Cincinnati Home Injury Prevention Study

Injury remains the leading cause of morbidity and mortality for U.S. children after the
first year of life and the home is the leading location of injury for younger U.S. children.
Residential injury results in more than 1.7 million emergency visits in children younger
than 5 years of age annually in the U.S. resulting in over $3 billion in medical care costs
and $800 per emergency visit. Therefore, interventions that can effect sizable reductions in
childhood injury in the home could result in substantial reductions in pain and suffering
while saving potentially hundreds of millions of dollars in healthcare costs.

Previous trials have failed to achieve comprehensive and durable installation of home safety
products to reduce exposure to injury hazards in the indoor environments of young children.
Children of mothers who are eligible and enrolled in home visitation programs and children
of mothers with elevated depressive symptoms have been shown to be at risk for injury in the
home. Inadequate maternal supervisory behavior has also been shown to increase the risk for
home injury. This project will test the efficacy of an intervention to reduce exposure to
injury hazards in the home and subsequent preventable and medically attended injury in young
children of first-time, impoverished mothers.

This randomized control trial will test the efficacy of a public health intervention to
reduce exposure to injury hazards through the proper installation of safety devices in the
home and subsequent preventable and medically attended injury in the Every Child Succeeds
(ECS) population. Participants will be randomized to either receive injury prevention
measures or be a part of a literacy effort that provides developmentally appropriate books
and reading materials to mothers and children, and encourages mothers to gain interest in
reading with their child.

Mothers that participate in the Every Child Succeeds (ECS) home visitation program, have
completed at least one ECS home visit, and have a child less than 5 months of age will be
enrolled in the study. Index children will be followed for 24 months after randomization and
interventions or up to the age of approximately 36 months. Measures of maternal and child
psychology, child behavior and temperament will be obtained during home visits. Maternal
supervision and childhood injuries will be assessed repeatedly during quarterly phone
questionnaires and home visits.

Experimental Group: In homes of children randomized to the intervention arm of the trial, a
comprehensive observational survey of living spaces will be undertaken. The study will
examine living spaces to which a child may be exposed including 5 high-exposure, high-risk
areas (main activity room, kitchen, child's bedroom and bathrooms, and stairways). In
addition to quantifying hazards, the area of rooms will be obtained allowing for
determination of both the number and density of injury hazards.

The hazards identified by the intervention team 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 and progressively
less 'passive' and less durable options last. After consent is obtained, passive measures
will be installed across the living space as indicated.

One goal of the study is to determine whether installed products that modify exposure to the
injury hazards can reduce unintentional injury across the leading mechanisms for young
children over time. Another goal is to determine the required maintenance of installed
products over time. At routine home visits or at the request of a participant prior to the
18-month follow-up time point, installed interventions will be assessed for their presence
and function and broken or malfunctioning products will be repaired or replaced if it is
within the study budget. Additionally, if the study budget allows, the investigators will
repeat the injury hazard survey and perform the installation intervention if a family
relocates prior to the child being 24-months of age, within a 3 hour driving radius of
CCHMC, and has not moved more than three times.

Control Group: Mothers and children randomly assigned to the control condition will also
benefit from participation in the trial. Similar to the intervention arm, they will undergo
home surveys and annual visits for assessment of injury hazards. In addition, families in
this control group will receive a program which seeks to promote literacy by providing
developmentally appropriate books, materials and possibly a library card 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, and council mothers about the importance of
literacy and reading books to their child.

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