Cincinnati Home Injury Prevention Study (CHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327092
Recruitment Status : Unknown
Verified December 2015 by Dr. Kieran Phelan, Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Active, not recruiting
First Posted : April 1, 2011
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Dr. Kieran Phelan, Children's Hospital Medical Center, Cincinnati

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Injury in the Home Other: Injury Intervention Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Injury Prevention in a Home Visitation Population
Study Start Date : September 2010
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
No Intervention: Literacy Group
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.
Experimental: Injury Intervention Group
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
Other: Injury Intervention Group
The 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).

Primary Outcome Measures :
  1. Any modifiable and medically-attended injury in enrolled children [ Time Frame: Quarterly (baseline & annual home visits, quarterly phone surveys) (up to 4 years) ]
    Primary outcome measures will include any phone calls, clinic, and ED visits for falls, cuts/lacerations, contusion/crush, burn/scald, abrasions, and poisoning injuries sustained by enrolled children in the home that were potentially modifiable by the installed safety products. Modifiable injury events are defined as those whose hazard exposure and associated mechanism was potentially modified by the intervention (ie stairgate reducing exposure to a stairway and subsequent stairway fall injury) and include fall, cut/pierce, struck/strike, burn, and poisoning mechanisms.

Secondary Outcome Measures :
  1. Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children. [ Time Frame: Annually (up to 4 years) ]
    Verification of self-reports will be accomplished through annual medical record review. Emergency visit reports will be confirmed by matching the maternal report to the Hamilton County Injury Surveillance System (HCISS) a data repository of all injuries resulting in emergency visits, hospitalizations, and deaths for all persons presenting to Hamilton County hospitals and emergency departments.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327092

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Kieran Phelan, MD Children's Hospital Medical Center, Cincinnati

Responsible Party: Dr. Kieran Phelan, Principal Investigator, Children's Hospital Medical Center, Cincinnati Identifier: NCT01327092     History of Changes
Other Study ID Numbers: 1R01HD066115-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Dr. Kieran Phelan, Children's Hospital Medical Center, Cincinnati:
Injury Prevention
Cincinnati Home Injury Prevention
Injury Hazards
Modifiable Injury Hazards
Literacy Promotion
Reduce exposure to injury hazards
preventable and medically attended injury
young children

Additional relevant MeSH terms:
Wounds and Injuries