Cincinnati Home Injury Prevention Study (CHIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Dr. Kieran Phelan, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01327092
First received: March 30, 2011
Last updated: January 2, 2013
Last verified: December 2012
  Purpose

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 Intervention
Injury in the Home
Other: Injury Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Injury Prevention in a Home Visitation Population

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Any modifiable and medically-attended injury in enrolled children [ Time Frame: Quarterly (baseline & annual home visits, quarterly phone surveys) (up to 4 years) ] [ Designated as safety issue: Yes ]
    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:
  • Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children. [ Time Frame: Annually (up to 4 years) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327092

Contacts
Contact: Kieran Phelan, MD 513-636-3231 kieran.phelan@cchmc.org
Contact: Stacey Liddy, MS 513-636-1951 stacey.liddy@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Kieran Phelan, MD    513-636-3231    kieran.phelan@cchmc.org   
Principal Investigator: Kieran Phelan, MD, MSc         
Sub-Investigator: Bruce Lanphear, MD, MPH         
Sub-Investigator: Robert Ammerman, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Kieran Phelan, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Responsible Party: Dr. Kieran Phelan, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01327092     History of Changes
Other Study ID Numbers: 1R01HD066115-01A1
Study First Received: March 30, 2011
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014