Cincinnati Home Injury Prevention Study (CHIP)
|ClinicalTrials.gov 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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327092
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|Principal Investigator:||Kieran Phelan, MD||Children's Hospital Medical Center, Cincinnati|