跳至主要内容
临床试验/NCT01327092
NCT01327092Unknown不适用

Injury Prevention in a Home Visitation Population

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2010年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
650
试验地点
2
主要终点
Any modifiable and medically-attended injury in enrolled children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Literacy Group

No Intervention

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.

Injury Intervention Group

Experimental

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

干预措施: Injury Intervention Group (Other)

结局指标

主要结局

Any modifiable and medically-attended injury in enrolled children

时间窗: 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.

次要结局

  • Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children.(Annually (up to 4 years))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kieran Phelan

Principal Investigator

Children's Hospital Medical Center, Cincinnati

研究点 (2)

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