跳至主要内容
临床试验/NCT00927264
NCT00927264已完成不适用

A+ Head Start Intervention for Smoke Free Homes

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2009年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
2
主要终点
Air Nicotine Levels

研究概览

简要总结

Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.

详细描述

About 90% of nonsmoking people in the US are exposed to ETS. More than 50 chemicals identified in ETS have been found to cause cancer and exposure has been linked to heart disease in adults and SIDS, ear infections and numerous respiratory problems, including asthma in children. In 2007, the Environmental Protection Agency and the Office of Head Start-a national program that provides economically disadvantaged children services to enhance their social and cognitive development-announced a new initiative to promote smoke-free homes for children in Head Start programs. Because Head Start reaches high-risk, low-income preschool children, it offers a timely intervention for reducing children's exposure to ETS. Head Start also attempts to engage parents, which is an important component of reducing household ETS exposure among children. This study will determine the effectiveness of a home-delivered, motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in the Baltimore City Head Start program and whose households include a smoker.

Participation in this study will last 1 year. First, all participating families will be visited at home by a study staff person who will attach special filters that will track the amount of nicotine in the various rooms of the house. During this initial visit, the participating children will undergo weight and height measurements and saliva sampling. About a week later, the filters will be collected, a 2nd saliva samples will be taken and parents will be interviewed about their family and child's health. Families will then be randomly assigned to one of two groups. Both groups will received educational information about reducing tobacco smoke exposure. One group will also receive the home-delivered, motivational interviewing-based program aimed to reduce ETS. This program will consist of 2 home visits and 2 phone calls, both led by health counselor who will teach participants how to reduce their child's exposure to tobacco smoke. The home visits will occur during Weeks 1 & 2 and the phone calls will occur during Weeks 3 & 6. Follow-up visits for all participating families will occur at Months 3,6 and 12 and will involve repeat filter testing, saliva monitoring and interviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

For masking we were unable to mask the caregiver and child participant since they knew if they were receiving intervention component. The investigator was masked, but outcome assessor may have known group assignment.

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child enrolled in Baltimore City Head Start
  • Smoker living in the home with child

排除标准

  • No smoker in home with child
  • Does not speak English
  • Is enrolled in other respiratory research study

研究组 & 干预措施

Behavioral

Experimental

Motivational Interviewing Intervention Plus Education

Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.

干预措施: Motivational Interviewing Intervention for ETS Reduction (Behavioral)

Education Only

Active Comparator

Caregivers will receive only educational program for ETS reduction.

干预措施: Educational Program for ETS Reduction (Behavioral)

结局指标

主要结局

Air Nicotine Levels

时间窗: Measured at Baseline, 3, 6 and 12 months

Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)

次要结局

  • Number of Participants Who Report Endorsing a Home Smoking Ban(Measured at baseline, 3, 6 and 12 months)
  • Health Care Utilization by Child- Self Report From Parent/Caregiver(Measured at baseline and 3, 6 and 12 months)
  • ETS Reduction, as Measured by Child's Cotinine Levels(Measured at Baseline, 3, 6 and 12 months)
  • Respiratory Function of Child by Self Report of Parent(Measured at Baseline, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验