An Intervention to Protect Young Children From Tobacco Smoke Exposure
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in child exposure to tobacco smoke as assessed by log hair nicotine
研究概览
简要总结
The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children
详细描述
The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.
This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •There are no additional exclusion criteria
研究组 & 干预措施
Intervention
- Motivational interviews (3 visits) + supportive phone calls
- Feedback of child hair nicotine levels
- Feedback of home air quality (PM2.5)
- New Media (Website and/or Facebook with information and parental forum)
干预措施: Behavioral Early (Behavioral)
Control Regular
This group will get no intervention during the study period. Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5))
干预措施: Behavioral Late (Behavioral)
Control Expanded
This group will get no intervention during the study period. However, participants will fill out a detailed questionnaire on parental perceptions of exposure and risk, as well as questions on social norms, self-efficacy, and knowledge Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5))
干预措施: Behavioral Late (Behavioral)
结局指标
主要结局
Change in child exposure to tobacco smoke as assessed by log hair nicotine
时间窗: Baseline and 6 months post-enrollment
A small amount of hair will be taken from the child's head near the scalp and sent to a laboratory for analysis
次要结局
- Change in smoking practices in the car as reported by parents(Baseline and 6 months post-enrollment)
- Child health services utilization(6 months post-enrollment)
- Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Parental perceptions of risk due to smoking, intervention versus control group(6 months post-enrollment)
- Parental perceptions of tobacco smoke exposure, intervention versus control group(6 months post-enrollement)
- Correlations between parentally-reported exposure and child log hair nicotine(6 months)
- Change in smoking practices in the home as reported by parents(Baseline and 6 months post-enrollment)
- Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Change in parentally-reported number of cigarettes smoked(Baseline and 6 months post-enrollment)
- Change in parental perceptions of risk due to smoking, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Child health(6 months post-enrollment)
- Change in child exposure to tobacco smoke as assessed by parental report(Baseline and 6 months post-enrollment)
- Change in parental smoking(Baseline and 6 months post-enrollment)
研究者
Laura J. Rosen
Senior Lecturer and Chair, Dept. of Health Promotion
Tel Aviv University