The Impact of a Tobacco Control Intervention in African-American Families
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
研究概览
地位
详细说明
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Augusta、Georgia、美国、30912
- Georgia Health Sciences University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- child being of African-American ethnicity
- in a 4th grade classroom of randomized schools
- parent or guardian that 4th grade child resides with at least 50% of the time
- have access to a telephone or mobile phone
Exclusion Criteria:
- not being a child of African-American ethnicity
- not being a parent or guardian that an eligible child lives with at least 50% of the time
- not having access to a telephone or cell phone
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：LifeSkills training
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LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence. Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions.
其他名称：
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
其他名称：
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有源比较器：Healthy Lifestyle Behaviors
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The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools. Parents will also be given health related information by mail to parallel the information students receive in school health classes.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary prevention of tobacco use in youth
大体时间：Baseline
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Self-report and salivary cotinine is assessed to measure this outcome
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Baseline
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Primary prevention of tobacco use in youth
大体时间：Year 2
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Self-report and salivary cotinine is assessed to measure this outcome.
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Year 2
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Primary prevention of tobacco use in youth
大体时间：Year 4
|
Self-report and salivary cotinine is assessed to measure this outcome.
|
Year 4
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Smoking cessation in parents/guardians
大体时间：3 months
|
3 months
|
|
Smoking cessation in parents/guardians
大体时间：6 months
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6 months
|
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Smoking cessation in parents/guardians
大体时间：Year 1
|
Year 1
|
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Smoking cessation in parents/guardians
大体时间：Year 2
|
Year 2
|
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Smoking cessation in parents/guardians
大体时间：Year 4
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Year 4
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合作者和调查者
调查人员
- 首席研究员：Martha S Tingen, PhD、Augusta University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.