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临床试验/NCT00217893
NCT00217893已完成不适用

ETS Reduction in High-Risk Preteens: A Controlled Trial

San Diego State University2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2003年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
2
主要终点
ETS exposure

研究概览

简要总结

This study will determine the effect of combining counseling, urine cotinine feedback, and incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to smoking among high-risk preteens.

详细描述

BACKGROUND:

Parent counseling reduced children's ETS exposure in previous studies. This study will determine if interventions directed to preteens alone can reduce ETS exposure. The original pilot study showed that counseling reduced preteen's ETS exposure. New analyses showed that counseling reduced exposure to preteens in the NIH asthma study. A third pilot study showed that counseling plus feedback and incentives reduced preteens' ETS exposure. Based on these results, the number of counseling sessions were decreased to 10, inclusion criteria were liberalized, and recruitment sources were added to assure feasibility.

DESIGN NARRATIVE:

This study will determine the effect of combining counseling, feedback, and incentives on reducing second hand smoke (SHS) exposure and susceptibility to smoking among high-risk preteens. Two hundred youth aged 8 to 13 years old, including African American, Latino, Anglo, and other racial/ethnic groups, will be recruited. Preteens must be nonsmokers who are exposed to ETS in their home. Youth will be recruited sequentially and assigned to usual education or a combination of counseling, cotinine feedback, and contingent incentives. Outcome measures will be obtained prior to intervention, and at Months 5, 9, and 12. Preteens in the intervention condition will receive eight in-home counseling sessions and seven phone counseling sessions over a 5-month period. Urine samples will be analyzed for cotinine using highly sensitive (detection limit .05 ng/ml) and reliable procedures as employed by CDC (ID-LC/MS/MS). The same measures will be used for cotinine feedback for preteens in the intervention condition. Repeated measures analyses of differential exposure to ETS will be employed. Mixed effect regression (REML) and generalized estimating equations (GEE) models will be used for outcome analyses. Exploratory analyses will address questions about the environmental and social determinants of tobacco use and ETS exposure based on the researcher's Behavioral Ecological Model.

Primary objectives include the following: 1) to determine whether counseling plus cotinine feedback and incentives reduces ETS exposure more than does usual tobacco control education (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Month 5); and 2) to determine whether the experimental condition results in differential maintenance in ETS exposure-reduction compared to usual tobacco control education during follow-up (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Months 9 and 12).

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
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Non-smoking preteen
  • Resides in San Diego county
  • Smoker lives in the household
  • Exposed to an average of 2 cigarettes per day over the week prior to study entry OR urine cotinine greater than or equal to 2.0 ng/mL

排除标准

  • Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime

结局指标

主要结局

ETS exposure

时间窗: Measured from baseline to 5 months

Maintenance in ETS exposure-reduction

时间窗: Measured 5, 9, and 12 months post-baseline

次要结局

  • Multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure(Measured from baseline through 5, 9, and 12 months)
  • Tobacco use experimentation(Measured from baseline through 5, 9, and 12 months)
  • Experimentation with alcohol/drugs(Measured from baseline through 5, 9, and 12 months)
  • Avoidance of ETS exposure from family members and friends(Measured from baseline through 5, 9, and 12 months)

研究者

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

Melbourne Hovell

Principal Investigator

San Diego State University

研究点 (2)

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