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临床试验/NCT00682474
NCT00682474已完成2 期

School Nurse-Delivered Smoking Cessation Intervention

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 1,058 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
1,058
试验地点
2
主要终点
Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.

研究概览

简要总结

The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke.

详细描述

Smoking is the largest preventable cause of disease and premature death in the United States. Adolescent smoking is the greatest predictor of adult smoking and is associated with adverse health effects during adolescence. Twenty-two percent of high school students report current smoking (past 30 days). As the primary health professional in the school setting, school nurses have a tremendous opportunity to play a key role in treating adolescent smokers. A randomized controlled trial (RCT) conducted by the investigators in 71 high schools in Massachusetts demonstrated the feasibility of school nurses delivering a four-session individual counseling intervention to adolescents who want to stop smoking and its potential efficacy in increasing self-reported short term (6-week and 3-month) quit rates. Although promising, the preliminary study lacked biochemical validation and long-term follow-up on the maintenance of the intervention effects, and was conducted with a primarily white student population. This application seeks to evaluate the effectiveness of the intervention using a more rigorous methodology, including biochemical validation of self-reported smoking behavior and longer-term follow-up (6 and 12 months post-intervention), a study design that compares the intervention to an information only attention-control condition, and recruitment from ethnically diverse schools to increase the generalizability of our findings.

The overall aim of the proposed study is to conduct a randomized controlled school-based trial (RCT) to evaluate the effectiveness of a school nurse-delivered smoking cessation intervention in increasing 30 day abstinence rates among high school students who smoke. Forty high schools serving a diverse student population will be recruited and randomly assigned to one of two conditions: (1) Special Intervention (SI) - four 30-minute individual patient-centered smoking cessation counseling intervention sessions based on the Public Health Service (PHS) clinical practice guideline delivered by school nurses; or (2) Information Only (IO) attention-control comparison condition - four individual sessions with the school nurse to check smoking status and deliver a standardized series of informational pamphlets on smoking and cessation. Participant assessments will occur at study entry (baseline) and at 3-,12-month follow-up. Thirty students enrolled in grades 9 through 12 who report smoking within the past 30 days and willingness to participate in a smoking cessation intervention study will be recruited from each school (n=1200) to provide 25 completed assessments per school at 12-month follow-up (n=1000). If found effective, the study products (i.e., intervention protocol, student materials, training manual, and estimated costs of intervention implementation) will facilitate dissemination of the intervention to school nurses nationally.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • enrolled in grades 9-12
  • report smoking at least one puff of a cigarette in the past 30 days
  • willingness to participate in a smoking cessation intervention study
  • able to speak and read English
  • able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols
  • intending to remain enrolled in the school for the remainder of the school year
  • willing to provide contact information for the next 12 months

排除标准

  • unwilling/unable to provide informed assent
  • planning to move out of the area in the next 6 months

结局指标

主要结局

Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year.

时间窗: 3 months and 1 year post baseline

次要结局

  • Reduction in number of cigarettes and days smoked(3 months and 1 year post baseline)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Pbert

Professor of Medicine

University of Massachusetts, Worcester

研究点 (2)

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