Curbing Tobacco Use in Suburban and Rural Schools

Study Overview
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Brief Summary
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Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders: Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care? Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care? Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care? Stages of Change (tertiary): Does the intervention have an impact on progression through the stages of smoking and spit tobacco acquisition and cessation compared to standard care? Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation? Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking at baseline and 12-month follow-up to determine whether predictors differ among White, African-American, and Hispanic students.

Detailed Description
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The proposed study will test the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. Supplemented by cyber-support (chat room and bulletin board), the intervention program also will make use of a human social support environment (via trained school personnel, chat rooms, bulletin boards). The study will use a nested cohort design in which high schools are the unit of design, allocation, and analysis. Tenth-grade students (ages 14-16) within each intervention school will receive a 7-week interactive, Internet-based tobacco prevention and cessation curriculum. Using computerized surveys, study participants will be evaluated at baseline, 6-month, 12-month, and 18-month follow-ups. The study has been designed to permit analyses sensitive enough to detect differences for the two primary hypotheses: reductions in smoking initiation and smoking cessation. Trends in ST use after exposure to the intervention program will also be assessed. The design will also permit analysis of stage-of-change dynamics and mediators for both acquisition and cessation of both forms of tobacco.

Official Title
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Curbing Tobacco Use in Suburban and Rural Schools

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Smoking Prevention Program
* Behavioral: Focus Group
* Behavioral: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 14-16 years of age (9th and 10th-graders) who speak, read and write English Subjects are students from schools located in suburban and rural communities approximately 200 miles from Houston. Subjects with approved parental consent Exclusion Criteria: 1) Disruptive individuals who are not able to work with the program

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Prevention & Cessation Program<br> | Behavioral: Smoking Prevention Program<br>* Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.<br>Behavioral: Focus Group<br>* A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.<br>Behavioral: Survey<br>* On-line evaluations and questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in smoking initiation |  | Baseline, 6-month, 12-month, and 18-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation |  | Baseline, 6-month, 12-month, and 18-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidemiology, Cancer Prevention, Smoking Cessation, Smoking Prevention, Focus Groups