Clinical Trials Directory

Trials / Completed

CompletedNCT00513097

Curbing Tobacco Use in Suburban and Rural Schools

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
1,289 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
14 Years – 16 Years
Healthy volunteers
Accepted

Summary

Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders: 1. Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care? 2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care? 3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care? 4. 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? 5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation? 6. Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up. 7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up 8. 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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSmoking Prevention ProgramInteractive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.
BEHAVIORALFocus GroupA total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.
BEHAVIORALSurveyOn-line evaluations and questionnaires

Timeline

Start date
2006-07-25
Primary completion
2017-10-18
Completion
2017-10-18
First posted
2007-08-08
Last updated
2017-11-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00513097. Inclusion in this directory is not an endorsement.