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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Smoking Prevention Program | Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco. |
| BEHAVIORAL | Focus Group | A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation. |
| BEHAVIORAL | Survey | On-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.