- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926339
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen Middle School of the El Paso Independent School District to implement smoke free youth coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco Use (TATU) model developed by the American Lung Association, the American Cancer Society, and the American Heart Association. Participating youth will be trained to develop and deliver anti-tobacco presentations to younger students. Each school will have a separate youth coalition operating under the guidance of an adult coordinator. High school youth will present to middle school classes, whereas middle school youth will present to 4th and 5th graders.
To evaluate the efficacy of the TATU program, we will randomly assign students in physical education classes to receive TATU presentations or a control condition. Confidential surveys about tobacco will be administered at the beginning and end of the school year. Analyses will compare intervention and control students on smoking susceptibility, perceptions of harm from tobacco use, tobacco industry perceptions, and social norms on tobacco use.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Texas
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El Paso, Texas, United States, 79902
- The University of Texas Health Science Center at Houston, School of Public Health, El Paso Regional Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students from participating schools
- 6th to 8th grade students
- Classes must be willing to receive presentations in the fall and spring semesters.
Exclusion Criteria:
- Students from non-participating schools
- Students not able to read English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teens Against Tobacco Use presentation
Students in the intervention group will receive anti-tobacco presentations from Teens Against Tobacco Use Members
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Students receive a series of 3 anti-tobacco presentations delivered by older peers
|
|
No Intervention: Control
Students in this group will receive a control presentation from their physical education teachers on a topic unrelated to tobacco.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tobacco Susceptibility assessed by Likert scale questions drawn primarily from the global youth tobacco survey
Time Frame: Change from Baseline Tobacco Susceptibility at 7 months
|
Tobacco susceptibility captures the likelihood of using tobacco in the future.
It will be assessed by likert scale questions drawn primarily from the global youth tobacco survey.
It will be analyzed as a continuous variable that will be standardized, so outcomes will represent standard deviation unit differences in tobacco susceptibility.
|
Change from Baseline Tobacco Susceptibility at 7 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Louis D Brown, Ph.D., The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SPH-16-0534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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