- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02535559
Longitudinal Evaluation of Teens Against Tobacco Use
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 smoke-free presentations, the investigators will first match pairs of classrooms willing to have a presentation and then randomly assign one classroom in each pair to either receive a series of two presentations first (intervention condition) or later in the school year (control condition). The day after each presentation to a classroom in the intervention condition, investigators will administer a brief survey about tobacco to students in both the intervention class and its matched control class, who have not yet received a presentation. Analyses will compare intervention and control classrooms on tobacco susceptibility.
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 4th to 8th grade student
- Classroom must be willing to be randomly assigned to either receive presentations earlier in the school year or late in the school year.
Exclusion Criteria:
- Classes in participating schools that are not in the 4th to 8th grade
- 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 |
|---|---|
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Experimental: Intervention
Classes receive anti-tobacco presentations from Teens Against Tobacco Use members
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Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.
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No Intervention: Wait list control
Classes continue as usual without receiving anti-tobacco presentations from Teens Against Tobacco Use members until the end of the year, when data collection is complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in tobacco susceptibility at 24 hours as assessed by 10 likert scale items drawn primarily from the global youth tobacco survey
Time Frame: baseline and 24 hours
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Tobacco susceptibility captures the likelihood of using tobacco in the future.
It is a continuous variable that will be standardized, so outcomes will represent standard deviation unit differences in tobacco susceptibility.
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baseline and 24 hours
|
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Change in tobacco susceptibility at 6 months as assessed by 10 likert scale items drawn primarily from the global youth tobacco survey
Time Frame: baseline and 6 months
|
baseline and 6 months
|
Collaborators and Investigators
Collaborators
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SPH-15-0500
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