Longitudinal Evaluation of Teens Against Tobacco Use

Tobacco Smoking Behavior Clinical Trial

Official title:

Longitudinal Evaluation of Teens Against Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535559
• Other study ID #: HSC-SPH-15-0500
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: August 17, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2290
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Smoking Behavior

Intervention

Behavioral:
• Teens Against Tobacco Use
Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston, School of Public Health, El Paso Regional Campus	El Paso	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Paso del Norte Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tobacco susceptibility at 24 hours as assessed by 10 likert scale items drawn primarily from the global youth tobacco survey	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.	baseline and 24 hours	No
Primary	Change in tobacco susceptibility at 6 months as assessed by 10 likert scale items drawn primarily from the global youth tobacco survey		baseline and 6 months	No