NCT02926339

Brief Summary

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to either receive 3 anti-tobacco presentations or 3 presentations on a different topic, unrelated to tobacco.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
639

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 4, 2016

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tobacco Susceptibility assessed by Likert scale questions drawn primarily from the global youth tobacco survey

    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

Study Arms (2)

Teens Against Tobacco Use presentation

EXPERIMENTAL

Students in the intervention group will receive anti-tobacco presentations from Teens Against Tobacco Use Members

Behavioral: Teens Against Tobacco Use presentation

Control

NO INTERVENTION

Students in this group will receive a control presentation from their physical education teachers on a topic unrelated to tobacco.

Interventions

Students receive a series of 3 anti-tobacco presentations delivered by older peers

Teens Against Tobacco Use presentation

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students from participating schools
  • th to 8th grade students
  • Classes must be willing to receive presentations in the fall and spring semesters.

You may not qualify if:

  • Students from non-participating schools
  • Students not able to read English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston, School of Public Health, El Paso Regional Campus

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Louis D Brown, PH.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations