NCT02535559

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

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

First Submitted

Initial submission to the registry

August 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

August 21, 2015

Last Update Submit

August 17, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Classes receive anti-tobacco presentations from Teens Against Tobacco Use members

Behavioral: Teens Against Tobacco Use

Wait list control

NO INTERVENTION

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.

Interventions

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th 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.

You may not qualify if:

  • Classes in participating schools that are not in the 4th to 8th grade
  • 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

August 21, 2015

First Posted

August 28, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations