Tobacco Smoking BehaviorNCT02926339
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
A study testing Teens Against Tobacco Use presentation in people with Tobacco Smoking Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking Behavior
- What is being tested?
- Teens Against Tobacco Use presentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students from participating schools
- 6th to 8th grade students
- Classes must be willing to receive presentations in the fall and spring semesters.
Who cannot join
- Students from non-participating schools
- Students not able to read English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston, School of Public Health, El Paso Regional Campus
El Paso, Texas, 79902
About this study
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.
Read the 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.
- Conditions
- Tobacco Smoking Behavior
- Being tested
- Teens Against Tobacco Use presentation
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens Against Tobacco Use presentationBehavioural
Students receive a series of 3 anti-tobacco presentations delivered by older peers
| Study group | Role | What they receive |
|---|---|---|
| Teens Against Tobacco Use presentation | Experimental | Students in the intervention group will receive anti-tobacco presentations from Teens Against Tobacco Use Members Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Tobacco Susceptibility at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoking BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- El Paso Independent School District, Paso del Norte Health Foundation
- Responsible party
- Principal investigator, Louis D. Brown, The University of Texas Health Science Center, Houston
- Investigators
- Louis D Brown, PH.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926339
- Sponsor's protocol ID
- HSC-SPH-16-0534
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
- ClinicalTrials.gov ID
- NCT02926339
- Acronym / sponsor ID
- HSC-SPH-16-0534
- Conditions
- Tobacco Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- El Paso Independent School District, Paso del Norte Health Foundation
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teens Against Tobacco Use presentation | Experimental | Behavioral: Teens Against Tobacco Use presentationStudents in the intervention group will receive anti-tobacco presentations from Teens Against Tobacco Use Members |
| Control | No intervention | –Students in this group will receive a control presentation from their physical education teachers on a topic unrelated to tobacco. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students from participating schools
- 6th to 8th grade students
- Classes must be willing to receive presentations in the fall and spring semesters.
Key exclusion criteria (2 listed)
- Students from non-participating schools
- Students not able to read English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teens Against Tobacco Use presentationStudents receive a series of 3 anti-tobacco presentations delivered by older peers | Behavioural | Teens Against Tobacco Use presentation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis D Brown, PH.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens Against Tobacco Use presentation in people with Tobacco Smoking Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.