Tobacco Smoking BehaviorNCT02535559
Longitudinal Evaluation of Teens Against Tobacco Use
A study testing Teens Against Tobacco Use 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 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking Behavior
- What is being tested?
- Teens Against Tobacco Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,290 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Classes in participating schools that are not in the 4th to 8th grade
- 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 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.
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 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.
- Conditions
- Tobacco Smoking Behavior
- Being tested
- Teens Against Tobacco Use
- 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 UseBehavioural
Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Classes receive anti-tobacco presentations from Teens Against Tobacco Use members Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- 2,290 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT02535559
- Sponsor's protocol ID
- HSC-SPH-15-0500
- Status last verified
- Aug 2016
- First submitted
- 21 Aug 2015
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Teens Against Tobacco Use
- ClinicalTrials.gov ID
- NCT02535559
- Acronym / sponsor ID
- HSC-SPH-15-0500
- Conditions
- Tobacco Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,290 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Paso del Norte Health Foundation
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 2015 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Teens Against Tobacco UseClasses receive anti-tobacco presentations from Teens Against Tobacco Use members |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Classes in participating schools that are not in the 4th to 8th grade
- 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 UseTeens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students. | Behavioural | Intervention |
Primary outcome
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
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.
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
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 19 Aug 2016.
Related trials for Tobacco Smoking Behavior
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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 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 2 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 19 Aug 2016. 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?
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). The study lists 2 primary outcomes in all. 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 19 Aug 2016.