Adolescent BehaviorNCT05081843
Pittsburgh and Rural Area High School Tobacco Prevention
A study testing AD IT UP media literacy intervention and Usual health education curriculum in people with Adolescent Behavior and Tobacco Use, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Tobacco Use, E-Cig Use
- What is being tested?
- AD IT UP media literacy intervention and Usual health education curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9th grade student
- enrolled at participating Pittsburgh-area school
Who cannot join
- Inability to read the surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.
Read the detailed description
Specific Aim 1: To assess 9th grade students' preferences for delivery of the web-based media literacy tobacco prevention program. Investigators will conduct focus groups with 9th grade students in each high school. Students will be shown clips from the program and asked to provide feedback about the preferred frequency and setting for the program.
Specific Aim 2: Investigators will conduct a pilot trial of the intervention via a cluster randomized controlled trial. The control group will receive their usual health education curriculum. The intervention group will receive their usual health education curriculum with the addition of the intervention. All students will be asked to complete a pre-test, a post-test, and two follow-up surveys (approximately 4 and 12 months post-intervention). Feasibility endpoints will include overall program completion, recruitment/attendance rates, and retention rates. Acceptability outcomes will assess student perceptions toward the intervention. A sub-aim will be to conduct focus groups and interviews with students, teachers, and administrators to assess implementation barriers and facilitators.
- Conditions
- Adolescent Behavior, Tobacco Use, E-Cig Use
- Being tested
- AD IT UP media literacy intervention, Usual health education curriculum
- Medical subject headings
- Adolescent Behavior, Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD IT UP media literacy interventionBehavioural
AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculumBehavioural
The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
| Study group | Role | What they receive |
|---|---|---|
| Usual Health Education Curriculum | Active comparator | Students will receive the school's usual health education curriculum. Receives: Behavioral: Usual health education curriculum |
| Usual Health Education Curriculum plus Intervention | Experimental | Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators. Receives: Behavioral: AD IT UP media literacy intervention; Behavioral: Usual health education curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study
Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent.
Measured: 1 month
Percentage of Participants Retained Through the Final Data Collection
Retention will be calculated as the percentage of 9th grade students who completed the baseline survey and also completed the 12 month follow-up survey.
Measured: 12 months
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Acceptability of the intervention will be assessed with closed-ended and open-ended items on the post-test survey immediately following completion of the intervention.
Students will be asked on a 5-point Likert scale with responses ranging from Strongly Agree to Strongly Disagree (with a neutral middle) their agreement about the following: "I enjoyed AD IT UP," "I understood AD IT UP," "AD IT UP was easy to use," "I tried my hardest when I was doing AD IT UP," "I think AD IT UP would be helpful to other kids my age," "I would recommend AD IT UP to a friend," and "I agree with AD IT UP's message." An answer of "Strongly Agree" or "Agree" on these items indicates high and moderate acceptability, respectively. Each of these items will be assessed individually, not as an overall scale.
Open-ended items will ask: what the student would change about AD IT UP, what the student liked about AD IT UP, what made AD IT UP fun, and what made AD IT UP not fun.
Measured: post-test immediately following completion of the intervention
Secondary outcomes (4)
Changes in Intention to Use Tobacco Products
Items used in this analysis:
If one of your best friends offered you a [NTP], would you smoke/use it?
This item was repeated for cigarettes, hookah, e-cigarettes, and cigars/cigarillos.
This item included the a 4-item response scale ranging from Definitely No to Definitely Yes for each of the 4 NTPs.
Susceptibility was considered any response except "Definitely No" and totaled for a possible range of 0 to 4. Answering anything other than "Definitely No" on any item is considered susceptible to using tobacco products. These were totaled for a possible range of 0 to 4, with higher scores representing greater susceptibility.
Measured: baseline vs. 12 month follow-up
Changes in Attitudes Toward Tobacco Products
Items to measure attitudes toward tobacco products will be included in all 4 surveys. These items include the following with a 10-item response scale ranging from Strongly Disagree to Strongly Agree.
E-cigarettes are not as bad for your health as other products. Using tobacco products at parties is fun. (added: Using e-cigarettes at parties is fun) Tobacco products help you deal with problems or stress. Smoking helps people stay thin. People who use e-cigarettes are more fun to be around than people who don't use e-cigarettes.
If someone starts using tobacco products every day, it is very hard for them to stop (reverse coded).
Smoking makes a person look more attractive. It would be very easy for me to get e-cigarettes if I wanted them.
Change in attitudes will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually and as an overall scale (range 0-90, with higher scores indicating a worse outcome).
Measured: baseline vs. 12 month follow-up
Changes in Normative Beliefs About Tobacco Products
Items to measure normative beliefs about tobacco products will be included in all 4 surveys. These items ask participants their rate how acceptable the following statements are among their friends using a 10-item response scale ranging from Very Acceptable to Very Unacceptable:
It is OK for people your age to smoke cigarettes. It is OK for people your age to use e-cigarettes. It is OK for people your age to use hookahs. It is OK for people your age to smoke cigars or cigarillos. A wealthy person is more likely to use tobacco products than a poor person. A successful person is more likely to use tobacco products than an unsuccessful person.
Changes in normative beliefs will be determined by the average increase or decrease in perceived acceptability of these statements. These items will be assessed individually, as well as an overall scale (range 0-60 with higher scores indicating a worse outcome).
Measured: baseline vs. 12 month follow-up
Change in Tobacco-related Media Literacy
Items to measure tobacco-related media literacy will be adapted from the Smoking Media Literacy Scale and included in all 4 surveys. The response scale for these 8 items is a 10-item scale from "Strongly Disagree" to "Strongly Agree."
Changes in media literacy will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually, as well as an overall scale (range 0-80, with higher scores indicating a worse outcome).
Measured: baseline vs. 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Mar 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jaime Sidani, University of Pittsburgh
- Investigators
- Jaime Sidani, PhD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081843
- Sponsor's protocol ID
- STUDY21030093
- Other IDs
- K12DA050607
- Status last verified
- Jun 2025
- First submitted
- 4 Oct 2021
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Appropriate data from this project will be made available via the Open ScienceFramework, which is recommended by the University of Pittsburgh Library System. Shareable data generated during the project will include longitudinal survey results, which will contain both quantitative and qualitative information. Survey data will be sufficiently de-identified and formatted in a broadly accessible spreadsheet format. Generic participant ID numbers will be available to link data across survey timepoints. These data will be made available with accompanying metadata (i.e., file descriptors and codebook). For example, available codebooks will include labels and descriptors for each quantitative survey variable as well as definitions used for qualitative coding.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students
- ClinicalTrials.gov ID
- NCT05081843
- Acronym / sponsor ID
- STUDY21030093
- Conditions
- Adolescent Behavior, Tobacco Use, E-Cig Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.
Detailed description
Specific Aim 1: To assess 9th grade students' preferences for delivery of the web-based media literacy tobacco prevention program. Investigators will conduct focus groups with 9th grade students in each high school. Students will be shown clips from the program and asked to provide feedback about the preferred frequency and setting for the program.
Specific Aim 2: Investigators will conduct a pilot trial of the intervention via a cluster randomized controlled trial. The control group will receive their usual health education curriculum. The intervention group will receive their usual health education curriculum with the addition of the intervention. All students will be asked to complete a pre-test, a post-test, and two follow-up surveys (approximately 4 and 12 months post-intervention). Feasibility endpoints will include overall program completion, recruitment/attendance rates, and retention rates. Acceptability outcomes will assess student perceptions toward the intervention. A sub-aim will be to conduct focus groups and interviews with students, teachers, and administrators to assess implementation barriers and facilitators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Health Education Curriculum | Active comparator | Behavioral: Usual health education curriculumStudents will receive the school's usual health education curriculum. |
| Usual Health Education Curriculum plus Intervention | Experimental | Behavioral: AD IT UP media literacy intervention, Behavioral: Usual health education curriculumStudents will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 9th grade student
- enrolled at participating Pittsburgh-area school
Key exclusion criteria (1 listed)
- Inability to read the surveys
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 |
|---|---|---|
| AD IT UP media literacy interventionAD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media. | Behavioural | Usual Health Education Curriculum plus Intervention |
| Usual health education curriculumThe schools' regular health education curriculum includes classroom lectures, hands on activities and group work. | Behavioural | Usual Health Education Curriculum, Usual Health Education Curriculum plus Intervention |
Primary outcome
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study
Time frame: 1 month
Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent.
Percentage of Participants Retained Through the Final Data Collection
Time frame: 12 months
Retention will be calculated as the percentage of 9th grade students who completed the baseline survey and also completed the 12 month follow-up survey.
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Time frame: post-test immediately following completion of the intervention
Acceptability of the intervention will be assessed with closed-ended and open-ended items on the post-test survey immediately following completion of the intervention. Students will be asked on a 5-point Likert scale with responses ranging from Strongly Agree to Strongly Disagree (with a neutral middle) their agreement about the following: "I enjoyed AD IT UP," "I understood AD IT UP," "AD IT UP was easy to use," "I tried my hardest when I was doing AD IT UP," "I think AD IT UP would be helpful to other kids my age," "I would recommend AD IT UP to a friend," and "I agree with AD IT UP's message." An answer of "Strongly Agree" or "Agree" on these items indicates high and moderate acceptability, respectively. Each of these items will be assessed individually, not as an overall scale. Open-ended items will ask: what the student would change about AD IT UP, what the student liked about AD IT UP, what made AD IT UP fun, and what made AD IT UP not fun.
4 secondary outcomes
Changes in Intention to Use Tobacco Products
Time frame: baseline vs. 12 month follow-up
Changes in Attitudes Toward Tobacco Products
Time frame: baseline vs. 12 month follow-up
Changes in Normative Beliefs About Tobacco Products
Time frame: baseline vs. 12 month follow-up
Change in Tobacco-related Media Literacy
Time frame: baseline vs. 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Appropriate data from this project will be made available via the Open ScienceFramework, which is recommended by the University of Pittsburgh Library System. Shareable data generated during the project will include longitudinal survey results, which will contain both quantitative and qualitative information. Survey data will be sufficiently de-identified and formatted in a broadly accessible spreadsheet format. Generic participant ID numbers will be available to link data across survey timepoints. These data will be made available with accompanying metadata (i.e., file descriptors and codebook). For example, available codebooks will include labels and descriptors for each quantitative survey variable as well as definitions used for qualitative coding.
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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.
Jaime Sidani, PhD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AD IT UP media literacy intervention and Usual health education curriculum in people with Adolescent Behavior and Tobacco Use, run by University of Pittsburgh 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 1 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 4 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study (time frame: 1 month). The study lists 3 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 4 Jun 2025.