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| ID | Type | Description | Link |
|---|---|---|---|
| K12DA050607 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Health Education Curriculum | Active Comparator | Students will receive the school's usual health education curriculum. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD IT UP media literacy intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | post-test immediately following completion of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Sidani, PhD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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.
Data will become available approximately December 2023 and remain available for 3 years in accordance with the NIH Grants Policy Statement on Data Sharing.
Interested researchers will contact the PI to request access.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Health Education Curriculum | Students will receive the school's usual health education curriculum. Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
| FG001 | Usual Health Education Curriculum Plus Intervention | 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. AD IT UP media literacy intervention: 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 curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Health Education Curriculum | Students will receive the school's usual health education curriculum. Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
| BG001 | Usual Health Education Curriculum Plus Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | These numbers are the number of students that were present in the classroom on the day of the initial data collection, and thus eligible to participate. | Posted | Count of Participants | Participants | 1 month |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Health Education Curriculum | Students will receive the school's usual health education curriculum. Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaime Sidani | University of Pittsburgh School of Public Health | 412-383-0733 | jes107@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2023 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012907 | Smoking |
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|
| Usual health education curriculum | Behavioral | The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
|
| 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). | 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). | 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). | baseline vs. 12 month follow-up |
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. AD IT UP media literacy intervention: 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 curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Susceptible to cigarette use | Item asked: If one of your best friends offered you a cigarette, would you smoke it? Responses: Definitely Yes, Probably Yes, Probably No, Definitely No Susceptible if: answers anything other than Definitely No | Count of Participants | Participants |
|
| Susceptible to cigar smoking | Item asked: If one of your best friends offered you a cigar, would you smoke it? Responses: Definitely Yes, Probably Yes, Probably No, Definitely No Susceptible if: answers anything other than Definitely No | Count of Participants | Participants |
|
| Susceptible to e-cigarette use | Item asked: If one of your best friends offered you an e-cigarette, would you use it? Responses: Definitely Yes, Probably Yes, Probably No, Definitely No Susceptible if: answers anything other than Definitely No | Count of Participants | Participants |
|
| Susceptible to hookah use | Item asked: If one of your best friends offered you a hookah, would you smoke it? Responses: Definitely Yes, Probably Yes, Probably No, Definitely No Susceptible if: answers anything other than Definitely No | Count of Participants | Participants |
|
| Attitudes toward tobacco products | Measure description: 9 items that assessed agreement with statements about nicotine and tobacco products (see Study Protocol and Statistical Analysis Plan for exact item wording). 10-item response scale (Strongly Disagree -Strongly Agree) for each item; overall summary score calculated by averaging scores across all items. Higher score indicates worse outcome (i.e. more positive attitudes). | Mean | Standard Deviation | units on a scale |
|
| Normative Beliefs | Measure description: 6 items that assessed perceptions about friends' acceptance of NTPs (see Study Protocol and Statistical Analysis Plan for exact item wording). 10-item response scale (Very Unacceptable -Very Acceptable) for each item; overall summary score calculated by averaging scores across all items. Higher score indicates worse outcome (i.e. more perception of friends' acceptance). | Mean | Standard Deviation | units on a scale |
|
| Tobacco media literacy | Measure description: 8 items adapted from the Smoking Media Literacy Scale (see Study Protocol and Statistical Analysis Plan for exact item wording). 10-item response scale (Strongly Disagree -Strongly Agree) for each item; overall summary score calculated by averaging scores across all items. Higher score indicates worse outcome (i.e. less media literacy). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Health Education Curriculum Plus Intervention | 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. AD IT UP media literacy intervention: 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 curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. |
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| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
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| Primary | 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. | This data is from the intervention students who completed the post-test only. | Posted | Count of Participants | Participants | post-test immediately following completion of the intervention |
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| Secondary | 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. | NOTE: The original analysis was to be conducted for change between baseline and 12-month follow-up. Due to loss to follow-up over the 12-month tme period, the results presented here are for the immediate post-test, for which there was less loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | baseline vs. 12 month follow-up |
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| Secondary | 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). | NOTE: The original analysis was to be conducted for change between baseline and 12- month follow-up. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | baseline vs. 12 month follow-up |
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| Secondary | 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). | NOTE: The original analysis was to be conducted for change between baseline and 12-month follow-up. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to sollow-up. | Posted | Mean | Standard Deviation | units on a scale | baseline vs. 12 month follow-up |
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| Secondary | 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). | NOTE: The original analysis was to be conducted for change between baseline and 12-month followup. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | baseline vs. 12 month follow-up |
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|
|
| 0 |
| 158 |
| 0 |
| 158 |
| 0 |
| 158 |
| EG001 | Usual Health Education Curriculum Plus Intervention | 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. AD IT UP media literacy intervention: 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 curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work. | 0 | 160 | 0 | 160 | 0 | 160 |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Title | Measurements |
|---|---|
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| Agreed with "UP would be helpful to other kids my age" |
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| Agreed with "I agree with AD IT UP's message" |
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