Adolescent Behavior, E-Cig Use, Tobacco Use
Conditions
Brief 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.
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.
Interventions
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.
The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
Sponsors
Study design
Eligibility
Inclusion criteria
* 9th grade student * enrolled at participating Pittsburgh-area school
Exclusion criteria
* Inability to read the surveys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible 9th Grade Students Recruited to Participate in the Study | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Intention to Use Tobacco Products | baseline vs. 12 month follow-up | 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. |
| Change in Tobacco-related Media Literacy | baseline vs. 12 month follow-up | 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). |
| Changes in Attitudes Toward Tobacco Products | baseline vs. 12 month follow-up | 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). |
| Changes in Normative Beliefs About Tobacco Products | baseline vs. 12 month follow-up | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 158 |
| 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. | 160 |
| Total | 318 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 135 | 145 |
Baseline characteristics
| Characteristic | Total | Usual Health Education Curriculum | Usual Health Education Curriculum Plus Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 318 Participants | 158 Participants | 160 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Attitudes toward tobacco products | 3.29 units on a scale STANDARD_DEVIATION 1.45 | 3.24 units on a scale STANDARD_DEVIATION 1.53 | 3.32 units on a scale STANDARD_DEVIATION 1.36 |
| Normative Beliefs | 2.21 units on a scale STANDARD_DEVIATION 1.46 | 2.27 units on a scale STANDARD_DEVIATION 1.63 | 2.14 units on a scale STANDARD_DEVIATION 1.26 |
| Race/Ethnicity, Customized American Indian/Alaskan Native, non-Hispanic | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian, non-Hispanic | 36 Participants | 19 Participants | 17 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 12 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 14 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Missing | 32 Participants | 18 Participants | 14 Participants |
| Race/Ethnicity, Customized Multiracial, non-Hispanic | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 206 Participants | 97 Participants | 109 Participants |
| Region of Enrollment United States | 318 participants | 158 participants | 160 participants |
| Sex: Female, Male Female | 20 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 27 Participants | 13 Participants | 14 Participants |
| Susceptible to cigarette use Missing | 53 Participants | 27 Participants | 26 Participants |
| Susceptible to cigarette use Not Susceptible | 236 Participants | 120 Participants | 116 Participants |
| Susceptible to cigarette use Susceptible | 29 Participants | 11 Participants | 18 Participants |
| Susceptible to cigar smoking Missing | 51 Participants | 26 Participants | 25 Participants |
| Susceptible to cigar smoking Not Susceptible | 243 Participants | 124 Participants | 119 Participants |
| Susceptible to cigar smoking Susceptible | 24 Participants | 8 Participants | 16 Participants |
| Susceptible to e-cigarette use Missing | 54 Participants | 28 Participants | 26 Participants |
| Susceptible to e-cigarette use Not Susceptible | 220 Participants | 115 Participants | 105 Participants |
| Susceptible to e-cigarette use Susceptible | 44 Participants | 15 Participants | 29 Participants |
| Susceptible to hookah use Missing | 53 Participants | 27 Participants | 26 Participants |
| Susceptible to hookah use Not Susceptible | 241 Participants | 121 Participants | 120 Participants |
| Susceptible to hookah use Susceptible | 24 Participants | 10 Participants | 14 Participants |
| Tobacco media literacy | 7.79 units on a scale STANDARD_DEVIATION 1.71 | 7.78 units on a scale STANDARD_DEVIATION 1.69 | 7.79 units on a scale STANDARD_DEVIATION 1.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 160 |
| other Total, other adverse events | 0 / 158 | 0 / 160 |
| serious Total, serious adverse events | 0 / 158 | 0 / 160 |
Outcome results
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Health Education Curriculum | Percentage of Eligible 9th Grade Students Recruited to Participate in the Study | 158 Participants |
| Usual Health Education Curriculum Plus Intervention | Percentage of Eligible 9th Grade Students Recruited to Participate in the Study | 160 Participants |
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.
Time frame: post-test immediately following completion of the intervention
Population: This data is from the intervention students who completed the post-test only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Health Education Curriculum | Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program | Agreed with I understood AD IT UP | 81 Participants |
| Usual Health Education Curriculum | Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program | Agreed with AD IT UP was easy to use | 62 Participants |
| Usual Health Education Curriculum | Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program | Agreed with I tried my hardest when using AD IT UP | 66 Participants |
| Usual Health Education Curriculum | Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program | Agreed with UP would be helpful to other kids my age | 64 Participants |
| Usual Health Education Curriculum | Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program | Agreed with I agree with AD IT UP's message | 82 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Health Education Curriculum | Percentage of Participants Retained Through the Final Data Collection | 23 Participants |
| Usual Health Education Curriculum Plus Intervention | Percentage of Participants Retained Through the Final Data Collection | 15 Participants |
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).
Time frame: baseline vs. 12 month follow-up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Health Education Curriculum | Change in Tobacco-related Media Literacy | 7.98 units on a scale | Standard Deviation 1.68 |
| Usual Health Education Curriculum Plus Intervention | Change in Tobacco-related Media Literacy | 8.89 units on a scale | Standard Deviation 1.79 |
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).
Time frame: baseline vs. 12 month follow-up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Health Education Curriculum | Changes in Attitudes Toward Tobacco Products | 3.09 units on a scale | Standard Deviation 1.98 |
| Usual Health Education Curriculum Plus Intervention | Changes in Attitudes Toward Tobacco Products | 2.91 units on a scale | Standard Deviation 1.25 |
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.
Time frame: baseline vs. 12 month follow-up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Health Education Curriculum | Changes in Intention to Use Tobacco Products | 0.386 units on a scale | Standard Deviation 0.997 |
| Usual Health Education Curriculum Plus Intervention | Changes in Intention to Use Tobacco Products | 0.419 units on a scale | Standard Deviation 1.116 |
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).
Time frame: baseline vs. 12 month follow-up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Health Education Curriculum | Changes in Normative Beliefs About Tobacco Products | 2.43 units on a scale | Standard Deviation 2.07 |
| Usual Health Education Curriculum Plus Intervention | Changes in Normative Beliefs About Tobacco Products | 2.25 units on a scale | Standard Deviation 1.29 |