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Pittsburgh and Rural Area High School Tobacco Prevention

Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05081843
Enrollment
318
Registered
2021-10-18
Start date
2022-03-01
Completion date
2024-03-01
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, E-Cig Use, Tobacco Use

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

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* 9th grade student * enrolled at participating Pittsburgh-area school

Exclusion criteria

* Inability to read the surveys

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study1 monthParents 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 Collection12 monthsRetention 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 Programpost-test immediately following completion of the interventionAcceptability 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

MeasureTime frameDescription
Changes in Intention to Use Tobacco Productsbaseline vs. 12 month follow-upItems 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 Literacybaseline vs. 12 month follow-upItems 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 Productsbaseline vs. 12 month follow-upItems 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 Productsbaseline vs. 12 month follow-upItems 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

ArmCount
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
Total318

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up135145

Baseline characteristics

CharacteristicTotalUsual Health Education CurriculumUsual Health Education Curriculum Plus Intervention
Age, Categorical
<=18 years
318 Participants158 Participants160 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Attitudes toward tobacco products3.29 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 Beliefs2.21 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 Participants6 Participants3 Participants
Race/Ethnicity, Customized
Asian, non-Hispanic
36 Participants19 Participants17 Participants
Race/Ethnicity, Customized
Black, non-Hispanic
12 Participants8 Participants4 Participants
Race/Ethnicity, Customized
Hispanic or Latino
14 Participants5 Participants9 Participants
Race/Ethnicity, Customized
Missing
32 Participants18 Participants14 Participants
Race/Ethnicity, Customized
Multiracial, non-Hispanic
7 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Other
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White, non-Hispanic
206 Participants97 Participants109 Participants
Region of Enrollment
United States
318 participants158 participants160 participants
Sex: Female, Male
Female
20 Participants13 Participants7 Participants
Sex: Female, Male
Male
27 Participants13 Participants14 Participants
Susceptible to cigarette use
Missing
53 Participants27 Participants26 Participants
Susceptible to cigarette use
Not Susceptible
236 Participants120 Participants116 Participants
Susceptible to cigarette use
Susceptible
29 Participants11 Participants18 Participants
Susceptible to cigar smoking
Missing
51 Participants26 Participants25 Participants
Susceptible to cigar smoking
Not Susceptible
243 Participants124 Participants119 Participants
Susceptible to cigar smoking
Susceptible
24 Participants8 Participants16 Participants
Susceptible to e-cigarette use
Missing
54 Participants28 Participants26 Participants
Susceptible to e-cigarette use
Not Susceptible
220 Participants115 Participants105 Participants
Susceptible to e-cigarette use
Susceptible
44 Participants15 Participants29 Participants
Susceptible to hookah use
Missing
53 Participants27 Participants26 Participants
Susceptible to hookah use
Not Susceptible
241 Participants121 Participants120 Participants
Susceptible to hookah use
Susceptible
24 Participants10 Participants14 Participants
Tobacco media literacy7.79 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1580 / 160
other
Total, other adverse events
0 / 1580 / 160
serious
Total, serious adverse events
0 / 1580 / 160

Outcome results

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.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual Health Education CurriculumPercentage of Eligible 9th Grade Students Recruited to Participate in the Study158 Participants
Usual Health Education Curriculum Plus InterventionPercentage of Eligible 9th Grade Students Recruited to Participate in the Study160 Participants
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.

Time frame: post-test immediately following completion of the intervention

Population: This data is from the intervention students who completed the post-test only.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual Health Education CurriculumPercentage of Participants Indicating Moderate to High Acceptability of the AD IT UP ProgramAgreed with I understood AD IT UP81 Participants
Usual Health Education CurriculumPercentage of Participants Indicating Moderate to High Acceptability of the AD IT UP ProgramAgreed with AD IT UP was easy to use62 Participants
Usual Health Education CurriculumPercentage of Participants Indicating Moderate to High Acceptability of the AD IT UP ProgramAgreed with I tried my hardest when using AD IT UP66 Participants
Usual Health Education CurriculumPercentage of Participants Indicating Moderate to High Acceptability of the AD IT UP ProgramAgreed with UP would be helpful to other kids my age64 Participants
Usual Health Education CurriculumPercentage of Participants Indicating Moderate to High Acceptability of the AD IT UP ProgramAgreed with I agree with AD IT UP's message82 Participants
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.

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual Health Education CurriculumPercentage of Participants Retained Through the Final Data Collection23 Participants
Usual Health Education Curriculum Plus InterventionPercentage of Participants Retained Through the Final Data Collection15 Participants
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).

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.

ArmMeasureValue (MEAN)Dispersion
Usual Health Education CurriculumChange in Tobacco-related Media Literacy7.98 units on a scaleStandard Deviation 1.68
Usual Health Education Curriculum Plus InterventionChange in Tobacco-related Media Literacy8.89 units on a scaleStandard Deviation 1.79
p-value: 0.0595% CI: [0.208, 1.31]t-test, 2 sided
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).

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.

ArmMeasureValue (MEAN)Dispersion
Usual Health Education CurriculumChanges in Attitudes Toward Tobacco Products3.09 units on a scaleStandard Deviation 1.98
Usual Health Education Curriculum Plus InterventionChanges in Attitudes Toward Tobacco Products2.91 units on a scaleStandard Deviation 1.25
p-value: 0.0595% CI: [0.078, 0.99]t-test, 2 sided
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.

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.

ArmMeasureValue (MEAN)Dispersion
Usual Health Education CurriculumChanges in Intention to Use Tobacco Products0.386 units on a scaleStandard Deviation 0.997
Usual Health Education Curriculum Plus InterventionChanges in Intention to Use Tobacco Products0.419 units on a scaleStandard Deviation 1.116
p-value: 0.0595% CI: [-0.056, 0.522]t-test, 2 sided
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).

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.

ArmMeasureValue (MEAN)Dispersion
Usual Health Education CurriculumChanges in Normative Beliefs About Tobacco Products2.43 units on a scaleStandard Deviation 2.07
Usual Health Education Curriculum Plus InterventionChanges in Normative Beliefs About Tobacco Products2.25 units on a scaleStandard Deviation 1.29
p-value: 0.0595% CI: [-0.177, 0.829]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026