Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students
Phase: NA
Conditions: Adolescent Behavior, Tobacco Use, E-Cig Use
Sponsor: University of Pittsburgh

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Study Protocol and Statistical Analysis Plan 
Title of Study: Pittsburgh and Rural Area High School Tobacco Prevention 
ClinicalTrial.gov Identifier: NCT05081843 
Principal Investigator: Jaime E. Sidani PhD, MPH, CHES 
Date of Document: 3/16/2023 
 
 

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Table of Contents 
 
 
 
 
 
 
 
 
 
Page Number 
Study Protocol 
  Objectives………………………………………………………………..3 
  Design……………………………………………………………………3 
  Methods………………………………………………………………….3 
  Measures…………………………………………………………………4 
Statistical Analysis Plan…………………………………………………...6 
  Power and Sample Size…………………………………………………..7 
 
 

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Study Protocol 
Objectives: 
Despite advances in tobacco control, tobacco use among adults continues to be a major clinical and public 
health challenge in the United States. This is exacerbated by the recent increase in adolescent overall 
tobacco use, likely prompted by the increased popularity of alternative tobacco products (ATPs) such as e-
cigarettes. These products are marketed aggressively to adolescents online, and adolescents who engage 
with this marketing are more likely to initiate tobacco use. Considering adolescent tobacco initiation is 
associated with persistent nicotine addiction into adulthood, prevention efforts should be targeted at this 
population. Adolescent tobacco prevention programs that utilize a media literacy approach teach 
adolescents how to critically evaluate tobacco-related media messages. Designed for 9th grade 
students, the web-based media literacy program AD IT UP demonstrated initial feasibility and 
acceptability in 2011. In 2019, AD IT UP was updated to include ATPs and online tobacco marketing. 
However, the updated program has not yet been tested. The purpose of this study is to assess the 
feasibility and acceptability of the updated AD IT UP program among 9th grade students. We will conduct 
a cluster randomized trial comparing AD IT UP to usual substance use education in both high schools. 
Feasibility endpoints will assess completion of AD IT UP and associated assessments, while acceptability 
endpoints will assess student perceptions of AD IT UP. Secondary objectives are assess changes in 
intentions to use tobacco, attitudes, normative beliefs and tobacco media.  Data collected from this study 
will inform a subsequent large-scale randomized controlled trial of AD IT UP to assess efficacy in 
decreasing tobacco initiation in high school students.  
Design: 
We will conduct a cluster randomized controlled trial (RCT) in two high schools in Pittsburgh, PA.  
 
Methods: 
 
Sample and Recruitment. The two high schools will be selected according to the following criteria. 
Schools will have an adequate number of 9th-grade students (at least 130 at each school) to power this 
study. Each school must have at least 4 health classes to participate in the trial. One school will be located 
in a rural area and the other will be located in a suburban area. Parents will be sent a letter from the school 
informing them of the study aims and the procedure for opting out of consent. Student assent will be 
obtained before the all assessments. All assessments (intervention and control) and completion of AD IT 
UP (intervention) will be completed during regular class time in the school computer lab or on student 
devices (i.e., ChromeBook, iPad). 
Randomization. Each school will have 4 health classes. Prior to the intervention (Figure 2), in each 
school, two classes will be randomized to the intervention condition and two classes to usual education 
using a random number generator 
Pre-test Assessment and Assignment of Identifiers. In each school, all students (intervention and control) 
will be assigned a unique identifier and password, which will facilitate access to AD IT UP (intervention 
students), track progress through modules (intervention students), and link to the assessments (all 
students).  
 

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Intervention Condition. The intervention will be the updated AD IT UP web-based tobacco media literacy 
program. AD IT UP is self-paced and typically takes approximately 120 minutes to complete (including 
pre- and post-test assessments). In previous studies of the original AD IT UP, students completed AD IT 
UP over a series of 3 class periods delivered 1 week apart. Figure 2 presents this scenario.  
 
 
 
Control Condition. Many schools develop their own substance use prevention programming, so schools’ 
usual programming will be used to mimic what is expected in a future trial. Students in the control 
condition will complete assessments on similar schedules as intervention students (Figure 2).  
Post-test and Follow-up Assessments. Following the completion of the final AD IT UP module, all 
students will complete the post-test. Follow-up assessments will be completed at 4 and 12 months after 
the post-test (Figure 2).    
 
Measures: 
Feasibility Metrics. (Primary Outcome). Data for the assessment of feasibility will be descriptive with 
point estimates and 95% confidence intervals. One highly important quantitative outcome to inform a 
subsequent cluster randomized trial is overall retention of students. Therefore, our main outcome of 
feasibility will be determined by at least 60% of students completing the pre-test, post-test, and both 
follow-up assessments, consistent with previous research. Other feasibility outcomes and related cut-offs 
are presented in Table 1.  
Acceptability Metrics. Intervention participants will be asked to complete a series of acceptability items 
on the post-test assessment via close-ended 5-point Likert-type items (Table 1). These items are as 
follows: (1) I enjoyed AD IT UP, (2) I understood AD IT UP, (3) AD IT UP was easy to use, (4) I tried my 
hardest when I was doing AD IT UP, (5) I think AD IT UP would be helpful to other kids my age, (6) I 
would recommend AD IT UP to a friend, and (7) I agree with AD IT UP’s message.  
Secondary Outcomes. Although efficacy cannot be assessed through this pilot trial, we include as part of 
all assessments quantitative items that will be used in a future RCT (Table 1), which include 

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susceptibility to future use of tobacco products, attitudes toward tobacco products, normative beliefs 
about tobacco products, and tobacco-related media literacy. These will be assessed at all 4 assessments.  
• 
Susceptibility. Susceptibility will be assessed by asking participants whether they would use each 
tobacco product if it was offered to them by their best friend. Responses were Definitely Yes, 
Probably Yes, Probably No, and Definitely No. Separate items assessed susceptibility for 
cigarettes, cigars/cigarillos, e-cigarettes, and hookah. Consistent with previous literature, a 
participant was considered susceptible to use of an NTP if they answered anything other than 
“Definitely No” for that product.  
• 
Attitudes. Attitudes will be assessed via 8 items asking participants to assess their agreement with 
statements about NTPs using a 10-point Likert-type scale (Strongly Agree to Strongly Disagree). 
Items include: (1) E-cigarettes are not as bad for your health as other products, (2) Using tobacco 
products at parties is fun, (3) Tobacco products help you deal with problems or stress, (4) 
Smoking helps people stay thin, (5) People who use e-cigarettes are more fun to be around than 
people who don’t use e-cigarettes, (6) If someone starts using tobacco products every day, it is 
very hard for them to stop, (7) Smoking makes a person look more attractive, (8) It would be very 
easy for me to get e-cigarettes if I wanted them. NOTE: An additional item (Using e-cigarettes at 
parties is fun) was added, making this a 9 item scale. A summary scale will be created for 
attitudes by calculating average scores across all items.  
• 
Normative Beliefs. Normative beliefs will be assessed via 6 items asking participants to assess 
their perceptions about their friends’ acceptance of NTPs using a 10-point Likert-type scale (Very 
Acceptable to Very Unacceptable). Items include: (1) It is OK for people your age to smoke 
cigarettes, (2) It is OK for people your age to use e-cigarettes, (3) It is OK for people your age to 
use hookahs, (4) It is OK for people your age to smoke cigars or cigarillos, (4) A wealthy person 
is more likely to use tobacco products than a poor person, and (6) A successful person is more 
likely to use tobacco products than an unsuccessful person. A summary scale will be created for 
normative beliefs by calculating average scores across all items. 
• 
Tobacco-related Media Literacy. Tobacco-related media literacy will be assessed via adapted 
items from the Smoking Media Literacy Scale with 8 items using a 10-point Likert-type scale 
(Strongly Agree to Strongly Disagree). Items include: (1) To make money, tobacco companies 
will do anything they could get away with, (2) Certain tobacco products are specially designed to 
appeal to young children, (3) Tobacco advertisers try to link tobacco products to things that 
people want like love, beauty, and adventure, (4) There are often hidden messages in ads for 
tobacco products, (5) Movies scenes with people using tobacco products in them are constructed 
very carefully, (6) Tobacco product ads show scenes with a healthy feel to make people forget 
about the health risks, (7) Most movies and TV shows that show people using tobacco products 
make it look more attractive than it really is, (8) When you see a tobacco product ad, it is very 
important to think about what was left out of the ad about potential health problems. A summary 
scale will be created for tobacco-related media literacy by calculating average scores across all 
items. 
 
 

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Table 1. Summary of Measures and Related Cut-offs   
Measure  
Assessments  
Cut-offs (if applicable)  
  
T0  T1  T2  T3  T4    
Feasibility     
  
  
  
 
  
  
• 
Completion of all assessments 
(primary outcome) 
  
P  P  P  P  60% of students complete all assessments 
• 
Number of parents providing consent P    
  
 
  
95% of parents provide consent   
Acceptability  
  
  
  
 
  
  
• 
Likelihood of recommending AD IT UP 
to peers  
  
  
P   
  
85% reporting “agree” or “strongly agree”  
• 
Understanding AD IT UP  
  
  
P   
  
85% reporting “agree” or “strongly agree”  
• 
Whether AD IT UP would be helpful to 
others  
  
  
P   
  
85% reporting “agree” or “strongly agree”  
• 
Level of enjoyment while participating 
in AD IT UP  
  
  
P   
  
85% reporting “agree” or “strongly agree”  
• 
Agree with the message of AD IT UP 
 
 
P 
 
85% reporting “agree” or “strongly agree”  
• 
Ease of use of AD IT UP 
 
 
P 
 
85% reporting “agree” or “strongly agree”  
• 
Tried hard while using AD IT UP 
 
 
P 
 
85% reporting “agree” or “strongly agree”  
Secondary Outcome Variables  
  
  
  
 
  
Measurement  
• 
Intention-to-use tobacco products 
(cigarettes, e-cigarettes, hookah, cigars)   
  
P  P  P  P  4-item Likert-type scale  
(“Definitely no” to “Definitely yes”)  
• 
Attitudes and normative beliefs 
toward cigarettes, e-cigarettes, hookah, 
cigarillos 
  
P  P  P  P  Attitudes: 8 items with Likert scale (Strongly 
Agree to Strongly Disagree)  
 
Norm Beliefs: 6 items with Likert scale (“Very 
Acceptable to Very Unacceptable)  
• 
Tobacco-related media literacy 
  
P  P  P  P  8 items with Likert-type scale; (“SA” to “SD”)  
Socio-demographic Factors 
  
  
  
 
  
  
• 
Age; Sex; Race/ethnicity  
  
P    
 
  
Year; Male/Female/Other; Self-report  
 
Statistical Analysis Plan: 
Data will be analyzed using STATA.  
Primary Outcome (feasibility): To answer the primary outcome of feasibility, we will calculate the 
number and percentage of students who completed each of the four assessments. We will answer the 
outcome of eligible students who participate we will calculate the number and percentage of students who 
were present in the classroom and (1) eligible (i.e., not opted out by parents) and (2) assent to participate 
(i.e., agree to participate by clicking “yes” on the assent form and completing the baseline assessment). 
Acceptability: Acceptability will be assessed by calculating numbers and percentages for each of the 
seven overall program items. Acceptability is determined by answering “Agree” or “Strongly Agree.”  
Secondary Outcomes: Although efficacy cannot be determined by a pilot trial, we will also assess changes 
in susceptibility, attitudes, normative beliefs, and tobacco media literacy using descriptive statistics and 
compare changes in these scores from pre to post-test and from post-test to follow-up between the 
intervention and control groups using two-sample tests of proportion. NOTE: Due to insufficient retention 

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of students for the 1-year follow-up assessments, changes in NTP susceptibility we assessed these 
changes between baseline and post-test assessments.  
Power & Sample Size Justifications. Based upon a feasibility estimate of 60%, a sample size of 130 
students (65 in each condition) in each school will afford the ability to estimate feasibility with a 95% 
confidence interval width of 0.17.