Impact of Vaping Prevention Advertisements

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial is to determine whether exposure to vaping prevention advertisements (ads) reduce susceptibility to vaping among adolescents. Previous studies have been informative, but they have tended to be one-time experimental studies that do not replicate the repeated exposures to ads that people have in the real world. This study addresses this issue by repeatedly exposing participants to vaping prevention ads over time. Participants will be adolescents aged 13-17 who currently vape or who are susceptible to vaping. Participants will be randomly assigned to ad stimuli. They will be assigned to one of two The Real Cost trial arms-health harms or addiction-or to a control trial arm (probability of assignment is 1/3 for all trial arms). Participants in the study will take 4 online surveys over a 3-week period, once per week (At week 0, 1, 2, and 3). All participants will view randomized ad stimuli based on their trial arm and answer surveys items at each session.

Detailed Description
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Tobacco prevention mass media campaigns are a key tool for reducing tobacco use among adolescents. While vaping has increased greatly among adolescents, there has been a dearth of research on effective communication strategies to reduce vaping. This study will test the impact of advertisements from the Food and Drug Administration's The Real Cost campaign on reducing susceptibility to vaping in a randomized controlled trial, illuminating whether such ads are effective as well as what themes are most effective (i.e., health harms, addiction). The investigators focus on adolescents (ages 13-17) who currently vape or are at risk of vaping. Setting: The trial will be a longitudinal online study with 4 surveys over a 3 week period - 1 survey per week. Recruitment: Adolescent participants will be recruited through Qualtrics, an online survey panel platform. Interested prospective participants will complete a screening questionnaire to determine their eligibility. If eligible, Qualtrics will invite them to enroll in the trial. Informed Consent: Qualtrics will obtain parental consent online for adolescents who are eligible and interested in participating. After parental consent, adolescents will provide online assent prior to taking the survey. Randomization: After providing informed assent, Qualtrics survey software will randomly assign participants to one of the three trial arms. Participants will have an equal chance of being randomized to any of the 3 trial arms. Assessment: Participants in the study will take 4 surveys over a 3-week period. This will allow for multiple exposures to campaign ads. At week 0, randomize participants will be randomized to 1 of 2 FDA The Real Cost vaping prevention ad trial arms (health harms or addiction) or to a control arm (investigator created neutral ads about vaping). In each condition, participants will view 3 ads at each session, in a random order, corresponding to the theme they were assigned. At the first session (week 0), each participant will complete measures of vaping and smoking behavior, and will then view the ads that correspond to their trial arm. They will complete measures assessing message reactions after viewing each ad, followed by measures of susceptibility to vaping, vaping and smoking beliefs, and finally questions assessing demographics. For week 1 and 2 assessments, participants will complete measures of susceptibility to vaping, vaping and smoking beliefs, and vaping and smoking behavior. They will then view the same 3 ads from their trial arm and complete the message reactions measures. For the week 3 assessment, participants will only complete measures of susceptibility to vaping, vaping and smoking beliefs, and vaping and smoking behavior. Each survey will take approximately 15 minutes.

Official Title
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Impact of The Real Cost Vaping Prevention Advertisements on Adolescents

Conditions
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Vaping

Intervention / Treatment
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* Behavioral: The FDA's The REal Cost vaping prevention ads - Health harms theme
* Behavioral: The FDA's The Real Cost vaping prevention ads - Addiction theme
* Behavioral: Neutral vaping ads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages 13-17 years old Be able to read and speak English Be able to take an online survey in English Be susceptible to vaping Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Real Cost vaping prevention ads - Health effects theme<br> | Behavioral: The FDA's The REal Cost vaping prevention ads - Health harms theme<br>* Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about the health harms of vaping will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.<br>|
| Experimental: The Real Cost vaping prevention ads - Addiction theme<br> | Behavioral: The FDA's The Real Cost vaping prevention ads - Addiction theme<br>* Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about vaping addiction will be shown to participants at week 0, 1, and 2. Ads will be shown in a random order.<br>|
| Other: Neutral vaping ads<br> | Behavioral: Neutral vaping ads<br>* Three neutral (i.e., purely informational and without graphics) vaping video ads developed by the Investigators will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Susceptibility to Vaping Score | The 3-item Susceptibility to Vaping scale will be used to assess the extent to which adolescents are open to vaping. Response options are on a 1 to 4 scale. Overall scale scores are determined by summing scores of the 3 items and dividing by 3 (range 1-4), with higher scores representing a higher amount of the construct. | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean attention score | The 1-item mean attention measure assesses the extent to which a participant reports that an ad grabs their attention. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Week 2 | 
| Mean negative affect score | The 3-item negative affect scale assesses the extent to which an ad elicits negative emotion from the participant, such as fear or disgust. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 2 | 
| Mean cognitive elaboration score | The 3-item mean cognitive elaboration scale assesses the extent to which a participant thought about the addictiveness or harmfulness of vaping in the past 7 days. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean social interactions score | The 3-item mean social interactions scale assesses the extent to which a participant talked about the addictiveness or harmfulness of vaping with others in the past 7 days. Response options range on a scale from 1 (0 times) to 6 (11 or more times). Overall scale scores are determined by summing the scores (number of times) from the 3 items and dividing by 3 (range 0-33), with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean vaping health harm risk beliefs score | The 3-item vaping health harm risk beliefs scale assesses the extent to which a participant believes that vaping will lead to health harms. Response options are on a 1 to 5 scale. Overall scales scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean vaping addiction risk beliefs score | The 3-item vaping addiction risk beliefs scale assesses the extent to which a participant believes that vaping will lead to addiction. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean vaping attitudes score | The 3-item vaping attitudes scale assesses a participant's attitude towards vaping (e.g., good/bad). Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 3 | 
| Proportion of participants who vape (e-cigarette use) | Participants will be asked the number of days they vaped over the past 21 days. Vaping will be determined as follows: 0 days = non-vaper; 1 or more days = vaper | Week 3 | 
| Mean smoking health harm risk belief score | The 1-item mean smoking health harm risk belief measure assesses the extent to which a participant believes that smoking will lead to health harms. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean smoking addiction risk belief score | The 1-item mean smoking health harm risk belief measure assesses the extent to which a participant believes that smoking will lead to health harms. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean smoking attitude score | The 1-item mean smoking attitude measure assesses a participant's attitude toward smoking (i.e., good/bad). Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct. | Week 3 | 
| Mean susceptibility to smoking cigarettes | The 3-items mean susceptibility to smoking cigarettes scale assesses a participant's susceptibility to smoking cigarettes. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct. | Week 3 | 
| Proportion of participants who smoke cigarettes | Participants will be asked the number of days they smoked cigarettes over the past 21 days. Cigarette smoking will be determined as follows: 0 days = non-smoker; 1 or more days = smoker. | Week 3 |