Impact of Vaping Prevention Advertisements

Not Applicable

Completed

Conditions: Vaping

Interventions: 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

Registration Number: NCT04836455

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1565

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Real Cost vaping prevention ads - Health effects theme	The FDA's The REal Cost vaping prevention ads - Health harms theme	-
The Real Cost vaping prevention ads - Addiction theme	The FDA's The Real Cost vaping prevention ads - Addiction theme	-
Neutral vaping ads	Neutral vaping ads	-

Primary Outcome Measures

Name	Time	Method
Mean Susceptibility to Vaping Score	Week 3	The 3-item Susceptibility to Vaping Scale assesses the extent to which adolescents are open to vaping, using a 1 to 4 response option scale. Here, 1 indicates the lowest susceptibility to vaping, and 4 represents the highest, with higher values indicating a greater susceptibility to vaping - essentially, a worse outcome. The overall scale score is determined by averaging the scores of the three items, summing these scores and dividing by 3. This method results in a score range from a minimum of 1 to a maximum of 4.

Secondary Outcome Measures

Name	Time	Method
Mean Attention Score	Week 2	The 1-item mean attention measure assesses the extent to which a participant reports that an advertisement captures their attention. Response options range from 1 to 5, with higher scores indicating stronger attention, which is considered a better outcome.
Mean Vaping Addiction Risk Beliefs Score	Week 3	The 3-item Vaping Addiction Risk Beliefs Scale assesses the extent to which participants believe that vaping will lead to addiction. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with a score range from 1 to 5. Higher scores indicate stronger beliefs in the risk of addiction due to vaping, which is considered a better outcome.
Mean Social Interactions Score	Week 3	The 3-item Mean Social Interactions Scale assesses the extent to which a participant has discussed the addictiveness or harmfulness of vaping with others in the past 7 days. Response options range from 1 (0 times) to 6 (11 or more times). The overall scale score is calculated by averaging the three items, resulting in a score range from a minimum of 1 to a maximum of 6. Higher scores indicate more frequent social interactions, which are considered a better outcome.
Mean Smoking Health Harm Risk Belief Score	Week 3	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 range from 1 to 5, with higher scores indicating stronger beliefs in the health risks associated with smoking, which is considered a desirable outcome (i.e., better outcome).
Mean Vaping Health Harm Risk Beliefs Score	Week 3	The 3-item Vaping Health Harm Risk Beliefs Scale assesses the extent to which participants believe that vaping will lead to health harms. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with possible scores ranging from a minimum of 1 to a maximum of 5. Higher scores indicate stronger beliefs in the health risks associated with vaping, which is considered a better outcome.
Mean Smoking Attitude Score	Week 3	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 more positive attitude toward smoking, which is considered as less desirable outcome (i.e., worse outcome).
Mean Susceptibility to Smoking Cigarettes	Week 3	The 3-item Mean Susceptibility to Smoking Cigarettes Scale assesses a participant's susceptibility to smoking cigarettes. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with possible scores ranging from 1 to 5. Higher scores indicate a stronger susceptibility to smoking, which is considered a less desirable outcome (i.e., worse outcome).
Number of Days That Participants Who Smoke Cigarettes	Week 3	Participants will be asked to report the number of days they smoked cigarettes over the past 21 days. We chose to retain the continuous measure of the number of days smoking rather than dichotomizing this outcome, due to the substantial variability observed in the number of days cigarettes were used. A higher value indicates more days that participants smoked cigarettes, which is considered a less desirable outcome (i.e., worse outcome).
Mean Cognitive Elaboration Score	Week 3	The 3-item Mean Cognitive Elaboration Scale assesses the extent to which participants have thought about the addictiveness or harmfulness of vaping over the past 7 days. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with scores ranging from a minimum of 1 to a maximum of 5. Higher scores indicate greater cognitive elaboration, suggesting a more effective engagement with the content (a better outcome).
Mean Vaping Attitudes Score	Week 3	The 3-item Vaping Attitudes Scale assesses a participant's attitude towards vaping (e.g., good/bad). Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with scores ranging from 1 to 5. Higher scores indicate a more positive attitude toward vaping, which is considered a less desirable outcome (i.e., worse outcome).
Mean Smoking Addiction Risk Belief Score	Week 3	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 stronger health harm beliefs about smoking, which is a desirable outcome (i.e., better outcome).
Mean Negative Affect Score	Week 2	The 3-item Negative Affect Scale assesses the extent to which an advertisement elicits negative emotions from the participant, such as fear or disgust. Response options range from 1 to 5. The overall scale score is calculated by averaging the scores of the three items, resulting in a minimum possible score of 1 and a maximum of 5. Higher scores indicate stronger negative emotions. In the context of this assessment, higher negative emotions are considered a more effective (better) outcome.
Number of Days Participants Vape (E-cigarette Use)	Week 3	Participants will be asked to report the number of days they vaped over the past 21 days. We chose to retain the continuous measure of the number of days spent vaping rather than dichotomizing this outcome, due to the substantial variability observed in the number of days e-cigarettes were used. A higher value indicates more days that participants vaped, which is considered a less desirable outcome (i.e., worse outcome).