Trial on the Effect of E-cigarette Advertising on Cigarette Perceptions in Adolescents

Study Overview
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Brief Summary
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This research aims to investigate how exposure to advertising for Electronic Nicotine Delivery Systems (commonly called e-cigarettes) may lead to combustible smoking initiation in adolescents.

Detailed Description
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[3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic

Official Title
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Does Exposure to Electronic Nicotine Delivery Systems Advertising Affect Positive Smoking Expectancies and Social Normative Beliefs About Smoking?

Conditions
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Attentional Bias, Smoking Cues, Positive Perceptions About Cigarette Smoking, Social Norms, Smoking Susceptibility

Intervention / Treatment
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* Behavioral: E-cigarette ad exposure
* Other: non e-cigarette TV commercials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: Exclusion criteria will include inadequate English proficiency, and diagnosis of a learning or vision disorder.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-cigarette ad exposure<br>Participants in the e-cigarette ad exposure condition will view e-cigarette ads on the computer screen while having their eye movements tracked | Behavioral: E-cigarette ad exposure<br>* Participants view a series of e-cigarette TV commercials<br>|
| Sham Comparator: non e-cigarette ad exposure<br>Participants in the non e-cigarette ad exposure condition will view non e-cigarette ads on the computer screen while having their eye movements tracked | Other: non e-cigarette TV commercials<br>* Participants view a series of non e-cigarette TV commercials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in baseline in implicit positive smoking expectancies, measured by the implicit association test | Scores are measured by recording the amount of time (reaction time) it takes to categorize smoking-related words with positive (e.g., cool) and negative (e.g., cancer) words. Faster reaction times when categorizing smoking-related words with positive words is evidence of higher positive smoking expectancies. | baseline, within 5 minutes post intervention | 
| Amount of time spent looking at static smoking cues in e-cigarette advertisements | Eye-tracking will be used to measure the amount of time spent looking at static smoking cues in screen shots taken from e-cigarette advertisements. The amount time spent looking at a smoking cue is a measure how much attention was given to the smoking cue. The longer the looking time, the greater amount of attention. | approximately 30 minutes post intervention | 
| 7-item explicit positive smoking expectancies scale | Scores are measured on a 7-item scale. Positive smoking expectancies will be assessed using the following questions that follow the lead-in, Please tell me how you feel about the following statements. I think I would enjoy smoking; I think smoking would give me something to do when I'm bored; I think smoking would help me deal with problems or stress; I think smoking would help me stay thin; I think smoking would help me to feel more comfortable at parties; I think smoking would be relaxing; and I think smoking would make me look older. Responses are yes/no. Responses are coded as 1 for yes and 0 for no. Responses are then summed for a maximum positive smoking expectancy score out of 7. Higher scores mean higher positive smoking expectancies. | approximately 30 minutes post intervention | 
| 11-item scale that measures social normative beliefs about smoking | This 11-item scale assess social normative beliefs about smoking related to 1) perceived disapproval from family/friends, 2) perceived popularity among successful/elite, and 3) perceived prevalence. Disapproval scale questions are answered using a 4-point Likert scale (1 = Strongly disagree; 4 = Strongly agree). A total disapproval score (ranging from 1 to 4) is calculated by averaging responses to each question. Higher values indicate a higher disapproval score. Popularity scale questions are answered using a 4-point Likert scale (1 = Strongly disagree; 4 = Strongly agree). A total popularity score (ranging from 1 to 4) is calculated by averaging responses to each question. Higher values indicate a higher popularity score. Prevalence scale questions are answered using a percent scale from 0 - 100% in 10% increments. A total prevalence scale (from 0 to 100) is calculated by averaging the responses to each question. Higher values indicate a higher prevalence score. | approximately 30 minutes post intervention | 
| A 3-item scale that measures adolescent smoking susceptibility | This 3-item instrument is used to predict which never smokers are likely to start smoking by measuring their curiosity to use tobacco products. Item responses are on a 4-point Likert scale (definitely yes, probably yes, probably not, definitely not). To classify a respondent as not susceptible to smoking, the respondent must indicate definitely not to all four items. Any other response to any item classifies a respondent as susceptible. | approximately 30 minutes post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time looking at dynamic smoking cues in e-cigarette advertisements | Eye-tracking will be used to measure the total amount of time spent looking in realtime at smoking cues in TV commercials for e-cigarettes. The amount of time looking at smoking cues will be a measure of the amount of attention given to smoking cues. The longer the amount of time spent looking at smoking cues indicates that a greater amount of attention was given to the smoking cues. | During the intervention, approximately 15 minutes post baseline | 
| 18-item scale that measures character attributes of actors that appeared in the commercials | Character Attributes will be collected using a scale that measures participants beliefs about character attributes using the lead in: I think [Character Name] is:  using a 5-point Likert (1 = strongly disagree; 5 = strongly agree). There is a total of 6 attributes assessed: 1) smart (smart, intelligent, stupid), 2) successful (successful, achieves goals, gets what he/she wants), 3) attractive (physically attractive, ugly, good-looking), 4) funny (funny, humorous, makes me laugh), 5) respected (respected by others, receives approval, criticized by others), and 6) popular (has lots of friends, well liked, gets support from others). A total score (form 1 to 5) for each scale is calculated by averaging responses for each question within that scale. For each scale, a higher total score indicates higher beliefs about that attribute. | approximately 30 minutes post intervention | 
| 5-item scale that measure how much participants wish to be like the actors appearing in the commercials. | This 5-item is scale is used to quantify how much a participant would like to be like an actor appearing in a commercial. Questions are rated on a 5-point Likert scale (1 = Strongly Disagree; 5 = Strongly agree). A total identification score (from 1 to 25) is calculated by summing the responses to each question. A higher total score indicates a higher level of wishful identification. | approximately 30 minutes post intervention | 
| 13-item scale to measure risk perception about cigarette use | This 13-item scale measures risk perceptions associated with cigarette use. Questions are answered using a sliding percent scale from 0 - 100% in 10% increments. A risk perception scale is calculated (from 0 to 100) by averaging the responses to each question. Higher values indicate a higher risk perception. | approximately 30 minutes post intervention | 
| 13-item scale to Measure risk perception about e-cigarette use | This 13-item scale measures risk perceptions associated with e-cigarette use. Questions are answered using a sliding percent scale from 0 - 100% in 10% increments. A risk perception scale is calculated (from 0 to 100) by averaging the responses to each question. Higher values indicate a higher risk perception. | approximately 30 minutes post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positive Smoking expectancies, e-cigarette advertising, adolescents