Clinical trial NCT04836455: Impact of Vaping Prevention Advertisements
Official title: Impact of The Real Cost Vaping Prevention Advertisements on Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Food and Drug Administration (FDA)
name: National Cancer Institute (NCI)
First posted: 2021-04-08
Enrollment: 1565
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Susceptibility to Vaping Score
timeFrame: Week 3
Secondary outcomes:
measure: Mean Attention Score
timeFrame: Week 2
measure: Mean Negative Affect Score
timeFrame: Week 2
measure: Mean Cognitive Elaboration Score
timeFrame: Week 3
measure: Mean Social Interactions Score
timeFrame: Week 3
measure: Mean Vaping Health Harm Risk Beliefs Score
timeFrame: Week 3
measure: Mean Vaping Addiction Risk Beliefs Score
timeFrame: Week 3
measure: Mean Vaping Attitudes Score
timeFrame: Week 3
measure: Number of Days Participants Vape (E-cigarette Use)
timeFrame: Week 3
measure: Mean Smoking Health Harm Risk Belief Score
timeFrame: Week 3
measure: Mean Smoking Addiction Risk Belief Score
timeFrame: Week 3
measure: Mean Smoking Attitude Score
timeFrame: Week 3
measure: Mean Susceptibility to Smoking Cigarettes
timeFrame: Week 3
measure: Number of Days That Participants Who Smoke Cigarettes
timeFrame: Week 3
Other outcomes:
measure: Mean Perceived Message Effectiveness Score (UNC Youth Scale)
timeFrame: Week 2
measure: Mean Perceived Message Effectiveness Score (FDA Scale)
timeFrame: Week 2
measure: Mean Avoidance Score
timeFrame: Week 2
measure: Mean Reactance Score
timeFrame: Week 2
measure: Mean Vaping Social Enhancement Beliefs Score
timeFrame: Week 3
measure: Mean Vaping Affect Regulation Beliefs Score
timeFrame: Week 3
measure: Mean Vaping Injunctive Norms Score
timeFrame: Week 3
measure: Mean Vaping Refusal Self-efficacy
timeFrame: Week 3
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Seth Noar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noar SM, Gottfredson NC, Kieu T, Rohde JA, Hall MG, Ma H, Fendinger NJ, Brewer NT. Impact of Vaping Prevention Advertisements on US Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236370. doi: 10.1001/jamanetworkopen.2022.36370.