University of Southern California
Los Angeles, California, 90032, United States
Location status: Recruiting
NCT Number: NCT07721883
The purpose of this study is to present social media posts with varying combinations of flavor types and mentions of stealth use, to adolescents and determine whether these message characteristics increase adolescents' perceptions of these products and susceptibility to using these products.
Interested in participating?
Request Info14 year–17 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90032, United States
Location status: Recruiting
University of Southern California Social Behavioral and/or Secondary Research Protocol Template
General Information Study Title: TCORS3 Project 4: Social media influences on engagement and susceptibility to non-combustible tobacco product use among youth and young adults (AYA)
PI Name: Jennifer Unger, Ph.D.
Study Information
Social media is an increasingly important source of information on emerging tobacco products among adolescents. On social media platforms with large youth user bases (e.g., TikTok, Instagram), social media influencers (e.g., public figures, promoters, models, brand ambassadors) can promote novel non-combustible tobacco products on behalf of manufacturers and distributors via social media posts that may attract adolescents to nicotine use. Of concern is the emergence of novel oral nicotine products (ONPs) and e-cigarettes-both of which may leverage social media to market aspects of their products that could attract adolescents to tobacco use.
TCORS Project 4 includes two interrelated studies. Study 1 (not a clinical trial) will examine text (Twitter), picture (Instagram), and video (TikTok) posts in social media to determine whether tobacco-related posts that depict products with: a) concept flavors, b) stealth use, and c) other youth-appealing characteristics will generate more engagement (e.g., likes, favorites, shares), compared with tobacco-related posts that do not have these characteristics, respectively.
Study 2 (the current clinical trial) will present social media posts adapted from those found in Study 1, with varying combinations of flavor types and mentions of stealth use, to adolescents and determine whether these message characteristics increase adolescents' susceptibility to using these products.
I. Is susceptibility to use the ONP or e-cigarette products higher among youth assigned to view social media posts with concept or characterizing flavors and/or references to stealth use? II. Are the associations between social media post characteristics and susceptibility to use the product mediated by perceived harm and perceived social norms? III. Do the effects of flavors, stealth use, and influencers on susceptibility vary across demographic and tobacco use groups (e.g., age, gender, race/ethnicity, tobacco product use history)?
Inclusion & Exclusion Criteria
Inclusion and exclusion criteria for enrollment: Adolescents will be eligible to participate if they are students attending the schools where TCORS Project 2 (P2) will be collecting data (but not participating in the P2 cohort) and provide parental consent and youth assent. Exclusion criteria include lack of parent consent or student assent, inability to read English, or any cognitive or physical health condition that would preclude viewing stimuli on a computer screen and answering questions. There are no eligibility criteria based on previous tobacco product use because susceptibility (openness to trying a product in the future) can be assessed among ever-users as well as never-users.
Provide justification for including (or excluding) minors: The study is focused on associations between social media exposure to tobacco content and tobacco product use among adolescents and young adults (AYA), so adolescents (i.e., minors under 18) will be surveyed.
Sample considerations: TCORS P2 recruits from local area high schools and this project will recruit at the same schools. The research questions will look at differences in associations among demographic groups; therefore a diverse sample is needed. Los Angeles area high schools provide sex, racial and ethnic diversity. All eligible students will be invited to participate.
Where will Recruitment occur?
Schools will be recruited in Year 1. Data will not be collected from human subjects until the schools have been recruited and their information has been uploaded here.
X No ☐ Yes If yes, please answer the additional questions regarding International Research.
How will Recruitment happen?
Email from school personnel to students and parents.
Each year (Years 3-5), the researchers will recruit 1500 students attending the same high schools (across Los Angeles County) in which the USC TCORS is already conducting surveys. P2 will recruit the schools for the survey, using procedures that the school-based research team has developed and refined over the past 30 years. These procedures include obtaining approval from the school district's IRB or similar research review committee and meeting with principals and teachers to introduce the study. P2 will request access to specific classrooms of students for P2's longitudinal survey, and they will also request access to additional classrooms for P4. To avoid contaminating the ongoing observational cohort studies, the researchers will not show tobacco social media posts to students in the cohorts. Instead, the researchers will recruit classrooms of students who are not in the cohorts (e.g., when the cohorts are in 10th grade, the researchers will recruit 9th graders and 11th graders from the same schools). The first half of year in years 3-5, P2 will be collecting data from one grade level, so the researchers will have access to the other 3 grade levels in each high school. After obtaining approval from the district and school, the researchers ask the principal to send an email and paper letter to all parents in the selected classes. The email and letter will state that the school is partnering with USC to administer a 20-minute survey in class. The email will contain a link for parents to provide online consent or opt out. The paper letter will contain a QR code that parents can scan with their phones to provide online consent or opt out. For families that do not respond, the researchers will contact the parents by phone or text, using the contact information provided by the school (under FERPA, schools can provide directory information including parents' names and phone numbers unless they have opted out). After obtaining parental consent, the researchers will invite students to complete an online youth assent form and participate in the survey.
Role of the Investigator/Research Staff
Jennifer B. Unger, Ph.D. is Professor of Population and Public Health Sciences (PPHS) at USC. She has led multiple projects and cores in the USC Transdisciplinary Tobacco Use Research Center in the 2000s to investigate cultural influences on adolescent tobacco use, and multiple grants from the California Tobacco-Related Disease Research Program to study tobacco use among Hispanic, African American, and American Indian populations. She served as MPI for USC TCORS projects examining the prevalence, themes, and effects of tobacco content in social media for the 2013-2018 and 2018-2023 cycles and has directed a Population Core from 2018-2023 focused on data collection in local high schools.
Screening of Participants
X No:
Research Activities
Once.
X Yes:
Secondary/Archival/Existing Data
X No:
International Research NA
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The researchers are making stimuli that will appear to be social media posts about tobacco products. They will vary on two dimensions in a 3X2 design:
Type of flavor portrayed (flavored, unflavored, or concept flavor name) Whether the post portrays the tobacco product as concealable
Time frame: Immediately after viewing the stimuli
All of these are standard psychosocial measures from the Population Assessment of Tobacco and Health (PATH) survey.
Contact information is provided by the study sponsor or research team.
University of Southern California
Other
USC Tobacco Center of Regulatory Science - Project 4: Social Media Influences on Engagement and Susceptibility to Non-combustible Tobacco Product Use Among Youth and Young Adults (AYA)
Acronym: USC TCORS P4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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