[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07721883":3,"trial-entities:NCT07721883":86,"trial-summary:NCT07721883":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":59,"locations":61,"central_contacts":76,"overall_officials":80,"references":81,"see_also_links":82},"NCT07721883","UP-23-00724","Social Media Influences on Engagement and Susceptibility to Non-combustible Tobacco Product Use Among Youth and Young Adults (AYA)","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)","RECRUITING","2028-05-01","2026-07","2026-07-23","2025-07-01","University of Southern California","OTHER",false,"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.","University of Southern California Social Behavioral and\u002For Secondary Research Protocol Template\n\nGeneral 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)\n\nPI Name: Jennifer Unger, Ph.D.\n\nStudy Information\n\n1. What is the general purpose of the study? What do the investigators hope to learn? (Maximum 1-2 paragraphs of explanation).\n\n   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.\n\n   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.\n\n   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.\n2. List the Research Questions.\n\nI. 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\u002For 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\u002Fethnicity, tobacco product use history)?\n\nInclusion \\& Exclusion Criteria\n\n1. Describe the inclusion and exclusion criteria for enrollment.\n2. Provide justification for the population included.\n3. Please describe (maximum 1-2 paragraphs) how equity, diversity, and inclusion have been considered.\n\nInclusion 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.\n\nProvide 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.\n\nSample 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.\n\nWhere will Recruitment occur?\n\n1. List all sites or locations where researchers will recruit participants (e.g., on USC campus, place of employment, a specific elementary school, Amazon Turk, Qualtrics panel, specific groups within Facebook, Instagram, etc. Provide exact locations and\u002For weblinks as applicable).\n\n   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.\n2. Are the researchers specifically seeking any participants physically present in a country outside of the United States?\n\nX No ☐ Yes If yes, please answer the additional questions regarding International Research.\n\nHow will Recruitment happen?\n\n1. What format(s) will the researchers use to advertise (find) potential participants (e.g., Listservs, personal emails, public email, flyer, letter, phone call, social media post (e.g., Facebook, Twitter, Instagram)?\n\n   Email from school personnel to students and parents.\n2. Who will distribute the recruitment material, and how will it be distributed?\n\nEach 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.\n\nRole of the Investigator\u002FResearch Staff\n\n1. Will the primary investigator or research staff know any research participants, or have a past or present relationship with participants (e.g., supervisors, principals, any kind of authority or influence over the participants)? X No ☐ Yes: If yes, please explain the relationship.\n2. Will the primary investigator or research staff have a relationship with the data collection site? X No\n\n4\\. Researchers' relevant experience and background and\u002For that of research staff as it pertains to supporting and understanding the participants in the study .\n\nJennifer 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.\n\nScreening of Participants\n\n1\\. Will participants be screened?\n\nX No:\n\nResearch Activities\n\n1. List all activities (i.e., interviews, focus groups, surveys, interventions etc.) participants will be asked to perform and how long each activity will take. For studies with multiple populations, for each activity, specify which population is doing which activity.\n\n   1. High school students will be recruited in collaboration with P2 and school site administrators. Information on the study survey will be sent from the school to students and parents. Parents will complete consent forms online. Students will read a description of the study and assent form before they begin the survey, which will be administered online at the school site. No compensation will be given to participants. If the school allows, small gifts (such as USC pens, etc.) may be given to students.\n   2. Participating students will complete an online survey, programmed in REDCap, on their classroom Chromebooks (see measures in Table 1) directly onsite at the schools. In recent school-based surveys, the researchers have found that high schools, even those in low-SES areas, have at least one Chromebook per student. If necessary, the study will provide additional Chromebooks for students to use. After answering questions about their demographic characteristics and tobacco product use, participants will be randomly assigned to view social media posts about e-cigarettes and ONPs with vs. without specific post characteristics.\n   3. All survey data will be captured and stored in USC REDCap, which is password protected and encrypted, and stored on secure servers. No personally identifiable data will be collected.\n2. Where will researchers meet with participants for each listed activity? At their school site, once sites have agreed to participate.\n3. How many times will researchers meet with each participant for each activity listed?\n\n   Once.\n4. Are researchers using survey instruments, interview\u002Ffocus group questions, interview guides, etc., to collect data?\n\n   X Yes:\n5. Will the research uncover or discover information related to participant suicidality? X No\n\nSecondary\u002FArchival\u002FExisting Data\n\n1\\. Will the researchers be using any existing data sets?\n\nX No:\n\nInternational Research NA",[19],"Perceptions of Tobacco Products",[21],"tobacco, e-cigarette, social media","INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},4500,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Each intervention will be a picture of a social media post. The posts will vary (in a 3X2 factorial design) the type of flavor described and whether concealability is described.","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:\n\nType of flavor portrayed (flavored, unflavored, or concept flavor name) Whether the post portrays the tobacco product as concealable",[35,36,37,38,39,40],"Concept flavor tobacco product, depiction of concealment of product","Concept flavor tobacco product, no depiction of concealment of product","Flavored tobacco product, depiction of concealment of product","Flavored tobacco product, no depiction of concealment of product","Unflavored tobacco product, depiction of concealment of product","Unflavored tobacco product, no depiction of concealment of product",[42],{"measure":43,"description":44,"timeFrame":45},"Tobacco product use: Lifetime and past-month use of tobacco products Perceived harm of product Social norms about product use Susceptibility to tobacco use","All of these are standard psychosocial measures from the Population Assessment of Tobacco and Health (PATH) survey.","Immediately after viewing the stimuli",[],"ALL","14 Years","17 Years",true,{"inclusion":52,"exclusion":55,"raw_text":58},[53,54],"High school student","Provides parental consent and youth assent",[56,57],"No parental consent or youth assent","Can't read or speak English","Inclusion Criteria:\n\n* High school student\n* Provides parental consent and youth assent\n\nExclusion Criteria:\n\n* No parental consent or youth assent\n* Can't read or speak English",[60],"CHILD",[62],{"facility":13,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":73},"Los Angeles","California","90032","United States",[68],{"name":69,"role":70,"phone":71,"email":72},"Jennifer Unger, PhD","CONTACT","3233330580","unger@usc.edu",{"lat":74,"lon":75},34.05223,-118.24368,[77],{"name":78,"role":70,"phone":79,"email":72},"Jennifer B Unger, PhD","323-442-8234",[],[],[83],{"label":84,"url":85},"We will de-identify the data and upload it to an NIH-approved repository after the end of the study.","https:\u002F\u002Fresearch.usc.edu\u002Fnews\u002F2020\u002F11\u002Fusc-tobacco-center-of-regulatory-science\u002F",{"nct_id":4,"conditions":87,"biomarkers":90},[88,89],"Tobacco Use","Vaping",[],{"nct_id":4,"found":50,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study involving 4500 participants. It uses a 3x2 factorial design to test different social media post variations.","completed","Social Media Influences on Tobacco Product Use Among Youth","This study is looking at how social media posts about tobacco products might influence young people. Researchers will show adolescents, aged 14-17, different pictures of social media posts. These posts will vary in the type of flavor described (like flavored, unflavored, or a concept flavor name) and whether the tobacco product is shown as easy to hide. The goal is to understand if these different types of posts change how young people view tobacco products and if they make them more likely to consider using them. The study aims to enroll 4500 high school students.","Participants will be assessed immediately after viewing the stimuli to measure tobacco product use, perceived harm, social norms, and susceptibility to tobacco use.",95,"Participants will view social media posts and then answer questions about their perceptions of tobacco products and their susceptibility to using them. This will happen immediately after viewing the stimuli.","Not stated in the trial record.",[],"v2"]