Assessing the Effectiveness of Peer-Facilitated Versus Self-Navigated Tobacco Cessation Interventions for Youths

This study is based on the previous CEASE initiative conducted in Baltimore City using a community-based participatory research approach. The study will use a two-arm randomized clinical trial design. Baltimore City high schools and colleges will be randomly allocated to one of the two arms of the study: 1) the peer-facilitated arm and 2) the self-navigated arm.

A list of all identified high schools and colleges will be developed by the research assistant, including those that were engaged during the previous CEASE phases. Based on the characteristics of these schools and colleges, potential eligible partners will be identified, and contact information for each potential partner/site will be obtained. An outreach and engagement consultant will initiate and maintain contact with potential partners/host sites. Targeted outreach messages and resources will be developed and distributed in the form of study information sheet and flyers via email blasts, social media posts, and tabling at school/college events. Once the outreach and engagement consultant establishes contact, members of the research team might be invited to conduct an information session for the partnering school and colleges.

At the information session, interested schools/colleges will receive targeted communications orienting them to the Morgan CARES Network and information about the new iteration of the CEASE program: CEASE Youth. Following all partners' committed engagement or re-engagement, a Partnership Agreement will be developed with each interested entity. This agreement will specify the nature of the engagement (intervention site, recruitment assistance, dissemination activities, etc.) and points of contact for the partnering organization and the CEASE Youth program. The allocation of the host sites to different study arms will be random and blinded and done in a steering committee meeting to ensure the procedure is objective. Following the orientation of school staff, Peer Ambassadors (other high schools or college students) will be recruited, and an orientation and consent process for the peer ambassadors and their parents will be done.

Information sessions will be offered in the various sites as agreed upon with the partners. The information sessions will be offered to a general audience, including prospective participants at events and/or meetings either in-person or virtually via video conference platforms. An information session presentation will be delivered and will describe an overview of the program, eligibility for participation, and the study procedures. Interested high school students will complete a School Survey, which also includes the study eligibility questions, in-person or virtually, using a web-based survey. Participants who are eligible based on the eligibility screening through the school survey will be invited to be enrolled in the study and will complete a registration/enrollment form. Their information will be listed in the enrollment log. Participant IDs will be assigned to participants once they are enrolled in the study. Informed consent will be obtained before starting the intervention. Participating Youths and Young Adults will be recruited either by Peer Ambassadors (other high school or college students) during the first stage of the project (Pre-trial Assessment) or later through advertisement, word of mouth, and referral from school staff.

The data will be collected using forms built in KoboToolbox and will be exported from KoBoToolbox as an Excel file and will be imported to statistical software Stata for cleaning and analysis. The descriptive univariate analysis will be done to review each variable and summarize demographic information. The result will be presented as mean and standard deviation for continuous variables and percentage for categorical variables. The bivariate analysis will be done to compare quit rates with some potential predictor variables using Chi-square tests of independence for categorical variables (gender, race, education, employment) and Student's T-test for continuous variables (age and Fagerstrom score). The results will be presented as numbers with corresponding proportions for the Chi-square tests and presented as means with standard deviations for the T-tests. Multivariate analysis will be done using regression models to compare study outcomes in two study arms. The study will control for several socio-demographic characteristics and other variables. Sub-group analysis will be conducted based on age, gender, race/ethnicity, and other demographic characteristics to compare the effect of the intervention in these different groups.