Clinical trial NCT06053762: Identify the Usefulness of Peer-facilitated Versus Self-navigated Quit Tobacco Program for Youths.
Official title: Assessing the Effectiveness of Peer-Facilitated Versus Self-Navigated Tobacco Cessation Interventions for Youths
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Product Use
Keywords: Tobacco cessation program, Community-based participatory research, Peer-facilitated approach, Youth
Lead sponsor: Morgan State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-26
Enrollment: 630
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is a randomized clinical trial. The overarching goal of the study is to apply Community Based Participatory Research (CBPR) to reduce tobacco use among youth and young adults (14-21 y/o) in Baltimore City through a mixed-method approach adapted to the needs of youth and young adults. This study has partnered with the American Lung Association's Not On Tobacco (N-O-T) program and aims to deliver tobacco cessation classes. The study will target Baltimore City high schools and colleges, prioritizing facilities in underserved inner-city communities. The proposed research consists of a 2-arm trial where participants from four high schools and two colleges will be randomized to peer-facilitated tobacco cessation classes or self-navigated groups. The trial aims to assess the effectiveness of peer-facilitated tobacco cessation intervention compared to self-navigated tobacco cessation in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the tobacco cessation rate will be equal to or higher in the peer-facilitated arm than in the self-navigated arms. The secondary hypothesis is that the retention rate will be equal to or higher in the peer-facilitated arm compared to the self-navigated arm.

CEASE Youth tobacco cessation program is an eight-week program based on the American Lung Association's (ALA) Not On Tobacco (N-O-T) program. The ALA's N-OT program is acknowledged as an accessible and effective option for teen tobacco cessation. Participants in the peer-facilitated group will be given the evidence-based N-O-T program curriculum and provided with virtual materials, information, and resources by their assigned peer facilitators. Virtual tobacco cessation peer motivation sessions will be offered using the digital online platform Zoom, and the peer facilitators will communicate with the participants in between the classes. The participants in the self-navigated group will receive the same ALA N-O-T program curriculum and complete the eight-week sessions, but it will be self-navigated and without peer facilitations. No peer facilitator will be assigned to this group, and the participants will complete the curriculum by themselves. They will also receive other available resources, including information about the local tobacco cessation services available.

Detailed description: 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.

An Adverse Event Log will be kept by the program manager for each enrolled participant at each intervention site. The program manager will rank each adverse event that is logged by the level of severity, ranging from Mild to Life-Threatening. The likelihood that an adverse event is or is not related to the intervention will also be reported. The CEASE executive committee will outline the appropriate actions to take in response to the adverse event, and potential actions may include: None, Dose Modification, Medical Intervention, Hospitalization, Intervention Discontinued, or Other. The program manager will track and report actions taken. In addition to reporting the outcome of the adverse event, the program manager will also indicate whether or not the event was expected. Adverse events that are reported to be "Severe" or "Life-Threatening" are designated as a "Serious Adverse Event" on the Adverse Event Log as well. Should a Serious Adverse Event (SAE) occur, the program manager will immediately notify the PI. Upon being notified, the PI will complete the Serious Adverse Event Report form detailing the nature of the event and actions taken. All SAEs will be reported in accordance with the Morgan State University IRB procedures and the NIH regulatory and reporting mandates.

The program manager will record events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.

Adherence to the CEASE intervention will be measured by class attendance. Participants will need to attend the sessions provided in order to benefit from the expected effect of the intervention. The facilitators will record weekly attendance at sessions using the attendance sheet. The attendance records will be used in paying incentives for participation. Participants in both the peer-facilitated and self-navigated arms of the program should complete a maximum of 8 weeks of sessions. At the point of data analysis, all participants enrolled, whether they completed the eight sessions or not, will be included in the data. Participants who attend a total of three sessions out of the eight will, however, be regarded as having poor attendance/compliance in the program because they would not have received enough dosing. Participants who miss two consecutive sessions or three non-consecutive sessions, including the last session, will be regarded as being dropped out of the study. However, every attempt will be taken to follow up with all enrolled participants three months after the end of the intervention. Participants we are unable to reach at this point will be considered lost to follow-up.

The study participant's contact information will be securely stored at Morgan State University's Morgan CARES Center for Urban Health Disparities Research \& Innovation, and electronically for internal use during the study. At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated by the MSU IRB or NIMHD requirements. Study participant research data (signed informed consent and photo release forms, school surveys, follow-up surveys etc.) which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the MSU Morgan CARES center and electronically. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. Participant IDs will be assigned to participants once they are enrolled into the study. The key list linking the IDs with the participants identifying information will be securely maintained electronically, with access by only the PI, program manager, and selected trained research staff. The Peer facilitators will have sub-lists of the key list for their specific sites/groups, which they will carry safely from the site to their residences and keep properly secured at home until they can bring it to the Morgan CARES center. The security and safety features of the digital communication platforms to be used (Zoom) will be implemented to preserve confidentiality. Zoom meeting IDs will be kept private to the groups only. Passwords or waiting rooms will be used to control access. The study data entry and study management systems used by study sites and by Morgan CARES research staff will be secured and password protected. At the end of the study, all study databases will be de-identified and archived at the Prevention Sciences Research Center (PSRC).

Eligibility criteria: Inclusion Criteria:

* Current tobacco user (have used any tobacco product over the past 30 days)
* Individuals who are 14- 21 years old
* Individuals who are ready and willing to quit using tobacco
* Individuals who have access to a digital device (e.g., laptop/computer/tablet) with internet access or data

Exclusion Criteria:

* Individuals who have health conditions preventing them from providing consent will be excluded from the study.

Primary outcomes:
measure: Self-reported tobacco cessation
timeFrame: Self-reported tobacco cessation: 3-5 months post-intervention.
Secondary outcomes:
measure: Retention rate
timeFrame: Week 8
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Morgan CARES
state: Maryland
Study officials:
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