Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study

NCT ID: NCT07192601

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2028-04-30

Brief Summary

Investigators will create and implement an e-cigarette intervention for Hispanic/Latino (H/L) high school youth. Focus groups with the target population (i.e., H/L high school students) and meetings with a community advisory board (CAB) will inform this intervention. The intervention will be tested with 120 H/L high school e-cigarette users to assess feasibility and promise for reducing use.

Detailed Description

The e-cigarette cessation intervention will be grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT; Cavallo et al., 2007; Krishnan-Sarin et al., 2013; Vinci et al., 2020) that has been found to be effective in both adults, as well as adolescents. The CBT intervention will likely include a total of 6 weekly sessions adapted for e-cigarettes that will be developed by the investigators and in consultation with a community advisory board. Based on initial feedback from focus groups, the sessions will likely take place in person, be in a group format, and be no longer than 50 minutes in duration. Some sessions will also include the adolescents' caregivers. We propose a "Preparation to Quit" session conducted approximately one week prior to quitting, which incorporates motivational strategies and assistance to aid quitting, set a quit day, and make a quit plan. This will be followed by a "pre-quit" session on the day before the quit day to review the quit plan, and then an additional session after the quit day that will focus on: 1) coping with cravings and withdrawal symptoms and identifying high risk situations, 2) becoming assertive, developing refusal skills, 3) stress/anger management skills, 4) problem-solving skills, 5) enhancing communication and family dynamics, 6) behavioral activation and community reinforcement, and 7) relapse prevention and coping with lapses. Session content and format will be adapted to be culturally relevant and integrate needs and strengths that are gleaned from focus groups. In addition to attending sessions, participants will be asked to complete an in-person baseline questionnaire session (~1hr) and a salivary cotinine assessment to objectively quantify recent nicotine exposure to verify current e-cigarette usage prior to their first cessation session. Participants will also be asked to complete a weekly 5-minute online survey on REDCap reflecting past week substance use. Participants will complete a salivary cotinine assessment to objectively quantify nicotine exposure during their last intervention session. Participants will also be asked to complete a follow-up questionnaire session (30 minutes) three months after they have completed the intervention, as well as a salivary cotinine assessment.

Conditions

Vaping Teens; Vaping Behaviors; Vaping Cessation; Tobacco Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

See Intervention Section

Group Type: OTHER

E-cigarette Cessation Manual

Intervention Type: BEHAVIORAL

E-cigarette cessation manual development. Empirically supported treatment content. We anticipate grounding the intervention in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavior Therapy; CBT), which has been found to be effective with both adults and adolescents to quit cigarette smoking (Vinci, 2020). We anticipate including sessions that teach CBT skills to help adolescents quit e-cigarette use. These CBT skills and format will be adapted from prior manualized CBT smoking cessation interventions for adolescent smoking cessation and manualized CBT e-cigarette intervention for adolescents and young adults that are currently ongoing (e.g., Kong et al., 2017; Kong et al., 2021; Bold et al., 2022). The structure and content of the e-cigarette cessation manual will be further informed by themes and sub-themes from the focus group data analysis relating to both surface and deep structure cultural modifications.

Interventions

E-cigarette Cessation Manual

E-cigarette cessation manual development. Empirically supported treatment content. We anticipate grounding the intervention in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavior Therapy; CBT), which has been found to be effective with both adults and adolescents to quit cigarette smoking (Vinci, 2020). We anticipate including sessions that teach CBT skills to help adolescents quit e-cigarette use. These CBT skills and format will be adapted from prior manualized CBT smoking cessation interventions for adolescent smoking cessation and manualized CBT e-cigarette intervention for adolescents and young adults that are currently ongoing (e.g., Kong et al., 2017; Kong et al., 2021; Bold et al., 2022). The structure and content of the e-cigarette cessation manual will be further informed by themes and sub-themes from the focus group data analysis relating to both surface and deep structure cultural modifications.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Enrolled in high school or 14-18 years old
• Identify as being of Hispanic/Latino origin
• Report past month e-cigarette use and verified by saliva cotinine test

Exclusion Criteria

• having a history of severe psychiatric conditions (e.g., bipolar disorder)
• currently enrolled in or planning on enrolling in another e-cigarette and/or tobacco cessation intervention
• having potential difficulties comprehending study procedures (e.g., not able to speak/write in English or Spanish, have a severe learning disability)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James and Esther King Biomedical Research Program

OTHER

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Elisa M. Trucco, PhD

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FIU Center for Children and Families

Miami, Florida, United States

Countries

United States

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Other Identifiers

24K09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-24-0113

Identifier Type: -

Identifier Source: org_study_id