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

Not Applicable

Active, not recruiting

• Conditions: Vaping Behaviors; Vaping Teens; Tobacco Use Disorder; Vaping Cessation

• Registration Number: NCT07192601
• Lead Sponsor: Florida International University

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.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Primary Completion: 2027-12-31
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
E-Cigarette Assessment for Youth-Revised checklist	Baseline assessment: data will be reported on past 1-month and 1-year e-cigarette use Each weekly intervention session: data will be reported on past 1-week e-cigarette use Follow-up assessment: data will be reported on past 1-month e-cigarette use	This measure assesses the timing, brand, flavoring, quantity, and frequency of current and past e-cigarette use.
Salivary cotinine samples	Saliva cotinine samples that can detect past-week nicotine use will be obtained at Baseline (Week 0), at the end of treatment (Week 6), and at the 3-month follow-up after treatment completion (Week 18).	To biochemically verify self-reports of abstinence, saliva samples will be obtained using NicAlert cotinine test strips.
Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes	Baseline assessment: data will be reported on past 1-month symptoms Each weekly intervention session: data will be reported on past 1-week symptoms Follow-up assessment: data will be reported on past 1-month symptoms	The Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes (PROMIS-E) is a 4-item measure (each item scored on a 5-point Likert scale) that assesses nicotine dependence. Values range from 0 to 16 with higher scores representing worse outcomes.
Questionnaire of Vaping Craving	Baseline assessment: data will be reported on past 1-month craving Each weekly intervention session: data will be reported on past 1-week craving Follow-up assessment: data will be reported on past 1-month craving	The Questionnaire of Vaping Craving (QVC) is a 10-item measure (each item scored on a 7-point Likert scale) that assesses vaping craving. Values range from 10 to 70 with higher scores representing worse outcomes.
Wisconsin Smoking Nicotine Withdrawal Scale	Baseline assessment: data will be reported on past 1-week withdrawal symptoms Each weekly intervention session: data will be reported on past 1-week withdrawal symptoms Follow-up assessment: data will be reported on past 1-week withdrawal symptoms	The Wisconsin Smoking Nicotine Withdrawal Scale (WSWS) is a 28-item measure (each item scored on a 5-point Likert scale) that assesses nicotine withdrawal symptoms. Values range from 0 to 112 with higher scores representing worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Timeline Followback questionnaire	Baseline assessment: data will be reported on past 1-month and past 1-year substance use Each weekly intervention session: data will be reported on past 1-week substance use Follow-up assessment: data will be reported on past 1-month substance use	Frequency and quantity of current and past use of other substances beyond e-cigarettes (e.g., other tobacco products, alcohol, cannabis) will also be queried.
Adolescent E-Cigarette Consequences Questionnaire	Baseline assessment: data will be reported on past 1-week expectancies Follow-up assessment: data will be reported on past 1-week expectancies	The Adolescent E-Cigarette Consequences Questionnaire (AECQ) is a 31-item measure (each item scored on a 5-point Likert scale) that assesses outcome expectancies when using an e-cigarette. Values range from 31 to 155 with higher scores representing worse outcomes.
PROMIS Emotional Distress Depression and Anxiety Pediatric Item Bank	Baseline assessment: data will be reported on past 2-week symptoms experienced Follow-up assessment: data will be reported on past 2-week symptoms experienced	This is a 5-item measure (each item scored on a 5-point Likert scale) that assesses symptoms of depression and anxiety. Values range from 0 to 20 with higher scores representing worse outcomes.
Parental Monitoring, Child Disclosure, and Relationship Quality	Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions	This 22-item measure (each item scored on a 5-point Likert scale) assesses parental monitoring, child disclosure, and relationship quality. Values range from 0 to 88 with higher scores representing better outcomes.
Resistance to Peer Influence	Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions	The Resistance to Peer Influence (RPI) is a 10-item measure (each item scored on a 4-point Likert scale) that assesses an adolescent's ability to resist peer influence across multiple hypothetical scenarios. Values range from 0 to 40 with higher scores representing better outcomes.
Multidimensional Scale of Perceived Social Support	Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions	Social support (e.g., friends, family members) will be measured by this 12-item (each item scored on a 7-point Likert scale) measure. Values range from 12 to 84 with higher scores representing better outcomes.
Treatment Acceptability	Final weekly intervention session: data will be reported on past 2-month general impressions with the treatment.	Participants will complete a survey encompassing multiple-choice questions and open-ended text boxes regarding their satisfaction with the vaping cessation program.

Trial Locations

Locations (1)

FIU Center for Children and Families; 🇺🇸 Miami, Florida, United States