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

NCT07192601 | Active Not Recruiting

• 2 other identifiers: IRB-24-011324K09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

adolescents; vaping cessation; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (5)

• E-Cigarette Assessment for Youth-Revised checklist

  This measure assesses the timing, brand, flavoring, quantity, and frequency of current and past e-cigarette use.

  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

• Salivary cotinine samples

  To biochemically verify self-reports of abstinence, saliva samples will be obtained using NicAlert cotinine test strips.

  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).

• Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes

  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.

  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

• Questionnaire of Vaping 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.

  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

• Wisconsin Smoking Nicotine Withdrawal Scale

  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.

  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

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Single Arm

OTHER

See Intervention Section

Behavioral: E-cigarette Cessation Manual

Interventions

E-cigarette Cessation Manual 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.

Single Arm

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida International University: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

FIU Center for Children and Families

Miami, Florida, 33199, United States

Location

Related Publications (18)

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MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: As this is a pilot study, all participants (N=120) will be enrolled in the same vaping cessation program, which will be grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT) that has been found to be effective in both adults, as well as adolescents.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 25, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)