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

Electronic (e-)cigarettes are the most used nicotine product among U.S. youth. Hispanic/Latino (H/L) youth are at greater risk for e-cigarette use, yet few evidence-based cessation programs exist for youth, and even fewer are tailored to H/L youth. The current work will develop and pilot an e-cigarette cessation intervention for H/L high school youth, using focus groups with the target population and input from a community advisory board (CAB). The intervention will be tested with 120 H/L high school students who use e-cigarettes to assess its 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 (8)

• 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

The intervention is grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavior Therapy \[CBT\]; Vinci, 2020), as well as a manualized CBT e-cigarette intervention for adolescents and young adults (Kong et al., 2017; Kong et al., 2021). The structure and content of the manual were further informed by themes identified through focus groups. The newly developed BReATHE Program will consist of six 60-minute group sessions. "Building Knowledge for Change" focuses on nicotine vaping psychoeducation. "Recognizing the Triangle" introduces the cognitive triangle. "Anticipating Triggers" offers tools to cope with internal and external triggers to vape. "Tranquil Minds" offers relaxation techniques to manage negative emotions. "Healthy Communication" teaches clients more effective ways to communicate. "Educate Others" consists of reviewing skills and planning for the graduation ceremony where youth will teach family members what they learned.

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
• Fluent in English
• Identify as being of Hispanic/Latino origin
• Report current use of e-cigarettes (i.e., used ≥ 4x in the past month or at least 1x per week in the past month)

You may not qualify if:

• Having a history of severe psychiatric conditions (e.g., bipolar disorder, schizophrenia, psychosis, or schizoaffective 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, have a severe learning disability or other neurodevelopmental disorders)

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 (26)

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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 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)