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

Florida International University (FIU) logo

Florida International University (FIU)

Status

Active, not recruiting

Conditions

Vaping Cessation
Vaping Behaviors
Tobacco Use Disorder
Vaping Teens

Treatments

Behavioral: E-cigarette Cessation Manual

Study type

Interventional

Funder types

Other

Identifiers

NCT07192601
IRB-24-0113
24K09 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Single Arm
Other group
Description:
See Intervention Section
Treatment:
Behavioral: E-cigarette Cessation Manual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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