Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping

Vaping Clinical Trial

— V2V  

Official title:

Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05140915
• Other study ID #: H00021082
• Secondary ID: R34DA050992
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The dramatic increase in the use of e-cigarettes among U.S. adolescents has been called a national epidemic, with more adolescents now using e-cigarettes than traditional cigarettes. The high amounts of nicotine in e-cigarettes harm adolescents and put them at greater risk of becoming traditional cigarette smokers. The investigators propose to develop Vaper-to-Vaper (V2V), a suite of mobile peer driven tools including peer texting and coaching based on lessons learned in the investigators' prior tobacco intervention work, to engage and help adolescents use strategies to manage cravings and successfully quit.

Description:

The FDA and the US Surgeon General call the increasing use of e-cigarettes among U.S. adolescents an epidemic, with e-cigarette use exceeding combustible cigarette use. The high amounts of nicotine in e-cigarettes harm adolescent brain development, impacting learning, memory, and attention. Adolescent e-cigarette users also are at higher risk than non-users of transitioning to traditional cigarettes. While prevention is important, evidence-based interventions to engage and help adolescent e-cigarette users quit are critically needed. Key challenges include adolescents perceiving e-cigarette use to be of low risk resulting in a low intention to quit, and the major influence of peers in e-cigarette use. Given there currently are no evidence-based cessation interventions to assist adolescent e-cigarette users in quitting, as suggested by the American Academy of Pediatrics and FDA, the investigators propose to develop Vaper-to-Vaper (V2V), a multi-modal mobile peer driven intervention, based on lessons learned in our prior tobacco intervention work. Peer-driven interventions have been found to successfully improve smoking outcomes in adolescents, and the investigators have had success in developing peer-driven interventions for low motivated adult smokers. The Investigators therefore will adapt these approaches for adolescent e-cigarette users. V2V's goal will be to engage, educate, motivate, and facilitate the adolescent in using strategies to manage cravings and successfully quit. The V2V components will include: Peer Messaging (tailored messages pushed via texting), Peer Coaching (asynchronous communications with trained coaches via texting), and Gamification (using game design to motivate participation). Adapting these tools to the unique needs of adolescent e-cigarette users will further extend these tools into novel directions. For Aim 1 the investigators will convene a peer advisory panel of 20 adolescent e-cigarette users to participate in a qualitative assessment and further development of V2V components. In Aim 2 the investigators will evaluate the feasibility of the research protocols and the feasibility and acceptability of the V2V intervention in a pilot feasibility study with eighty adolescent e-cigarette users from 4 high schools (schools randomized to either V2V intervention or control) recruited and followed for 6 months. The investigators hypothesize being able to recruit 80 adolescents (20/school, 40 per study condition) and that >85% will be retained in each study condition at 6-month follow-up (Aim 2A). For Aim 2b the investigators will monitor V2V engagement (e.g., number of V2V texting quizzes completed, peer coaching interactions, peer videos viewed) and assess acceptability of and satisfaction with the program. For Aim 2C the investigators hypothesize that the intervention will be associated with greater cotinine-validated 7-day point prevalence vaping abstinence rates, lower time to first quit attempt, and less amount of e-cigarette use compared to control at 6-month follow-up. This Stage I project, adapting an existing intervention and feasibility/pilot testing, will provide the necessary materials and information to proceed to a subsequent large-scale Stage III R01 trial to test the efficacy of the V2V intervention in supporting adolescent e-cigarette users in quitting.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 30, 2024
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• Enrolled in grade 9-12 at participating high school
• Current e-cigarette user, as defined as a response greater than "0 days" to the question: "During the past 7 days, on how many days did you use e-cigarettes?" This eligibility criterion is modeled on a question in the 2018 National Youth Tobacco Survey (NYTS), a survey of U.S. middle and high school students which used a 30-day timeframe.
• Have a smartphone.
• English- or Spanish-speaking Exclusion Criteria: Unable or unwilling to provide informed assent or consent (in the case of those aged 18 years or older).

Related Conditions & MeSH terms

• E-cigarette Use
• Vaping

Intervention

Behavioral:
• Peer Messaging
Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.
• Peer Coaching via Text
Peer coaching, facilitated by texting
• Gamification
Gamification, designed to motivate participation

Other:
• E-Cigarette Cessation Materials
Written e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. The written materials will consist of two pamphlets from Journeyworks, selected based on: (1) their clear and attractive layout designed for a low-literacy audience, and (2) their providing both information re: e-cigarette use with a strong message about nicotine and nicotine addiction, E-Cigarettes: 8 Things Everyone Should Know, and support in quitting, How to Quit Vaping.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Recruitment and Retention	Investigators will asses the number of those screened, eligible, and consented who remain active in the program at 6 months.	6 months
Secondary	Acceptability of and Satisfaction with the Intervention	Investigators will access the acceptability of and satisfaction with the intervention, as measured by Client Satisfaction Questionnaire (CSQ-8).The overall CSQ-8 score is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. Similarly, investigators will look for association between summary score and cessation.	6 months
Secondary	Abstinence from Vaping as measured by Saliva Samples [Cotinine-validated 7-day point prevalence]	Cotinine-validated 7-day point prevalence abstinence, as measured by saliva samples collected from all; analyzed for those reporting 7-day abstinence; cut-off 11.4 ng/ml, cotinine-imputed abstinence when cotinine is missing.	6 months
Secondary	Time to First Quit Attempt	Time to first quit attempt, as evaluated by timeline followback method to assess the duration of abstinence and quit attempts.	6 months
Secondary	Change in e-Cigarette Use Intensity	Change in e-Cigarette use intensity, as measured by self-reported number of days and amount vaped in past 7 and 30 days.	6 months
Secondary	Change in e-Cigarette Use Frequency	Change in e-Cigarette use frequency, as measured by self-reported number of days and amount vaped in past 7 and 30 days.	6 months
Secondary	Number of Intervention Assessments Completed	Investigators will assess the system use (for V2V intervention only), as measured by the number of intervention assessments completed.	6 months
Secondary	Number of Peer Coaching Interactions	Investigators will assess the system use (for V2V intervention only), as measured by the number of peer coaching interactions completed.	6 months
Secondary	Number of Peer Videos Viewed	Investigators will assess the system use (for V2V intervention only), as measured by the number of peer videos viewed.	6 months
Secondary	Number of Games Engaged In	Investigators will assess the system use (for V2V intervention only), as measured by the number of games engaged in.	6 months
Secondary	Change in Self-Control Behavioral Capability	Assessment of change in self-control/behavioral capability, as measured by the Tangney self-discipline factor, an 11-item self-report measurement to assess individual differences in traits of self-control. Reponses are considered as ordinal and all analyses will be conducted to account for the categorical nature of the data.	6 months
Secondary	Change in Self-Efficacy	Assessment of change in self-efficacy, as measured by the Self-efficacy Questionnaire (SEQ-12).The SEQ-12 is a 12-item questionnaire with 6 questions pertaining to internal stimuli and external stimuli domains each. Two composite scores are computed for each of these domains by adding the individual items.	6 months
Secondary	Change in Stage of Change	Investigators will also assess the change in stage of change, as measured by Prochaska's Stages of Change. The stages of change are: Precontemplation, Contemplation, Preparation/Determination, Action/Willpower, Maintenance, and Relapse. Participants will self-report their stage of change at 0 and 6 months.	6 months
Secondary	Change in Severity of Nicotine Addiction	Investigators will assess the change in severity of nicotine addiction, as measured by the Hooked on Nicotine Checklist (HONC). The HONC is a 10-item instrument used to determine the onset and strength of tobacco dependence. The HONC is designed to identify the point at which an adolescent has lost full autonomy over their use of tobacco. A total score is calculated by summing the number of positive responses. The number of positive responses reflects the degree of dependence.	6 months