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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140915
Acronym
V2V
Enrollment
71
Registered
2021-12-02
Start date
2022-12-19
Completion date
2024-08-30
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-cigarette Use, Vaping

Keywords

Vaping, Adolescents

Brief 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.

Detailed 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.

Interventions

BEHAVIORALPeer Messaging

Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.

BEHAVIORALPeer Coaching via Text

Peer coaching, facilitated by texting

BEHAVIORALGamification

Gamification, designed to motivate participation

OTHERE-Cigarette Cessation Materials

E-cigarette cessation materials by the Research Coordinator at the time of study enrollment.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Participant Recruitment and Retention3 monthsInvestigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.

Secondary

MeasureTime frameDescription
Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]3 monthsCotinine-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.
Number of Peer Coaching Interactions3 monthsInvestigators will assess the system use (for V2V intervention only), as measured by the number of peer coaching interactions completed.
Number of Peer Videos Viewed3 monthsInvestigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of viewing peer videos.
Acceptability of and Satisfaction With the Intervention3 monthsInvestigators 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.
Change in Self-Efficacy ScoreBaseline and 3 monthsAssessment of change in self-efficacy, as measured by the Self-efficacy Questionnaire (SEQ-12). The SEQ-12 (Self-Efficacy) Score is the mean of 12 items coded 1 (Not at all confident) to 5 (Extremely Confident). The score can range from 1-5, with higher scores indicating better confidence to refrain from vaping.
Number of Participants With With Change in Stage of ChangeBaseline and 3 monthsInvestigators will also assess the change in stage of change, as measured by Prochaska's Stages of Change model. 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 3 months.
Change in Severity of Nicotine AddictionBaseline and 3 monthsInvestigators will assess the change in the severity of nicotine addiction, as measured by the Hooked on Nicotine Checklist. The Hooked on Nicotine Checklist Score is the sum of 10 items coded 0 (Not endorsed) or 1 (Endorsed). The possible range is 0-10, with higher scores indicating a higher level of addiction.
Number of Games Engaged In3 monthsInvestigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of reading gamification texts.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Students in school randomized to the intervention will receive: (1) peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit; (2) peer coaching, facilitated by texting; and (3) gamification, designed to motivate participation. 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
39
Control
Students in schools randomized to the control condition will be provided 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. 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.
32
Total71

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Categorical
<=18 years
23 Participants24 Participants47 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
16 Participants8 Participants24 Participants
Age, Continuous17.3 years
STANDARD_DEVIATION 1.2
16.8 years
STANDARD_DEVIATION 1
17.07 years
STANDARD_DEVIATION 1.1
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants15 Participants20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants16 Participants45 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants6 Participants
Grade
10th
6 Participants17 Participants23 Participants
Grade
11th
12 Participants8 Participants20 Participants
Grade
12th
15 Participants4 Participants19 Participants
Grade
9th
6 Participants3 Participants9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants8 Participants10 Participants
Race (NIH/OMB)
More than one race
4 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants6 Participants9 Participants
Race (NIH/OMB)
White
29 Participants18 Participants47 Participants
Region of Enrollment
United States
39 Participants32 Participants71 Participants
Sex/Gender, Customized
Female
20 Participants16 Participants36 Participants
Sex/Gender, Customized
Male
17 Participants16 Participants33 Participants
Sex/Gender, Customized
Non-Binary
1 Participants0 Participants1 Participants
Sex/Gender, Customized
Transgender
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 32
other
Total, other adverse events
0 / 390 / 32
serious
Total, serious adverse events
0 / 390 / 32

Outcome results

Primary

Participant Recruitment and Retention

Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionParticipant Recruitment and Retention37 Participants
ControlParticipant Recruitment and Retention31 Participants
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.

Time frame: 3 months

Population: The data for this outcome measure were based on participant self-report. As participants were not required to answer all survey questions, the number of participants analyzed reflects only those who responded to the specific questions related to this outcome on the surveys.

ArmMeasureValue (MEAN)Dispersion
InterventionAcceptability of and Satisfaction With the Intervention25.34 scores on a scaleStandard Deviation 4.65
ControlAcceptability of and Satisfaction With the Intervention24.95 scores on a scaleStandard Deviation 4.64
p-value: 0.77t-test, 2 sided
Secondary

Change in Self-Efficacy Score

Assessment of change in self-efficacy, as measured by the Self-efficacy Questionnaire (SEQ-12). The SEQ-12 (Self-Efficacy) Score is the mean of 12 items coded 1 (Not at all confident) to 5 (Extremely Confident). The score can range from 1-5, with higher scores indicating better confidence to refrain from vaping.

Time frame: Baseline and 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Self-Efficacy Score-.19 scores on a scaleStandard Deviation 0.2
ControlChange in Self-Efficacy Score.15 scores on a scaleStandard Deviation 0.22
Secondary

Change in Severity of Nicotine Addiction

Investigators will assess the change in the severity of nicotine addiction, as measured by the Hooked on Nicotine Checklist. The Hooked on Nicotine Checklist Score is the sum of 10 items coded 0 (Not endorsed) or 1 (Endorsed). The possible range is 0-10, with higher scores indicating a higher level of addiction.

Time frame: Baseline and 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Severity of Nicotine Addiction-.37 scores on a scaleStandard Deviation 0.79
ControlChange in Severity of Nicotine Addiction-1.19 scores on a scaleStandard Deviation 0.87
Secondary

Number of Games Engaged In

Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of reading gamification texts.

Time frame: 3 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Games Engaged InPrefer not to answer1 Participants
InterventionNumber of Games Engaged InAlways6 Participants
InterventionNumber of Games Engaged InUsually6 Participants
InterventionNumber of Games Engaged InAbout half the time6 Participants
InterventionNumber of Games Engaged InRarely10 Participants
InterventionNumber of Games Engaged InNever8 Participants
Secondary

Number of Participants With 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.

Time frame: 3 months

Population: The data for this outcome measure were based on participant self-report. As participants were not required to answer all survey questions, the number of participants analyzed reflects only those who responded to the specific questions related to this outcome on the surveys.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]5 Participants
ControlNumber of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence]5 Participants
Secondary

Number of Participants With With Change in Stage of Change

Investigators will also assess the change in stage of change, as measured by Prochaska's Stages of Change model. 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 3 months.

Time frame: Baseline and 3 months

Population: The data for this outcome measure were based on participant self-report. As participants were not required to answer all survey questions, the number of participants analyzed reflects only those who responded to the specific questions related to this outcome on the surveys.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With With Change in Stage of ChangeWorse5 Participants
InterventionNumber of Participants With With Change in Stage of ChangeSame15 Participants
InterventionNumber of Participants With With Change in Stage of ChangeBetter14 Participants
ControlNumber of Participants With With Change in Stage of ChangeWorse6 Participants
ControlNumber of Participants With With Change in Stage of ChangeSame17 Participants
ControlNumber of Participants With With Change in Stage of ChangeBetter7 Participants
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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionNumber of Peer Coaching Interactions5.05 Number of interactionsStandard Deviation 4.59
Secondary

Number of Peer Videos Viewed

Investigators will assess the system use (for V2V intervention only), as measured by the self-reported frequency of viewing peer videos.

Time frame: 3 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Peer Videos ViewedNever12 Participants
InterventionNumber of Peer Videos ViewedVery Rarely (Once)10 Participants
InterventionNumber of Peer Videos ViewedRarely (1-2 days/week)6 Participants
InterventionNumber of Peer Videos ViewedOccasionally (3-4 days/week)5 Participants
InterventionNumber of Peer Videos ViewedFrequently (5 days/week)2 Participants
InterventionNumber of Peer Videos ViewedVery Frequently0 Participants
InterventionNumber of Peer Videos ViewedPrefer not to answer2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026