E-cigarette Use, Vaping
Conditions
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
Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit.
Peer coaching, facilitated by texting
Gamification, designed to motivate participation
E-cigarette cessation materials by the Research Coordinator at the time of study enrollment.
Sponsors
Study design
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Recruitment and Retention | 3 months | Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence] | 3 months | 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. |
| Number of Peer Coaching Interactions | 3 months | Investigators will assess the system use (for V2V intervention only), as measured by the number of peer coaching interactions completed. |
| Number of Peer Videos Viewed | 3 months | Investigators 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 Intervention | 3 months | 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. |
| Change in Self-Efficacy Score | Baseline and 3 months | 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. |
| Number of Participants With With Change in Stage of Change | Baseline and 3 months | 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. |
| Change in Severity of Nicotine Addiction | Baseline and 3 months | 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. |
| Number of Games Engaged In | 3 months | Investigators 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
| Arm | Count |
|---|---|
| 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 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 24 Participants | 47 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 8 Participants | 24 Participants |
| Age, Continuous | 17.3 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 Participants | 15 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 16 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Grade 10th | 6 Participants | 17 Participants | 23 Participants |
| Grade 11th | 12 Participants | 8 Participants | 20 Participants |
| Grade 12th | 15 Participants | 4 Participants | 19 Participants |
| Grade 9th | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) White | 29 Participants | 18 Participants | 47 Participants |
| Region of Enrollment United States | 39 Participants | 32 Participants | 71 Participants |
| Sex/Gender, Customized Female | 20 Participants | 16 Participants | 36 Participants |
| Sex/Gender, Customized Male | 17 Participants | 16 Participants | 33 Participants |
| Sex/Gender, Customized Non-Binary | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Transgender | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 32 |
| other Total, other adverse events | 0 / 39 | 0 / 32 |
| serious Total, serious adverse events | 0 / 39 | 0 / 32 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Participant Recruitment and Retention | 37 Participants |
| Control | Participant Recruitment and Retention | 31 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Acceptability of and Satisfaction With the Intervention | 25.34 scores on a scale | Standard Deviation 4.65 |
| Control | Acceptability of and Satisfaction With the Intervention | 24.95 scores on a scale | Standard Deviation 4.64 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Self-Efficacy Score | -.19 scores on a scale | Standard Deviation 0.2 |
| Control | Change in Self-Efficacy Score | .15 scores on a scale | Standard Deviation 0.22 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Severity of Nicotine Addiction | -.37 scores on a scale | Standard Deviation 0.79 |
| Control | Change in Severity of Nicotine Addiction | -1.19 scores on a scale | Standard Deviation 0.87 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Games Engaged In | Prefer not to answer | 1 Participants |
| Intervention | Number of Games Engaged In | Always | 6 Participants |
| Intervention | Number of Games Engaged In | Usually | 6 Participants |
| Intervention | Number of Games Engaged In | About half the time | 6 Participants |
| Intervention | Number of Games Engaged In | Rarely | 10 Participants |
| Intervention | Number of Games Engaged In | Never | 8 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence] | 5 Participants |
| Control | Number of Participants With Abstinence From Vaping as Measured by Saliva Samples [Cotinine-validated 7-day Point Prevalence] | 5 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With With Change in Stage of Change | Worse | 5 Participants |
| Intervention | Number of Participants With With Change in Stage of Change | Same | 15 Participants |
| Intervention | Number of Participants With With Change in Stage of Change | Better | 14 Participants |
| Control | Number of Participants With With Change in Stage of Change | Worse | 6 Participants |
| Control | Number of Participants With With Change in Stage of Change | Same | 17 Participants |
| Control | Number of Participants With With Change in Stage of Change | Better | 7 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Number of Peer Coaching Interactions | 5.05 Number of interactions | Standard Deviation 4.59 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Peer Videos Viewed | Never | 12 Participants |
| Intervention | Number of Peer Videos Viewed | Very Rarely (Once) | 10 Participants |
| Intervention | Number of Peer Videos Viewed | Rarely (1-2 days/week) | 6 Participants |
| Intervention | Number of Peer Videos Viewed | Occasionally (3-4 days/week) | 5 Participants |
| Intervention | Number of Peer Videos Viewed | Frequently (5 days/week) | 2 Participants |
| Intervention | Number of Peer Videos Viewed | Very Frequently | 0 Participants |
| Intervention | Number of Peer Videos Viewed | Prefer not to answer | 2 Participants |