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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA050992 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Students in schools 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. |
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| Control | Active Comparator | Students in schools randomized to the control condition will be provided e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Messaging | Behavioral | Peer messages, written by current and former adolescent e-cigarette users and tailored by age and readiness-to-quit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment and Retention | Investigators will assess the number of those screened, eligible, and consented who remain active in the program at 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria: Unable or unwilling to provide informed assent or consent (in the case of those aged 18 years or older).
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| Name | Affiliation | Role |
|---|---|---|
| Rajani Sadasivam, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Lori Pbert, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38886719 | Derived | Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara JG, Sadasivam RS. Vaping cessation support recommendations from adolescents who vape: a qualitative study. BMC Public Health. 2024 Jun 17;24(1):1615. doi: 10.1186/s12889-024-19036-1. | |
| 38562810 | Derived | Pbert L, Dube CE, Nagawa CS, Simone DP, Wijesundara J, Sadasivam R. Vaping Cessation Support Recommendations from Adolescents Who Vape: A Qualitative Study. Res Sq [Preprint]. 2024 Mar 20:rs.3.rs-4077848. doi: 10.21203/rs.3.rs-4077848/v1. |
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The final dataset will be available within 12 months of the end of the funded grant period. Due to the nature of our research, we will be collecting identifying information (i.e. names, phone numbers). We will strip the final dataset of identifiers prior to release for sharing. Even though the final dataset will be striped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of study participants with unusual characteristics. Thus, we will make the data and associated documentation available to qualified academic investigators for non-commercial research under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Schools were randomized to either the intervention or control condition. Students in schools randomized to the intervention received: (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. |
| FG001 | Control | Schools were randomized to either the intervention or control condition. Students in schools randomized to the control condition were provided written e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 months |
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Adverse event data were collected over 3 months (participants' duration in the study).
For this study, the standard Adverse Event and Serious Adverse Event definitions were used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajani Sadasivam | University of Massachusetts Chan Medical School | (508) 856-8923 | rajani.sadasivam@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Dec 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2022 | Dec 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Peer Coaching via Text | Behavioral | Peer coaching, facilitated by texting |
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| Gamification | Behavioral | Gamification, designed to motivate participation |
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| E-Cigarette Cessation Materials | Other | E-cigarette cessation materials by the Research Coordinator at the time of study enrollment. |
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| 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | 3 months |
| 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. | Baseline and 3 months |
| 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. | Baseline and 3 months |
| 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. | Baseline and 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Grade | Count of Participants | Participants |
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| Control |
Students in schools randomized to the control condition will be provided e-cigarette cessation materials by the Research Coordinator at the time of study enrollment. E-Cigarette Cessation Materials: E-cigarette cessation materials by the Research Coordinator at the time of study enrollment. |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 3 months |
|
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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. | Posted | Mean | Standard Deviation | Number of interactions | 3 months |
|
|
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| 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. | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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. | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 months |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| Occasionally (3-4 days/week) |
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| Frequently (5 days/week) |
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| Very Frequently |
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| Prefer not to answer |
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| Rarely |
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| Never |
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| Prefer not to answer |
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| Better |
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