Nicotine VapingYES-CAN!NCT07009509
Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping
A study testing YES-CAN! program in people with Nicotine Vaping, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this pilot study is to determine the feasibility of a randomized trial of the YES-CAN! (Youth Engaged Strategies to Change Adolescent Norms) program to prevent nicotine vaping among adolescents. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Vaping
- What is being tested?
- YES-CAN! program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children enrolled in middle school grades 6-8 and high school grades 9-12 (age approximately 10-13 and 14-17); adults (over age 18) involved in educational system
Who cannot join
- Not able to read and write in English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Lori A Crane, PhD, MPH, 303-724-4385, lori.crane@cuanschutz.edu
About this study
Official title: Pilot and Feasibility Testing of a Peer-led Program to Prevent Youth Nicotine Vaping: The YES-CAN! Program
The goal of this pilot study is to determine the feasibility of a randomized trial of the YES-CAN! (Youth Engaged Strategies to Change Adolescent Norms) program to prevent nicotine vaping among adolescents. The program integrates the following evidence-based strategies: youth-adult collaboration; youth-developed narrative videos to convey health messages; peer leaders as change agents; and sustained implementation to change the normative environment. Two middle/high school communities will receive the YES-CAN! intervention. In each school community, a trained teacher will deliver a credit-earning middle or high school class to 25-30 middle or high school students, who will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among current users. Videos will use a narrative approach and integrate known determinants of vaping. Middle or high school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. In 6-8 sessions, middle or high school students will deliver their videos to all students in the associated middle school. A text messaging or other media component will reinforce and boost the effectiveness of the classroom sessions.
Aims for this pilot/feasibility study are:
- To determine the feasibility and acceptability of implementing the YES-CAN! program
- To determine the feasibility and acceptability of the research protocols that will be used in a future efficacy trial
Read the detailed description
This is a pilot/feasibility study of a school-based intervention in which middle and/or high school students develop and deliver a video-narrative-based intervention to middle school students in their school community. To provide evidence of feasibility for the purposes of planning for a large cluster-randomized trial, the investigators will implement the intervention and data collection protocols in two school communities within which students will be followed longitudinally. These school communities are middle schools and/or middle and high school pairs, where each middle school is one of the main schools that feeds into the related high school. The intervention will be delivered over one school year. Baseline and outcome measurements will be conducted via online survey within these schools at baseline, immediately after intervention delivery, and 1-year after baseline.
Within the middle and/or high schools, 25-30 students will participate in the video production and delivery. The school will be encouraged to invite a diverse range of students varying in academic success, gender, socio-economic status, and race/ethnicity to enroll in the credit-earning class. In the fall semester, enrolled students will receive a curriculum related to vaping, health risk communication, and video production. The fall semester will culminate in the completion of 6-8 short narrative videos that are ready for dissemination to middle schools. In the spring semester, students will develop skills and a structure for delivering a vaping prevention program to middle school students. Small groups of participating students will deliver the program in middle school classrooms. Students will be responsible for contacting teachers and scheduling sessions, which will occur mid-February through April, for a total of 6-8 sessions. The middle school sessions will address: health risks of vaping; resistance/refusal skills; healthy ways to cope with stress and anxiety; social skills; and other factors known to be related to nicotine vaping and other forms of substance use in youth. Students will also develop and implement a text message or other type of media campaign for middle school students to boost the effectiveness of the classroom sessions.
Analyses will be conducted using IBM SPSS Statistics 28, SAS Version 9.4 and Mplus Version 8.8. Analyses will be separate for middle school program recipients and the middle/high school program developers. Analyses will address the following domains:
Response rate: An aim is to understand survey response rates and missing data and to develop procedures to address these in the larger trial. Inferential statistics will be used to estimate parameters for key comparisons that assess response rates, student retention/missing data patterns, and random sampling relative to school-level characteristics. The investigators plan to stratify by sex and grade when selecting students for survey participation. This will provide a precise denominator for understanding response rates by these demographics. Response rates will first be assessed descriptively as a proportion of total sampled students within each school, summarized according to age, grade, sex, and race/ethnicity, and compared to overall school-level demographics using t-tests and chi-square or Fisher's exact analyses.
Retention: Given the longitudinal design and student mobility, attrition is anticipated. Students will be invited to complete follow-up surveys even if they missed earlier surveys to allow us to examine missing data patterns. To examine bias generated by attrition over time, the investigators will use independent samples t-tests, chi-square analyses, and regression modeling to compare key baseline variables such as demographic characteristics, vaping behaviors, knowledge, attitudes, perceived norms, and academic aspirations between those who complete 1 and 2 follow-up surveys vs. those lost to follow-up. The investigators will examine attrition in relation to baseline characteristics by regressing baseline constructs (e.g., vaping status, attitudes, norms) on retention status. This regression approach will allow for the testing of interaction terms (e.g., interaction terms of school, grade, and sex with retention status) to determine whether attrition differs by subgroups. Survey response rates will also be compared between middle and high school students and assessed descriptively in terms of time to completion and number of reminders needed. This will provide a way to gauge whether different methods are needed between types of schools, as well as the perceived value of incentives across schools.
Psychometric and distributional evaluation of measures: Baseline demographics and behavioral/attitudinal variables will be summarized using standard descriptive statistics (mean, SD, proportions). Outcome variables are dichotomous, continuous, and ordinal. The investigators will examine the distributional properties of observed data to inform analytic approaches for the larger trial. For psychometric analyses, the investigators will use a split half approach to randomly create EFA and CFA subsamples. Measurement models will be estimated separately for middle school recipient and middle/high school program developer samples, though the investigators will combine the two schools at each level to create the EFA and CFA subsamples (i.e., the middle school and high school EFA/CFA subsamples will include a random selection from each school). The multi-item scales have been derived from prior research, but use of both EFA and CFA will ensure their appropriate use in our local context. Similar constructs (e.g., descriptive norms, injunctive norms) are expected to be related but distinct, though this will be tested empirically using EFA and verified using CFA. EFA modeling will be carried out using maximum likelihood estimation and promax rotation, with final models chosen based on fit (RMSEA), simple structure, and magnitude of factor loadings. The resulting measurement structure from EFA modeling will be estimated in the independent random sample using CFA and interpreted based on model fit (model chi square, RMSEA, and comparative fit index), magnitude and significance of factor loadings, correlations among factors, and internal consistency reliability (Cronbach's alpha).
Subgroup Comparisons: Formal subgroup comparisons (e.g., sex, grade) are proposed to test differences in baseline variables (e.g., vaping use and related attitudes, perceived norms, resistance skills) to better understand how to address unique determinants of vaping among student subgroups in the videos.
School: Analyses will be carried out to compare the two middle schools that receive the program and the two middle/high schools that develop the program on all baseline demographic, behavioral, and attitudinal variables. This is necessary to understand between-school differences for planning a larger trial. Independent samples t-tests and chi-square models, as well as models adjusted for grade and sex using a regression-based framework, may be used. In the larger future efficacy trial, inclusion of additional schools will allow for modeling of school-level fixed and random effects (i.e., three-level model of time nested within students nested within schools).
Sex and Grade: Following the same analytic approach used for school differences, the investigators will test baseline psychosocial variables by sex and grade. The initial approach will be to use bivariate models (t-tests, chi-square) to test sex and grade effects separately, though the investigators will extend this approach to regression modeling of adjusted effects (e.g., sex differences adjusted for grade) as well as potential interaction effects (e.g., sex differences depend on grade).Finally, among middle/high students, the investigators will compare student characteristics measured at baseline between the group of middle/high school students enrolled in the intervention class vs. the broader sample of those students not in the class, both within school and across schools. Student characteristics include sex, age, race/ethnicity, vaping measures (knowledge, attitudes, perceived norms, and behaviors), and positive youth development measures.
- Conditions
- Nicotine Vaping
- Being tested
- YES-CAN! program
- Keywords
- Nicotine Vaping, Adolescents, School, Behavior change, Social norms, Electronic cigarettes
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YES-CAN! programBehavioural
Youth Engaged Strategies to Change Adolescent Norms
| Study group | Role | What they receive |
|---|---|---|
| YES-CAN! Intervention | Experimental | A credit-earning middle or high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 students will be enrolled. Students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. Students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. Students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions. Receives: Behavioral: YES-CAN! program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ever vaped at baseline
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
Measured: Baseline
Ever vaped at 9 months
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
Measured: 9 months
Every vaped at 12 months
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
Measured: 12 months
Secondary outcomes (24)
Vaping susceptibility at baseline
The average of 2 susceptibility items (I would like to know what vaping feels like; I am curious about vaping) answered on a 5-point scale: 1=completely false, 5=completely true. Scores range from 1 (low susceptibility) to 5 (high susceptibility)
Measured: Baseline
Vaping susceptibility at 9 months
The average of 2 susceptibility items (I would like to know what vaping feels like; I am curious about vaping) answered on a 5-point scale: 1=completely false, 5=completely true. Scores range from 1 (low susceptibility) to 5 (high susceptibility)
Measured: 9 months
Vaping susceptibility at 12 months
The average of 2 susceptibility items (I would like to know what vaping feels like; I am curious about vaping) answered on a 5-point scale: 1=completely false, 5=completely true. Scores range from 1 (low susceptibility) to 5 (high susceptibility)
Measured: 12 months
Days vaped in the past month at baseline
Number of days the participant vaped in the past 30 days, with answers: 0 days (1). 1-2 days (2), 3-5 days (3), 6-9 days (4), 10-19 days (5), 20-29 days (6), all 30 days (7)
Measured: Baseline
Days vaped in past 30 days at 9 months
Number of days the participant vaped in the past 30 days, with answers: 0 days (1). 1-2 days (2), 3-5 days (3), 6-9 days (4), 10-19 days (5), 20-29 days (6), all 30 days (7)
Measured: 9 months
Days vaped in the past 30 days at 12 months
Number of days the participant vaped in the past 30 days, with answers: 0 days (1). 1-2 days (2), 3-5 days (3), 6-9 days (4), 10-19 days (5), 20-29 days (6), all 30 days (7)
Measured: 12 months
Intention to vape at baseline
Participant intention to vape in the next 12 months. Answers include: never (1), once (2), a few times (3), a few times a month (4), a few times a week (5), every day (6).
Measured: Baseline
Intention to vape at 9 months
Participant intention to vape in the next 12 months. Answers include: never (1), once (2), a few times (3), a few times a month (4), a few times a week (5), every day (6).
Measured: 9 months
Intention to vape at 12 months
Participant intention to vape in the next 12 months. Answers include: never (1), once (2), a few times (3), a few times a month (4), a few times a week (5), every day (6).
Measured: 12 months
Vaping knowledge at baseline
A scale that measures knowledge about nicotine vaping. The scale is developed from 7 true/false items. Participant is awarded 1 point for each correct answer. Scores range from 0 (no correct answers) to 7 (all questions answered correctly)
Measured: Baseline
Vaping knowledge at 9 months
A scale that measures knowledge about nicotine vaping. The scale is developed from 7 true/false items. Participant is awarded 1 point for each correct answer. Scores range from 0 (no correct answers) to 7 (all questions answered correctly)
Measured: 9 months
Vaping knowledge at 12 months
A scale that measures knowledge about nicotine vaping. The scale is developed from 7 true/false items. Participant is awarded 1 point for each correct answer. Scores range from 0 (no correct answers) to 7 (all questions answered correctly)
Measured: 12 months
Vaping attitudes at baseline
A scale that measures attitudes towards vaping. The scale is an average of 9 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with low scores indicating attitudes more favorable towards vaping.
Measured: Baseline
Vaping attitudes at 9 months
A scale that measures attitudes towards vaping. The scale is an average of 9 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with low scores indicating attitudes more favorable towards vaping.
Measured: 9 months
Vaping attitudes at 12 months
A scale that measures attitudes towards vaping. The scale is an average of 9 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with low scores indicating attitudes more favorable towards vaping.
Measured: 12 months
Vaping perceived norms at baseline
A scale that measures perceived norms about vaping. The scale is an average of 7 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with high scores indicating perceived norms supportive of vaping.
Measured: Baseline
Vaping perceived norms at 9 months
A scale that measures perceived norms about vaping. The scale is an average of 7 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with high scores indicating perceived norms supportive of vaping.
Measured: 9 months
Vaping perceived norms at 12 months
A scale that measures perceived norms about vaping. The scale is an average of 7 questions measured from completely true (1) to completely false (5). Scale scores range from 1 to 5 with high scores indicating perceived norms supportive of vaping.
Measured: 12 months
Vaping resistance skills at baseline
A scale that measures the likelihood of using three strategies for resisting vaping if offered the chance. Items are measured from very likely (1) to very unlikely (5). Scale score is the average of the three items with scores ranging from 1 (very likely to use resistance strategies) to 5 (very unlikely to use resistance strategies).
Measured: Baseline
Vaping resistance skills at 9 months
A scale that measures the likelihood of using three strategies for resisting vaping if offered the chance. Items are measured from very likely (1) to very unlikely (5). Scale score is the average of the three items with scores ranging from 1 (very likely to use resistance strategies) to 5 (very unlikely to use resistance strategies).
Measured: 9 months
Vaping resistance skills at 12 months
A scale that measures the likelihood of using three strategies for resisting vaping if offered the chance. Items are measured from very likely (1) to very unlikely (5). Scale score is the average of the three items with scores ranging from 1 (very likely to use resistance strategies) to 5 (very unlikely to use resistance strategies).
Measured: 12 months
Ever smoked tobacco cigarette at baseline
Whether participant has ever smoked cigarettes, even once or twice Scores range from "no" (0) to "yes" (1)
Measured: Baseline
Ever smoked tobacco cigarette at 9 months
Whether participant has ever smoked cigarettes, even once or twice Scores range from "no" (0) to "yes" (1)
Measured: 9 months
Ever smoked tobacco cigarettes at 12 months
Whether participant has ever smoked cigarettes, even once or twice Scores range from "no" (0) to "yes" (1)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Aug 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Nicotine VapingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A credit-earning high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 10th through 12th grade students will be enrolled. High school students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. High school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. High school students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions
- Masking
- None (open label)
- Enrolment
- 1,166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Lori A Crane, PhD, MPH, Principal investigator, University of Colorado, DenverNancy L Asdigian, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009509
- Sponsor's protocol ID
- 23-1396
- Other IDs
- 5R34DA058218
- Acronym
- YES-CAN!
- Status last verified
- Jul 2025
- First submitted
- 29 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Survey data will be fully de-identified, preserved and shared. Scientific data will be made available in CSV format that can be processed in a variety of statistical software packages. To facilitate data use, the study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels. Variable descriptions include a brief explanation of the questionnaire item content or of the constructed measure. Value labels tie individual numeric response codes to descriptive responses from the questionnaire. Public use study data and associated documentation will be made available to the research community free of charge through the Data Sharing for Demographic Research (DSDR) data repository hosted at ICPSR. Datasets in DSDR will be findable and identifiable through a study digital object identifier (DOI) minted by ICPSR.
Publications
Alzahrani T, Pena I, Temesgen N, Glantz SA. Association Between Electronic Cigarette Use and Myocardial Infarction. Am J Prev Med. 2018 Oct;55(4):455-461. doi: 10.1016/j.amepre.2018.05.004. Epub 2018 Aug 22.
PubMed 30166079Miech R, Johnston L, O'Malley PM, Bachman JG, Patrick ME. Trends in Adolescent Vaping, 2017-2019. N Engl J Med. 2019 Oct 10;381(15):1490-1491. doi: 10.1056/NEJMc1910739. Epub 2019 Sep 18. No abstract available.
PubMed 31532955Kechter A, Cho J, Miech RA, Barrington-Trimis JL, Leventhal AM. Nicotine dependence symptoms in U.S. youth who use JUUL E-cigarettes. Drug Alcohol Depend. 2021 Oct 1;227:108941. doi: 10.1016/j.drugalcdep.2021.108941. Epub 2021 Aug 4.
PubMed 34416679Vogel EA, Prochaska JJ, Ramo DE, Andres J, Rubinstein ML. Adolescents' E-Cigarette Use: Increases in Frequency, Dependence, and Nicotine Exposure Over 12 Months. J Adolesc Health. 2019 Jun;64(6):770-775. doi: 10.1016/j.jadohealth.2019.02.019.
PubMed 31122507Berry KM, Fetterman JL, Benjamin EJ, Bhatnagar A, Barrington-Trimis JL, Leventhal AM, Stokes A. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths. JAMA Netw Open. 2019 Feb 1;2(2):e187794. doi: 10.1001/jamanetworkopen.2018.7794.
PubMed 30707232Asdigian NL, Riggs NR, Valverde PA, Crane LA. Reducing Youth Vaping: A Pilot Test of the Peer-Led "Youth Engaged Strategies for Changing Adolescent Norms!" (YES-CAN!) Program. Health Promot Pract. 2023 Sep;24(5):956-962. doi: 10.1177/15248399221100793. Epub 2022 Jun 9.
PubMed 35678642Tobacco prevention tool kit. Stanford Medicine Tobacco Prevention Tool Kit website. https://med.stanford.edu/tobaccopreventiontoolkit.html. Accessed January 7, 2023.
National Youth Tobacco Survey. https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm. 2022. Accessed March 5, 2023.
Monitoring the Future Survey. https://nida.nih.gov/research-topics/trends-statistics/monitoring-future. 2021. Accessed March 5, 2023.
Youth Risk Behavior Survey. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm 2020. Accessed March 5, 2023.
Population Assessment of Tobacco and Health Study (PATH, youth interview). https://pathstudyinfo.nih.gov/. 2022. Accessed March 5, 2023.
Gorukanti A, Delucchi K, Ling P, Fisher-Travis R, Halpern-Felsher B. Adolescents' attitudes towards e-cigarette ingredients, safety, addictive properties, social norms, and regulation. Prev Med. 2017 Jan;94:65-71. doi: 10.1016/j.ypmed.2016.10.019. Epub 2016 Oct 20.
PubMed 27773711Farrelly MC, Duke JC, Crankshaw EC, Eggers ME, Lee YO, Nonnemaker JM, Kim AE, Porter L. A Randomized Trial of the Effect of E-cigarette TV Advertisements on Intentions to Use E-cigarettes. Am J Prev Med. 2015 Nov;49(5):686-693. doi: 10.1016/j.amepre.2015.05.010. Epub 2015 Jul 7.
PubMed 26163170Spoth R, Guyll M, Trudeau L, Goldberg-Lillehoj C. Two studies of proximal outcomes and implementation quality of universal preventive interventions in a community-university collaboration context. J Community Psychol. 2002;30(5), 499-518. https://doi.org/10.1002/jcop.10021
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Testing of a Peer-led Program to Prevent Youth Nicotine Vaping: The YES-CAN! Program
- ClinicalTrials.gov ID
- NCT07009509
- Acronym / sponsor ID
- YES-CAN! / 23-1396
- Conditions
- Nicotine Vaping
- Keywords
- Nicotine Vaping, Adolescents, School, Behavior change, Social norms, Electronic cigarettes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,166 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to determine the feasibility of a randomized trial of the YES-CAN! (Youth Engaged Strategies to Change Adolescent Norms) program to prevent nicotine vaping among adolescents. The program integrates the following evidence-based strategies: youth-adult collaboration; youth-developed narrative videos to convey health messages; peer leaders as change agents; and sustained implementation to change the normative environment. Two middle/high school communities will receive the YES-CAN! intervention. In each school community, a trained teacher will deliver a credit-earning middle or high school class to 25-30 middle or high school students, who will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among current users. Videos will use a narrative approach and integrate known determinants of vaping. Middle or high school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. In 6-8 sessions, middle or high school students will deliver their videos to all students in the associated middle school. A text messaging or other media component will reinforce and boost the effectiveness of the classroom sessions.
Aims for this pilot/feasibility study are:
- To determine the feasibility and acceptability of implementing the YES-CAN! program
- To determine the feasibility and acceptability of the research protocols that will be used in a future efficacy trial
Detailed description
This is a pilot/feasibility study of a school-based intervention in which middle and/or high school students develop and deliver a video-narrative-based intervention to middle school students in their school community. To provide evidence of feasibility for the purposes of planning for a large cluster-randomized trial, the investigators will implement the intervention and data collection protocols in two school communities within which students will be followed longitudinally. These school communities are middle schools and/or middle and high school pairs, where each middle school is one of the main schools that feeds into the related high school. The intervention will be delivered over one school year. Baseline and outcome measurements will be conducted via online survey within these schools at baseline, immediately after intervention delivery, and 1-year after baseline.
Within the middle and/or high schools, 25-30 students will participate in the video production and delivery. The school will be encouraged to invite a diverse range of students varying in academic success, gender, socio-economic status, and race/ethnicity to enroll in the credit-earning class. In the fall semester, enrolled students will receive a curriculum related to vaping, health risk communication, and video production. The fall semester will culminate in the completion of 6-8 short narrative videos that are ready for dissemination to middle schools. In the spring semester, students will develop skills and a structure for delivering a vaping prevention program to middle school students. Small groups of participating students will deliver the program in middle school classrooms. Students will be responsible for contacting teachers and scheduling sessions, which will occur mid-February through April, for a total of 6-8 sessions. The middle school sessions will address: health risks of vaping; resistance/refusal skills; healthy ways to cope with stress and anxiety; social skills; and other factors known to be related to nicotine vaping and other forms of substance use in youth. Students will also develop and implement a text message or other type of media campaign for middle school students to boost the effectiveness of the classroom sessions.
Analyses will be conducted using IBM SPSS Statistics 28, SAS Version 9.4 and Mplus Version 8.8. Analyses will be separate for middle school program recipients and the middle/high school program developers. Analyses will address the following domains:
Response rate: An aim is to understand survey response rates and missing data and to develop procedures to address these in the larger trial. Inferential statistics will be used to estimate parameters for key comparisons that assess response rates, student retention/missing data patterns, and random sampling relative to school-level characteristics. The investigators plan to stratify by sex and grade when selecting students for survey participation. This will provide a precise denominator for understanding response rates by these demographics. Response rates will first be assessed descriptively as a proportion of total sampled students within each school, summarized according to age, grade, sex, and race/ethnicity, and compared to overall school-level demographics using t-tests and chi-square or Fisher's exact analyses.
Retention: Given the longitudinal design and student mobility, attrition is anticipated. Students will be invited to complete follow-up surveys even if they missed earlier surveys to allow us to examine missing data patterns. To examine bias generated by attrition over time, the investigators will use independent samples t-tests, chi-square analyses, and regression modeling to compare key baseline variables such as demographic characteristics, vaping behaviors, knowledge, attitudes, perceived norms, and academic aspirations between those who complete 1 and 2 follow-up surveys vs. those lost to follow-up. The investigators will examine attrition in relation to baseline characteristics by regressing baseline constructs (e.g., vaping status, attitudes, norms) on retention status. This regression approach will allow for the testing of interaction terms (e.g., interaction terms of school, grade, and sex with retention status) to determine whether attrition differs by subgroups. Survey response rates will also be compared between middle and high school students and assessed descriptively in terms of time to completion and number of reminders needed. This will provide a way to gauge whether different methods are needed between types of schools, as well as the perceived value of incentives across schools.
Psychometric and distributional evaluation of measures: Baseline demographics and behavioral/attitudinal variables will be summarized using standard descriptive statistics (mean, SD, proportions). Outcome variables are dichotomous, continuous, and ordinal. The investigators will examine the distributional properties of observed data to inform analytic approaches for the larger trial. For psychometric analyses, the investigators will use a split half approach to randomly create EFA and CFA subsamples. Measurement models will be estimated separately for middle school recipient and middle/high school program developer samples, though the investigators will combine the two schools at each level to create the EFA and CFA subsamples (i.e., the middle school and high school EFA/CFA subsamples will include a random selection from each school). The multi-item scales have been derived from prior research, but use of both EFA and CFA will ensure their appropriate use in our local context. Similar constructs (e.g., descriptive norms, injunctive norms) are expected to be related but distinct, though this will be tested empirically using EFA and verified using CFA. EFA modeling will be carried out using maximum likelihood estimation and promax rotation, with final models chosen based on fit (RMSEA), simple structure, and magnitude of factor loadings. The resulting measurement structure from EFA modeling will be estimated in the independent random sample using CFA and interpreted based on model fit (model chi square, RMSEA, and comparative fit index), magnitude and significance of factor loadings, correlations among factors, and internal consistency reliability (Cronbach's alpha).
Subgroup Comparisons: Formal subgroup comparisons (e.g., sex, grade) are proposed to test differences in baseline variables (e.g., vaping use and related attitudes, perceived norms, resistance skills) to better understand how to address unique determinants of vaping among student subgroups in the videos.
School: Analyses will be carried out to compare the two middle schools that receive the program and the two middle/high schools that develop the program on all baseline demographic, behavioral, and attitudinal variables. This is necessary to understand between-school differences for planning a larger trial. Independent samples t-tests and chi-square models, as well as models adjusted for grade and sex using a regression-based framework, may be used. In the larger future efficacy trial, inclusion of additional schools will allow for modeling of school-level fixed and random effects (i.e., three-level model of time nested within students nested within schools).
Sex and Grade: Following the same analytic approach used for school differences, the investigators will test baseline psychosocial variables by sex and grade. The initial approach will be to use bivariate models (t-tests, chi-square) to test sex and grade effects separately, though the investigators will extend this approach to regression modeling of adjusted effects (e.g., sex differences adjusted for grade) as well as potential interaction effects (e.g., sex differences depend on grade).Finally, among middle/high students, the investigators will compare student characteristics measured at baseline between the group of middle/high school students enrolled in the intervention class vs. the broader sample of those students not in the class, both within school and across schools. Student characteristics include sex, age, race/ethnicity, vaping measures (knowledge, attitudes, perceived norms, and behaviors), and positive youth development measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A credit-earning high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 10th through 12th grade students will be enrolled. High school students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. High school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. High school students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions
| Arm | Type | Receives |
|---|---|---|
| YES-CAN! Intervention | Experimental | Behavioral: YES-CAN! programA credit-earning middle or high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 students will be enrolled. Students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. Students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. Students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children enrolled in middle school grades 6-8 and high school grades 9-12 (age approximately 10-13 and 14-17); adults (over age 18) involved in educational system
Key exclusion criteria (1 listed)
- Not able to read and write in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YES-CAN! programYouth Engaged Strategies to Change Adolescent Norms | Behavioural | YES-CAN! Intervention |
Primary outcome
Ever vaped at baseline
Time frame: Baseline
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
Ever vaped at 9 months
Time frame: 9 months
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
Every vaped at 12 months
Time frame: 12 months
Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)
24 secondary outcomes
Vaping susceptibility at baseline
Time frame: Baseline
Vaping susceptibility at 9 months
Time frame: 9 months
Vaping susceptibility at 12 months
Time frame: 12 months
Days vaped in the past month at baseline
Time frame: Baseline
Days vaped in past 30 days at 9 months
Time frame: 9 months
Days vaped in the past 30 days at 12 months
Time frame: 12 months
Intention to vape at baseline
Time frame: Baseline
Intention to vape at 9 months
Time frame: 9 months
Intention to vape at 12 months
Time frame: 12 months
Vaping knowledge at baseline
Time frame: Baseline
Vaping knowledge at 9 months
Time frame: 9 months
Vaping knowledge at 12 months
Time frame: 12 months
Vaping attitudes at baseline
Time frame: Baseline
Vaping attitudes at 9 months
Time frame: 9 months
Vaping attitudes at 12 months
Time frame: 12 months
Vaping perceived norms at baseline
Time frame: Baseline
Vaping perceived norms at 9 months
Time frame: 9 months
Vaping perceived norms at 12 months
Time frame: 12 months
Vaping resistance skills at baseline
Time frame: Baseline
Vaping resistance skills at 9 months
Time frame: 9 months
Vaping resistance skills at 12 months
Time frame: 12 months
Ever smoked tobacco cigarette at baseline
Time frame: Baseline
Ever smoked tobacco cigarette at 9 months
Time frame: 9 months
Ever smoked tobacco cigarettes at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 30166079Alzahrani T, Pena I, Temesgen N, Glantz SA. Association Between Electronic Cigarette Use and Myocardial Infarction. Am J Prev Med. 2018 Oct;55(4):455-461. doi: 10.1016/j.amepre.2018.05.004. Epub 2018 Aug 22.
- Background: PubMed 31532955Miech R, Johnston L, O'Malley PM, Bachman JG, Patrick ME. Trends in Adolescent Vaping, 2017-2019. N Engl J Med. 2019 Oct 10;381(15):1490-1491. doi: 10.1056/NEJMc1910739. Epub 2019 Sep 18. No abstract available.
- Background: PubMed 34416679Kechter A, Cho J, Miech RA, Barrington-Trimis JL, Leventhal AM. Nicotine dependence symptoms in U.S. youth who use JUUL E-cigarettes. Drug Alcohol Depend. 2021 Oct 1;227:108941. doi: 10.1016/j.drugalcdep.2021.108941. Epub 2021 Aug 4.
- Background: PubMed 31122507Vogel EA, Prochaska JJ, Ramo DE, Andres J, Rubinstein ML. Adolescents' E-Cigarette Use: Increases in Frequency, Dependence, and Nicotine Exposure Over 12 Months. J Adolesc Health. 2019 Jun;64(6):770-775. doi: 10.1016/j.jadohealth.2019.02.019.
- Background: PubMed 30707232Berry KM, Fetterman JL, Benjamin EJ, Bhatnagar A, Barrington-Trimis JL, Leventhal AM, Stokes A. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths. JAMA Netw Open. 2019 Feb 1;2(2):e187794. doi: 10.1001/jamanetworkopen.2018.7794.
- Background: PubMed 35678642Asdigian NL, Riggs NR, Valverde PA, Crane LA. Reducing Youth Vaping: A Pilot Test of the Peer-Led "Youth Engaged Strategies for Changing Adolescent Norms!" (YES-CAN!) Program. Health Promot Pract. 2023 Sep;24(5):956-962. doi: 10.1177/15248399221100793. Epub 2022 Jun 9.
- BackgroundTobacco prevention tool kit. Stanford Medicine Tobacco Prevention Tool Kit website. https://med.stanford.edu/tobaccopreventiontoolkit.html. Accessed January 7, 2023.
- BackgroundNational Youth Tobacco Survey. https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm. 2022. Accessed March 5, 2023.
- BackgroundMonitoring the Future Survey. https://nida.nih.gov/research-topics/trends-statistics/monitoring-future. 2021. Accessed March 5, 2023.
- BackgroundYouth Risk Behavior Survey. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm 2020. Accessed March 5, 2023.
- BackgroundPopulation Assessment of Tobacco and Health Study (PATH, youth interview). https://pathstudyinfo.nih.gov/. 2022. Accessed March 5, 2023.
- Background: PubMed 27773711Gorukanti A, Delucchi K, Ling P, Fisher-Travis R, Halpern-Felsher B. Adolescents' attitudes towards e-cigarette ingredients, safety, addictive properties, social norms, and regulation. Prev Med. 2017 Jan;94:65-71. doi: 10.1016/j.ypmed.2016.10.019. Epub 2016 Oct 20.
- Individual participant dataSharing planned: Yes. Survey data will be fully de-identified, preserved and shared. Scientific data will be made available in CSV format that can be processed in a variety of statistical software packages. To facilitate data use, the study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels. Variable descriptions include a brief explanation of the questionnaire item content or of the constructed measure. Value labels tie individual numeric response codes to descriptive responses from the questionnaire. Public use study data and associated documentation will be made available to the research community free of charge through the Data Sharing for Demographic Research (DSDR) data repository hosted at ICPSR. Datasets in DSDR will be findable and identifiable through a study digital object identifier (DOI) minted by ICPSR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori A Crane, PhD, MPH principal investigator
University of Colorado, Denver
Nancy L Asdigian, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YES-CAN! program in people with Nicotine Vaping, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori A Crane, PhD, MPH (3037244385, lori.crane@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ever vaped at baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07009509, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.