Trial Outcomes & Findings for Network Intervention to Prevent Vaping (NCT NCT04678245)
NCT ID: NCT04678245
Last Updated: 2026-08-26
Results Overview
Self reported use of any electronic vaping product during the past 30 days, assessed using participant questionnaire. The outcome is reported as the number of participants reporting any vaping within the previous 30 days.
COMPLETED
NA
3950 participants
28 months
2026-08-26
Participant Flow
Nineteen schools in 14 school districts recruited students across three cohorts. A total of 2,967 students completed the baseline assessment. Additional eligible students entered the study at subsequent assessment waves, resulting in a cumulative enrollment of 3,950 participants. The final analysis sample included 3,515 participants.
The first two cohorts had 4 schools, so two each were assigned to waitlist and intervention. To balance school size, in the third cohort one large district (3 middle schools) was randomized with 3 smaller schools.
Unit of analysis: School
Participant milestones
| Measure |
Immediate Above the Influence-Vaping Intervention
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). Participants included all current students in the grade being assessed; therefore, the number of participants eligible for assessment varied across study waves.
|
Delayed Above the Influence-Vaping Intervention
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months. Participants included all current students in the grade being assessed; therefore, the number of participants eligible for assessment varied across study waves.
|
|---|---|---|
|
Baseline
STARTED
|
1815 8
|
1747 10
|
|
Baseline
COMPLETED
|
1460 8
|
1507 10
|
|
Baseline
NOT COMPLETED
|
355 0
|
240 0
|
|
Wave 2
STARTED
|
1601 7
|
1735 10
|
|
Wave 2
COMPLETED
|
1196 7
|
1436 10
|
|
Wave 2
NOT COMPLETED
|
405 0
|
299 0
|
|
Wave 3
STARTED
|
1625 6
|
1453 9
|
|
Wave 3
COMPLETED
|
1175 6
|
1210 9
|
|
Wave 3
NOT COMPLETED
|
450 0
|
243 0
|
|
Wave 4
STARTED
|
1359 6
|
1734 10
|
|
Wave 4
COMPLETED
|
930 6
|
1265 10
|
|
Wave 4
NOT COMPLETED
|
429 0
|
469 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Network Intervention to Prevent Vaping
Baseline characteristics by cohort
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1460 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
|
Delayed Above the Influence-Vaping Intervention
n=1507 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
|
Total
n=2967 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.12 years
STANDARD_DEVIATION 0.34 • n=31 Participants
|
13.14 years
STANDARD_DEVIATION 0.36 • n=49 Participants
|
13.13 years
STANDARD_DEVIATION 0.35 • n=80 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
683 Participants
n=31 Participants
|
669 Participants
n=49 Participants
|
1352 Participants
n=80 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
695 Participants
n=31 Participants
|
747 Participants
n=49 Participants
|
1442 Participants
n=80 Participants
|
|
Sex/Gender, Customized
Sex · Other/Not Reported
|
82 Participants
n=31 Participants
|
91 Participants
n=49 Participants
|
173 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
533 Participants
n=31 Participants
|
203 Participants
n=49 Participants
|
736 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
913 Participants
n=31 Participants
|
1287 Participants
n=49 Participants
|
2200 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=31 Participants
|
17 Participants
n=49 Participants
|
31 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
24 Participants
n=31 Participants
|
9 Participants
n=49 Participants
|
33 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=31 Participants
|
71 Participants
n=49 Participants
|
111 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
199 Participants
n=31 Participants
|
163 Participants
n=49 Participants
|
362 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
802 Participants
n=31 Participants
|
1050 Participants
n=49 Participants
|
1852 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
50 Participants
n=31 Participants
|
93 Participants
n=49 Participants
|
143 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
342 Participants
n=31 Participants
|
121 Participants
n=49 Participants
|
463 Participants
n=80 Participants
|
|
30 day any vaping
|
52 Participants
n=31 Participants
|
54 Participants
n=49 Participants
|
106 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: The analysis includes participants who completed the 28 month assessment for this outcome.
Self reported use of any electronic vaping product during the past 30 days, assessed using participant questionnaire. The outcome is reported as the number of participants reporting any vaping within the previous 30 days.
Outcome measures
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1800 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
Delayed Above the Influence-Vaping Intervention
n=1715 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
|---|---|---|
|
Number of Participants With Any Past 30 Day Any Vaping
|
108 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: 28 monthsPopulation: The analysis includes participants who completed the 28 month assessment for this outcome.
Self reported nicotine containing electronic vaping product use during the previous 30 days, assessed by participant questionnaire. The outcome is reported as the number of participants reporting nicotine vaping.
Outcome measures
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1800 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
Delayed Above the Influence-Vaping Intervention
n=1715 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
|---|---|---|
|
Number of Participants With Any Past 30 Day Nicotine Vaping
|
92 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: 28 monthsPopulation: The analysis includes participants who completed the 28 month assessment for this outcome.
Perceived harm of electronic vaping products was assessed using a single questionnaire item scored from 0 (No risk) to 3 (Great risk). Higher scores indicate greater perceived harm.
Outcome measures
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1800 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
Delayed Above the Influence-Vaping Intervention
n=1715 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
|---|---|---|
|
Score Electronic Vaping Product Harm
|
2.324 0 (no risk) to 3 (great risk)
Standard Deviation .921
|
2.716 0 (no risk) to 3 (great risk)
Standard Deviation .819
|
SECONDARY outcome
Timeframe: 28 monthsPopulation: The analysis includes participants who completed the 28 month assessment for this outcome.
Attitudes toward electronic vaping products were assessed using participant responses to 7 items evaluating whether vaping is good, fun, interesting, or exciting. Responses were averaged to produce a mean score ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate more favorable attitudes toward vaping.
Outcome measures
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1800 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
Delayed Above the Influence-Vaping Intervention
n=1715 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
|---|---|---|
|
Mean Electronic Vaping Product Attitudes
|
.63 1 (str disagree) to 5 (str agree)
Standard Deviation .859
|
.57 1 (str disagree) to 5 (str agree)
Standard Deviation .886
|
SECONDARY outcome
Timeframe: 28 monthsPopulation: The analysis includes participants who completed the 28 month assessment for this outcome.
Participants identified trusted adults at school with whom they could discuss personal concerns. The outcome is reported as the total number of trusted adults identified (range 0 to 7).
Outcome measures
| Measure |
Immediate Above the Influence-Vaping Intervention
n=1800 Participants
School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
Delayed Above the Influence-Vaping Intervention
n=1715 Participants
Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.
Above the Influence-Vaping (ATI-V): Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
|
|---|---|---|
|
Total Number of Trusted Adults
|
1.45 0 to 7 adults named
Standard Deviation 1.651
|
1.90 0 to 7 adults named
Standard Deviation 1.701
|
Adverse Events
Immediate Above the Influence-Vaping Intervention
Delayed Above the Influence-Vaping Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter A. Wyman
University of Rochester Medical Center, Psychiatry Department
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place