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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3950 participants

Primary outcome timeframe

28 months

Results posted on

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Above the Influence-Vaping Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 5852733374

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place