Trial Outcomes & Findings for Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products (NCT NCT03682900)

NCT ID: NCT03682900

Last Updated: 2023-11-01

Results Overview

Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2673 participants
• Primary outcome timeframe: baseline; six months
• Results posted on: 2023-11-01

Participant Flow

The study took place in the schools from January 6, 2020 through June 10, 2022. Within 43 recruited schools, 2906 5th grade students were initially eligible for participation. Among these students, 111 had parents who actively declined their participation, resulting in 2795 students within randomized schools, as eligible for enrollment. Among these, 2673 were enrolled in the study, as defined by completing the baseline and/or follow-up assessment.

No events.

Unit of analysis: schools

Participant milestones

Measure	Intervention Students in intervention schools were expected to complete Click City®: Tobacco, a computer-based program designed to prevent subsequent tobacco use. Students were expected to do a 15 to 20 minute lesson two times a week for four weeks. Participation also consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program.	Control Students in control schools were expected to complete their usual tobacco curriculum, designed to prevent tobacco use. Students completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over the same period that students in the intervention group completed Click City®: Tobacco.
Overall Study STARTED	1346 22	1327 21
Overall Study COMPLETED	1346 22	1327 21
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products

Baseline characteristics by cohort

Measure	Intervention n=1233 Participants Students in the intervention group were expected to complete Click City®: Tobacco, a computer-based program designed to prevent subsequent tobacco use. Students were expected to do a 15 to 20 minute lesson two times a week for four weeks. Participation also consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program.	Control n=1215 Participants Students in control schools were expected to complete their usual tobacco curriculum, designed to prevent tobacco use. Students completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over the same period that students in the intervention group completed Click City®: Tobacco.	Total n=2448 Participants Total of all reporting groups
Age, Categorical <=18 years	1233 Participants n=5 Participants	1215 Participants n=7 Participants	2448 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Gender · boy	576 Participants n=5 Participants	545 Participants n=7 Participants	1121 Participants n=5 Participants
Sex/Gender, Customized Gender · girl	594 Participants n=5 Participants	580 Participants n=7 Participants	1174 Participants n=5 Participants
Sex/Gender, Customized Gender · neither boy nor girl	59 Participants n=5 Participants	44 Participants n=7 Participants	103 Participants n=5 Participants
Sex/Gender, Customized Gender · not reported (missing)	4 Participants n=5 Participants	46 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	370 Participants n=5 Participants	371 Participants n=7 Participants	741 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	863 Participants n=5 Participants	840 Participants n=7 Participants	1703 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	44 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) White	1093 Participants n=5 Participants	1067 Participants n=7 Participants	2160 Participants n=5 Participants
Race (NIH/OMB) More than one race	60 Participants n=5 Participants	56 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Student's use of tobacco prior to the trial Students used tobacco	82 Participants n=5 Participants	122 Participants n=7 Participants	204 Participants n=5 Participants
Student's use of tobacco prior to the trial Students did not use tobacco	1145 Participants n=5 Participants	1091 Participants n=7 Participants	2236 Participants n=5 Participants
Student's use of tobacco prior to the trial Not reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Family members' current use of tobacco Family member uses nicotine	489 Participants n=5 Participants	523 Participants n=7 Participants	1012 Participants n=5 Participants
Family members' current use of tobacco Family member does not use nicotine	741 Participants n=5 Participants	689 Participants n=7 Participants	1430 Participants n=5 Participants
Family members' current use of tobacco Not reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline; six months

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Behavioral Intentions to Vape E-cigarettes	-.14 score on a scale Standard Deviation 1.325	0.0 score on a scale Standard Deviation 1.20

PRIMARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Measured by two items assessing the student's intentions to smoke cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with a potential range from 2 to 10. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Behavioral Intentions to Smoke Cigarettes	-.12 score on a scale Standard Deviation 1.026	.04 score on a scale Standard Deviation 1.125

PRIMARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Measured by four items, assessing the student's willingness to vape e-cigarettes if the opportunity presented itself (with a group of kids with e-cigaretes available and with kids who are vaping and you want to be a part of the group. Willingness to vape was assessed for two levels, "try a few vapes" and "try vaping several times in a row". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Willingness to Vape E-cigarettes	-.07 score on a scale Standard Deviation 1.77	.14 score on a scale Standard Deviation 2.00

PRIMARY outcome

Timeframe: baseline; six weeks

Population: Students were nested within schools. Students are the unit of analysis.

Measured by four items, assessing the student's willingness to smoke cigarettes if the opportunity presented itself ("with a group of kids with cigarettes available" and "with kids who are smoking and you want to be a part of the group". Willingness to smoke was assessed for two levels, "try a few puffs" and "smoking the whole cigarette". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Willingness to Smoke Cigarettes	-.05 score on a scale Standard Deviation 1.42	.12 score on a scale Standard Deviation 1.635

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Schools were randomly assigned to an arm.

Students rate what they "think kids who smoke are like" using a three-point rating scale from "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score goes from 3 to 9. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Favorable Social Images of Smokers	-.87 score on a scale Standard Deviation 1.175	-.16 score on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools and schools are randomly assigned to condition.

Students rate what they "think kids who vape e-carettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Favorable Social Images of E-cigarette Vapers	-.87 score on a scale Standard Deviation 1.255	-.17 score on a scale Standard Deviation 1.635

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Students rate what they "think other 5th grade kids think kids who smoke cigarettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1327 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1346 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Normative Social Images of Smokers	-.56 score on a scale Standard Deviation 1.015	-.16 score on a scale Standard Deviation 1.315

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Students rate what they "think other 5th grade kids think kids who vape e-cigarettes are like" using a three-point rating scale using "not at all like this" (1) to "very much like this" (3) to rate three attributes, "popular", "cool or neat" and "exciting". The three attributes are summed and the potential score ranges from 3 to 9. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Normative Social Images of Vapers	-.62 score on a scale Standard Deviation 1.08	-.19 score on a scale Standard Deviation 1.445

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Students indicated their perception of friends' approval of their smoking of each of three levels of cigarettes, trying, smoking a few, and smoking a few a day. Responses to each item ranged from "yes" (1) to "no" (3). Summing the three levels ranged from 3 to 9, with a higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Friends Approval of Smoking	-.10 score on a scale Standard Deviation .78	.01 score on a scale Standard Deviation .92

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students nested within schools.

Students indicated their perception of friends' approval of their vaping of each of three levels of cigarettes, trying, vaping a few, and vaping a few a day. Responses to each item ranged from "yes" (1) to "no" (3). Summing the three levels ranged from 3 to 9, with a higher score indicating a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Friends Approval of Vaping	-.14 score on a scale Standard Deviation .93	.04 score on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Perception of the risk of getting four diseases ("breathing problems", "asthma", "ear infections" "heart disease", and "lung disease or cancer") as a result of being "often around someone who smokes". Responses for each disease are on a five point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of five items ranged from 4 to 20. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Second-hand Smoke Exposure	3.00 score on a scale Standard Deviation 4.05	.90 score on a scale Standard Deviation 3.905

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although the school was the unit of randomization, the student is the unit of analysis.

Perception of the risk of getting each of four diseases ("breathing problems", "asthma", "ear infections" , and "lung disease or cancer") as a result of being "often around someone who vapes". Responses for each disease are on a five point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of four items ranged from 4 to 20. The follow-up measure was subtracted from the baseline measure, with a higher score indicating a favorable outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Second-hand Vape Exposure	3.27 score on a scale Standard Deviation 4.195	1.02 score on a scale Standard Deviation 3.955

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Students are the unit of analysis.

Perception of risk of getting three diseases (lung cancer, serious breathing diseases, and heart disease) as a result of three levels of cigarettes, "one", "a few cigarettes a day for two years", "a pack of cigarettes a day for two years". Responses for each disease and each level ranged from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of nine items ranged from 9 to 45. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Cumulative Consequences of Smoking	1.60 score on a scale Standard Deviation 8.365	-.09 score on a scale Standard Deviation 8.38

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested with schools, which are randomized to condition. Students are the unit of analysis.

Perception of risk of getting three diseases (lung cancer, serious breathing diseases, and heart disease) as a result of three levels of e-cigarettes, "one time", "a few times a day for two years", "Twenty or more times a day for two years'. Responses for each disease and each level ranged from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of nine items ranged from 9 to 45. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Cumulative Consequences of Vaping	3.05 score on a scale Standard Deviation 8.410	.35 score on a scale Standard Deviation 8.335

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Risk of smoking each cigarette was measured by two items indicating what would happen to a 12 year old who started smoking, "every cigarette smoked hurts them a bit" and "The very next cigarette probably won't hurt their bodies". The response scale was a five-point scale ranging from "strongly agree" (1) to "strongly disagree" (5). The scale consisted of summing both items with the former item reversed scored. Scale scores ranged from 2 to 10. A higher score indicated a more favorable outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Smoking Each Cigarette	.68 score on a scale Standard Deviation 1.650	.19 score on a scale Standard Deviation 1.665

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Schools are the unit of assignment while students are the unit of analysis.

Risk of vaping each e-cigarette was measured by two items indicating what would happen to a 12 year old who started vaping, "every e-cigarette vaped hurts them a bit" and "the very next e-cigarette probably won't hurt their bodies". The response scale was a five-point scale ranging from "strongly agree" (1) to "strongly disagree" (5). The scale consisted of summing both items with the former item reversed scored. Scale scores ranged from 2 to 10. A higher score indicated a more better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Vaping Each E-cigarette	.78 score on a scale Standard Deviation 1.685	.24 score on a scale Standard Deviation 1.725

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Change in perception of risk of getting addicted to smoking as a result of five levels of smoking, ranging from "one time" to a "a pack of cigarettes a day for five years". Responses for each level were on a five-point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale of the five items ranged from 5 to 25. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Addiction From Smoking	2.27 score on a scale Standard Deviation 5.905	.72 score on a scale Standard Deviation 6.045

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Perception of risk of getting addicted to vaping as a result of vaping five levels of increasing quantities of e-cigarettes, ranging from "one time" to a "20 times a day for 5 years". Responses for each level were on a five-point scale ranging from "no chance" (1) to "certain to happen" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Addiction From Vaping	2.49 score on a scale Standard Deviation 5.92	.73 score on a scale Standard Deviation 5.98

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Students answered "how much control do you think you would have over quitting smoking" using a four-point response scale ranging from "no control" (1) to "total control" (4). Perception of control was indicated within four levels of increasing quantities of cigarettes, ranging from "tried a cigarette" to "a pack a day for five years". The four Items were summed to form a scale with the total scale ranging from 4 to 16. A higher score means a worse outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Control Over Quitting Smoking	-8.53 score on a scale Standard Deviation 13.265	-1.90 score on a scale Standard Deviation 14.605

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Students answered "how much control do you think you would have over quitting vaping e-cigarettes" using a four-point response scale ranging from "no control" (1) to "total control" (4). Students indicated thier perception of control within each of four levels of increasing quantities of e-cigarettes, ranging from "tried vaping" to "20 times a day for five years". The four Items were summed to form a scale with the total scale ranging from 4 to 16. A lower score indicated a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Control Over Vaping	-7.93 score on a scale Standard Deviation 13.60	-1.99 score on a scale Standard Deviation 14.78

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Perception of risk of difficulty quitting smoking as a result of vaping five levels of increasing quantities of cigarettes smoked, ranging from "one cigarette" to a " a pack of cigarettes a day for 5 years". Responses for each level were on a five-point scale ranging from "Very easy" (1) to "Very difficult" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score meant a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Difficulty Quitting Smoking	2.39 score on a scale Standard Deviation 4.485	.19 score on a scale Standard Deviation 4.865

SECONDARY outcome

Timeframe: baseline; six weeks

Population: Students are nested within schools. Although schools are the unit of randomization, students are the unit of analysis.

Perception of risk of difficulty of quitting vaping as a result of vaping five levels of increasing quantities of e-cigarettes vaped, ranging from "one time" to a " 20 times a day for 5 years". Responses for each level were on a five-point scale ranging from "Very easy" (1) to "Very difficult" (5). Items were summed to form a scale. The total scale ranged from 5 to 25. A higher score means a better outcome.

Outcome measures

Measure	Intervention n=1346 Participants Participation consisted of a baseline assessment one-week prior to starting the program, and a follow-up assessment one-week following completion of the program. The expectation was that students complete two lessons a week of the computer-based program over a four-week period. Click City®: Tobacco: A computer-based program assigned to students designed to prevent subsequent tobacco use. Students complete one 15 to 20 minute lesson two times a week for four weeks.	Control n=1327 Participants Students in control schools completed the baseline and follow-up assessments during the same week as students in their yoked intervention school. The expectation was that students would participate in the standard tobacco curriculum over this period. Usual tobacco curriculum: Students complete their usual curriculum designed to prevent tobacco use
Change in Perception of Risk of Difficulty Quitting Vaping	2.38 score on a scale Standard Deviation 4.645	.16 score on a scale Standard Deviation 4.970

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Judy A. Andrews, Senior Scientist

Oregon Research Behavioral Intervention Strategies, Inc.

Phone: 541-484-2123

Email: Judy.Andrews@Influentsin.com

Results disclosure agreements

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