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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03682900
Enrollment
2673
Registered
2018-09-25
Start date
2019-10-01
Completion date
2022-06-30
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

e-cigarettes, prevention, middle school, smoking

Brief summary

The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum. This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.

Detailed description

Given the increase in prevalence of e-cigarette use among youth, investigators modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. Investigators conducted a pragmatic randomized trial with 5th grade students in schools across Arizona and Oregon to evaluate the effectiveness of the updated program in a real-world setting. Forty-five schools were randomized to the intervention condition, wherein students used the updated version of Click City®: Tobacco, or the control condition, wherein students were taught their usual tobacco prevention curriculum. Students in the intervention schools decreased their intentions and willingness to use e-cigarettes and cigarettes significantly, as compared to students in control schools. The intervention also significantly changed all etiological mechanisms. The effects on all outcomes of the intervention were similar as a function of state (Arizona vs Oregon), gender, ethnicity (Hispanic vs not Hispanic), and historical timing (prior to school closures in 2020 vs after schools re-opened in 2022). The intervention was also more effective for at-risk students, as defined by student's previous tobacco use, current family use and/or high in sensation seeking. Close to 90% of the students completed the entire program, and most completed it in 3 to 4 weeks, the expected time frame. The effectiveness of the updated Click City®: Tobacco was demonstrated in a real world setting and findings suggested that all students can potentially benefit from the program.

Interventions

OTHERClick 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.

OTHERUsual Tobacco Curriculum

Students complete their usual curriculum designed to prevent tobacco use.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Oregon Research Behavioral Intervention Strategies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Schools were stratified by state, size of school (small, medium, large) and desired start date and randomized to intervention or control. Intervention and control schools were yoked for the timing of assessments (baseline and follow-up assessments).

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* A 5th grade student in one of the recruited schools * Student speaks English as a first or second language * Passive parental consent to participate

Exclusion criteria

* Special needs students identified by the classroom teacher as a student who would not understand the questionnaire or the program * Teacher indicates that they cannot comprehend English.

Design outcomes

Primary

MeasureTime frameDescription
Change in Behavioral Intentions to Vape E-cigarettesbaseline; six monthsMeasured 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.
Change in Behavioral Intentions to Smoke Cigarettesbaseline; six weeksMeasured 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.
Change in Willingness to Vape E-cigarettesbaseline; six weeksMeasured 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.
Change in Willingness to Smoke Cigarettesbaseline; six weeksMeasured 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.

Secondary

MeasureTime frameDescription
Change in Perception of Friends Approval of Smokingbaseline; six weeksStudents 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.
Change in Perception of Friends Approval of Vapingbaseline; six weeksStudents 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.
Change in Perception of Risk of Second-hand Smoke Exposurebaseline; six weeksPerception 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.
Change in Perception of Risk of Second-hand Vape Exposurebaseline; six weeksPerception 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.
Change in Perception of Risk of Cumulative Consequences of Smokingbaseline; six weeksPerception 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.
Change in Perception of Risk of Cumulative Consequences of Vapingbaseline; six weeksPerception 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.
Change in Perception of Risk of Smoking Each Cigarettebaseline; six weeksRisk 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.
Change in Favorable Social Images of Smokersbaseline; six weeksStudents 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.
Change in Perception of Risk of Addiction From Smokingbaseline; six weeksChange 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.
Change in Perception of Risk of Addiction From Vapingbaseline; six weeksPerception 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.
Change in Perception of Control Over Quitting Smokingbaseline; six weeksStudents 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.
Change in Perception of Control Over Vapingbaseline; six weeksStudents 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.
Change in Perception of Risk of Difficulty Quitting Smokingbaseline; six weeksPerception 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.
Change in Perception of Risk of Difficulty Quitting Vapingbaseline; six weeksPerception 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.
Change in Perception of Risk of Vaping Each E-cigarettebaseline; six weeksRisk 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.
Change in Favorable Social Images of E-cigarette Vapersbaseline; six weeksStudents 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.
Change in Normative Social Images of Smokersbaseline; six weeksStudents 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.
Change in Normative Social Images of Vapersbaseline; six weeksStudents 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

No events.

Participants by arm

ArmCount
Intervention
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.
1,233
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.
1,215
Total2,448

Baseline characteristics

CharacteristicInterventionControlTotal
Age, Categorical
<=18 years
1233 Participants1215 Participants2448 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
370 Participants371 Participants741 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
863 Participants840 Participants1703 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants4 Participants4 Participants
Family members' current use of tobacco
Family member does not use nicotine
741 Participants689 Participants1430 Participants
Family members' current use of tobacco
Family member uses nicotine
489 Participants523 Participants1012 Participants
Family members' current use of tobacco
Not reported
3 Participants3 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
16 Participants19 Participants35 Participants
Race (NIH/OMB)
Asian
29 Participants23 Participants52 Participants
Race (NIH/OMB)
Black or African American
29 Participants44 Participants73 Participants
Race (NIH/OMB)
More than one race
60 Participants56 Participants116 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants4 Participants4 Participants
Race (NIH/OMB)
White
1093 Participants1067 Participants2160 Participants
Sex/Gender, Customized
Gender
boy
576 Participants545 Participants1121 Participants
Sex/Gender, Customized
Gender
girl
594 Participants580 Participants1174 Participants
Sex/Gender, Customized
Gender
neither boy nor girl
59 Participants44 Participants103 Participants
Sex/Gender, Customized
Gender
not reported (missing)
4 Participants46 Participants50 Participants
Student's use of tobacco prior to the trial
Not reported
6 Participants2 Participants8 Participants
Student's use of tobacco prior to the trial
Students did not use tobacco
1145 Participants1091 Participants2236 Participants
Student's use of tobacco prior to the trial
Students used tobacco
82 Participants122 Participants204 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,3460 / 1,327
other
Total, other adverse events
0 / 1,3460 / 1,327
serious
Total, serious adverse events
0 / 1,3460 / 1,327

Outcome results

Primary

Change in Behavioral Intentions to Smoke Cigarettes

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Behavioral Intentions to Smoke Cigarettes-.12 score on a scaleStandard Deviation 1.026
ControlChange in Behavioral Intentions to Smoke Cigarettes.04 score on a scaleStandard Deviation 1.125
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within conditionp-value: =0Mixed Models Analysis
Primary

Change in Behavioral Intentions to Vape E-cigarettes

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.

Time frame: baseline; six months

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Behavioral Intentions to Vape E-cigarettes-.14 score on a scaleStandard Deviation 1.325
ControlChange in Behavioral Intentions to Vape E-cigarettes0.0 score on a scaleStandard Deviation 1.2
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: =0Mixed Models Analysis
Primary

Change in Willingness to Smoke Cigarettes

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Willingness to Smoke Cigarettes-.05 score on a scaleStandard Deviation 1.42
ControlChange in Willingness to Smoke Cigarettes.12 score on a scaleStandard Deviation 1.635
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: =0.033Mixed Models Analysis
Primary

Change in Willingness to Vape E-cigarettes

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Willingness to Vape E-cigarettes-.07 score on a scaleStandard Deviation 1.77
ControlChange in Willingness to Vape E-cigarettes.14 score on a scaleStandard Deviation 2
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: =0.044Mixed Models Analysis
Secondary

Change in Favorable Social Images of E-cigarette Vapers

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Favorable Social Images of E-cigarette Vapers-.87 score on a scaleStandard Deviation 1.255
ControlChange in Favorable Social Images of E-cigarette Vapers-.17 score on a scaleStandard Deviation 1.635
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Favorable Social Images of Smokers

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Favorable Social Images of Smokers-.87 score on a scaleStandard Deviation 1.175
ControlChange in Favorable Social Images of Smokers-.16 score on a scaleStandard Deviation 1.53
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Normative Social Images of Smokers

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Normative Social Images of Smokers-.56 score on a scaleStandard Deviation 1.015
ControlChange in Normative Social Images of Smokers-.16 score on a scaleStandard Deviation 1.315
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Normative Social Images of Vapers

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Normative Social Images of Vapers-.62 score on a scaleStandard Deviation 1.08
ControlChange in Normative Social Images of Vapers-.19 score on a scaleStandard Deviation 1.445
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Control Over Quitting Smoking

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Control Over Quitting Smoking-8.53 score on a scaleStandard Deviation 13.265
ControlChange in Perception of Control Over Quitting Smoking-1.90 score on a scaleStandard Deviation 14.605
Comparison: Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Control Over Vaping

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Control Over Vaping-7.93 score on a scaleStandard Deviation 13.6
ControlChange in Perception of Control Over Vaping-1.99 score on a scaleStandard Deviation 14.78
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Friends Approval of Smoking

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Friends Approval of Smoking-.10 score on a scaleStandard Deviation 0.78
ControlChange in Perception of Friends Approval of Smoking.01 score on a scaleStandard Deviation 0.92
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Friends Approval of Vaping

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.

Time frame: baseline; six weeks

Population: Students nested within schools.

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Friends Approval of Vaping-.14 score on a scaleStandard Deviation 0.93
ControlChange in Perception of Friends Approval of Vaping.04 score on a scaleStandard Deviation 1.11
Comparison: Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Addiction From Smoking

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Addiction From Smoking2.27 score on a scaleStandard Deviation 5.905
ControlChange in Perception of Risk of Addiction From Smoking.72 score on a scaleStandard Deviation 6.045
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Addiction From Vaping

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Addiction From Vaping2.49 score on a scaleStandard Deviation 5.92
ControlChange in Perception of Risk of Addiction From Vaping.73 score on a scaleStandard Deviation 5.98
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Cumulative Consequences of Smoking

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Cumulative Consequences of Smoking1.60 score on a scaleStandard Deviation 8.365
ControlChange in Perception of Risk of Cumulative Consequences of Smoking-.09 score on a scaleStandard Deviation 8.38
Comparison: Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Cumulative Consequences of Vaping

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Cumulative Consequences of Vaping3.05 score on a scaleStandard Deviation 8.41
ControlChange in Perception of Risk of Cumulative Consequences of Vaping.35 score on a scaleStandard Deviation 8.335
Comparison: Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Difficulty Quitting Smoking

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Difficulty Quitting Smoking2.39 score on a scaleStandard Deviation 4.485
ControlChange in Perception of Risk of Difficulty Quitting Smoking.19 score on a scaleStandard Deviation 4.865
Comparison: Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Difficulty Quitting Vaping

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Difficulty Quitting Vaping2.38 score on a scaleStandard Deviation 4.645
ControlChange in Perception of Risk of Difficulty Quitting Vaping.16 score on a scaleStandard Deviation 4.97
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Second-hand Smoke Exposure

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Second-hand Smoke Exposure3.00 score on a scaleStandard Deviation 4.05
ControlChange in Perception of Risk of Second-hand Smoke Exposure.90 score on a scaleStandard Deviation 3.905
Comparison: Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Second-hand Vape Exposure

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Second-hand Vape Exposure3.27 score on a scaleStandard Deviation 4.195
ControlChange in Perception of Risk of Second-hand Vape Exposure1.02 score on a scaleStandard Deviation 3.955
Comparison: Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Smoking Each Cigarette

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Smoking Each Cigarette.68 score on a scaleStandard Deviation 1.65
ControlChange in Perception of Risk of Smoking Each Cigarette.19 score on a scaleStandard Deviation 1.665
Comparison: Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis
Secondary

Change in Perception of Risk of Vaping Each E-cigarette

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.

Time frame: baseline; six weeks

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

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Perception of Risk of Vaping Each E-cigarette.78 score on a scaleStandard Deviation 1.685
ControlChange in Perception of Risk of Vaping Each E-cigarette.24 score on a scaleStandard Deviation 1.725
Comparison: Data were analyzed using a general linear model with students nested within schools and schools nested within condition.p-value: <0.001Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026