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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: Click City®: Tobacco
* Other: Usual Tobacco Curriculum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Click City Tobacco Prevention Program<br>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. | Other: Click City®: Tobacco<br>* 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.<br>|
| Experimental: Control: Usual Tobacco Prevention Curriculum<br>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. | Other: Usual Tobacco Curriculum<br>* Students complete their usual curriculum designed to prevent tobacco use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline; six months | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 
| 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. | baseline; six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarettes, prevention, middle school, smoking