- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682900
Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Springfield, Oregon, United States, 97477
- Oregon Research Behavioral Intervention Strategies, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention: Click City Tobacco Prevention Program
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.
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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.
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Experimental: Control: Usual Tobacco Prevention Curriculum
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.
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Students complete their usual curriculum designed to prevent tobacco use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Intentions to Vape E-cigarettes
Time Frame: baseline; six months
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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.
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baseline; six months
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Change in Behavioral Intentions to Smoke Cigarettes
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Willingness to Vape E-cigarettes
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Willingness to Smoke Cigarettes
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Favorable Social Images of Smokers
Time Frame: baseline; six weeks
|
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.
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baseline; six weeks
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Change in Favorable Social Images of E-cigarette Vapers
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Normative Social Images of Smokers
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Normative Social Images of Vapers
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Friends Approval of Smoking
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Friends Approval of Vaping
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Second-hand Smoke Exposure
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Second-hand Vape Exposure
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Cumulative Consequences of Smoking
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Cumulative Consequences of Vaping
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Smoking Each Cigarette
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Vaping Each E-cigarette
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Addiction From Smoking
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Addiction From Vaping
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Control Over Quitting Smoking
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Control Over Vaping
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Difficulty Quitting Smoking
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Change in Perception of Risk of Difficulty Quitting Vaping
Time Frame: baseline; six weeks
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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.
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baseline; six weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Judy A Andrews, PhD, Oregon Research Behavioral Intervention Strategies, Inc.
- Principal Investigator: Judith S. Gordon, PhD, University of Arizon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DA044025
- 2R44DA044025 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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