Expanding the Click City Tobacco Prevention Program

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: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Click City®: Tobacco; Other: Usual tobacco curriculum

Detailed Description

Given the increase in prevalence of e-cigarette use among youth, we modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. We 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.

• Study Type: Interventional
• Enrollment (Actual): 2673
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A 5th grade student in one of the recruited schools
• Student speaks English as a first or second language

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Experimental: Control; 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; Students complete their usual curriculum designed to prevent tobacco use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Behavioral Intentions to vape e-cigarettes	intentions to vape e-cigarettes in the future	six weeks
Decrease in Behavioral Intentions to smoke cigarettes	Intentions to smoke cigarettes in the future	six weeks
Decrease in willingness to vape e-cigarettes	Willingness to vape e-cigarettes if the opportunity presented itself	six weeks
Decrease in willingness to smoke cigarettes	Willingness to smoke cigarettes if the opportunity presented itself	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease favorable social images of smokers	Ratings of attributes describing what kids who smoke are like	six weeks
Decrease favorable social images of e-cigarette vapers	Ratings of attributes describing what kids who vape are like	six weeks
Decrease normative social images of smokers	Ratings of attributes describing what kids who smoke are like	six weeks
Decrease normative social images of vapers	Ratings of attributes describing what kids who smoke are like	six weeks
Decrease perception of friends approval of smoking	Perception of friends' approval of the use of each of three levels of cigarettes	six weeks
Decrease perception of friends approval of vaping	Perception of friends' approval of the use of each of three levels of cigarettes	six weeks
Increase perception of risk of second-hand smoke exposure	Perception of risk of three health problems resulting from being around a smoker a lot	six weeks
Increase perception of risk of second-hand vape exposure	Perception of risk of three health problems resulting from being around a vaper a lot	six weeks
Increase perception of risk of cumulative consequences of smoking	Perception of risk of getting three diseases as a result of three levels of length of smoking	six weeks
Increase perception of risk of cumulative consequences of vaping	Perception of risk of getting three diseases as a result of three levels of length of vaping	six weeks
Increase perception of risk of smoking each cigarette	Agreement with risk of smoking, as measured by two items	six weeks
Increase perception of risk of vaping each e-cigarette	Agreement with risk of vaping, as measured by two items	six weeks
Increase perception of risk of addiction from smoking	Perception of risk of addiction as a result of three levels of extent of smoking	six weeks
Increase perception of risk of addiction from vaping	Perception of risk of addiction as a result of three levels of extent of vaping	six weeks
Decrease perception of control over smoking	Perception of control over smoking after as a result of an increase in extent of smoking	six weeks
Decrease perception of control over vaping	Perception of control over smoking after as a result of an increase in extent of smoking	six weeks
Increase perception of risk of difficulty quitting smoking	Perception of difficulty in quitting smoking as a result of three levels of smoking	six weeks
Increase perception of risk of difficulty quitting vaping	Perception of difficulty in quitting vaping as a result of three levels of vaping.	six weeks

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: prevention; tobacco use
• Other Study ID Numbers: NCT 03682900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No