Expanding the Click City Tobacco Prevention Program

Sponsor
Oregon Research Behavioral Intervention Strategies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05730322
Collaborator
(none)
2,673
1
2
29.1
91.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Click City®: Tobacco
  • Other: Usual tobacco curriculum
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2673 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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)
Primary Purpose:
Prevention
Official Title:
Expanding the Click City Tobacco Prevention Program
Actual Study Start Date :
Jan 6, 2020
Actual Primary Completion Date :
Jun 10, 2022
Actual Study Completion Date :
Jun 10, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Decrease in Behavioral Intentions to vape e-cigarettes [six weeks]

    intentions to vape e-cigarettes in the future

  2. Decrease in Behavioral Intentions to smoke cigarettes [six weeks]

    Intentions to smoke cigarettes in the future

  3. Decrease in willingness to vape e-cigarettes [six weeks]

    Willingness to vape e-cigarettes if the opportunity presented itself

  4. Decrease in willingness to smoke cigarettes [six weeks]

    Willingness to smoke cigarettes if the opportunity presented itself

Secondary Outcome Measures

  1. Decrease favorable social images of smokers [six weeks]

    Ratings of attributes describing what kids who smoke are like

  2. Decrease favorable social images of e-cigarette vapers [six weeks]

    Ratings of attributes describing what kids who vape are like

  3. Decrease normative social images of smokers [six weeks]

    Ratings of attributes describing what kids who smoke are like

  4. Decrease normative social images of vapers [six weeks]

    Ratings of attributes describing what kids who smoke are like

  5. Decrease perception of friends approval of smoking [six weeks]

    Perception of friends' approval of the use of each of three levels of cigarettes

  6. Decrease perception of friends approval of vaping [six weeks]

    Perception of friends' approval of the use of each of three levels of cigarettes

  7. Increase perception of risk of second-hand smoke exposure [six weeks]

    Perception of risk of three health problems resulting from being around a smoker a lot

  8. Increase perception of risk of second-hand vape exposure [six weeks]

    Perception of risk of three health problems resulting from being around a vaper a lot

  9. Increase perception of risk of cumulative consequences of smoking [six weeks]

    Perception of risk of getting three diseases as a result of three levels of length of smoking

  10. Increase perception of risk of cumulative consequences of vaping [six weeks]

    Perception of risk of getting three diseases as a result of three levels of length of vaping

  11. Increase perception of risk of smoking each cigarette [six weeks]

    Agreement with risk of smoking, as measured by two items

  12. Increase perception of risk of vaping each e-cigarette [six weeks]

    Agreement with risk of vaping, as measured by two items

  13. Increase perception of risk of addiction from smoking [six weeks]

    Perception of risk of addiction as a result of three levels of extent of smoking

  14. Increase perception of risk of addiction from vaping [six weeks]

    Perception of risk of addiction as a result of three levels of extent of vaping

  15. Decrease perception of control over smoking [six weeks]

    Perception of control over smoking after as a result of an increase in extent of smoking

  16. Decrease perception of control over vaping [six weeks]

    Perception of control over smoking after as a result of an increase in extent of smoking

  17. Increase perception of risk of difficulty quitting smoking [six weeks]

    Perception of difficulty in quitting smoking as a result of three levels of smoking

  18. Increase perception of risk of difficulty quitting vaping [six weeks]

    Perception of difficulty in quitting vaping as a result of three levels of vaping.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Research Behavioral Intervention Strategies, Inc. Eugene Oregon United States 97403

Sponsors and Collaborators

  • Oregon Research Behavioral Intervention Strategies, Inc.

Investigators

  • Principal Investigator: Judy A Andrews, Oregon Research Behavioral Intervention Strategies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judy Andrews, Senior Research Scientist, Oregon Research Behavioral Intervention Strategies, Inc.
ClinicalTrials.gov Identifier:
NCT05730322
Other Study ID Numbers:
  • NCT 03682900
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 17, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Judy Andrews, Senior Research Scientist, Oregon Research Behavioral Intervention Strategies, Inc.

Study Results

No Results Posted as of Feb 17, 2023