Clinical trial NCT03682900: Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
Official title: Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: e-cigarettes
prevention
middle school
smoking
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-09-25
Enrollment: 2673
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Behavioral Intentions to Vape E-cigarettes
timeFrame: baseline; six months
measure: Change in Behavioral Intentions to Smoke Cigarettes
timeFrame: baseline; six weeks
measure: Change in Willingness to Vape E-cigarettes
timeFrame: baseline; six weeks
measure: Change in Willingness to Smoke Cigarettes
timeFrame: baseline; six weeks
Secondary outcomes:
measure: Change in Favorable Social Images of Smokers
timeFrame: baseline; six weeks
measure: Change in Favorable Social Images of E-cigarette Vapers
timeFrame: baseline; six weeks
measure: Change in Normative Social Images of Smokers
timeFrame: baseline; six weeks
measure: Change in Normative Social Images of Vapers
timeFrame: baseline; six weeks
measure: Change in Perception of Friends Approval of Smoking
timeFrame: baseline; six weeks
measure: Change in Perception of Friends Approval of Vaping
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Second-hand Smoke Exposure
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Second-hand Vape Exposure
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Cumulative Consequences of Smoking
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Cumulative Consequences of Vaping
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Smoking Each Cigarette
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Vaping Each E-cigarette
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Addiction From Smoking
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Addiction From Vaping
timeFrame: baseline; six weeks
measure: Change in Perception of Control Over Quitting Smoking
timeFrame: baseline; six weeks
measure: Change in Perception of Control Over Vaping
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Difficulty Quitting Smoking
timeFrame: baseline; six weeks
measure: Change in Perception of Risk of Difficulty Quitting Vaping
timeFrame: baseline; six weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: Judy A Andrews, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizon
name: Judith S. Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: