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

O

Oregon Research Behavioral Intervention Strategies

Status

Completed

Conditions

Tobacco Use

Treatments

Other: Usual Tobacco Curriculum
Other: Click City®: Tobacco

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT03682900
DA044025
2R44DA044025 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,673 patients

Sex

All

Ages

9 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,673 participants in 2 patient groups

Intervention: Click City Tobacco Prevention Program
Experimental group
Description:
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.
Treatment:
Other: Click City®: Tobacco
Control: Usual Tobacco Prevention Curriculum
Experimental group
Description:
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.
Treatment:
Other: Usual Tobacco Curriculum

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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