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

NCT ID: NCT03682900

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2673 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-06-30

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Click City®: Tobacco

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Usual Tobacco Curriculum

Intervention Type: OTHER

Students complete their usual curriculum designed to prevent tobacco use.

Interventions

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.

Intervention Type: OTHER

Usual Tobacco Curriculum

Students complete their usual curriculum designed to prevent tobacco use.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy A Andrews, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Intervention Strategies, Inc.

Judith S. Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizon

Locations

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2R44DA044025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA044025

Identifier Type: -

Identifier Source: org_study_id

NCT05730322

Identifier Type: -

Identifier Source: nct_alias