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

NCT03682900 | Completed Results

• 2 other identifiers: DA0440252R44DA044025
• Study Type: interventional
• Target: 2,673
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use

Keywords

e-cigarettes; prevention; middle school; smoking

Outcome Measures

Primary Outcomes (4)

• Change in Behavioral Intentions to Vape E-cigarettes

  Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.

  baseline; six months

• Change in Behavioral Intentions to Smoke Cigarettes

  Measured by two items assessing the student's intentions to smoke cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with a potential range from 2 to 10. A higher score means a worse outcome.

  baseline; six weeks

• Change in Willingness to Vape E-cigarettes

  Measured by four items, assessing the student's willingness to vape e-cigarettes if the opportunity presented itself (with a group of kids with e-cigaretes available and with kids who are vaping and you want to be a part of the group. Willingness to vape was assessed for two levels, "try a few vapes" and "try vaping several times in a row". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

  baseline; six weeks

• Change in Willingness to Smoke Cigarettes

  Measured by four items, assessing the student's willingness to smoke cigarettes if the opportunity presented itself ("with a group of kids with cigarettes available" and "with kids who are smoking and you want to be a part of the group". Willingness to smoke was assessed for two levels, "try a few puffs" and "smoking the whole cigarette". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

  baseline; six weeks

Secondary Outcomes (18)

• Change in Favorable Social Images of Smokers

  baseline; six weeks

• Change in Favorable Social Images of E-cigarette Vapers

  baseline; six weeks

• Change in Normative Social Images of Smokers

  baseline; six weeks

• Change in Normative Social Images of Vapers

  baseline; six weeks

• Change in Perception of Friends Approval of Smoking

  baseline; six weeks

Study Arms (2)

Intervention: Click City Tobacco Prevention Program

EXPERIMENTAL

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

Control: Usual Tobacco Prevention Curriculum

EXPERIMENTAL

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

Interventions

Click City®: Tobacco 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.

Intervention: Click City Tobacco Prevention Program

Usual Tobacco Curriculum OTHER

Students complete their usual curriculum designed to prevent tobacco use.

Control: Usual Tobacco Prevention Curriculum

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Conditions

Tobacco Use; Vaping; Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The trial was interrupted half way through by school closures as a result of the pandemic. The trial was re-instated two years later. There were no differences on the effect of the intervention due to timing of the implementation of the trial (prior to versus following school closures). Technical problems led to inability to match IDs. The data for these participants was dropped from that portion of the study.

Results Point of Contact

• Title: Judy A. Andrews, Senior Scientist
• Organization: Oregon Research Behavioral Intervention Strategies, Inc.

Judy.Andrews@Influentsin.com

541-484-2123

Study Officials

• Judy A Andrews, PhD

  Oregon Research Behavioral Intervention Strategies, Inc.

  PRINCIPAL INVESTIGATOR

• Judith S. Gordon, PhD

  University of Arizon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: October 1, 2019
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)