Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
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|ClinicalTrials.gov Identifier: NCT03682900|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : March 13, 2019
The overarching goal of the proposed Phase II research is to demonstrate the short-term effectiveness of the modification of an existing, effective, computer-based, tobacco prevention program, Click City®: Tobacco, to prevent the initiation of e-cig use among youth.
A secondary goal is to modify the program to increase marketability by expanding the range of devices on which the program can be delivered (e.g., tablets to desktops), simplifying the student user interface, and providing more robust teacher/administrator functionality.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use||Other: Click City Tobacco Prevention Program||Not Applicable|
In a previous research study the investigators developed and tested an effective tobacco prevention program to be used in 5th and 6th grade classrooms as tobacco prevention curriculum. The prevalence of e-cigarette (e-cig) use has recently increased dramatically, greatly exceeding that of cigarette use. Considering the health effects of e-cigs, and the increased probability that adolescents will become addicted to nicotine through the use of e-cigs a crucial need was recognized for the incorporation of e-cigs into the original tobacco prevention program. In Phase I the investigators were able to create two new activities that changed specific risk factors predictive of e-cig use. Two existing activities were modified to target not only risk factors related to smoking but also to e-cigarette use. Phase II will develop additional content targeting e-cigs and modify graphics and language throughout the program to include e-cigs. The finished program will contain 10 lessons to be used in fifth grade classrooms and a booster containing 6 activities to be used in sixth grade classrooms.
This project, which targets 5th graders with a booster in 6th grade, aims to prevent the initiation of the use of tobacco products including e-cigs, later in adolescence. This school-based, internet delivered program targets established risk factors predictive of youth's behavioral intentions and willingness to use tobacco products, both predictors of subsequent use.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3636 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Click City Tobacco Prevention Program
Click City program used as part of school curriculum
Other: Click City Tobacco Prevention Program
Fifth and sixth grade classroom tobacco prevention computer activities designed to postpone or prevent youth smoking, through changing theoretically-based risk factors predictive of subsequent use.
No Intervention: Usual Tobacco Prevention Curriculum
Will vary by school district.
- Change intentions to smoke [ Time Frame: Baseline, up to week 10 ]Intentions to smoke in the next year and in the future will be assessed on a 1-5 scale (from "definitely not" to "definitely will").
- Change intentions to use e-cigarettes [ Time Frame: Baseline, up to week 10 ]Intentions to use e-cigarettes in the next year and in the future will be assessed on a 1-5 scale (from "definitely not" to "definitely will").
- Change willingness to smoke [ Time Frame: Baseline, up to week 10 ]6 scales to measure willingness to smoke if the opportunity arose, including if offered and if available with response items ranging from 'not at all willing' (=1) to 'very willing' (=5).
- Change willingness to use e-cigarettes [ Time Frame: Baseline, up to week 10 ]6 scales to measure willingness to use e-cigarettes if the opportunity arose, including if offered and if available with response items ranging from 'not at all willing' (=1) to 'very willing' (=5).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682900
|Contact: David R Smithfirstname.lastname@example.org|
|Principal Investigator:||Judy Andrews||Oregon Research Behavioral Intervention Strategies, Inc.|