- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815591
Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
April 21, 2022 updated by: Yale University
To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and youth programs nationwide with whom to partner.
For this project, the play2PREVENT Lab will provide these programs access to the tobacco use reduction/prevention game that the lab has created (smokeSCREEN).
Program and school staff will enroll participants between the ages of 10-16 to play smokeSCREEN during their after school, school, and youth program.
Before and after gameplay, participants will answer assessment questions related to their attitudes, beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use.
The data will be transmitted electronically via the LimeSurvey data collection platform to the Lab, for further analysis.
None of the Lab staff will have contact with participants or after-school/school/youth program coordinators or staff.
Study Type
Interventional
Enrollment (Actual)
560
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- play2PREVENT Lab at the Yale Center for Health & Learning Games
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Anyone with a userID and password.
Exclusion Criteria:
- Does not fit the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: adolescents between ages of 10-16
Adolescents given a pre-post survey to measure the effect of the game and building that into the smokeSCREEN video game to anonymously collect information on players' perspectives, beliefs, attitudes, intentions, social norms, and behaviors around tobacco use, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.
|
smokeSCREEN tobacco use reduction/prevention web-based game.
The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.
Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products.
Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in beliefs
Time Frame: baseline
|
Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention.
Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey.
For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.
|
baseline
|
|
Changes in beliefs
Time Frame: immediately after game play is completed
|
Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), after they have played the videogame intervention.
Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on beliefs about cigarettes, e-cigarettes, and flavored tobacco were used for the survey.
For beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 responses ranging from unlikely to very likely.
|
immediately after game play is completed
|
|
Change in knowledge
Time Frame: Baseline
|
Participants completed a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention.
Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys.
For knowledge, questions had 3 response choices (yes, not, and not sure).
|
Baseline
|
|
Change in knowledge
Time Frame: immediately after game play is completed
|
Participants completed a post-survey through a secured, data collection website (LimeSurvey Data Collection Software), played the videogame intervention.
Fourteen questions were designed from the National Youth Tobacco Survey (2014)13 that focused on knowledge about cigarettes, e-cigarettes, and flavored tobacco were used for the surveys.
For knowledge, questions had 3 response choices (yes, not, and not sure).
|
immediately after game play is completed
|
|
Change in intentions
Time Frame: Baseline
|
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention.
Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco.
For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
|
Baseline
|
|
Change in behaviors
Time Frame: Immediately after gameplay is completed
|
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention.
Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco.
For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
|
Immediately after gameplay is completed
|
|
Changes in social norms
Time Frame: Baseline
|
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention.
Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco.
Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option).
Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
|
Baseline
|
|
Changes in social norms
Time Frame: Immediately after gameplay is completed
|
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention.
Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco.
Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option).
Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
|
Immediately after gameplay is completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gameplay satisfaction: post-test survey
Time Frame: immediately after game play is completed
|
The post-test survey, administered through a secured, data collection website (LimeSurvey Data Collection Software), will include an additional 10 items on the game intervention experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents; 4 response choices ranging from strongly disagree to strongly agree.
|
immediately after game play is completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lynn Fiellin, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
January 11, 2019
First Submitted That Met QC Criteria
January 23, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000023070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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