- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107936
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeSCREEN)
October 17, 2018 updated by: Yale University
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.
Study Overview
Detailed Description
The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.
For this sub-study we will further develop, expand, and refine the smokeSCREEN game and increase the game's reach on a national platform.
The study will conduct the proposed evaluation by: working with game developers to develop a web- based version of the game, creating a pre-post survey to measure the effect of the game and building that into the smokeSCREEN game to anonymously collect information on players' knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.
Study Type
Interventional
Enrollment (Actual)
40
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
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Connecticut
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Hamden, Connecticut, United States, 06517
- Hamden Youth Center
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New Haven, Connecticut, United States, 06511
- Yale New Haven Hospital
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New Haven, Connecticut, United States, 06511
- Leadership, Education, and Athletics Partnership (LEAP) Inc.
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New Haven, Connecticut, United States, 06513
- Farnam Neighborhood House
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be able and willing to sit at a computer or mobile device for 45-60 minutes per session to play the game and answer questions before and after playing video game.
- be enrolled in a youth program that we have a partnership with
Exclusion Criteria:
- up to the discretion of the study team
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 |
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Experimental: smokeSCREEN game play
Participants are instructed to access the web-based videogame intervention, smokeSCREEN, through a secured website and play the game using their unique User ID and password.
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smokeSCREEN is web-based videogame intervention focused on tobacco use prevention in teens.
The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.smokeSCREEN.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beliefs about smoking pre-test survey
Time Frame: Baseline
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Participants completed a pre-survey through a secured, data collection website (Qualtrics Data Collection Software) and then 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 beliefs, questions had 4-5 choices ranging from strongly disagree to strongly agree or definitely yes to definitely not, or 5 response choices ranging from very unlikely to very likely.
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Baseline
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Beliefs about smoking post-test survey
Time Frame: immediately after game play is completed
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Participants completed a post-survey through a secured, data collection website (Qualtrics 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 response choices ranging from very unlikely to very likely.
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immediately after game play is completed
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Knowledge about smoking pre-test survey
Time Frame: Baseline
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Participants completed a pre-survey through a secured, data collection website (Qualtrics 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).
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Baseline
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Knowledge about smoking post-test survey.
Time Frame: immediately after game play is completed
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Participants completed a pre-survey through a secured, data collection website (Qualtrics Data Collection Software), played the videogame intervention, and then completed a post-survey using the same data collection website.
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 survey.
For knowledge, questions had 3 response choices (yes, not, and not sure).
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immediately after game play is completed
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Game experience satisfaction post-test survey
Time Frame: immediately after game play is completed
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The post-test survey included an additional 5 items on game experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents (e.g., "I would tell my friends to play this game," 4 response choices, ranging from strongly disagree to strongly agree).
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immediately after game play is completed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lynn E. 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)
January 1, 2017
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
October 19, 2018
Last Update Submitted That Met QC Criteria
October 17, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1401013293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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