Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)

• ClinicalTrials.gov Identifier: NCT03722888
• Recruitment Status: Completed
• First Posted: October 29, 2018
• Last Update Posted: October 29, 2018
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.

Condition or disease	Intervention/treatment	Phase
Smoking	Device: smokeSCREEN video game	Not Applicable

Detailed Description:

The specific aims of this sub-study are:

Specific Aim #1: Work with game development team to develop a web-based version of smokeSCREEN.

Specific Aim # 2: Build a pre-post survey into the smokeSCREEN game to anonymously collect survey information on players' perspectives, beliefs, behaviors around smoking.

Specific Aim # 3: Collaborate with youth programs to pilot test the implementation of the new web-based version of smokeSCREEN into youth programs.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Intervention Model: Single Group Assignment
• Intervention Model Description: single group study with pre-post design
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
• Actual Study Start Date: October 25, 2017
• Actual Primary Completion Date: April 23, 2018
• Actual Study Completion Date: September 28, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: adolescents who have previously smoked; 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, behaviors around smoking, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.

Device: smokeSCREEN video game; smokeSCREEN video game 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.

Outcome Measures

Primary Outcome Measures :

1. To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - pre test survey. [ Time Frame: baseline ]
   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.
2. To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - post test survey. [ Time Frame: immediately after game play is completed ]
   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.
3. To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - pre test survey. [ Time Frame: baseline ]
   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).
4. To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - post test survey. [ Time Frame: immediately after game play is completed ]
   Participants completed a post-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).

Secondary Outcome Measures :

1. To collect data on participants' gameplay experience and satisfaction. [ Time Frame: immediately after game play is completed ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Include individuals who have smoked a cigarette previously (since we are evaluating the use of tobacco products in this study, we are including individuals who have previously smoked a cigarette)
• Willing to sit at a computer/tablet/smartphone and play a video game for 45-60 minutes and answer questions before and after playing the video game.
• Be enrolled in a youth program that we have a partnership with.

Exclusion Criteria:

• Does not fit the inclusion criteria.

Contacts and Locations

Locations

United States, Connecticut

Hamden Youth Center

Hamden, Connecticut, United States, 06517

Leadership, Education, and Athletics Partnership (LEAP) Inc.

New Haven, Connecticut, United States, 06511

Farnam Neighborhood House

New Haven, Connecticut, United States, 06513

Sponsors and Collaborators

Yale University

Investigators

• Study Director: Lynn Fiellin, MD; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03722888 History of Changes
• Other Study ID Numbers: 140103293_IV
• First Posted: October 29, 2018
• Last Update Posted: October 29, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Marijuana Use; Substance-Related Disorders; Mental Disorders