Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents

Smoking Cessation Clinical Trial

Official title:

Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815591
• Other study ID #: 2000023070
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

• Anyone with a userID and password.

Exclusion Criteria:

• Does not fit the inclusion criteria

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Device:
• smokeSCREEN web-based game
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.

Locations

Country	Name	City	State
United States	play2PREVENT Lab at the Yale Center for Health & Learning Games	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in beliefs	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
Primary	Changes in beliefs	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
Primary	Change in knowledge	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
Primary	Change in knowledge	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
Primary	Change in intentions	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
Primary	Change in behaviors	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
Primary	Changes in social norms	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
Primary	Changes in social norms	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	Gameplay satisfaction: post-test survey	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