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Trial record 11 of 19 for:    E-cigarettes youth

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

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ClinicalTrials.gov Identifier: NCT03815591
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking Device: smokeSCREEN web-based game Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Anyone with a userID and password.

Exclusion Criteria:

  • Does not fit the inclusion criteria

Information from the National Library of Medicine

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): NCT03815591


Contacts
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Contact: Kimberly Hieftje, PhD 203-737-5595 kimberly.hieftje@yale.edu

Locations
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United States, Connecticut
play2PREVENT Lab at the Yale Center for Health & Learning Games Recruiting
New Haven, Connecticut, United States, 06519
Contact: Lynn E Fiellin, MD    203-737-3347    lynn.sullivan@yale.edu   
Contact: Kimberly Hieftje, PhD    (203) 737-5595    kimberly.hieftje@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Lynn Fiellin, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03815591     History of Changes
Other Study ID Numbers: 2000023070
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
smoking
tobacco
e-cigarettes
flavored tobacco