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

Primary Purpose

Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smokeSCREEN video game
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hamden Youth Center
  • Leadership, Education, and Athletics Partnership (LEAP) Inc.
  • Farnam Neighborhood House

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adolescents who have previously smoked

Arm Description

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.

Outcomes

Primary Outcome Measures

To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - pre test survey.
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.
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - post test survey.
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.
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - pre test survey.
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).
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - post test survey.
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

To collect data on participants' gameplay experience and satisfaction.
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).

Full Information

First Posted
October 23, 2018
Last Updated
October 25, 2018
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03722888
Brief Title
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)
Official Title
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
April 23, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group study with pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adolescents who have previously smoked
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
smokeSCREEN video game
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - pre test survey.
Description
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.
Time Frame
baseline
Title
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - post test survey.
Description
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.
Time Frame
immediately after game play is completed
Title
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - pre test survey.
Description
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).
Time Frame
baseline
Title
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - post test survey.
Description
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).
Time Frame
immediately after game play is completed
Secondary Outcome Measure Information:
Title
To collect data on participants' gameplay experience and satisfaction.
Description
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).
Time Frame
immediately after game play is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Fiellin, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Hamden Youth Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Leadership, Education, and Athletics Partnership (LEAP) Inc.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Farnam Neighborhood House
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06513
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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