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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722888
Other study ID # 140103293_IV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2017
Est. completion date September 28, 2018

Study information

Verified date October 2018
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 28, 2018
Est. primary completion date April 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Hamden Youth Center Hamden Connecticut
United States Farnam Neighborhood House New Haven Connecticut
United States Leadership, Education, and Athletics Partnership (LEAP) Inc. 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 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. baseline
Primary 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. immediately after game play is completed
Primary 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). baseline
Primary 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). immediately after game play is completed
Secondary 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). immediately after game play is completed
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