NCT03722888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 23, 2018

Last Update Submit

October 25, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

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

    immediately after game play is completed

Study Arms (1)

adolescents who have previously smoked

EXPERIMENTAL

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

Interventions

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.

adolescents who have previously smoked

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hamden Youth Center

Hamden, Connecticut, 06517, United States

Location

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

New Haven, Connecticut, 06511, United States

Location

Farnam Neighborhood House

New Haven, Connecticut, 06513, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lynn Fiellin, MD

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single group study with pre-post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 29, 2018

Study Start

October 25, 2017

Primary Completion

April 23, 2018

Study Completion

September 28, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations