NCT03107936

Brief Summary

To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.

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 Jan 2017

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

December 19, 2016

Last Update Submit

October 17, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Beliefs about smoking 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

  • Beliefs about smoking 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

  • Knowledge about smoking 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

  • Knowledge about smoking post-test survey.

    Participants completed a pre-survey through a secured, data collection website (Qualtrics Data Collection Software), played the videogame intervention, and then completed a post-survey using the same data collection website. 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 survey. For knowledge, questions had 3 response choices (yes, not, and not sure).

    immediately after game play is completed

  • Game experience satisfaction post-test survey

    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

Study Arms (1)

smokeSCREEN game play

EXPERIMENTAL

Participants are instructed to access the web-based videogame intervention, smokeSCREEN, through a secured website and play the game using their unique User ID and password.

Behavioral: smokeSCREEN game

Interventions

smokeSCREEN 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.

smokeSCREEN game play

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • must be able and willing to sit at a computer or mobile device for 45-60 minutes per session to play the game and answer questions before and after playing video game.
  • be enrolled in a youth program that we have a partnership with

You may not qualify if:

  • up to the discretion of the study team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hamden Youth Center

Hamden, Connecticut, 06517, United States

Location

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

New Haven, Connecticut, 06511, United States

Location

Yale New Haven Hospital

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 E. Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

April 11, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations