SmokingsmokeSCREENNCT03107936
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
A study testing smokeSCREEN game in people with Smoking, run by Yale University at 4 sites in United States.
Trial summary
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- smokeSCREEN game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- up to the discretion of the study team
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hamden Youth Center
Hamden, Connecticut, 06517
Leadership, Education, and Athletics Partnership (LEAP) Inc.
New Haven, Connecticut, 06511
Yale New Haven Hospital
New Haven, Connecticut, 06511
Farnam Neighborhood House
New Haven, Connecticut, 06513
About this study
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.
Read the detailed description
The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs. For this sub-study we will further develop, expand, and refine the smokeSCREEN game and increase the game's reach on a national platform. The study will conduct the proposed evaluation by: working with game developers to develop a web- based version of the game, creating a pre-post survey to measure the effect of the game and building that into the smokeSCREEN game to anonymously collect information on players' knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.
- Conditions
- Smoking
- Being tested
- smokeSCREEN game
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokeSCREEN gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: smokeSCREEN game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: immediately after game play is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startJan 2017
- Primary completionMar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn E. Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107936
- Sponsor's protocol ID
- 1401013293
- Acronym
- smokeSCREEN
- Status last verified
- Oct 2018
- First submitted
- 19 Dec 2016
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
- ClinicalTrials.gov ID
- NCT03107936
- Acronym / sponsor ID
- smokeSCREEN / 1401013293
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.
Detailed description
The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs. For this sub-study we will further develop, expand, and refine the smokeSCREEN game and increase the game's reach on a national platform. The study will conduct the proposed evaluation by: working with game developers to develop a web- based version of the game, creating a pre-post survey to measure the effect of the game and building that into the smokeSCREEN game to anonymously collect information on players' knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot test how the game can be implemented in real world settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smokeSCREEN game play | Experimental | Behavioral: smokeSCREEN gameParticipants 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- up to the discretion of the study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smokeSCREEN gamesmokeSCREEN 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. | Behavioural | smokeSCREEN game play |
Primary outcome
Beliefs about smoking pre-test survey
Time frame: Baseline
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.
Beliefs about smoking post-test survey
Time frame: immediately after game play is completed
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.
Knowledge about smoking pre-test survey
Time frame: Baseline
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).
Knowledge about smoking post-test survey.
Time frame: immediately after game play is completed
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).
Game experience satisfaction post-test survey
Time frame: immediately after game play is completed
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn E. Fiellin, MD principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smokeSCREEN game in people with Smoking, run by Yale University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs about smoking pre-test survey (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.