Smoking CessationNCT03815591
Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
A study testing smokeSCREEN web-based game in people with Smoking Cessation and Smoking, run by Yale University at 1 site in United States.
Trial summary
To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and 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 Cessation, Smoking
- What is being tested?
- smokeSCREEN web-based game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Dec 2021
- 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
- Anyone with a userID and password.
Who cannot join
- Does not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
play2PREVENT Lab at the Yale Center for Health & Learning Games
New Haven, Connecticut, 06519
About this study
To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.
Read the detailed description
For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will provide these programs access to the tobacco use reduction/prevention game that the lab has created (smokeSCREEN). Program and school staff will enroll participants between the ages of 10-16 to play smokeSCREEN during their after school, school, and youth program. Before and after gameplay, participants will answer assessment questions related to their attitudes, beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The data will be transmitted electronically via the LimeSurvey data collection platform to the Lab, for further analysis. None of the Lab staff will have contact with participants or after-school/school/youth program coordinators or staff.
- Conditions
- Smoking Cessation, Smoking
- Being tested
- smokeSCREEN web-based game
- Keywords
- smoking, tobacco, e-cigarettes, flavored tobacco
- Medical subject headings
- Smoking Cessation, Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokeSCREEN web-based gameDevice
smokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. 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 |
|---|---|---|
| adolescents between ages of 10-16 | 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, attitudes, intentions, social norms, and behaviors around tobacco use, and collaborating with youth programs to pilot test how the game can be implemented in real world settings. Receives: Device: smokeSCREEN web-based game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in beliefs
Participants completed a pre-survey through a secured, data collection website (LimeSurvey 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 responses ranging from unlikely to very likely.
Measured: baseline
Changes in beliefs
Participants completed a post-survey through a secured, data collection website (LimeSurvey 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 responses ranging from unlikely to very likely.
Measured: immediately after game play is completed
Change in knowledge
Participants completed a pre-survey through a secured, data collection website (LimeSurvey 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
Change in knowledge
Participants completed a post-survey through a secured, data collection website (LimeSurvey 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: immediately after game play is completed
Change in intentions
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
Measured: Baseline
Change in behaviors
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
Measured: Immediately after gameplay is completed
Changes in social norms
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
Measured: Baseline
Changes in social norms
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
Measured: Immediately after gameplay is completed
Secondary outcomes (1)
Gameplay satisfaction: post-test survey
The post-test survey, administered through a secured, data collection website (LimeSurvey Data Collection Software), will include an additional 10 items on the game intervention experience and satisfaction from items designed for a previous videogame study on sexual risk reduction in young adolescents; 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 posted24 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn Fiellin, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815591
- Sponsor's protocol ID
- 2000023070
- Status last verified
- Apr 2022
- First submitted
- 11 Jan 2019
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
- ClinicalTrials.gov ID
- NCT03815591
- Acronym / sponsor ID
- 2000023070
- Conditions
- Smoking Cessation, Smoking
- Keywords
- smoking, tobacco, e-cigarettes, flavored tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jan 2019 (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 examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.
Detailed description
For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will provide these programs access to the tobacco use reduction/prevention game that the lab has created (smokeSCREEN). Program and school staff will enroll participants between the ages of 10-16 to play smokeSCREEN during their after school, school, and youth program. Before and after gameplay, participants will answer assessment questions related to their attitudes, beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The data will be transmitted electronically via the LimeSurvey data collection platform to the Lab, for further analysis. None of the Lab staff will have contact with participants or after-school/school/youth program coordinators or staff.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents between ages of 10-16 | Experimental | Device: smokeSCREEN web-based gameAdolescents 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, attitudes, intentions, social norms, and behaviors around tobacco use, and collaborating with youth programs to pilot test how the game can be implemented in real world settings. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Anyone with a userID and password.
Key exclusion criteria (1 listed)
- Does not fit the inclusion criteria
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 web-based gamesmokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. 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. | Device | adolescents between ages of 10-16 |
Primary outcome
Changes in beliefs
Time frame: baseline
Participants completed a pre-survey through a secured, data collection website (LimeSurvey 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 responses ranging from unlikely to very likely.
Changes in beliefs
Time frame: immediately after game play is completed
Participants completed a post-survey through a secured, data collection website (LimeSurvey 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 responses ranging from unlikely to very likely.
Change in knowledge
Time frame: Baseline
Participants completed a pre-survey through a secured, data collection website (LimeSurvey 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).
Change in knowledge
Time frame: immediately after game play is completed
Participants completed a post-survey through a secured, data collection website (LimeSurvey 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).
Change in intentions
Time frame: Baseline
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
Change in behaviors
Time frame: Immediately after gameplay is completed
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' intention of using cigarettes, e-cigarettes, and flavored tobacco. For questions assessing participants' intention of using tobacco products, response options range from definitely not to definitely yes (4 choices).
Changes in social norms
Time frame: Baseline
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
Changes in social norms
Time frame: Immediately after gameplay is completed
Participants will complete a pre-survey through a secured, data collection website (LimeSurvey Data Collection Software), immediately before playing the videogame intervention. Survey questions, adapted from the National Youth and Tobacco Use Survey (FDA, 2018), will assess participants' social norms surrounding the use of cigarettes, ecigarettes, and flavored tobacco. Questions assessing the number of friends/peers who use tobacco products will range from 0 to 4 (including an "I don't know" option). Questions, such as "How would your best friends act toward you if you smoked cigarettes," have response options ranging from very unfriendly to very friendly (4 choices).
1 secondary outcome
Gameplay satisfaction: post-test survey
Time frame: immediately after game play is completed
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 22 Apr 2022.
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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 Fiellin, MD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smokeSCREEN web-based game in people with Smoking Cessation and Smoking, run by Yale University at 1 site 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 1 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in beliefs (time frame: baseline). The study lists 8 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 22 Apr 2022.