SmokingNCT03722888
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)
A study testing smokeSCREEN video game in people with Smoking, run by Yale University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- smokeSCREEN video game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2017to 28 Sep 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Does not fit the inclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hamden Youth Center
Hamden, Connecticut, 06517
Leadership, Education, and Athletics Partnership (LEAP) Inc.
New Haven, Connecticut, 06511
Farnam Neighborhood House
New Haven, Connecticut, 06513
About this study
Official title: Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.
Read the detailed 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.
- Conditions
- Smoking
- Being tested
- smokeSCREEN video 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 video gameDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: smokeSCREEN video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: immediately after game play is completed
Secondary outcomes (1)
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).
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 posted29 Oct 2018
- Study start25 Oct 2017
- Primary completion23 Apr 2018
- Study completion28 Sep 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
- Model description
- single group study with pre-post design
- 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 Fiellin, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722888
- Sponsor's protocol ID
- 140103293_IV
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 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
- NCT03722888
- Acronym / sponsor ID
- 140103293_IV
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 29 Oct 2018 (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.
The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group study with pre-post design
| Arm | Type | Receives |
|---|---|---|
| adolescents who have previously smoked | Experimental | Device: smokeSCREEN video 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, behaviors around smoking, and collaborating with youth programs to pilot test how the game can be implemented in real world settings. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
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 video gamesmokeSCREEN 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. | Device | adolescents who have previously smoked |
Primary outcome
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - 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.
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - 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.
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - 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).
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' knowledge involving tobacco product use - 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), 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).
1 secondary outcome
To collect data on participants' gameplay experience and satisfaction.
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 29 Oct 2018.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smokeSCREEN video game in people with Smoking, run by Yale University at 3 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 3 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 29 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 3 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?
To determine the impact of a web-based prevention videogame intervention prototype, smokeSCREEN, on participants' beliefs involving tobacco product use - pre test survey. (time frame: baseline). The study lists 4 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 29 Oct 2018.