Effect of Game in Increasing Environmental Health LiteracyEarly Phase 1SE3NCT05875467
Evaluation of Prototype for Simulation for Environmental Exposure Education (SE3)
A Early Phase 1 study testing SE3 Game in people with Effect of Game in Increasing Environmental Health Literacy, run by dfusion Inc at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test a prototype of a new educational game about environmental health literacy with middle school age youth. The main questions it aims to answer are: Does playing the game increase knowledge about environmental health? Does playing the game improve environmental health literacy?… Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Game in Increasing Environmental Health Literacy
- What is being tested?
- SE3 Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2023to 3 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In middle school.
- Ability to use a mobile tablet.
- Have access to wifi in location of intervention implementation.
- Reside in the geographic areas of implementation: California, Michigan, Florida
Who cannot join
- Age not within middle school range.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Monroe Middle School
San Jose, California, 95128
Virtual Study
Scotts Valley, California, 95066
About this study
Official title: Evaluation of Prototype Game for Simulation for Environmental Exposure Education
The goal of this clinical trial is to test a prototype of a new educational game about environmental health literacy with middle school age youth. The main questions it aims to answer are:
- Does playing the game increase knowledge about environmental health?
- Does playing the game improve environmental health literacy?
- Does playing the game increase interest and confidence in science?
Participants will be asked to:
- Take a survey at the beginning of the study
- Play the game for a minimum of 50 minutes
- Take a survey at the end of the study
Read the detailed description
The proposed project will establish the technical merit and feasibility of producing and using a serious game to improve environmental health literacy among young people. A small evaluation is being conducted to assess the impact of the prototype game on environmental health knowledge, literacy, ability to understand mitigation, and impact on science interest and confidence.
Participants will be middle school youth, typically ages 11-15, who are currently enrolled in middle school. Participants are being recruited by the projects education advisor (CA) and youth community board members (MI).
Investigators will conduct an evaluation with 45 middle school age participants from communities disproportionately impacted by environmental risk. The goal is to test the usability and playability of the prototype and assess the games impact on outcomes. The participant will complete a short online pre-test assessment (environmental health knowledge), participate in either a 50 play session or a week long play period logging a minimum of 50 minutes. At the end of the play period the participant will complete a short post-test with similar questions to the pre-test plus additional questions about their usage, satisfaction with, and enjoyment of the game. During independent game use, the app will collect metrics on usage, player performance, and conditional knowledge including the ability to apply concepts in context. Participants will each receive a $100 gift card.
- Being tested
- SE3 Game
- Keywords
- environmental health, game, air quality, STEM, health literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SE3 GameOther
A prototype online game designed to increase environmental health literacy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, Intervention with SE3 Game | Experimental | This is a single arm study. This arm will receive the intervention. This intervention is a prototype of online game, about 50 minutes in duration. The online game provides gameplay that allows the user, with a gameplay narrative, to identify and remove sources of environmental hazards in the home environment. Participants play the prototype game for about 50 minutes at which time the intervention is complete. Receives: Other: SE3 Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Environmental Health Indoor Air Pollution Knowledge Score
Based on a scale created for this study the Environmental Health Indoor Air Pollution Knowledge Score is comprised of a series of questions about indoor environmental pollution. The scores from the question are summed to create a total score. The scale ranges from 0 to 17 with a higher score indicating greater knowledge.
Measured: Day 1 to Day 7
Secondary outcomes (3)
Change in Environmental Health Mitigation Knowledge Score
Based on a scale created for this study the Environmental Mitigation Knowledge Score is comprised of a series of questions about what can mitigate indoor air pollution. The scores from the questions are summed to create a total score. The score range is 0 to 14 with higher scores indicating greater knowledge.
Measured: Day 1 to Day 7
Change in Environmental Health Interest Score
Based on a scale created for this study the Environmental Health Interest Score is comprised of a series of questions to assess interest. The scores from the question are summed to create a total score. The score range is 4 to 24 with higher scores indicating greater environmental health literacy.
Measured: Day 1 to Day 7
Change in Science Interest and Confidence Score
Based on a scale created for the Science Interest and Confidence Score is comprised of a series of questions about interest in science and perceived skill in science. The scores from the question are summed to create a total score. The score range is 1 to 5, with higher scores indicating more science interest and confidence.
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start30 May 2023
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Effect of Game in Increasing Environmental Health LiteracyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- dfusion Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Tamara Kuhn, MA, Principal investigator, dfusion Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875467
- Sponsor's protocol ID
- R43ES024563
- Other IDs
- 1R43ES034563-01
- Acronym
- SE3
- Status last verified
- Mar 2025
- First submitted
- 16 May 2023
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prototype Game for Simulation for Environmental Exposure Education
- ClinicalTrials.gov ID
- NCT05875467
- Acronym / sponsor ID
- SE3 / R43ES024563
- Keywords
- environmental health, game, air quality, STEM, health literacy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- dfusion IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Posted 12 Mar 2025
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 clinical trial is to test a prototype of a new educational game about environmental health literacy with middle school age youth. The main questions it aims to answer are:
- Does playing the game increase knowledge about environmental health?
- Does playing the game improve environmental health literacy?
- Does playing the game increase interest and confidence in science?
Participants will be asked to:
- Take a survey at the beginning of the study
- Play the game for a minimum of 50 minutes
- Take a survey at the end of the study
Detailed description
The proposed project will establish the technical merit and feasibility of producing and using a serious game to improve environmental health literacy among young people. A small evaluation is being conducted to assess the impact of the prototype game on environmental health knowledge, literacy, ability to understand mitigation, and impact on science interest and confidence.
Participants will be middle school youth, typically ages 11-15, who are currently enrolled in middle school. Participants are being recruited by the projects education advisor (CA) and youth community board members (MI).
Investigators will conduct an evaluation with 45 middle school age participants from communities disproportionately impacted by environmental risk. The goal is to test the usability and playability of the prototype and assess the games impact on outcomes. The participant will complete a short online pre-test assessment (environmental health knowledge), participate in either a 50 play session or a week long play period logging a minimum of 50 minutes. At the end of the play period the participant will complete a short post-test with similar questions to the pre-test plus additional questions about their usage, satisfaction with, and enjoyment of the game. During independent game use, the app will collect metrics on usage, player performance, and conditional knowledge including the ability to apply concepts in context. Participants will each receive a $100 gift card.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, Intervention with SE3 Game | Experimental | Other: SE3 GameThis is a single arm study. This arm will receive the intervention. This intervention is a prototype of online game, about 50 minutes in duration. The online game provides gameplay that allows the user, with a gameplay narrative, to identify and remove sources of environmental hazards in the home environment. Participants play the prototype game for about 50 minutes at which time the intervention is complete. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- In middle school.
- Ability to use a mobile tablet.
- Have access to wifi in location of intervention implementation.
- Reside in the geographic areas of implementation: California, Michigan, Florida
Key exclusion criteria (1 listed)
- Age not within middle school range.
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 |
|---|---|---|
| SE3 GameA prototype online game designed to increase environmental health literacy | Other | Single Arm, Intervention with SE3 Game |
Primary outcome
Change in Environmental Health Indoor Air Pollution Knowledge Score
Time frame: Day 1 to Day 7
Based on a scale created for this study the Environmental Health Indoor Air Pollution Knowledge Score is comprised of a series of questions about indoor environmental pollution. The scores from the question are summed to create a total score. The scale ranges from 0 to 17 with a higher score indicating greater knowledge.
3 secondary outcomes
Change in Environmental Health Mitigation Knowledge Score
Time frame: Day 1 to Day 7
Change in Environmental Health Interest Score
Time frame: Day 1 to Day 7
Change in Science Interest and Confidence Score
Time frame: Day 1 to Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.
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.
Tamara Kuhn, MA principal investigator
dfusion Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SE3 Game in people with Effect of Game in Increasing Environmental Health Literacy, run by dfusion Inc at 2 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 4 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Environmental Health Indoor Air Pollution Knowledge Score (time frame: Day 1 to Day 7). 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 12 Mar 2025.