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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43ES034563-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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:
Participants will be asked to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SE3 Game | Other | A prototype online game designed to increase environmental health literacy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Kuhn, MA | dfusion Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Middle School | San Jose | California | 95128 | United States | ||
| Virtual Study |
The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.
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This was a single arm study so participants were not assigned to a group. No recruited participants were excluded prior to participation.
Recruitment took place during an approximately one-month period. Participants were recruited in one middle-school classroom (two classes) in San Jose, CA. Additional participants for across the country were recruited through referrals from teachers and other education advisors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm, Intervention With SE3 Game | 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. SE3 Game: A prototype online game designed to increase environmental health literacy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm, Intervention With SE3 Game | 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. SE3 Game: A prototype online game designed to increase environmental health literacy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 7 |
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From initial recruitment to post test was a 30 day period. Data were collected during this period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm, Intervention With SE3 Game | 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. SE3 Game: A prototype online game designed to increase environmental health literacy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | dfusion Inc | 8312225103 | tamara.kuhn@dfusioninc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2024 | Dec 20, 2024 | Prot_SAP_000.pdf |
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| 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. | 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. | Day 1 to Day 7 |
| Scotts Valley |
| California |
| 95066 |
| United States |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 7 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 7 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 1 to Day 7 |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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