- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875467
Evaluation of Prototype for Simulation for Environmental Exposure Education (SE3) (SE3)
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
Study Overview
Status
Intervention / Treatment
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 youth ages 11-13 who are currently 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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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California
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San Jose, California, United States, 95128
- Monroe Middle School
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Scotts Valley, California, United States, 95066
- Virtual Study
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age not within middle school range.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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A prototype online game designed to increase environmental health literacy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Environmental Health Knowledge Score
Time Frame: Day 1 to Day 5
|
Based on a scale created for this study the Environmental Health 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 40 with a higher score indicating greater knowledge.
|
Day 1 to Day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Environmental Health Mitigation Knowledge Score
Time Frame: Day 1 to Day 5
|
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 5
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Environmental Health Literacy Score
Time Frame: Day 1 to Day 5
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Based on a scale created for this study the Environmental Health Literacy Score is comprised of a series of questions about comfort and willingness to share information about pollution.
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 5
|
Science Interest and Confidence Score
Time Frame: Day 1 to Day 5
|
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 5 to 25, with higher scores indicating more science interest and confidence.
|
Day 1 to Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamara Kuhn, MA, dfusion Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R43ES024563
- 1R43ES034563-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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