Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05875467
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2023-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Prototype for Simulation for Environmental Exposure Education (SE3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tamara.kuhn@dfusioninc.com', 'phone': '8312225103', 'title': 'Chief Executive Officer', 'organization': 'dfusion Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From initial recruitment to post test was a 30 day period. Data were collected during this period.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Environmental Health Indoor Air Pollution Knowledge Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '4.67', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.042', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 7', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Environmental Health Mitigation Knowledge Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'spread': '1.75', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.928', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 7', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Environmental Health Interest Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'classes': [{'categories': [{'measurements': [{'value': '.932', 'spread': '2.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.022', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 7', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Science Interest and Confidence Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '3.57', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 7', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'This was a single arm study so participants were not assigned to a group. No recruited participants were excluded prior to participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm, Intervention With SE3 Game', 'description': '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.\n\nSE3 Game: A prototype online game designed to increase environmental health literacy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '15'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Non binary', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-20', 'size': 95192, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-20T15:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2023-05-16', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-06', 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Environmental Health Indoor Air Pollution Knowledge Score', 'timeFrame': 'Day 1 to Day 7', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Environmental Health Mitigation Knowledge Score', 'timeFrame': 'Day 1 to Day 7', 'description': '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.'}, {'measure': 'Change in Environmental Health Interest Score', 'timeFrame': 'Day 1 to Day 7', 'description': '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.'}, {'measure': 'Change in Science Interest and Confidence Score', 'timeFrame': 'Day 1 to Day 7', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['environmental health', 'game', 'air quality', 'STEM', 'health literacy'], 'conditions': ['Effect of Game in Increasing Environmental Health Literacy']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does playing the game increase knowledge about environmental health?\n* Does playing the game improve environmental health literacy?\n* Does playing the game increase interest and confidence in science?\n\nParticipants will be asked to:\n\n* Take a survey at the beginning of the study\n* Play the game for a minimum of 50 minutes\n* Take a survey at the end of the study', 'detailedDescription': '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.\n\nParticipants 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).\n\nInvestigators 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In middle school.\n* Ability to use a mobile tablet.\n* Have access to wifi in location of intervention implementation.\n* Reside in the geographic areas of implementation: California, Michigan, Florida\n\nExclusion Criteria:\n\n* Age not within middle school range.'}, 'identificationModule': {'nctId': 'NCT05875467', 'acronym': 'SE3', 'briefTitle': 'Evaluation of Prototype for Simulation for Environmental Exposure Education (SE3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'dfusion Inc'}, 'officialTitle': 'Evaluation of Prototype Game for Simulation for Environmental Exposure Education', 'orgStudyIdInfo': {'id': 'R43ES024563'}, 'secondaryIdInfos': [{'id': '1R43ES034563-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43ES034563-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm, Intervention with SE3 Game', 'description': '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.', 'interventionNames': ['Other: SE3 Game']}], 'interventions': [{'name': 'SE3 Game', 'type': 'OTHER', 'description': 'A prototype online game designed to increase environmental health literacy', 'armGroupLabels': ['Single Arm, Intervention with SE3 Game']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Monroe Middle School', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95066', 'city': 'Scotts Valley', 'state': 'California', 'country': 'United States', 'facility': 'Virtual Study', 'geoPoint': {'lat': 37.05106, 'lon': -122.01468}}], 'overallOfficials': [{'name': 'Tamara Kuhn, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dfusion Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dfusion Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}