Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT05858593
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2023-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positive Youth Development in the Metaverse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will be masked to which study condition they are assigned to.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-regulation', 'timeFrame': 'One-time assessment post-treatment (at 8 weeks)', 'description': 'Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true)'}, {'measure': 'Mental well-being', 'timeFrame': 'One-time assessment post-treatment (at 8 weeks)', 'description': 'Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)'}], 'secondaryOutcomes': [{'measure': 'Engagement', 'timeFrame': '8 weeks', 'description': 'Number of hours of programming delivered for both in-person and VR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'positive youth development', 'afterschool program'], 'conditions': ['Healthy', 'Healthy Lifestyle', 'Childhood ALL', 'Behavior, Child']}, 'descriptionModule': {'briefSummary': "This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings.", 'detailedDescription': "This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. It will also empower youth to engage with the afterschool program at their own pace by providing a safe space to learn and practice their socioemotional skills. Implemented at scale, these benefits of a VR-integrated afterschool program will be able to address the issues of health inequity head on by expanding access to high quality afterschool content without incurring high operating costs. The results from this pilot study will provide a critical foundation to apply for an extramurally funded clinical trial to demonstrate the efficacy of a VR-integrated afterschool program on youth mental wellbeing.\n\nAim 1: Determine feasibility of a VR-integrated afterschool program where youth can access the VR content on their own at home.\n\nAim 2: Test the hypothesis that complementing the in-person afterschool program with VR will increase a) engagement and b) socioemotional competencies in youth.\n\nAim 3: Test the hypothesis that youth will demonstrate better mental wellbeing when the in-person afterschool program is complemented with VR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children enrolled in the Chess \\& Community program\n* Between the ages of 9-17\n* The parent/primary caregiver of these children\n\nExclusion Criteria:\n\n* Children who are unable to wear a VR headset will not be recruited'}, 'identificationModule': {'nctId': 'NCT05858593', 'briefTitle': 'Positive Youth Development in the Metaverse', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth', 'orgStudyIdInfo': {'id': '00006669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.', 'interventionNames': ['Behavioral: Virtual reality curriculum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.', 'interventionNames': ['Behavioral: No Virtual reality curriculum']}], 'interventions': [{'name': 'Virtual reality curriculum', 'type': 'BEHAVIORAL', 'description': 'Rather than rely on mere exposure to devices, participants in the treatment group will receive a curriculum that integrates the devices into traditional content delivered through the after school program.', 'armGroupLabels': ['Treatment']}, {'name': 'No Virtual reality curriculum', 'type': 'BEHAVIORAL', 'description': 'Children will be able to use the same devices but will not have access to a curriculum that integrates the devices with traditional content delivered through the after school program.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Athens Chess & Community', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified data used in published analyses will be made available upon request to other researchers with a verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications. Intellectual property rights to all software applications and hardware products will be maintained by the University of Georgia.', 'accessCriteria': 'Verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sun Joo (Grace) Ahn, PHD', 'investigatorAffiliation': 'University of Georgia'}}}}