Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT06394193
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Va Meh Du Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-24', 'size': 203068, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-27T09:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The 20 anticipated coach participants, 10 will be assigned to the intervention and 10 will be assigned to the comparison group; assignment will occur based on availability.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological well-being', 'timeFrame': 'Month 6', 'description': 'Flourishing Scale (FS-8). FS-8 is an eight-item validated survey measuring psychological well-being by addressing different aspects of positive mental health (e.g. I lead a purposeful and meaningful life). Participants indicate their disagreement or agreement with each statement on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Scores range from 8 to 56, with higher scores indicating better levels of psychological well-being.'}], 'secondaryOutcomes': [{'measure': 'Coach retention rate', 'timeFrame': 'Month 6', 'description': 'count and percentage for coach retention'}, {'measure': 'Player retention rate', 'timeFrame': 'Month 6', 'description': 'count and percentage for player retention'}, {'measure': 'Coach completion rate', 'timeFrame': 'Month 6', 'description': 'count and percentage for coach participants, including participation in coach training and in soccer practice sessions'}, {'measure': 'Player completion rate', 'timeFrame': 'Month 6', 'description': 'player count and percentage for player participants, including participation in in soccer practice sessions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'Karenni', 'community support'], 'conditions': ['Mental Health Wellness']}, 'descriptionModule': {'briefSummary': 'This study is a conceptually integrated community-based participatory research study that includes the design and evaluation of an intervention to promote mental wellness and physical activity for Karenni children and young adults.', 'detailedDescription': 'This study is a non-randomized equivalent design of an implementation and evaluation of an intervention to promote mental health and wellness among Karenni young adults and children by engaging in evidence-based mental health practices, relationship-building and physical activity through the team sport of soccer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men/male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identifies as Karenni\n* Speaks English or Karenni\n* Currently lives in Forsyth County\n* Male gender\n* Consents to participate\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06394193', 'briefTitle': 'Va Meh Du Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Va Meh Du: An Intervention to Promote Mental Wellness Among Karenni Young Adults and Children', 'orgStudyIdInfo': {'id': 'IRB00111733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community-based Participatory Research', 'description': 'Coaching a six-month soccer program with the Va Meh Du intervention', 'interventionNames': ['Behavioral: Community-based participatory research intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Soccer Coaching', 'description': 'Standard six month soccer program without the Va Meh Du Intervention.'}], 'interventions': [{'name': 'Community-based participatory research intervention', 'type': 'BEHAVIORAL', 'description': 'Two training sessions (roughly two hours each) to train them in the intervention structure and curriculum', 'armGroupLabels': ['Community-based Participatory Research']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Stephanie Daniel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Ana Sucaldito, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}