Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:35 AM
Study NCT ID:
NCT07305467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase I will include focus groups youth interviews (n=30) and a youth advisory board (n=15)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grounded theory of firearm related change', 'timeFrame': 'Fifteen, 60-minute meetings (Baseline to the completion of the document)', 'description': 'A document that outlines the description of the attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage), designed by the Youth Participatory Action Research (YPAR) Advisory Board during their fifteen, 60-min meetings.'}, {'measure': 'SAFE Futures content', 'timeFrame': 'After the development of the document and through the end of the focus group development of the Intervention manual', 'description': 'Intervention manual developed by the focus group interactions with the interviewees'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Firearm injury prevention', 'community based programs', 'youth advisory board'], 'conditions': ['Prevention']}, 'descriptionModule': {'briefSummary': 'Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.', 'detailedDescription': 'This study will utilize youth participatory action research (YPAR) to co-develop the SAFE Futures intervention. The SAFE Futures Intervention is a grounded theory of firearm-related behavior change, and it has developed the SAFE Futures single-session intervention through focus groups and youth participatory action research.\n\nThe study is designed to determine whether adding SAFE Futures to the Emerging Leaders program reduces risk factors associated with intentional firearm violence and suicide among high-risk youth. An advisory board of N=15 high-risk youth will be recruited, and data from focus groups will be analyzed using grounded theory methodology to examine attitudes, norms, personal agency, and contextual influences that promote or deter youth from engaging in risky and safe firearm behaviors (e.g., gun carrying, safe storage). The youth advisory board will use the resulting theory to develop SAFE Futures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth aged approximately 13-17 years.\n* Identified as at elevated risk for firearm-related injury (e.g., history of violent injury, referred by violence prevention programs).\n* Able to provide assent (and parental/guardian consent if under 18).\n* Sufficient proficiency in English to complete study procedures.\n\nExclusion Criteria:\n\n* Significant cognitive impairment or developmental disability that would preclude comprehension of the intervention content or study procedures.\n* Current psychiatric or medical instability requiring immediate treatment or hospitalization. - Non-English speaking (due to limited resources for translation of study measures and intervention materials in this pilot).'}, 'identificationModule': {'nctId': 'NCT07305467', 'briefTitle': 'Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)', 'orgStudyIdInfo': {'id': 'HM300000392 Phase 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interviewees', 'description': 'Interviews with youth (30 participants) to identify relevant firearm-specific risk and protective factors that will be used to develop the theory and intervention in collaboration with an advisory board of 15 youth. (Members of the YPAR are eligible to participate in both arms).', 'interventionNames': ['Other: Semi-structured focus groups']}, {'type': 'OTHER', 'label': 'Youth Participatory Action Research (YPAR) Advisory Board', 'description': 'The advisory board of 15 youth. The advisory board will assist in developing the focus group protocol for Phase 1 qualitative data collection. (Members of the YPAR are eligible to participate in both arms).', 'interventionNames': ['Other: Establish an advisory board of high-risk youth', 'Other: Feedback and advice sessions', 'Other: Youth advisory board training', 'Other: Semi-structured focus groups']}], 'interventions': [{'name': 'Establish an advisory board of high-risk youth', 'type': 'OTHER', 'description': 'Fifteen high-risk youth will be recruited to establish an advisory board', 'armGroupLabels': ['Youth Participatory Action Research (YPAR) Advisory Board']}, {'name': 'Feedback and advice sessions', 'type': 'OTHER', 'description': 'The youth advisory board will provide feedback and advice on the research questions, methodology, and interpretation of data through approximately fifteen, 60-minute meetings', 'armGroupLabels': ['Youth Participatory Action Research (YPAR) Advisory Board']}, {'name': 'Youth advisory board training', 'type': 'OTHER', 'description': 'Youth will be trained in the social-ecological model and health behavior change theories, to better conceptualize the link between theory and intervention content, and to participate in the research process more actively.', 'armGroupLabels': ['Youth Participatory Action Research (YPAR) Advisory Board']}, {'name': 'Semi-structured focus groups', 'type': 'OTHER', 'description': 'Will participate in a semi-structured focus group protocol developed in collaboration with the youth advisory board while incorporating knowledge from the empirical literature and health behavior change theories.', 'armGroupLabels': ['Interviewees', 'Youth Participatory Action Research (YPAR) Advisory Board']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': "Kelly O'Connor", 'role': 'CONTACT'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': "Kelly O'Connor", 'role': 'CONTACT', 'email': 'kelly.oconnor@vcuhealth.org', 'phone': '804-628-6294'}], 'overallOfficials': [{'name': "Kelly O'Connor", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}