Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-31 @ 11:58 AM
Study NCT ID:
NCT04192318
Status:
TERMINATED
Last Update Posted:
2022-03-25
First Post:
2019-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-20', 'size': 248016, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-09T16:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Due to COVID, enrollment and data collection was shut down. Project was funded by training grant which ended before COVID restrictions were sufficiently lifted to resume enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in youth violence - self report', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report aggression'}, {'measure': 'Change in youth violence - caregiver report', 'timeFrame': 'Baseline to 6 months', 'description': 'Caregiver-report of youth aggression'}, {'measure': 'Change in youth dating violence', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report physical and psychological dating aggression'}, {'measure': 'Change in youth sexual violence', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report sexual aggression'}], 'secondaryOutcomes': [{'measure': 'Re-injury rate', 'timeFrame': '6 months', 'description': 'Hospital records of number of youth participants who experienced another injury due to violence between the intervention and 6-month follow-up'}, {'measure': 'Community resources', 'timeFrame': '6 months', 'description': 'Self-report: Number of community resources youth are engaging in'}, {'measure': 'Lost to follow-up rates', 'timeFrame': '6 months', 'description': 'Study report: The number of youth who we are unable to complete the follow-up assessment for because they are unreachable or decline to continue participation.'}, {'measure': 'Change in trauma symptoms', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report trauma symptoms'}, {'measure': 'Change in substance use', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report of substance use'}, {'measure': 'Change in alcohol use', 'timeFrame': 'Baseline to 6 months', 'description': 'Self-report of alcohol use'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence in Adolescence']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.', 'detailedDescription': "This study will test if youth who receive the Bridging the Gap (BTG) and Communities that Care (CTC Plus) will see greater improvements than youth who either receive BTG only, CTC Plus only or no intervention. This study will allow researchers to learn more about the intervention's effectiveness for a range of violent outcomes. It will also help researchers understand if violence prevention efforts affect other behaviors, such as drug use and rates of violent re-injury.\n\nParticipants will be asked to complete surveys about their behavior, personality, and experiences, and their parent/child's personality, behavior, and experiences. These surveys take about 45-60 minutes to complete. These questionnaires will be completed before the intervention has taken place and then again 6 months later. Participation in this study will last up to 6 months. Approximately 408 individuals will participate in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Violently injured youth receiving treatment at VCU\n2. Aged between 12 and 21 years old\n3. Living in Richmond City\n\n1\\. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Ages \\<12 and \\>21 years\n3. Prisoners are excluded'}, 'identificationModule': {'nctId': 'NCT04192318', 'briefTitle': 'Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative', 'orgStudyIdInfo': {'id': 'HM20017786'}, 'secondaryIdInfos': [{'id': '1K01CE003160-01', 'link': 'https://reporter.nih.gov/quickSearch/1K01CE003160-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospital-based violence prevention with community initiative', 'description': 'Youth who are living in communities that receive Communities that Care Prevention System (CTC) will also receive Bridging the Gap (BTG), a hospital-based violence prevention program with 6-months of community case management.', 'interventionNames': ['Behavioral: Bridging the Gap', 'Other: Communities that Care (CTC)']}, {'type': 'EXPERIMENTAL', 'label': 'Hybrid hospital based violence prevention', 'description': 'Youth who do not live in a community that has CTC but will receive BTG.', 'interventionNames': ['Behavioral: Bridging the Gap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Youth living in a community without the CTC program and will receive treatment as usual (TAU) in the hospital.', 'interventionNames': ['Other: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment as usual with community initiative', 'description': 'Youth living in a community with the CTC program and will receive treatment as usual (TAU) in the hospital.', 'interventionNames': ['Other: Communities that Care (CTC)', 'Other: Treatment as usual']}], 'interventions': [{'name': 'Bridging the Gap', 'type': 'BEHAVIORAL', 'description': 'Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy.', 'armGroupLabels': ['Hospital-based violence prevention with community initiative', 'Hybrid hospital based violence prevention']}, {'name': 'Communities that Care (CTC)', 'type': 'OTHER', 'description': "In CTC programs stakeholders elect evidence-based prevention strategies that are most appropriate for their community. These evidence-based strategies target their community's specific needs, such as reducing risk factors while supporting and increasing protective factors.", 'armGroupLabels': ['Hospital-based violence prevention with community initiative', 'Treatment as usual with community initiative']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Treat and release', 'armGroupLabels': ['Treatment as usual', 'Treatment as usual with community initiative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Nicholas Thomson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be made available after the main study findings have been published and up to five years after study completion.', 'ipdSharing': 'YES', 'description': 'Anonymized data will be available for sharing.', 'accessCriteria': "Data are available for sharing with researchers requesting data from the Principal Investigator. Interested investigators will be required to complete a Data Use Agreement Form which outlines the specific data being requested and a summary of the research question(s). Distribution of data and associated documentation will be subject to review by the research team (PI and study team). The Data Use Agreement provides a commitment to: a) use the data only for research purposes, and not to identify any individual participant, b) secure the data using appropriate security measures and computer technology, and c) destroy and/or return the data after analyses are completed. The interested investigators shall provide the data analytic plan and study aims for the PI and study team's approval."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}