Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-27 @ 7:37 AM
Study NCT ID:
NCT00527358
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2007-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of SAFER Latinos' Program to Prevent Youth Violence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2007-09-06', 'studyFirstSubmitQcDate': '2007-09-06', 'lastUpdatePostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Youth violence', 'timeFrame': 'within the next 2 years after intervention started'}], 'secondaryOutcomes': [{'measure': 'family cohesion', 'timeFrame': 'within the next 2 years after start of intervention'}, {'measure': 'school bonding', 'timeFrame': 'within the next 2 years after start of intervention'}, {'measure': 'exposure to antisocial, substance abusing, or violent peers', 'timeFrame': 'within the next 2 years after start of intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['violence'], 'conditions': ['Violence']}, 'descriptionModule': {'briefSummary': 'This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.', 'detailedDescription': 'To prevent youth involvement in violence, outreach workers will work with families and youth to improve school bonding, family cohesion and awareness and utilization of existing services; and a youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.\n\nFollowing implementation of the intervention, we will collect detailed process data (regarding implementation), and evaluate impact/outcome using a quasi-experimental design with baseline (prior to intervention) and two followup data collections in both the intervention and a control community (Culmore, Virginia), measuring change in a selected set of aggregate community variables that represent mediating factors and outcomes for youth violence in Langley Park. Data will be collected via a survey and focus groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* youth 12-24 and their caregiver\n\nExclusion Criteria:\n\n* residence outside of Langley Park or Culmore'}, 'identificationModule': {'nctId': 'NCT00527358', 'briefTitle': "Evaluation of SAFER Latinos' Program to Prevent Youth Violence", 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': "Evaluation of SAFER Latinos' Program to Prevent Youth Violence", 'orgStudyIdInfo': {'id': 'CDC-NCIPC-4924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAFER', 'description': 'The intervention community will receive 4 services:\n\n1. community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;\n2. youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, and provide education about avoiding violence;\n3. school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;\n4. Youth drop-in center: will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.', 'interventionNames': ['Behavioral: SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Business as usual.'}], 'interventions': [{'name': 'SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)', 'type': 'BEHAVIORAL', 'description': '1. community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;\n2. youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence;\n3. school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;\n4. Youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.', 'armGroupLabels': ['SAFER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Mark Edberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joanne Klevens', 'class': 'FED'}, 'collaborators': [{'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'Latin American Youth Center', 'class': 'UNKNOWN'}, {'name': 'Latino Federation of Greater Washington', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'epidemiologist', 'investigatorFullName': 'Joanne Klevens', 'investigatorAffiliation': 'Centers for Disease Control and Prevention'}}}}