Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 4:28 AM
Study NCT ID:
NCT00164268
Status:
COMPLETED
Last Update Posted:
2007-09-10
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ke Ala Lokahi Demonstration Project for Sexual and Domestic Violence Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-06', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subsequent incidents of intimate partner or sexual violence for up to 2 years post-intervention'}], 'secondaryOutcomes': [{'measure': 'Attitudes, behaviors, and cultural identity assessed at 3-months, 6-months, and 15-months following treatment initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intimate partner violence', 'Sexual violence', 'Cultural intervention', 'Native Hawaiian'], 'conditions': ['Domestic Violence']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.', 'detailedDescription': 'Turning Point for Families in Hilo, Hawaii is developing, implementing, and evaluating a culturally-based intervention using Native Hawaiian values, beliefs, and practices to address intimate partner and sexual violence among Native Hawaiian perpetrators and victims/survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women self-identified as Native Hawaiian referred for agency services due to intimate partner or sexual violence\n\nExclusion Criteria:\n\n* See above. No other exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00164268', 'briefTitle': 'Ke Ala Lokahi Demonstration Project for Sexual and Domestic Violence Prevention', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Ke Ala Lokahi Demonstration Project for the Early Intervention and Prevention of Sexual and Domestic Violence Among Racial and Ethnic Populations', 'orgStudyIdInfo': {'id': 'CDC-NCIPC-11249'}, 'secondaryIdInfos': [{'id': 'US4/CCU919035-02'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ke Ala Lokahi (Native Hawaiian cultural intervention)', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '96721', 'city': 'Hilo', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Turning Point for Families', 'geoPoint': {'lat': 19.72991, 'lon': -155.09073}}], 'overallOfficials': [{'name': 'Linda Slutter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turning Point for Families'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}}}}