Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT03288935
Status:
WITHDRAWN
Last Update Posted:
2024-10-15
First Post:
2017-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma Informed Care for Newly Resettled Refugees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "A substantial decrease in refugee arrivals in Virginia didn't allow the investigator to continue the study as planned.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in resettlement distress', 'timeFrame': 'Baseline to 6 months', 'description': 'Penn State Worry Questionnaire, which captures pervasiveness, excessiveness, and uncontrollability of worry. Scores range from 16 to 80 with higher values indicating more worry.'}], 'secondaryOutcomes': [{'measure': 'Change in emotional well-being', 'timeFrame': 'Baseline to 6 months', 'description': 'Refugee Health Screener-15, a 75 item screening tool with lower scores indicating better well-being'}, {'measure': 'Resettlement Outcomes', 'timeFrame': 'Baseline to 6 months', 'description': 'Post-Migration Living Difficulties, a self-assessment tool which measures adverse post -migration experiences in five different domains, included two related asylum-seeking factors. Scores range from 23 to 115 with higher values indicating more serious problems.'}, {'measure': 'Change in Social Adaptation', 'timeFrame': 'Baseline to 6 months', 'description': 'Social Adaptation Self-evaluation Scale. Scores range from 0 to 63 with higher values indicating better social adjustment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refugee', 'trauma-informed case management (TICM)', 'trauma-informed cultural orientation (TICO)', 'PTSD', 'depression', 'refugee resettlement'], 'conditions': ['Mental Stress', 'Emotional Stress']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate early-phase interventions for refugee wellness promotion and build evidence for dissemination of the intervention model and curricula through refugee resettlement programs, local and national.', 'detailedDescription': "This study will examine the main effects of trauma-informed case management (TICM) and trauma-informed cultural orientation (TICO) interventions, respectively, in reducing resettlement distress and increasing coping capacity, which will improve emotional wellness and social adaptation and thus resettlement outcomes. This project will also test the interaction effects of two-tiered intervention model, discerning effective and ineffective components of the intervention model. Differences in effects across intervention conditions may inform how improvement in what outcomes or which phase can affect refugees' wellness and adjustment over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refugee adults who arrive in Richmond or Charlottesville between January and February 2018\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03288935', 'briefTitle': 'Trauma Informed Care for Newly Resettled Refugees', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Trauma Informed Care for Refugee Newcomers in Virginia: A Factorial Design of Effectiveness-Implementation Hybrid Research', 'orgStudyIdInfo': {'id': 'HM20011389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (TICM only)', 'description': 'Assigned to TICM group after reception \\& placement.', 'interventionNames': ['Behavioral: TICM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (TICO only)', 'description': 'Assigned to TICO group after reception \\& placement.', 'interventionNames': ['Behavioral: TICO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 (TICM & TICO)', 'description': 'Assigned to both TICM and TICO group after reception \\& placement.', 'interventionNames': ['Behavioral: TICM', 'Behavioral: TICO']}, {'type': 'NO_INTERVENTION', 'label': 'Group 4 (None)', 'description': 'No additional intervention after reception \\& placement'}], 'interventions': [{'name': 'TICM', 'type': 'BEHAVIORAL', 'description': 'The TICM will be designed to include the seven domains of trauma-informed care articulated by SAMHSA (2014): 1) early screening and comprehensive assessment; 2) consumer driven care and services; 3) trauma-informed, responsive and educated workforce; 4) emerging and evidence-informed best practices; 5) safe and secure environments; 6) trauma-informed community partnerships; and 7) a performance monitoring system. The trained agency case managers and staff will provide the TICM to 50 newly resettled refugees during their regular R\\&P service period (i.e., 60 days).', 'armGroupLabels': ['Group 1 (TICM only)', 'Group 3 (TICM & TICO)']}, {'name': 'TICO', 'type': 'BEHAVIORAL', 'description': "The community-based TICO will be based on the Im's CHW that comprises 8 sessions (2 hour per session), co-facilitated by trained refugee peer mentors and community service providers. The TICO sessions will include interactive sessions on healthy eating, healthy body and healthy mind, acculturation \\& resettlement stress, understanding trauma and stress, healthy coping, helping others, and community building.", 'armGroupLabels': ['Group 2 (TICO only)', 'Group 3 (TICM & TICO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Hyojin Im, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth Univeristy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}