Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
Study NCT ID:
NCT03629366
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-07-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supported Employment for Refugees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016832', 'term': 'Employment, Supported'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D004651', 'term': 'Employment'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012050', 'term': 'Rehabilitation, Vocational'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Competitive employment (register data and log books)', 'timeFrame': '12 months', 'description': 'Competitive employment will be assessed using register data from the State Register of Employers and Employees. Analyses will be carried out using both intention-to-treat and per protocol analyses. For per protocol analyses, log books from the service providers in the intervention group will be used.'}], 'secondaryOutcomes': [{'measure': 'Acculturation (survey data)', 'timeFrame': '12 months', 'description': 'Acculturation will be assessed using the Vancouver Index of Acculturation (VIA)'}, {'measure': 'Psychological distress (survey data)', 'timeFrame': '12 months', 'description': 'Psychological distress will be assessed using the Hopkins Symptom Checklist-25 (HSCL-25)'}, {'measure': 'Posttraumatic stress (survey data)', 'timeFrame': '12 months', 'description': 'Posttraumatic stress will be assessed using the PTSD Checklist for DSM-5 (PCL-5)'}, {'measure': 'Global well-being (survey data)', 'timeFrame': '12 months', 'description': 'Global well-being will be assessed using a 10-point Cantril Ladder Scale'}, {'measure': 'Health-related quality of life (survey data)', 'timeFrame': '12 months', 'description': 'Health-related quality of life will be assessed using the Euro-Qol Visual Analog Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refugees', 'Supported Employment', 'Individual Placement and Support', 'Employment', 'Vocational Rehabilitation', 'Mental Health'], 'conditions': ['Refugees']}, 'descriptionModule': {'briefSummary': 'Humanitarian crises related to the Syrian conflict have led to a large increase in refugees in Europe in the recent years. There is need for effective approaches to increase labor market participation among refugees, and to reduce the impact of unfavorable exclusion mechanisms among this group. The Supported Employment for Refugees (the SER-trial) is a randomized controlled trial investigating the effectiveness of Supported Employment (SE) for newly arrived refugees who are involved in the mandatory introduction program provided for all refugees in Norway. SE is an intervention that has proved effective in promoting competitive employment among patients with severe mental illness in over twenty international randomized controlled trials, and is currently being evaluated for various new patient groups in ongoing trials. The SER-trial is however the first trial to evaluate the effect of SE for the target group of refugees (who may or may not have mental illness).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refugees in the city of Bergen, Norway\n* Expressed desire to work\n* Able to have a simple conversation in Norwegian or English\n\nExclusion Criteria:\n\n* No expressed desire to work\n* Unable to have a simple conversation in Norwegian or English'}, 'identificationModule': {'nctId': 'NCT03629366', 'acronym': 'SER', 'briefTitle': 'Supported Employment for Refugees', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'Supported Employment for Refugees', 'orgStudyIdInfo': {'id': '811270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supported Employment (SE)', 'description': 'Follow-up with Supported Employment (SE), provided by a job specialist trained in the eight evidence-based principles of Individual Placement and Support (IPS). The SE intervention is provided in addition to the mandatory introduction program for refugees in Norway (treatment as usual).', 'interventionNames': ['Behavioral: Supported Employment (SE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual (TAU)', 'description': 'Follow-up with treatment as usual, which involves participation in the mandatory introduction program provided for all refugees in Norway. The program includes training in Norwegian language and culture, as well as the various traditional employment schemes offered by the Norwegian labor and welfare Administration.', 'interventionNames': ['Behavioral: Treatment as usual (TAU)']}], 'interventions': [{'name': 'Supported Employment (SE)', 'type': 'BEHAVIORAL', 'description': 'Supported Employment', 'armGroupLabels': ['Supported Employment (SE)']}, {'name': 'Treatment as usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual', 'armGroupLabels': ['Treatment as usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Bergen', 'country': 'Norway', 'facility': 'NORCE Norwegian Research Centre', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Vigdis Sveinsdottir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NORCE Norwegian Research Centre'}, {'name': 'Tonje Fyhn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NORCE Norwegian Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Labour and Welfare Administration', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}