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Supported Employment for Refugees (SER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629366
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Refugees Behavioral: Supported Employment (SE) Behavioral: Treatment as usual (TAU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Supported Employment for Refugees
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: Supported Employment (SE)
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).
Behavioral: Supported Employment (SE)
Supported Employment

Active Comparator: Treatment as usual (TAU)
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.
Behavioral: Treatment as usual (TAU)
Treatment as usual




Primary Outcome Measures :
  1. Competitive employment (register data and log books) [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Acculturation (survey data) [ Time Frame: 12 months ]
    Acculturation will be assessed using the Vancouver Index of Acculturation (VIA)

  2. Psychological distress (survey data) [ Time Frame: 12 months ]
    Psychological distress will be assessed using the Hopkins Symptom Checklist-25 (HSCL-25)

  3. Posttraumatic stress (survey data) [ Time Frame: 12 months ]
    Posttraumatic stress will be assessed using the PTSD Checklist for DSM-5 (PCL-5)

  4. Global well-being (survey data) [ Time Frame: 12 months ]
    Global well-being will be assessed using a 10-point Cantril Ladder Scale

  5. Health-related quality of life (survey data) [ Time Frame: 12 months ]
    Health-related quality of life will be assessed using the Euro-Qol Visual Analog Scale



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Refugees in the city of Bergen, Norway
  • Expressed desire to work
  • Able to have a simple conversation in Norwegian or English

Exclusion Criteria:

  • No expressed desire to work
  • Unable to have a simple conversation in Norwegian or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629366


Locations
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Norway
Uni Research
Bergen, Norway, 5020
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
Norwegian Labour and Welfare Administration
Investigators
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Principal Investigator: Vigdis Sveinsdottir NORCE Norwegian Research Centre AS
Principal Investigator: Tonje Fyhn NORCE Norwegian Research Centre AS

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Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT03629366     History of Changes
Other Study ID Numbers: 811270
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NORCE Norwegian Research Centre AS:
Refugees
Supported Employment
Individual Placement and Support
Employment
Vocational Rehabilitation
Mental Health