Supported Employment for Refugees (SER)

September 15, 2020 updated by: NORCE Norwegian Research Centre AS
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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway, 5020
        • NORCE Norwegian Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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).
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.
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acculturation (survey data)
Time Frame: 12 months
Acculturation will be assessed using the Vancouver Index of Acculturation (VIA)
12 months
Psychological distress (survey data)
Time Frame: 12 months
Psychological distress will be assessed using the Hopkins Symptom Checklist-25 (HSCL-25)
12 months
Posttraumatic stress (survey data)
Time Frame: 12 months
Posttraumatic stress will be assessed using the PTSD Checklist for DSM-5 (PCL-5)
12 months
Global well-being (survey data)
Time Frame: 12 months
Global well-being will be assessed using a 10-point Cantril Ladder Scale
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vigdis Sveinsdottir, PhD, NORCE Norwegian Research Centre
  • Principal Investigator: Tonje Fyhn, NORCE Norwegian Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

May 30, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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