- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629366
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Keywords
Other Study ID Numbers
- 811270
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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