RefugeesSERNCT03629366
Supported Employment for Refugees
A study testing Supported Employment (SE) and Treatment as usual (TAU) in people with Refugees, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refugees
- What is being tested?
- Supported Employment (SE) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2017to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Refugees in the city of Bergen, Norway
- Expressed desire to work
- Able to have a simple conversation in Norwegian or English
Who cannot join
- No expressed desire to work
- Unable to have a simple conversation in Norwegian or English
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Refugees
- Being tested
- Supported Employment (SE), Treatment as usual (TAU)
- Keywords
- Refugees, Supported Employment, Individual Placement and Support, Employment, Vocational Rehabilitation, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported Employment (SE)Behavioural
Supported Employment
Treatment as usual (TAU)Behavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Supported Employment (SE) | Experimental | 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). Receives: Behavioral: Supported Employment (SE) |
| Treatment as usual (TAU) | Active comparator | 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. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competitive employment (register data and log books)
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.
Measured: 12 months
Secondary outcomes (5)
Acculturation (survey data)
Acculturation will be assessed using the Vancouver Index of Acculturation (VIA)
Measured: 12 months
Psychological distress (survey data)
Psychological distress will be assessed using the Hopkins Symptom Checklist-25 (HSCL-25)
Measured: 12 months
Posttraumatic stress (survey data)
Posttraumatic stress will be assessed using the PTSD Checklist for DSM-5 (PCL-5)
Measured: 12 months
Global well-being (survey data)
Global well-being will be assessed using a 10-point Cantril Ladder Scale
Measured: 12 months
Health-related quality of life (survey data)
Health-related quality of life will be assessed using the Euro-Qol Visual Analog Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 May 2017
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RefugeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Vigdis Sveinsdottir, PhD, Principal investigator, NORCE Norwegian Research CentreTonje Fyhn, Principal investigator, NORCE Norwegian Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629366
- Sponsor's protocol ID
- 811270
- Acronym
- SER
- Status last verified
- Sep 2020
- First submitted
- 9 Jul 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Employment for Refugees
- ClinicalTrials.gov ID
- NCT03629366
- Acronym / sponsor ID
- SER / 811270
- Conditions
- Refugees
- Keywords
- Refugees, Supported Employment, Individual Placement and Support, Employment, Vocational Rehabilitation, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Employment (SE) | Experimental | Behavioral: 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). |
| Treatment as usual (TAU) | Active comparator | Behavioral: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Refugees in the city of Bergen, Norway
- Expressed desire to work
- Able to have a simple conversation in Norwegian or English
Key exclusion criteria (2 listed)
- No expressed desire to work
- Unable to have a simple conversation in Norwegian or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supported Employment (SE)Supported Employment | Behavioural | Supported Employment (SE) |
| Treatment as usual (TAU)Treatment as usual | Behavioural | Treatment as usual (TAU) |
Primary outcome
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.
5 secondary outcomes
Acculturation (survey data)
Time frame: 12 months
Psychological distress (survey data)
Time frame: 12 months
Posttraumatic stress (survey data)
Time frame: 12 months
Global well-being (survey data)
Time frame: 12 months
Health-related quality of life (survey data)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vigdis Sveinsdottir, PhD principal investigator
NORCE Norwegian Research Centre
Tonje Fyhn principal investigator
NORCE Norwegian Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported Employment (SE) and Treatment as usual (TAU) in people with Refugees, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Competitive employment (register data and log books) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.