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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03629366
Other study ID # 811270
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date May 30, 2020

Study information

Verified date September 2020
Source NORCE Norwegian Research Centre AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date May 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Supported Employment (SE)
Supported Employment
Treatment as usual (TAU)
Treatment as usual

Locations

Country Name City State
Norway NORCE Norwegian Research Centre Bergen

Sponsors (2)

Lead Sponsor Collaborator
NORCE Norwegian Research Centre AS Norwegian Labour and Welfare Administration

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary Acculturation (survey data) Acculturation will be assessed using the Vancouver Index of Acculturation (VIA) 12 months
Secondary Psychological distress (survey data) Psychological distress will be assessed using the Hopkins Symptom Checklist-25 (HSCL-25) 12 months
Secondary Posttraumatic stress (survey data) Posttraumatic stress will be assessed using the PTSD Checklist for DSM-5 (PCL-5) 12 months
Secondary Global well-being (survey data) Global well-being will be assessed using a 10-point Cantril Ladder Scale 12 months
Secondary Health-related quality of life (survey data) Health-related quality of life will be assessed using the Euro-Qol Visual Analog Scale 12 months
See also
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Completed NCT04069559 - Migrant Health Promotion Program for University Students N/A
Completed NCT01427829 - Computer-assisted Psychosocial Risk Assessment (CaPRA) for Refugee Health and Settlement N/A
Completed NCT03528239 - The Use of Hospital and Emergency Department of Refugee Patients