NCT03629366

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

July 9, 2018

Last Update Submit

September 15, 2020

Conditions

Keywords

RefugeesSupported EmploymentIndividual Placement and SupportEmploymentVocational RehabilitationMental Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Acculturation (survey data)

    12 months

  • Psychological distress (survey data)

    12 months

  • Posttraumatic stress (survey data)

    12 months

  • Global well-being (survey data)

    12 months

  • Health-related quality of life (survey data)

    12 months

Study Arms (2)

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).

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.

Behavioral: Treatment as usual (TAU)

Interventions

Supported Employment

Supported Employment (SE)

Treatment as usual

Treatment as usual (TAU)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NORCE Norwegian Research Centre

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Employment, SupportedTherapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

EmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vigdis Sveinsdottir, PhD

    NORCE Norwegian Research Centre

    PRINCIPAL INVESTIGATOR
  • Tonje Fyhn

    NORCE Norwegian Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 14, 2018

Study Start

May 1, 2017

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations