Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supported Employment and Preventing Early Disability (SEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375074
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The share of young workers falling into early work disability is an increasingly important problem in Norway. Early withdrawal or exclusion from the labor market leads to large individual and societal costs. The SEED-trial is a randomized controlled trial aiming to provide evidence-based knowledge about different approaches to prevent permanent disability and increase labor market participation in this important and vulnerable group. The trial includes young adults aged 18-30 years who are at risk of early work disability, and the participants will be randomly assigned to 1 of 2 interventions, both aimed at facilitating participation in working life:

  1. Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
  2. Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training

Both interventions are currently provided by The Norwegian Labor and Welfare Administration (NAV). Supported Employment was introduced recently and is currently being implemented, while traditional vocational rehabilitation with sheltered employment has been around for years. However, no Norwegian controlled studies have been conducted on these practices in this population. The current study will therefore provide new knowledge of the effect of traditional as well as new and promising interventions to increase labor market participation and prevent early disability.


Condition or disease Intervention/treatment Phase
Unemployment Behavioral: Supported Employment Behavioral: Traditional Vocational Rehabilitation Not Applicable

Detailed Description:
A detailed study protocol was published in BMC Public Health in 2016, and is openly available in fulltext at: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3280-x
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Supported Employment and Preventing Early Disability (SEED)
Study Start Date : May 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Supported Employment
Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.
 Behavioral: Supported Employment
Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.
Experimental: Traditional Vocational Rehabilitation
Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment.
 Behavioral: Traditional Vocational Rehabilitation
Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Any competitive employment (yes/no) [ Time Frame: 12 months ]
    Several sources of information for competitive employment will be used: Survey data for hours worked and success in employment, and register data for receipt of social security benefits, income, financial assistance, and educational activity.


Secondary Outcome Measures :
  1. Physical and mental health [ Time Frame: 12 months ]
    Survey data (anxiety, depression, disability, fatigue, subjective health complaints, quality of life)

  2. Coping [ Time Frame: 12 months ]
    Survey data

  3. Illness perceptions [ Time Frame: 12 months ]
    Survey data

  4. Alcohol and drug abuse [ Time Frame: 12 months ]
    Survey data

  5. Cost effectiveness [ Time Frame: 12 months ]
    Cost/benefit analysis


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Not in employment or education
  • Receiving temporary benefits
  • Intended for the VR service "traineeships in sheltered businesses"

Exclusion criteria:

  • Not expressing interest in getting help to obtain competitive work
  • Insufficient language skills to answer questionnaires in Norwegian
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375074


Locations
Layout table for location information
Norway
NORCE Norwegian Research Centre
Bergen, Norway, 5008
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
The Research Council of Norway
Investigators
Layout table for investigator information
Principal Investigator: Silje Endresen Reme, PhD NORCE Norwegian Research Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT02375074    
Other Study ID Numbers: 227002/H20
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Keywords provided by NORCE Norwegian Research Centre AS:
Supported Employment
Vocational Rehabilitation
Youth
Sick leave
Disability
 Coping
Work
Occupational
Labor market participation
Randomized Controlled Trial