- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375074
Supported Employment and Preventing Early Disability (SEED)
Supported Employment and Preventing Early Disability (SEED)
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:
- Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5008
- NORCE Norwegian Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supported Employment
Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.
|
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.
|
Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical and mental health
Time Frame: 12 months
|
Survey data (anxiety, depression, disability, fatigue, subjective health complaints, quality of life)
|
12 months
|
Coping
Time Frame: 12 months
|
Survey data
|
12 months
|
Illness perceptions
Time Frame: 12 months
|
Survey data
|
12 months
|
Alcohol and drug abuse
Time Frame: 12 months
|
Survey data
|
12 months
|
Cost effectiveness
Time Frame: 12 months
|
Cost/benefit analysis
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Silje Endresen Reme, PhD, NORCE Norwegian Research Centre
Publications and helpful links
General Publications
- Sveinsdottir V, Lie SA, Bond GR, Eriksen HR, Tveito TH, Grasdal AL, Reme SE. Individual placement and support for young adults at risk of early work disability (the SEED trial). A randomized controlled trial. Scand J Work Environ Health. 2020 Jan 1;46(1):50-59. doi: 10.5271/sjweh.3837. Epub 2019 Jun 6.
- Sveinsdottir V, Eriksen HR, Baste V, Hetland J, Reme SE. Young adults at risk of early work disability: who are they? BMC Public Health. 2018 Oct 16;18(1):1176. doi: 10.1186/s12889-018-6095-0.
- Sveinsdottir V, Tveito TH, Bond GR, Grasdal AL, Lie SA, Reme SE. Protocol for the SEED-trial: Supported Employment and preventing Early Disability. BMC Public Health. 2016 Jul 15;16:579. doi: 10.1186/s12889-016-3280-x.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 227002/H20
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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