UnemploymentSEEDNCT02375074
Supported Employment and Preventing Early Disability
A study testing Supported Employment and Traditional Vocational Rehabilitation in people with Unemployment, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Unemployment
- What is being tested?
- Supported Employment and Traditional Vocational Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- May 2014to Jul 2018
- 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 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Not in employment or education
- Receiving temporary benefits
- Intended for the VR service "traineeships in sheltered businesses"
Who cannot join
- Not expressing interest in getting help to obtain competitive work
- Insufficient language skills to answer questionnaires in Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Unemployment
- Being tested
- Supported Employment, Traditional Vocational Rehabilitation
- Keywords
- Supported Employment, Vocational Rehabilitation, Youth, Sick leave, Disability, Coping, Work, Occupational, Labor market participation, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported EmploymentBehavioural
Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.
Traditional Vocational RehabilitationBehavioural
Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
| Study group | Role | What they receive |
|---|---|---|
| Supported Employment | Experimental | Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training. Receives: Behavioral: Supported Employment |
| Traditional Vocational Rehabilitation | Experimental | Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment. Receives: Behavioral: Traditional Vocational Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any competitive employment (yes/no)
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.
Measured: 12 months
Secondary outcomes (5)
Physical and mental health
Survey data (anxiety, depression, disability, fatigue, subjective health complaints, quality of life)
Measured: 12 months
Coping
Survey data
Measured: 12 months
Illness perceptions
Survey data
Measured: 12 months
Alcohol and drug abuse
Survey data
Measured: 12 months
Cost effectiveness
Cost/benefit analysis
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 posted2 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UnemploymentStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Silje Endresen Reme, PhD, Principal investigator, NORCE Norwegian Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375074
- Sponsor's protocol ID
- 227002/H20
- Acronym
- SEED
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2014
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31170299Sveinsdottir 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.
PubMed 30326872Sveinsdottir 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.
PubMed 27422271
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Employment and Preventing Early Disability (SEED)
- ClinicalTrials.gov ID
- NCT02375074
- Acronym / sponsor ID
- SEED / 227002/H20
- Conditions
- Unemployment
- Keywords
- Supported Employment, Vocational Rehabilitation, Youth, Sick leave, Disability, Coping, Work, Occupational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- May 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Mar 2015 (estimated)
- 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.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Employment | Experimental | Behavioral: Supported EmploymentSupported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training. |
| Traditional Vocational Rehabilitation | Experimental | Behavioral: Traditional Vocational RehabilitationTraditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Not in employment or education
- Receiving temporary benefits
- Intended for the VR service "traineeships in sheltered businesses"
Key exclusion criteria (2 listed)
- Not expressing interest in getting help to obtain competitive work
- Insufficient language skills to answer questionnaires in Norwegian
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 EmploymentSupported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training. | Behavioural | Supported Employment |
| Traditional Vocational RehabilitationTraditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment | Behavioural | Traditional Vocational Rehabilitation |
Primary outcome
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.
5 secondary outcomes
Physical and mental health
Time frame: 12 months
Coping
Time frame: 12 months
Illness perceptions
Time frame: 12 months
Alcohol and drug abuse
Time frame: 12 months
Cost effectiveness
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 17 Sep 2020.
- Results publication: PubMed 31170299Sveinsdottir 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.
- Derived from this study: PubMed 30326872Sveinsdottir 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.
- Derived from this study: PubMed 27422271Sveinsdottir 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.
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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.
Silje Endresen Reme, PhD 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 and Traditional Vocational Rehabilitation in people with Unemployment, 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 17 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?
Any competitive employment (yes/no) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375074, which also lists 3 linked publications.
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 17 Sep 2020.