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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02375074
Other study ID # 227002/H20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date July 2018

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

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 29 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway NORCE Norwegian Research Centre Bergen

Sponsors (2)

Lead Sponsor Collaborator
NORCE Norwegian Research Centre AS The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary Physical and mental health Survey data (anxiety, depression, disability, fatigue, subjective health complaints, quality of life) 12 months
Secondary Coping Survey data 12 months
Secondary Illness perceptions Survey data 12 months
Secondary Alcohol and drug abuse Survey data 12 months
Secondary Cost effectiveness Cost/benefit analysis 12 months
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