- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273530
Integrated Supported Employment in Mainland China
September 5, 2017 updated by: TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
Integrated Supported Employment for People With Schizophrenia in Mainland China: A Randomized Controlled Trial
In this randomized controlled trial, the researchers investigated the effectiveness of integrated supported employment (ISE) as compared with individual placement and support (IPS) and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland China.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n = 54), IPS (n = 54), and or TVR (n = 54).
Blinded assessments of employment status, job tenure, and psychological outcomes were conducted at admission, completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 years or older;
- Diagnosis of schizophrenia for at least 2 years
- Being unemployed
- Willing to give informed consent
- Having no obvious cognitive, learning, or neurological impairment
- Having completed primary school education
- Having a desire to work
Exclusion Criteria:
• Having score lower than 18 on the 30-item Mini-Mental State Examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Integrated Supported Employment
Individual placement support intervention plus work-related social skills training
|
vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
|
|
NO_INTERVENTION: Individualised Placement Support
Individual placement support intervention with pre-vocational training followed by placing individual participants to the job according to their preference and abilities
|
|
|
NO_INTERVENTION: Traditional Vocational Rehabilitation
general pre-vocational training and placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Employment rate
Time Frame: 4 months
|
employment status, employed or unemployed
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Job tenure, duration
Time Frame: completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
|
how long the job lasts
|
completion of the 3-mo program, and follow-up at 7, 11, and 15 mo.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hector WH Tsang, PhD, HKPolyu
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2013
Primary Completion (ACTUAL)
August 15, 2015
Study Completion (ACTUAL)
December 20, 2015
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (ACTUAL)
September 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 6, 2017
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not yet decided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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