- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682263
Supported Employment Demonstration (SED)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SSA contracted with Westat to implement and evaluate the Supported Employment Demonstration (SED). The SED provides integrated mental health and vocational services to people with mental illness who were recently denied Social Security disability benefits. The evaluation will determine the impact of the SED on employment, clinical recovery, and receipt of disability payments. The evaluation is using a randomized controlled trial design to compare the outcomes of two treatment groups and a control group. In the full-service arm (n = 1,000), participants receive services from an Individual Placement and Support employment specialist, a care manager, and a nurse care coordinator (NCC) who provides medication management support, as well as modest funding for out-of-pocket prescriptions, essential work-related expenses, and other services in the participant's treatment plan. The basic-service arm (n=1,000), which is expected to cost about 50 percent less than the full-service arm, provides all services and funds except the NCC. Participants in the usual services (control) group (n = 1,000) seek services as they normally would but receive a comprehensive guide to local, state, and national resources.
Data collection includes computer-assisted baseline (in-person) and blinded quarterly (telephone) interviews with participants, collection of SSA administrative and site-level program data, site visits (including fidelity assessments), qualitative interviews with site administrators and service providers, focus groups with study participants, and person-centered ethnographic interviews with participants and nonparticipants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Lancaster, California, United States, 93535
- Penny Lane Centers
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Colorado
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Denver, Colorado, United States, 80204
- Mental Health Center of Denver
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Florida
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Saint Petersburg, Florida, United States, 33713
- Boley Centers
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Illinois
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Chicago, Illinois, United States, 60623
- Trilogy
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Chicago, Illinois, United States, 60626
- Trilogy
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Galesburg, Illinois, United States, 61401
- Bridgeway
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Kewanee, Illinois, United States, 61443
- Bridgeway
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Loves Park, Illinois, United States, 61111
- Bridgeway
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Macomb, Illinois, United States, 61455
- Bridgeway
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Normal, Illinois, United States, 61761
- Bridgeway
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Pekin, Illinois, United States, 61554
- Bridgeway
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Kansas
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Wichita, Kansas, United States, 67208
- Mental Health Association of South Central Kansas
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Kentucky
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Bardstown, Kentucky, United States, 40004
- Communicare
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Brandenburg, Kentucky, United States, 40108
- Communicare
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Elizabethtown, Kentucky, United States, 42701
- Communicare
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Hardinsburg, Kentucky, United States, 40143
- Communicare
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Hodgenville, Kentucky, United States, 42748
- Communicare
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Lebanon, Kentucky, United States, 40033
- Communicare
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Leitchfield, Kentucky, United States, 42754
- Communicare
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Radcliff, Kentucky, United States, 40160
- Communicare
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Maryland
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Bethesda, Maryland, United States, 20814
- Cornerstone Montgomery
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Hollywood, Maryland, United States, 20636
- Pathways
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Rockville, Maryland, United States, 20850
- Cornerstone Montgomery
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Silver Spring, Maryland, United States, 20902
- Cornerstone Montgomery
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Upper Marlboro, Maryland, United States, 20775
- Pathways
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Waldorf, Maryland, United States, 20601
- Pathways
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Vinfen
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Minnesota
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Minneapolis, Minnesota, United States, 55418
- RISE
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New York
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Bay Shore, New York, United States, 11706
- Family Service League The Olsten Family Center
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East Hampton, New York, United States, 11937
- Family Service League The Olsten Family Center
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Huntington, New York, United States, 11743
- Family Service League The Olsten Family Center
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Mastic, New York, United States, 11950
- Family Service League The Olsten Family Center
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Mattituck, New York, United States, 11952
- Family Service League The Olsten Family Center
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Ohio
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Cincinnati, Ohio, United States, 45205
- Greater Cincinnati Behavioral Health Services
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Cincinnati, Ohio, United States, 45206
- Greater Cincinnati Behavioral Health Services
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Cincinnati, Ohio, United States, 45237
- Greater Cincinnati Behavioral Health Services
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Lorain, Ohio, United States, 44055
- The Nord Center
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Sheffield, Ohio, United States, 44035
- The Nord Center
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Oklahoma
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Tulsa, Oklahoma, United States, 74114
- Mental Health Association Oklahoma
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Tulsa, Oklahoma, United States, 74119
- Mental Health Association Oklahoma
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Oregon
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Milwaukie, Oregon, United States, 97267
- Cascadia
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Portland, Oregon, United States, 97206
- Cascadia
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Portland, Oregon, United States, 97212
- Cascadia
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Portland, Oregon, United States, 97220
- Cascadia
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South Carolina
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Anderson, South Carolina, United States, 29625
- Anderson-Oconee-Pickens Mental Health Center
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Tennessee
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Bristol, Tennessee, United States, 37620
- Frontier Health
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Greeneville, Tennessee, United States, 37743
- Frontier Health
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Johnson City, Tennessee, United States, 37601
- Frontier Health
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Kingsport, Tennessee, United States, 37660
- Frontier Health
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Knoxville, Tennessee, United States, 37917
- Helen Ross McNabb Center
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Washington
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Everett, Washington, United States, 98204
- Sunrise Services
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Mount Vernon, Washington, United States, 98273
- Sunrise Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals denied Social Security disability benefits (SSDI or SSI)
- Individuals alleging a mental impairment
- Live in Community Mental Health Agency (CMHA) catchment area
- Legally competent
- Express desire to improve work situation
Exclusion Criteria:
- Intellectual disability
- Reside in a nursing home or custodial institution
- Already receiving supported employment services from CMHA site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full Service Treatment
The Full Service Arm receives the Individual Placement and Support (IPS) model of employment services integrated with behavioral health services and care management services, as well as Medication Management Support (MMS) from a Nurse Care Coordinator (NCC).
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Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, care management services, and Medication Management Support provided by a Nurse Care Coordinator (NCC).
|
Experimental: Basic Service Treatment
The Basic Service Arm receives the Individual Placement and Support (IPS) model of employment services integrated with behavioral health services and care management services.
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Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.
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No Intervention: Usual Services
Members of the Usual Service group seek services as they normally would (or would not) in their community.
At the time of randomization, each Usual Services group member receives a comprehensive manual describing mental health and employment services in their local community, as well as state and national resources.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment
Time Frame: 36 months
|
Whether participant is employed in a paying job at any time during the 36 month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment (Competitive)
Time Frame: 36 months
|
Whether a participant is employed in a community job that pays at least minimum wage (as defined by the resident state) and is "owned" by the employer rather than a mental health center or rehabilitation agency at any time during the 36 month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
|
Total Hours Worked
Time Frame: 36 months
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The reported total number of hours worked for pay during the 36-month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
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Days to First Job
Time Frame: 36 months
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The number of days from enrollment date to first job during the 36-month study period, for those not employed at enrollment. Assessed via quarterly computer-assisted telephone interviews. |
36 months
|
Months Employed
Time Frame: 36 months
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The number of months employed during the 36-month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
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Job Tenure
Time Frame: 36 months
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The longest number of consecutive months employed for any single job during the 36-month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
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Total Earnings
Time Frame: 36 months
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Total amount of reported earnings over the 36-month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
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Months above SGA
Time Frame: 36 months
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The number of months the participant reported earnings above Substantial Gainful Activity (SGA) levels over the 36-month study period. Assessed via quarterly computer-assisted telephone interviews. |
36 months
|
Short-Form 12 Health Survey (SF-12) Mental Component Score (MCS)
Time Frame: 36 months
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The difference between the Short-Form 12 Health Survey (SF-12) Mental Component Score (MCS) measured at baseline (Baseline Survey) and at study exit (final quarterly follow-up survey). Higher values of the SF-12 MCS indicate better outcomes. A higher SF-12 MCS at study exit than at baseline indicates a positive change. Assessed via computer-assisted telephone interviews. |
36 months
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Time Until Award
Time Frame: 36 months
|
The number of study days to disability award. Assessed using Social Security Administration administrative data. |
36 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William Frey, Ph.D., Westat
- Principal Investigator: Robert Drake, MD, Ph.D., Westat
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SS00-16-60014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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