Supported Employment Demonstration (SED)

The purpose of this study is to determine whether offering an evidence-based package of employment supports integrated with mental health services has a positive impact on employment and clinical recovery, and delays or diminishes the need for disability benefits.

Study Overview

• Status: Completed
• Conditions: Mental Impairment
• Intervention / Treatment: Behavioral: Full Service; Behavioral: Basic Service

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: Interventional
• Enrollment (Actual): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Lancaster, California, United States, 93535
      • Penny Lane Centers
  • Colorado
    • Denver, Colorado, United States, 80204
      • Mental Health Center of Denver
  • Florida
    • Saint Petersburg, Florida, United States, 33713
      • Boley Centers
  • Illinois
    • Chicago, Illinois, United States, 60623
      • Trilogy
    • Chicago, Illinois, United States, 60626
      • Trilogy
    • Galesburg, Illinois, United States, 61401
      • Bridgeway
    • Kewanee, Illinois, United States, 61443
      • Bridgeway
    • Loves Park, Illinois, United States, 61111
      • Bridgeway
    • Macomb, Illinois, United States, 61455
      • Bridgeway
    • Normal, Illinois, United States, 61761
      • Bridgeway
    • Pekin, Illinois, United States, 61554
      • Bridgeway
  • Kansas
    • Wichita, Kansas, United States, 67208
      • Mental Health Association of South Central Kansas
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Communicare
    • Brandenburg, Kentucky, United States, 40108
      • Communicare
    • Elizabethtown, Kentucky, United States, 42701
      • Communicare
    • Hardinsburg, Kentucky, United States, 40143
      • Communicare
    • Hodgenville, Kentucky, United States, 42748
      • Communicare
    • Lebanon, Kentucky, United States, 40033
      • Communicare
    • Leitchfield, Kentucky, United States, 42754
      • Communicare
    • Radcliff, Kentucky, United States, 40160
      • Communicare
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Cornerstone Montgomery
    • Hollywood, Maryland, United States, 20636
      • Pathways
    • Rockville, Maryland, United States, 20850
      • Cornerstone Montgomery
    • Silver Spring, Maryland, United States, 20902
      • Cornerstone Montgomery
    • Upper Marlboro, Maryland, United States, 20775
      • Pathways
    • Waldorf, Maryland, United States, 20601
      • Pathways
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Vinfen
  • Minnesota
    • Minneapolis, Minnesota, United States, 55418
      • RISE
  • New York
    • Bay Shore, New York, United States, 11706
      • Family Service League The Olsten Family Center
    • East Hampton, New York, United States, 11937
      • Family Service League The Olsten Family Center
    • Huntington, New York, United States, 11743
      • Family Service League The Olsten Family Center
    • Mastic, New York, United States, 11950
      • Family Service League The Olsten Family Center
    • Mattituck, New York, United States, 11952
      • Family Service League The Olsten Family Center
  • Ohio
    • Cincinnati, Ohio, United States, 45205
      • Greater Cincinnati Behavioral Health Services
    • Cincinnati, Ohio, United States, 45206
      • Greater Cincinnati Behavioral Health Services
    • Cincinnati, Ohio, United States, 45237
      • Greater Cincinnati Behavioral Health Services
    • Lorain, Ohio, United States, 44055
      • The Nord Center
    • Sheffield, Ohio, United States, 44035
      • The Nord Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74114
      • Mental Health Association Oklahoma
    • Tulsa, Oklahoma, United States, 74119
      • Mental Health Association Oklahoma
  • Oregon
    • Milwaukie, Oregon, United States, 97267
      • Cascadia
    • Portland, Oregon, United States, 97206
      • Cascadia
    • Portland, Oregon, United States, 97212
      • Cascadia
    • Portland, Oregon, United States, 97220
      • Cascadia
  • South Carolina
    • Anderson, South Carolina, United States, 29625
      • Anderson-Oconee-Pickens Mental Health Center
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Frontier Health
    • Greeneville, Tennessee, United States, 37743
      • Frontier Health
    • Johnson City, Tennessee, United States, 37601
      • Frontier Health
    • Kingsport, Tennessee, United States, 37660
      • Frontier Health
    • Knoxville, Tennessee, United States, 37917
      • Helen Ross McNabb Center
  • Washington
    • Everett, Washington, United States, 98204
      • Sunrise Services
    • Mount Vernon, Washington, United States, 98273
      • Sunrise Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

3

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).	Behavioral: Full Service; 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.	Behavioral: Basic Service; Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Employment (Competitive)	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	The reported total number of hours worked for pay during the 36-month study period. Assessed via quarterly computer-assisted telephone interviews.	36 months
Days to First Job	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	The number of months employed during the 36-month study period. Assessed via quarterly computer-assisted telephone interviews.	36 months
Job Tenure	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
Total Earnings	Total amount of reported earnings over the 36-month study period. Assessed via quarterly computer-assisted telephone interviews.	36 months
Months above SGA	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)	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
Time Until Award	The number of study days to disability award. Assessed using Social Security Administration administrative data.	36 months

Collaborators and Investigators

• Sponsor: Westat
• Collaborators: United States Social Security Administration
• Investigators: Principal Investigator: William Frey, Ph.D., Westat; Principal Investigator: Robert Drake, MD, Ph.D., Westat

Publications and helpful links

General Publications

• Taylor JA, Salkever DS, Frey WD, Riley J, Marrow J. Enrollment in the Supported Employment Demonstration: An Employment Intervention for Denied Disability Benefits Applicants with a Mental Impairment. Adm Policy Ment Health. 2022 Nov;49(6):909-926. doi: 10.1007/s10488-021-01159-x. Epub 2021 Aug 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2017
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

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)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No