Supported Employment Demonstration

Not Applicable

Completed

• Conditions: Mental Impairment

• Registration Number: NCT03682263
• Lead Sponsor: Westat

Brief Summary

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.

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 Timeline

• Study Start: 2017-12-02
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Employment	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.

Secondary Outcome Measures

Name	Time	Method
Employment (Competitive)	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.
Short-Form 12 Health Survey (SF-12) Mental Component Score (MCS)	36 months	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.
Job Tenure	36 months	The longest number of consecutive months employed for any single job during the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.
Time Until Award	36 months	The number of study days to disability award.; Assessed using Social Security Administration administrative data.
Months Employed	36 months	The number of months employed during the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.
Months above SGA	36 months	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.
Total Hours Worked	36 months	The reported total number of hours worked for pay during the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.
Days to First Job	36 months	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.
Total Earnings	36 months	Total amount of reported earnings over the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.

Trial Locations

Locations (20)

Penny Lane Centers; 🇺🇸 Lancaster, California, United States

Mental Health Center of Denver; 🇺🇸 Denver, Colorado, United States

Boley Centers; 🇺🇸 Saint Petersburg, Florida, United States

Trilogy; 🇺🇸 Chicago, Illinois, United States

Bridgeway; 🇺🇸 Pekin, Illinois, United States

Mental Health Association of South Central Kansas; 🇺🇸 Wichita, Kansas, United States

Communicare; 🇺🇸 Radcliff, Kentucky, United States

Cornerstone Montgomery; 🇺🇸 Silver Spring, Maryland, United States

Pathways; 🇺🇸 Waldorf, Maryland, United States

Vinfen; 🇺🇸 Boston, Massachusetts, United States

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