Supported Employment Demonstration

Mental Impairment Clinical Trial

— SED  

Official title:

Supported Employment Demonstration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682263
• Other study ID #: SS00-16-60014
• Status: Completed
• Phase: N/A
• Start date: December 2, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Westat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Anderson-Oconee-Pickens Mental Health Center	Anderson	South Carolina
United States	Communicare	Bardstown	Kentucky
United States	Family Service League The Olsten Family Center	Bay Shore	New York
United States	Cornerstone Montgomery	Bethesda	Maryland
United States	Vinfen	Boston	Massachusetts
United States	Communicare	Brandenburg	Kentucky
United States	Frontier Health	Bristol	Tennessee
United States	Trilogy	Chicago	Illinois
United States	Trilogy	Chicago	Illinois
United States	Greater Cincinnati Behavioral Health Services	Cincinnati	Ohio
United States	Greater Cincinnati Behavioral Health Services	Cincinnati	Ohio
United States	Greater Cincinnati Behavioral Health Services	Cincinnati	Ohio
United States	Mental Health Center of Denver	Denver	Colorado
United States	Family Service League The Olsten Family Center	East Hampton	New York
United States	Communicare	Elizabethtown	Kentucky
United States	Sunrise Services	Everett	Washington
United States	Bridgeway	Galesburg	Illinois
United States	Frontier Health	Greeneville	Tennessee
United States	Communicare	Hardinsburg	Kentucky
United States	Communicare	Hodgenville	Kentucky
United States	Pathways	Hollywood	Maryland
United States	Family Service League The Olsten Family Center	Huntington	New York
United States	Frontier Health	Johnson City	Tennessee
United States	Bridgeway	Kewanee	Illinois
United States	Frontier Health	Kingsport	Tennessee
United States	Helen Ross McNabb Center	Knoxville	Tennessee
United States	Penny Lane Centers	Lancaster	California
United States	Communicare	Lebanon	Kentucky
United States	Communicare	Leitchfield	Kentucky
United States	The Nord Center	Lorain	Ohio
United States	Bridgeway	Loves Park	Illinois
United States	Bridgeway	Macomb	Illinois
United States	Family Service League The Olsten Family Center	Mastic	New York
United States	Family Service League The Olsten Family Center	Mattituck	New York
United States	Cascadia	Milwaukie	Oregon
United States	RISE	Minneapolis	Minnesota
United States	Sunrise Services	Mount Vernon	Washington
United States	Bridgeway	Normal	Illinois
United States	Bridgeway	Pekin	Illinois
United States	Cascadia	Portland	Oregon
United States	Cascadia	Portland	Oregon
United States	Cascadia	Portland	Oregon
United States	Communicare	Radcliff	Kentucky
United States	Cornerstone Montgomery	Rockville	Maryland
United States	Boley Centers	Saint Petersburg	Florida
United States	The Nord Center	Sheffield	Ohio
United States	Cornerstone Montgomery	Silver Spring	Maryland
United States	Mental Health Association Oklahoma	Tulsa	Oklahoma
United States	Mental Health Association Oklahoma	Tulsa	Oklahoma
United States	Pathways	Upper Marlboro	Maryland
United States	Pathways	Waldorf	Maryland
United States	Mental Health Association of South Central Kansas	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Westat	United States Social Security Administration

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Months Employed	The number of months employed during the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.	36 months
Secondary	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
Secondary	Total Earnings	Total amount of reported earnings over the 36-month study period.; Assessed via quarterly computer-assisted telephone interviews.	36 months
Secondary	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
Secondary	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
Secondary	Time Until Award	The number of study days to disability award.; Assessed using Social Security Administration administrative data.	36 months