Clinical trial NCT03682263: Supported Employment Demonstration
Official title: Supported Employment Demonstration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Impairment
Lead sponsor: Westat
Sponsor class: OTHER
Collaborators: name: United States Social Security Administration
First posted: 2018-09-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Employment
timeFrame: 36 months
Secondary outcomes:
measure: Employment (Competitive)
timeFrame: 36 months
measure: Total Hours Worked
timeFrame: 36 months
measure: Days to First Job
timeFrame: 36 months
measure: Months Employed
timeFrame: 36 months
measure: Job Tenure
timeFrame: 36 months
measure: Total Earnings
timeFrame: 36 months
measure: Months above SGA
timeFrame: 36 months
measure: Short-Form 12 Health Survey (SF-12) Mental Component Score (MCS)
timeFrame: 36 months
measure: Time Until Award
timeFrame: 36 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Penny Lane Centers
state: California
city: Denver
country: United States
facility: Mental Health Center of Denver
state: Colorado
city: Saint Petersburg
country: United States
facility: Boley Centers
state: Florida
city: Chicago
country: United States
facility: Trilogy
state: Illinois
city: Chicago
country: United States
facility: Trilogy
state: Illinois
city: Galesburg
country: United States
facility: Bridgeway
state: Illinois
city: Kewanee
country: United States
facility: Bridgeway
state: Illinois
city: Loves Park
country: United States
facility: Bridgeway
state: Illinois
city: Macomb
country: United States
facility: Bridgeway
state: Illinois
city: Normal
country: United States
facility: Bridgeway
state: Illinois
city: Pekin
country: United States
facility: Bridgeway
state: Illinois
city: Wichita
country: United States
facility: Mental Health Association of South Central Kansas
state: Kansas
city: Bardstown
country: United States
facility: Communicare
state: Kentucky
city: Brandenburg
country: United States
facility: Communicare
state: Kentucky
city: Elizabethtown
country: United States
facility: Communicare
state: Kentucky
city: Hardinsburg
country: United States
facility: Communicare
state: Kentucky
city: Hodgenville
country: United States
facility: Communicare
state: Kentucky
city: Lebanon
country: United States
facility: Communicare
state: Kentucky
city: Leitchfield
country: United States
facility: Communicare
state: Kentucky
city: Radcliff
country: United States
facility: Communicare
state: Kentucky
city: Bethesda
country: United States
facility: Cornerstone Montgomery
state: Maryland
city: Hollywood
country: United States
facility: Pathways
state: Maryland
city: Rockville
country: United States
facility: Cornerstone Montgomery
state: Maryland
city: Silver Spring
country: United States
facility: Cornerstone Montgomery
state: Maryland
city: Upper Marlboro
country: United States
facility: Pathways
state: Maryland
city: Waldorf
country: United States
facility: Pathways
state: Maryland
city: Boston
country: United States
facility: Vinfen
state: Massachusetts
city: Minneapolis
country: United States
facility: RISE
state: Minnesota
city: Bay Shore
country: United States
facility: Family Service League The Olsten Family Center
state: New York
city: East Hampton
country: United States
facility: Family Service League The Olsten Family Center
state: New York
city: Huntington
country: United States
facility: Family Service League The Olsten Family Center
state: New York
city: Mastic
country: United States
facility: Family Service League The Olsten Family Center
state: New York
city: Mattituck
country: United States
facility: Family Service League The Olsten Family Center
state: New York
city: Cincinnati
country: United States
facility: Greater Cincinnati Behavioral Health Services
state: Ohio
city: Cincinnati
country: United States
facility: Greater Cincinnati Behavioral Health Services
state: Ohio
city: Cincinnati
country: United States
facility: Greater Cincinnati Behavioral Health Services
state: Ohio
city: Lorain
country: United States
facility: The Nord Center
state: Ohio
city: Sheffield
country: United States
facility: The Nord Center
state: Ohio
city: Tulsa
country: United States
facility: Mental Health Association Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Mental Health Association Oklahoma
state: Oklahoma
city: Milwaukie
country: United States
facility: Cascadia
state: Oregon
city: Portland
country: United States
facility: Cascadia
state: Oregon
city: Portland
country: United States
facility: Cascadia
state: Oregon
city: Portland
country: United States
facility: Cascadia
state: Oregon
city: Anderson
country: United States
facility: Anderson-Oconee-Pickens Mental Health Center
state: South Carolina
city: Bristol
country: United States
facility: Frontier Health
state: Tennessee
city: Greeneville
country: United States
facility: Frontier Health
state: Tennessee
city: Johnson City
country: United States
facility: Frontier Health
state: Tennessee
city: Kingsport
country: United States
facility: Frontier Health
state: Tennessee
city: Knoxville
country: United States
facility: Helen Ross McNabb Center
state: Tennessee
city: Everett
country: United States
facility: Sunrise Services
state: Washington
city: Mount Vernon
country: United States
facility: Sunrise Services
state: Washington
Study officials:
affiliation: Westat
name: William Frey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Westat
name: Robert Drake, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.