Supported Employment Demonstration

NCT ID: NCT03682263

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-02

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Full Service

Intervention Type BEHAVIORAL

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 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.

Group Type EXPERIMENTAL

Basic Service

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Basic Service

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Social Security Administration

UNKNOWN

Sponsor Role collaborator

Westat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Frey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Westat

Robert Drake, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Westat

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penny Lane Centers

Lancaster, California, United States

Site Status

Mental Health Center of Denver

Denver, Colorado, United States

Site Status

Boley Centers

St. Petersburg, Florida, United States

Site Status

Trilogy

Chicago, Illinois, United States

Site Status

Trilogy

Chicago, Illinois, United States

Site Status

Bridgeway

Galesburg, Illinois, United States

Site Status

Bridgeway

Kewanee, Illinois, United States

Site Status

Bridgeway

Loves Park, Illinois, United States

Site Status

Bridgeway

Macomb, Illinois, United States

Site Status

Bridgeway

Normal, Illinois, United States

Site Status

Bridgeway

Pekin, Illinois, United States

Site Status

Mental Health Association of South Central Kansas

Wichita, Kansas, United States

Site Status

Communicare

Bardstown, Kentucky, United States

Site Status

Communicare

Brandenburg, Kentucky, United States

Site Status

Communicare

Elizabethtown, Kentucky, United States

Site Status

Communicare

Hardinsburg, Kentucky, United States

Site Status

Communicare

Hodgenville, Kentucky, United States

Site Status

Communicare

Lebanon, Kentucky, United States

Site Status

Communicare

Leitchfield, Kentucky, United States

Site Status

Communicare

Radcliff, Kentucky, United States

Site Status

Cornerstone Montgomery

Bethesda, Maryland, United States

Site Status

Pathways

Hollywood, Maryland, United States

Site Status

Cornerstone Montgomery

Rockville, Maryland, United States

Site Status

Cornerstone Montgomery

Silver Spring, Maryland, United States

Site Status

Pathways

Upper Marlboro, Maryland, United States

Site Status

Pathways

Waldorf, Maryland, United States

Site Status

Vinfen

Boston, Massachusetts, United States

Site Status

RISE

Minneapolis, Minnesota, United States

Site Status

Family Service League The Olsten Family Center

Bay Shore, New York, United States

Site Status

Family Service League The Olsten Family Center

East Hampton, New York, United States

Site Status

Family Service League The Olsten Family Center

Huntington, New York, United States

Site Status

Family Service League The Olsten Family Center

Mastic, New York, United States

Site Status

Family Service League The Olsten Family Center

Mattituck, New York, United States

Site Status

Greater Cincinnati Behavioral Health Services

Cincinnati, Ohio, United States

Site Status

Greater Cincinnati Behavioral Health Services

Cincinnati, Ohio, United States

Site Status

Greater Cincinnati Behavioral Health Services

Cincinnati, Ohio, United States

Site Status

The Nord Center

Lorain, Ohio, United States

Site Status

The Nord Center

Sheffield, Ohio, United States

Site Status

Mental Health Association Oklahoma

Tulsa, Oklahoma, United States

Site Status

Mental Health Association Oklahoma

Tulsa, Oklahoma, United States

Site Status

Cascadia

Milwaukie, Oregon, United States

Site Status

Cascadia

Portland, Oregon, United States

Site Status

Cascadia

Portland, Oregon, United States

Site Status

Cascadia

Portland, Oregon, United States

Site Status

Anderson-Oconee-Pickens Mental Health Center

Anderson, South Carolina, United States

Site Status

Frontier Health

Bristol, Tennessee, United States

Site Status

Frontier Health

Greeneville, Tennessee, United States

Site Status

Frontier Health

Johnson City, Tennessee, United States

Site Status

Frontier Health

Kingsport, Tennessee, United States

Site Status

Helen Ross McNabb Center

Knoxville, Tennessee, United States

Site Status

Sunrise Services

Everett, Washington, United States

Site Status

Sunrise Services

Mount Vernon, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34405312 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SS00-16-60014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Independence Project
NCT03543722 UNKNOWN NA
Recovery Group Pilot
NCT00522613 COMPLETED NA