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Mental ImpairmentSEDNCT03682263

Supported Employment Demonstration

A study testing Full Service and Basic Service in people with Mental Impairment, run by Westat at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 49 years
Conditions the study is for
Mental Impairment
What is being tested?
Full Service and Basic Service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
52 sitesUnited States
Study dates
2 Dec 2017to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Intellectual disability
  • Reside in a nursing home or custodial institution
  • Already receiving supported employment services from CMHA site

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Anderson-Oconee-Pickens Mental Health Center

    Anderson, South Carolina, 29625

  • Communicare

    Bardstown, Kentucky, 40004

  • Family Service League The Olsten Family Center

    Bay Shore, New York, 11706

  • Cornerstone Montgomery

    Bethesda, Maryland, 20814

  • Vinfen

    Boston, Massachusetts, 02118

  • Communicare

    Brandenburg, Kentucky, 40108

  • Frontier Health

    Bristol, Tennessee, 37620

  • Trilogy

    Chicago, Illinois, 60623

  • Trilogy

    Chicago, Illinois, 60626

  • Greater Cincinnati Behavioral Health Services

    Cincinnati, Ohio, 45205

  • Greater Cincinnati Behavioral Health Services

    Cincinnati, Ohio, 45206

  • Greater Cincinnati Behavioral Health Services

    Cincinnati, Ohio, 45237

  • Mental Health Center of Denver

    Denver, Colorado, 80204

  • Family Service League The Olsten Family Center

    East Hampton, New York, 11937

  • Communicare

    Elizabethtown, Kentucky, 42701

  • Sunrise Services

    Everett, Washington, 98204

  • Bridgeway

    Galesburg, Illinois, 61401

  • Frontier Health

    Greeneville, Tennessee, 37743

  • Communicare

    Hardinsburg, Kentucky, 40143

  • Communicare

    Hodgenville, Kentucky, 42748

  • Pathways

    Hollywood, Maryland, 20636

  • Family Service League The Olsten Family Center

    Huntington, New York, 11743

  • Frontier Health

    Johnson City, Tennessee, 37601

  • Bridgeway

    Kewanee, Illinois, 61443

  • Frontier Health

    Kingsport, Tennessee, 37660

  • Helen Ross McNabb Center

    Knoxville, Tennessee, 37917

  • Penny Lane Centers

    Lancaster, California, 93535

  • Communicare

    Lebanon, Kentucky, 40033

  • Communicare

    Leitchfield, Kentucky, 42754

  • The Nord Center

    Lorain, Ohio, 44055

  • Bridgeway

    Loves Park, Illinois, 61111

  • Bridgeway

    Macomb, Illinois, 61455

  • Family Service League The Olsten Family Center

    Mastic, New York, 11950

  • Family Service League The Olsten Family Center

    Mattituck, New York, 11952

  • Cascadia

    Milwaukie, Oregon, 97267

  • RISE

    Minneapolis, Minnesota, 55418

  • Sunrise Services

    Mount Vernon, Washington, 98273

  • Bridgeway

    Normal, Illinois, 61761

  • Bridgeway

    Pekin, Illinois, 61554

  • Cascadia

    Portland, Oregon, 97206

  • Cascadia

    Portland, Oregon, 97212

  • Cascadia

    Portland, Oregon, 97220

  • Communicare

    Radcliff, Kentucky, 40160

  • Cornerstone Montgomery

    Rockville, Maryland, 20850

  • The Nord Center

    Sheffield, Ohio, 44035

  • Cornerstone Montgomery

    Silver Spring, Maryland, 20902

  • Boley Centers

    St. Petersburg, Florida, 33713

  • Mental Health Association Oklahoma

    Tulsa, Oklahoma, 74114

  • Mental Health Association Oklahoma

    Tulsa, Oklahoma, 74119

  • Pathways

    Upper Marlboro, Maryland, 20775

  • Pathways

    Waldorf, Maryland, 20601

  • Mental Health Association of South Central Kansas

    Wichita, Kansas, 67208

Other trials in United States

About this study

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.

Read the 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.

Being tested
Full Service, Basic Service

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full ServiceBehavioural

    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 ServiceBehavioural

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

Study groups in NCT03682263
Study groupRoleWhat they receive
Full Service TreatmentExperimentalThe 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).
Receives: Behavioral: Full Service
Basic Service TreatmentExperimentalThe Basic Service Arm receives the Individual Placement and Support (IPS) model of employment services integrated with behavioral health services and care management services.
Receives: Behavioral: Basic Service
Usual ServicesNo interventionMembers 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 months

Secondary outcomes (9)

  1. 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.

    Measured: 36 months

  2. 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.

    Measured: 36 months

  3. 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.

    Measured: 36 months

  4. Months Employed

    The number of months employed during the 36-month study period.

    Assessed via quarterly computer-assisted telephone interviews.

    Measured: 36 months

  5. 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.

    Measured: 36 months

  6. Total Earnings

    Total amount of reported earnings over the 36-month study period.

    Assessed via quarterly computer-assisted telephone interviews.

    Measured: 36 months

  7. 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.

    Measured: 36 months

  8. 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.

    Measured: 36 months

  9. Time Until Award

    The number of study days to disability award.

    Assessed using Social Security Administration administrative data.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start2 Dec 2017
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03682263
Sponsor's protocol ID
SS00-16-60014
Acronym
SED
Status last verified
Apr 2022
First submitted
19 Sep 2018
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34405312

Questions about this trial

What is this clinical trial studying?

A study testing Full Service and Basic Service in people with Mental Impairment, run by Westat at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Employment (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03682263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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