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Completed

NCT Number: NCT03682263

Supported Employment Demonstration

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.

Completed

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penny Lane Centers, Lancaster, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full Service

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

Behavioral

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

Primary outcomes

  1. Employment

    Time frame: 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 outcomes

  1. Employment (Competitive)

    Time frame: 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.

  2. Total Hours Worked

    Time frame: 36 months

    The reported total number of hours worked for pay during the 36-month study period.

    Assessed via quarterly computer-assisted telephone interviews.

  3. Days to First Job

    Time frame: 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.

  4. Months Employed

    Time frame: 36 months

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

    Assessed via quarterly computer-assisted telephone interviews.

  5. Job Tenure

    Time frame: 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.

  6. Total Earnings

    Time frame: 36 months

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

    Assessed via quarterly computer-assisted telephone interviews.

  7. Months above SGA

    Time frame: 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.

  8. Short-Form 12 Health Survey (SF-12) Mental Component Score (MCS)

    Time frame: 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.

  9. Time Until Award

    Time frame: 36 months

    The number of study days to disability award.

    Assessed using Social Security Administration administrative data.

Sponsors and collaborators

Lead sponsor

Westat

Other

Collaborators

  • United States Social Security Administration

Registry information

Acronym: SED

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2018
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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