Full Service
BehavioralReceive 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).
NCT Number: NCT03682263
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.
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Notify Me18 year–49 year
All sexes
Interventional
Not applicable
Penny Lane Centers, Lancaster, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.
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.
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.
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.
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.
Time frame: 36 months
The number of months employed during the 36-month study period.
Assessed via quarterly computer-assisted telephone interviews.
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.
Time frame: 36 months
Total amount of reported earnings over the 36-month study period.
Assessed via quarterly computer-assisted telephone interviews.
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.
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.
Time frame: 36 months
The number of study days to disability award.
Assessed using Social Security Administration administrative data.
Westat
Other
Acronym: SED
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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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