Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04004364 |
Recruitment Status :
Recruiting
First Posted : July 2, 2019
Last Update Posted : October 11, 2021
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Condition or disease | Intervention/treatment |
---|---|
First Episode Psychosis | Other: Coordinated Specialty Care (CSC) |
The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation.
The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.
Study Type : | Observational |
Estimated Enrollment : | 700 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes |
Actual Study Start Date : | April 1, 2020 |
Estimated Primary Completion Date : | July 27, 2024 |
Estimated Study Completion Date : | July 27, 2024 |

- Other: Coordinated Specialty Care (CSC)
CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.
- Number of Enrolled participants [ Time Frame: 5 years of the project ]Number of enrolled participants into the learning health system

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Ages Eligible for Study: | 15 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Enrolled in CSC program
Exclusion Criteria:
- none

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004364
Contact: Patricia Marcy, BSN | 347-439-8035 | pmarcy@northwell.edu | |
Contact: Cristina Gonzalez, MS | 347-804-3605 |
United States, Florida | |
Henderson Behavioral Health | Recruiting |
Lauderdale Lakes, Florida, United States, 33319 | |
Contact: Suzelle Guinart |
Responsible Party: | Northwell Health |
ClinicalTrials.gov Identifier: | NCT04004364 |
Other Study ID Numbers: |
19-0307 |
First Posted: | July 2, 2019 Key Record Dates |
Last Update Posted: | October 11, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |