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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH117766 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vera Institute of Justice | OTHER |
| University of Illinois at Chicago | OTHER |
| University of South Florida | OTHER |
| National Institute of Mental Health (NIMH) |
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The investigators will implement a multifaceted Target Education Campaign (TEC) within the three jails about recognizing early psychotic symptoms and referring to the Correctional Health Services. This campaign will include print materials and targeted trainings for Correction Officers. To develop all aspects of the TEC, the investigators will convene a workgroup, meeting biweekly for the first 6 months, including the entire investigative team, as well as experts at the Center for Practice Innovations (CPI). Depending on the nature of agreed-upon educational materials, the investigators will use specific areas of expertise at CPI for development. Materials will provide specific, actionable, and persuasive messaging about: (1) how to identify select signs of psychosis, (2) how to refer to the Specialized Early Engagement Support Service (SEESS) (in year 2), and (3) the effectiveness of early treatment through coordinated specialty care for early psychosis. Messaging will be continuous in the three jails.
Because Correction Officers in the three jails of interest are critically positioned to influence pathways to care, print materials will be supplemented with professional outreach and education by the SEESS. Roll-call is the approved venue by which all ongoing education happens for Correction Officers. Roll-calls take place at the beginning of each shift (7am, 3pm, 11pm) every day of the week in the same location and last ~ 15 - 20 minutes; all staff starting that shift attend. During roll-call, brief messages (2-3 minutes) will be delivered by the Controlling Captains, which is the standard practice for communicating important information to Correction Officers. Both daytime and overnight shifts will receive the targeted training for the 24 months of the TEC.
The investigators will collect pre-TEC (baseline) and during-TEC (at 6 months and 12 months) data from Correction Officers through brief surveys, which will be used to test changes in mean scores for knowledge, behavioral expectations, and self-efficacy, which are three key constructs from Social Cognitive Theory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Educational Campaign (TEC) for Correction Officers | Experimental | The investigators will implement a Targeted Educational Campaign (TEC) within 3 jails. The TEC is designed to lead to referrals of detainees (previously not detected as having potential mental health concerns) to Correctional Health Services (CHS) by Correction Officers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Educational Campaign | Behavioral | Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the Correction Health Services staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes). Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times; pre-exposure, after 6 months, and after 12 months from the beginning of the TEC. |
| Measure | Description | Time Frame |
|---|---|---|
| Correction Officers' Knowledge at Baseline | Survey-based scores on knowledge/skills at baseline. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | Baseline |
| Correction Officers' Knowledge at 6 Months | Survey-based scores on knowledge/skills at 6-months. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | 6 months |
| Correction Officers' Knowledge at 12 Months | Survey-based scores on knowledge/skills at 12-months. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | 12 months |
| Correction Officers' Behavioral Expectations at Baseline | Survey-based scores on behavioral expectations at baseline. To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Baseline |
| Correction Officers' Behavioral Expectations at 6 Months | Survey-based scores on behavioral expectations at 6-months To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T. Compton, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10027 | United States |
Data collected from this clinical trials research will be deposited into the National Institute of Mental Health Data Archive (NDA). In order to deposit the data, the investigators will use a consent form that allows broad data sharing within the research community. A global unique identifier (GUID) will be created for each research participant using the software that NIMH provides. Dr. Compton and the research coordinator will work with NIMH to create data dictionaries that are relevant to their research. The investigators will share our results, positive and negative, specific to the cohorts and outcome measures studied.
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Correction officers (COs) were recruited at each of the 3 time points, baseline, 6 months and 12 months, but did not overlap (different COs at each time point) so the recruitment information will not report on a total # enrolled on a continuum (i.e., total number at the beginning, and then how many moved on to 6 months and to 12 months).
Recruitment of the study sample took place in 3 jails on Rikers Island in New York City (NYC): Anna M. Kross Center (AMKC), Rose M. Singer Center (RMSC), and the Robert N. Davoren Complex (RNDC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Targeted Educational Campaign (TEC) for Correction Officers | The investigators will implement a Targeted Educational Campaign (TEC) within 3 jails at New York City's Rikers Island. The TEC is designed to lead to referrals of detainees (previously not detected as having potential mental health concerns) to Correctional Health Services (CHS) by Correction Officers. Targeted Educational Campaign: Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the Correction Health Services staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes). Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times; pre-exposure, after 6 months, and after 12 months from the beginning of the TEC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 6 Months |
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| 12 Months |
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Includes all Correction Officers (COs) that were recruited at all time points (baseline, 6 months and 12 months).
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Educational Campaign (TEC) for Correction Officers | The investigators will implement a Targeted Educational Campaign (TEC) within 3 jails at New York City's Rikers Island. The TEC is designed to lead to referrals of detainees (previously not detected as having potential mental health concerns) to Correctional Health Services (CHS) by Correction Officers. Targeted Educational Campaign: Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the Correction Health Services staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes). Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times; pre-exposure, after 6 months, and after 12 months from the beginning of the TEC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Correction officers (COs) were recruited at each of the 3 time points, baseline, 6 months and 12 months, but did not overlap (different COs at each time point) so the recruitment information will not report on a total # enrolled on a continuum (i.e., total number at the beginning, and then how many moved on to 6 months and to 12 months). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correction Officers' Knowledge at Baseline | Survey-based scores on knowledge/skills at baseline. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | Only 200 Correction Officers (COs) completed this survey at baseline and therefore data exists for only 200 COs. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted Educational Campaign (TEC) for Correction Officers | The investigators will implement a Targeted Educational Campaign (TEC) within 3 jails at New York City's Rikers Island. The TEC is designed to lead to referrals of detainees (previously not detected as having potential mental health concerns) to Correctional Health Services (CHS) by Correction Officers. Targeted Educational Campaign: Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the Correction Health Services staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes). Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times; pre-exposure, after 6 months, and after 12 months from the beginning of the TEC. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Compton | Columbia University | 646-774-8476 | mtc2176@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2022 | Jul 25, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2020 | Aug 19, 2022 | ICF_002.pdf |
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| NIH |
Feasibility and Acceptability Study
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| 6 months |
| Correction Officers' Behavioral Expectations at 12 Months | Survey-based scores on behavioral expectations at 12 months. To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | 12 months |
| Correction Officers' Self-Efficacy at Baseline | Survey-based scores on self-efficacy at baseline. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Baseline |
| Correction Officers' Self-Efficacy at 6 Months | Survey-based scores on self-efficacy at 6-months. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | 6 months |
| Correction Officers' Self-Efficacy at 12 Months | Survey-based scores on self-efficacy at 12-months. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | 12 months |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Educational Attainment | Count of Participants | Participants |
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| Location of Enrollment | Count of Participants | Participants |
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| Primary | Correction Officers' Knowledge at 6 Months | Survey-based scores on knowledge/skills at 6-months. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | Only 123 Correction Officers (COs) completed this survey at 6 months and therefore data exists for only 123 COs. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Primary | Correction Officers' Knowledge at 12 Months | Survey-based scores on knowledge/skills at 12-months. To measure behavioral capability (knowledge/skills), the investigators used the Correction Officers' Behavioral Capability Scale, which has a minimum value of 0 and maximum value of 10. Higher scores mean better knowledge about psychosis and therefore a better outcome. | Only 128 Correction Officers (COs) completed this survey at 12 months and therefore data exists for only 128 COs. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Primary | Correction Officers' Behavioral Expectations at Baseline | Survey-based scores on behavioral expectations at baseline. To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 200 Correction Officers (COs) completed this survey at baseline and therefore data exists for only 200 COs. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Correction Officers' Behavioral Expectations at 6 Months | Survey-based scores on behavioral expectations at 6-months To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 123 Correction Officers (COs) completed this survey at 6 months and therefore data exists for only 123 COs. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Primary | Correction Officers' Behavioral Expectations at 12 Months | Survey-based scores on behavioral expectations at 12 months. To measure expectation, the investigators used the Correction Officers' Expectations Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 128 Correction Officers (COs) completed this survey at 12 months and therefore data exists for only 128 COs. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Primary | Correction Officers' Self-Efficacy at Baseline | Survey-based scores on self-efficacy at baseline. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 200 Correction Officers (COs) completed this survey at baseline and therefore data exists for only 200 COs. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Correction Officers' Self-Efficacy at 6 Months | Survey-based scores on self-efficacy at 6-months. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 123 Correction Officers (COs) completed this survey at 6 months and therefore data exists for only 123 COs. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Primary | Correction Officers' Self-Efficacy at 12 Months | Survey-based scores on self-efficacy at 12-months. To measure self-efficacy, the investigators used the Correction Officers' Self-Efficacy Scale, which has a minimum value of 8 and a maximum value of 32. Higher scores mean a better outcome. | Only 128 Correction Officers (COs) completed this survey at 12 months and therefore data exists for only 128 COs. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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