Improving Mental Health Treatment for Individuals in Crisis Interacting With the Criminal-Legal System

June 2, 2026 updated by: Cambridge Health Alliance
The proposed Center will leverage burgeoning real-time data linkage capabilities among health systems, Medicaid payors, and criminal legal (e.g., jail booking data, jail release data) systems, to identify individuals coming in and out of jail for suicide assessment and prevention, and to better coordinate care across these disparate systems. This Center will advance the fields of suicide prevention and criminal legal system-based mental health by solving a well-known, central problem in both fields: the inability to track and intervene with individuals moving in and out of both and often multiple systems. The goal is near-term reductions in the U.S. suicide rate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1040

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Treatment as Usual (TAU) arm

    1. Cambridge Health Alliance (CHA) patients from the cities other than Cambridge considered to be in the "catchment area" of CHA (Everett, Chelsea, Somerville, Medford, Malden, and Winthrop)
    2. Ages 18-100
    3. Identified as having police involvement between 2009 and 2025. Treatment as Usual patients will be identified using "targeted limited chart review methods" used in our prior studies, "scraping" clinical notes in the Electronic Health Records for criminal legal involvement. Initial Identification terms, "police", "arrest", "court", "summons", "jail", and "crime" will be used to identify candidates for police involvement, downloading the sentence in which the keyword appeared and the sentence before and after. Next, an iterative process of editing of the search terms will be conducted to remove patients with negation of the keyword ("did not commit a crime"), and other sentence characteristics that generate false positives ("cardiac arrest"). Samples of the resulting dataset will be taken, accuracy assessed by examining the surrounding sentences, leading to further iterations and repetition of the process until a high level of accuracy is achieved.

  2. FSJS arm

    1. Cambridge Health Alliance patients from Cambridge
    2. Ages 18-100
    3. Individuals who have come into contact with the Cambridge Police Department (as identified in the FSJS data) between 2009 and 2025.

  3. FSJS+Navigator arm

    1. Recruited during the study period in the CHA ED
    2. Ages 18-100

    3. Individuals who are brought into the Emergency Department under police supervision (excluding individuals currently incarcerated)

      • involuntarily brought to the Emergency Department for psychiatric evaluation because they are considered to be a risk to themselves or others (MA Law 123(12)); or
      • the subject of a police call for service for a mental health issue who are willingly admitted to the Emergency Department

Exclusion Criteria

  1. Treatment as Usual (TAU) arm

    1. Cambridge Health Alliance patients residing in the City Cambridge are excluded from the TAU arm
    2. Under the age of 18
    3. Individuals with no identified criminal legal system contact during the study time period (no criminal legal involvement found in the targeted limited chart review method).
    4. Any individual incarcerated at the Middlesex Jail/Prison that has not been released by the end of the period of data collection (December 31, 2025).

  2. FSJS arm

    1. Cambridge Health Alliance patients outside of Cambridge will be excluded from the FSJS arm
    2. Under the age of 18
    3. Any individual incarcerated at the Middlesex Jail/Prison that has not been released by the end of the period of data collection (December 31, 2025)

  3. FSJS+Navigator arm

    1. Under the age of 18
    2. Any individual who becomes incarcerated during the course of the study

    3. Individuals who enter the Emergency Department not under police supervision

      • For example, individuals will be excluded who voluntarily come to the ED seeking psychiatric care because they feel they may be a risk to themselves or others
      • Individuals brought to the ED from a jail or court ordered to the ED as an alternative to jail or prison

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FSJS + Navigator
40 patients recruited during the study period in the Cambridge Health Alliance Emergency Department (ED) Ages 18-100 Individuals who are brought into the ED under police supervision (excluding individuals currently incarcerated) involuntarily brought to the ED for psychiatric evaluation because they are considered to be a risk to themselves or others (MA Law 123(12)); or the subject of a police call for service for a mental health issue who are willingly admitted to the ED
Other: FSJS+Navigator Intervention
The FSJS+Navigator intervention adds an Emergency Department (ED)-based Systems Navigator, a community health worker with lived experience (as family member or patient) with criminal legal and mental health systems, to the FSJS. This navigator will enhance communication between Cambridge Police Department (CPD), Cambridge Health Alliance (CHA), and community agencies by being the needed "point person" within the healthcare system (the FSJS intervention only has a CPD-based social worker) to maintain communication to improve mental health services and prevent deeper legal involvement. The Navigator engages with the FSJS process in step i) of the above sequence, engaging the patient in the CHA ED and obtaining consent. The Navigator then discusses the case with the presenting CPD officer, and relays critical information about the context of the service call to ED staff. Next, the Navigator will administer the baseline CAT-MH/SS and assess additional needs (employment, housing, food).
Experimental: Treatment as usual (TAU)
This arm will consist of 2160 eligible individuals identified to have had criminal legal involvement in Cambridge Health Alliance catchment area cities other than Cambridge (Everett, Somerville, Malden, Medford, Chelsea, Revere, Winthrop). Police departments in these Treatment as Usual cities have no programs that link police officers and clinicians to follow up on safety planning and services. These individuals will be identified as having police involvement between 2009 and 2025.
Other: Treatment as usual (TAU)
TAU patients will be identified using "targeted limited chart review methods" used in our prior studies, "scraping" clinical notes in the EHR for criminal legal involvement. Initial Identification terms, "police", "arrest", "court", "summons", "jail", and "crime" will be used to identify candidates for police involvement, downloading the sentence in which the keyword appeared and the sentence before and after. Next, an iterative process of editing of the search terms will be conducted to remove patients with negation of the keyword ("did not commit a crime"), and other sentence characteristics that generate false positives ("cardiac arrest"). Samples of the resulting dataset will be taken, accuracy assessed by examining the surrounding sentences, leading to further iterations and repetition of the process until a high level of accuracy is achieved.
Experimental: FSJS
Consists of 200 Cambridge Health Alliance Patients Ages 18-100 Individuals who have come into contact with the Cambridge Police Department (as identified in the FSJS data) between 2009 and 2025.
Other: FSJS
Documentation and follow-up by the Cambridge Police Department (CPD) for all mental health-related police calls, including involuntary and voluntary Emergency Department admissions; Established partnerships with city departments, healthcare systems, clergy, courts, businesses, and mental health advocates to ensure timely engagement in mental health treatment and community-based services; Required 40 hours of officer crisis intervention training (CIT), and additional sessions on trauma- informed policing, mental health, race, and crisis negotiation; and Staffing of sworn and civilian staff including specially-trained officers designated to work with individuals living with mental illness, homelessness, and substance abuse.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Past-year medically treated suicide attempt at baseline and 12 months
Time Frame: Baseline and 12 months
Number of participants with a past-year medically treated suicide attempt. This will be measured at baseline and 12 months will be collected using the electronic health record (EHR) data.
Baseline and 12 months
Suicide Severity and Behaviors using Computerized Adaptive Test Suicide Scale (CAT-SS) at Baseline and 12 Months
Time Frame: Baseline and 12 months
The CAT-SS measures Severity of Suicide Risk will be assessed using CAT-SS, providing severity on a 0-100 point scale, and risk-stratification to negligible, intermediate and high risk. It is highly sensitive and specific to the Columbia Suicide Severity Rating Scale, and predicts future suicide events with high precision and accuracy.
Baseline and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Individual Interactions with the Criminal Legal System at Baseline and 12 Months
Time Frame: From enrollment through 12 months
Number of calls about each individual to the Cambridge Police Department (CPD) Number of arrests Number of admissions to the Middlesex County Jail Repeat admission to the Middlesex County Jail
From enrollment through 12 months
Frequency of Healthcare Services Used by Patients at Baseline and 12 Months
Time Frame: From enrollment through 12 months
Number of Emergency Department visits Number of behavioral health inpatient visits Number of behavioral health outpatient mental health (MH) visits
From enrollment through 12 months
Number of Individual Interactions between Hospitals and the Criminal-Legal System at Baseline and 12 Months
Time Frame: From enrollment through 12 months
Number of involuntary hospitalizations that require Cambridge Police Department (CPD) interaction
From enrollment through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cambridge Health Alliance

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Michigan State University
Mount Auburn Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHA-IRB-22-23-156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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