ClinicalTrials.gg
RecruitingNCT06564948Updated Jun 4, 2026

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

An interventional study of Treatment as usual (TAU) and FSJS in Suicide Risk and Psychiatric Disorders, sponsored by Cambridge Health Alliance. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,040
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
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Study summary

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.

02

Conditions studied

  • Suicide Risk
  • Psychiatric Disorders

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03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 1,040 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
1,040 participants (estimated)

Study arms

  • 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)

  • 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

  • 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

Interventions

  • OtherTreatment 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.

  • OtherFSJS

    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.

  • OtherFSJS+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).

06

What researchers measure

Primary outcomes

  1. Past-year medically treated suicide attempt at 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.

    Time frame: Baseline and 12 months

  2. Suicide Severity and Behaviors using Computerized Adaptive Test Suicide Scale (CAT-SS) at 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.

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Number of Individual Interactions with the Criminal Legal System at Baseline and 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

    Time frame: From enrollment through 12 months

  2. Number of Individual Interactions between Hospitals and the Criminal-Legal System at Baseline and 12 Months

    Number of involuntary hospitalizations that require Cambridge Police Department (CPD) interaction

    Time frame: From enrollment through 12 months

  3. Frequency of Healthcare Services Used by Patients at Baseline and 12 Months

    Number of Emergency Department visits Number of behavioral health inpatient visits Number of behavioral health outpatient mental health (MH) visits

    Time frame: From enrollment through 12 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Sep 2027, 31 months after the start.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 31 months is close to that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2024
First posted
Aug 21, 2024
StartActual
Feb 1, 2025
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06564948
Lead sponsor
Cambridge Health Alliance
Collaborators
Michigan State University, Mount Auburn Hospital
Responsible party
Sponsor
First posted
Aug 21, 2024
Start date
Feb 1, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Benjamin Cook
Contact
bcook@cha.harvard.edu
617-806-8741
Taylor Witkowski
Contact
twitkowski@challiance.org
617-806-8751

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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