Suicide RiskNCT06564948
Improving Mental Health Treatment for Individuals in Crisis Interacting With the Criminal-Legal System
A study testing Treatment as usual (TAU), FSJS and FSJS+Navigator Intervention in people with Suicide Risk and Psychiatric Disorders, run by Cambridge Health Alliance at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Suicide Risk, Psychiatric Disorders
- What is being tested?
- Treatment as usual (TAU), FSJS and FSJS+Navigator Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment as Usual (TAU) arm
- 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)
- Ages 18-100
- 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.
- FSJS arm
- Cambridge Health Alliance patients from Cambridge
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- Ages 18-100
- Individuals who have come into contact with the Cambridge Police Department (as identified in the FSJS data) between 2009 and 2025.
- FSJS+Navigator arm
- Recruited during the study period in the CHA ED
- Ages 18-100
- 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
Who cannot join
- Treatment as Usual (TAU) arm
- Cambridge Health Alliance patients residing in the City Cambridge are excluded from the TAU arm
- Under the age of 18
- 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).
- 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).
- FSJS arm
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- Cambridge Health Alliance patients outside of Cambridge will be excluded from the FSJS arm
- Under the age of 18
- 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)
- FSJS+Navigator arm
- Under the age of 18
- Any individual who becomes incarcerated during the course of the study
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cambridge Health Alliance
Cambridge, Massachusetts, 02141
Benjamin Cook, 617-806-8741, bcook@cha.harvard.edu
Taylor Witkowski, 617-806-8751, twitkowski@challiance.org
About this study
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.
- Conditions
- Suicide Risk, Psychiatric Disorders
- Being tested
- Treatment as usual (TAU), FSJS, FSJS+Navigator Intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual (TAU)Other
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.
FSJSOther
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.
FSJS+Navigator InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Experimental | 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. Receives: Other: Treatment as usual (TAU) |
| FSJS | Experimental | 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. Receives: Other: FSJS |
| FSJS + Navigator | Experimental | 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 Receives: Other: FSJS+Navigator Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
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.
Measured: Baseline and 12 months
Secondary outcomes (3)
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
Measured: From enrollment through 12 months
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
Measured: From enrollment through 12 months
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
Measured: From enrollment through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Feb 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Preliminary effectiveness of FSJS+Navigator model on suicide severity and clinical outcomes using CAT-SS/MH, mental health, and mental health treatment/criminal legal outcomes will be assessed. Assessments occur at baseline, 1, 3, and 6 months, providing key statistics (distribution, correlation of outcome over time, missingness) needed to inform a fully-powered Hybrid II trial. Improvement in medically treated suicide attempts and CAT-SS indicators will be assessed over time using repeated measures ANOVA. This study is a non-experimental longitudinal design comparing treatment group (FSJS+Navigator) to 2 control groups (FSJS Only and Treatment As Usual). We will assess the following as moderators of intervention effects: sex, race/ethnicity, past suicide attempt, past behavioral health treatment, Area Deprivation index, mental health professional shortage area score, per capita incarceration, and other area-level social determinants of health variables using stratified and DDD models.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, Mount Auburn Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564948
- Sponsor's protocol ID
- CHA-IRB-22-23-156
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No