Suicide and Self-harmNCT05579600
Suicide Prevention for Criminal Legal Involved Managed Care Subscribers
A study testing Caring Contacts letters in people with Suicide and Self-harm, run by Butler Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effects of a suicide prevention intervention for individuals released from jail. The main question it aims to answer is: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? Participants will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- Caring Contacts letters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45,155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years old
- Released from an Ohio jail
- enrolled in Medicaid through CareSource
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managed Care Updates of Subscriber Criminal Legal System Involvement for Suicide Prevention
The goal of this clinical trial is to test the effects of a suicide prevention intervention for individuals released from jail. The main question it aims to answer is: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? Participants will include subscribers of a managed care organization (MCO). Intervention includes sending subscribers Caring Contacts letters for 6-months following jail release to target healthcare re-engagement and suicide prevention.
- Conditions
- Suicide and Self-harm
- Being tested
- Caring Contacts letters
- Keywords
- suicidal behavior, jail release, behavioral health providers, suicide training
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring Contacts lettersBehavioural
Caring Contacts involves sending individuals at risk for suicide brief, non- demanding messages of care.
| Study group | Role | What they receive |
|---|---|---|
| Caring Contact letters | Experimental | Caring Contact letters will be mailed to a randomly selected group of managed care subscribers over a 6-month period following jail release. Receives: Behavioral: Caring Contacts letters |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Attempt
A suicide attempt is defined as "engaging in a potentially self-injurious behavior, associated with at least some intent to die as a result of the act." We will assess total number of subsequent attempts using the already-developed Mental Health Research Network (MHRN) algorithm for extracting suicide attempt information from claims data
Measured: 6-months
Secondary outcomes (4)
All-cause Injury and Poisoning
All-cause injury and poisoning data will be extracted from ICD-10 data.
Measured: 6-months
Outpatient Behavioral Health Service Linkage
We will extract number of outpatient behavioral health (i.e., mental health or substance use) visits during the 12 months prior to and 6 months following jail release from claims data.
Measured: 18 months
CareSource Member Services (CMS) Line Use
Caring Contact messages will list the CMS phone number (which is answered by the Care Management Team, who are trained to assess and connect callers to the appropriate services) as a way to reach out. Care Source will track calls to this line by subscribers in all study conditions.
Measured: 6-months
Inpatient and Emergency Department Mental Health Care Visits
Data on inpatient and emergency department mental health visits will be extracted from claims data using MHRN algorithms.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Sep 2022
- Primary completion3 Sep 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide and Self-harmStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Sponsor
- Investigators
- Sarah Arias, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579600
- Sponsor's protocol ID
- 1P50MH127512-01A1 8577
- Other IDs
- 1P50MH127512-01A1
- Status last verified
- Oct 2025
- First submitted
- 11 Oct 2022
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arias SA, Sperber K, Jones R, Taxman FS, Miller TR, Zylberfuden S, Weinstock LM, Brown GK, Ahmedani B, Johnson JE. Managed care updates of subscriber jail release to prompt community suicide prevention: clinical trial protocol. BMC Health Serv Res. 2023 Nov 16;23(1):1265. doi: 10.1186/s12913-023-10249-5.
PubMed 37974126Arias SA, Sperber K, Jones R, Taxman FS, Miller TR, Zylberfuden S, Weinstock LM, Brown GK, Ahmedani B, Johnson JE. Managed Care Updates of Subscriber Jail Release to Prompt Community Suicide Prevention: Clinical Trial Protocol. Res Sq [Preprint]. 2023 Sep 25:rs.3.rs-3350204. doi: 10.21203/rs.3.rs-3350204/v1.
PubMed 37841869