SuicideNCT05587530
Zero Suicide Implementation in Outpatient Mental Health Clinics
A study testing Treatment engagement and retention intervention for suicidal clients in people with Suicide, run by Columbia University at 1 site in United States.
Trial summary
The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Suicide
- What is being tested?
- Treatment engagement and retention intervention for suicidal clients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 18-64 years
- Medicaid eligible
- Currently receiving outpatient behavioral healthcare for suicide-related reasons
- Willingness to participate in the pilot intervention
- Willingness to complete a 1-month follow-up assessment
- Inclusion Criteria (peer specialists delivering pilot intervention):
Show all 11Show fewer
- Any adult participant (18+) is acceptable, though most will be expected to be working age (e.g., 18-65 years old)
- Certified peer specialists working in an outpatient behavioral health setting
- Has experience working with clients enrolled in behavioral healthcare for suicide-related reasons
- Willingness to participate in training and deliver the pilot intervention
- Willingness to complete the pre-training, post-training, and 1-month follow-up assessment
Who cannot join
- Lacks capacity to consent
- Not fluent to read, write, and/or speak in English
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Zero Suicide Implementation and Evaluation in Outpatient Mental Health Clinics
The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal.
This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care.
In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.
Read the detailed description
Suicide is the 10th leading cause of death in the US, killing more than 47,000 Americans each year. US suicide deaths have increased dramatically, a staggering 62% increase over the past two decades. While suicide research has made great strides in the development of "best practices" for screening, risk assessment, suicide-specific clinical interventions, and follow-up protocols, there is a striking gap between assessment and intervention development and the implementation of these practices in typical clinical settings.Furthermore, very little research has explored if the "best practices" recommended by clinical experts and researchers are deemed feasible, acceptable, or even desirable by clients experiencing suicidal thoughts and behavior.
- Conditions
- Suicide
- Being tested
- Treatment engagement and retention intervention for suicidal clients
- Keywords
- Suicide Prevention, Engagement, Retention, Outpatient behavioral health
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment engagement and retention intervention for suicidal clientsBehavioural
The manualized behavioral intervention for treatment engagement and retention of suicidal clients will be based on client and staff stakeholder preferences, informed by data from qualitative participatory interviews and secondary data analysis of administrative databases (conducted in phase 1). In addition to factors identified by stakeholders, if deemed feasible and acceptable during phase 1, the intervention will include structured phone outreach, shared decision-making, and peer support.
| Study group | Role | What they receive |
|---|---|---|
| Treatment engagement and retention intervention for suicidal clients | Experimental | Participants will receive the manualized treatment engagement and retention protocol for suicidal outpatient clients (single-arm intervention pilot). The manualized treatment engagement and retention protocol will be based on client and staff stakeholder preferences, informed by data from qualitative participatory interviews and secondary data analysis of administrative databases (conducted in phase 1). Receives: Behavioral: Treatment engagement and retention intervention for suicidal clients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability (Adapted From the Treatment Acceptability and Preference Questionnaire)
Acceptability of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire
Measured: 1 month
Feasibility (Adapted From the Treatment Acceptability and Preference Questionnaire)
Feasibility of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire
Measured: 1 month
Satisfaction With the Intervention (Adapted From the Treatment Acceptability and Preference Questionnaire)
Satisfaction with the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from Treatment Acceptability and Preference Questionnaire
Measured: 1 month
Secondary outcomes (2)
Perceived Effectiveness
Perceived effectiveness of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention
Measured: 1 month
Engagement
Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Nov 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: As of 09/2025, the study was unable to be completed due to the administrative pause of research activities at the New York State Psychiatric Institute.
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.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Informed by data from qualitative participatory interviews and secondary data analysis of administrative databases and based on client and staff stakeholder preferences, the investigators will develop a manualized treatment engagement and retention protocol for suicidal outpatient clients. To determine feasibility and acceptability of the manualized treatment engagement and retention protocol for suicidal outpatient clients, the investigators will conduct a small pilot study with 15 clients across 1-2 clinics (single arm intervention pilot).
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lisa Dixon, Columbia University
- Investigators
- Lisa B. Dixon, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587530
- Sponsor's protocol ID
- AAAV1378
- Other IDs
- R56MH112139, 8320, 1383713
- Status last verified
- Dec 2025
- First submitted
- 29 Jul 2022
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Suicide Implementation and Evaluation in Outpatient Mental Health Clinics
- ClinicalTrials.gov ID
- NCT05587530
- Acronym / sponsor ID
- AAAV1378
- Conditions
- Suicide
- Keywords
- Suicide Prevention, Engagement, Retention, Outpatient behavioral health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As of 09/2025, the study was unable to be completed due to the administrative pause of research activities at the New York State Psychiatric Institute.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal.
This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care.
In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.
Detailed description
Suicide is the 10th leading cause of death in the US, killing more than 47,000 Americans each year. US suicide deaths have increased dramatically, a staggering 62% increase over the past two decades. While suicide research has made great strides in the development of "best practices" for screening, risk assessment, suicide-specific clinical interventions, and follow-up protocols, there is a striking gap between assessment and intervention development and the implementation of these practices in typical clinical settings.Furthermore, very little research has explored if the "best practices" recommended by clinical experts and researchers are deemed feasible, acceptable, or even desirable by clients experiencing suicidal thoughts and behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Informed by data from qualitative participatory interviews and secondary data analysis of administrative databases and based on client and staff stakeholder preferences, the investigators will develop a manualized treatment engagement and retention protocol for suicidal outpatient clients. To determine feasibility and acceptability of the manualized treatment engagement and retention protocol for suicidal outpatient clients, the investigators will conduct a small pilot study with 15 clients across 1-2 clinics (single arm intervention pilot).
| Arm | Type | Receives |
|---|---|---|
| Treatment engagement and retention intervention for suicidal clients | Experimental | Behavioral: Treatment engagement and retention intervention for suicidal clientsParticipants will receive the manualized treatment engagement and retention protocol for suicidal outpatient clients (single-arm intervention pilot). The manualized treatment engagement and retention protocol will be based on client and staff stakeholder preferences, informed by data from qualitative participatory interviews and secondary data analysis of administrative databases (conducted in phase 1). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age range 18-64 years
- Medicaid eligible
- Currently receiving outpatient behavioral healthcare for suicide-related reasons
- Willingness to participate in the pilot intervention
- Willingness to complete a 1-month follow-up assessment
Key exclusion criteria (2 listed)
- Lacks capacity to consent
- Not fluent to read, write, and/or speak in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment engagement and retention intervention for suicidal clientsThe manualized behavioral intervention for treatment engagement and retention of suicidal clients will be based on client and staff stakeholder preferences, informed by data from qualitative participatory interviews and secondary data analysis of administrative databases (conducted in phase 1). In addition to factors identified by stakeholders, if deemed feasible and acceptable during phase 1, the intervention will include structured phone outreach, shared decision-making, and peer support. | Behavioural | Treatment engagement and retention intervention for suicidal clients |
Primary outcome
Acceptability (Adapted From the Treatment Acceptability and Preference Questionnaire)
Time frame: 1 month
Acceptability of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire
Feasibility (Adapted From the Treatment Acceptability and Preference Questionnaire)
Time frame: 1 month
Feasibility of the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from the Treatment Acceptability and Preference Questionnaire
Satisfaction With the Intervention (Adapted From the Treatment Acceptability and Preference Questionnaire)
Time frame: 1 month
Satisfaction with the treatment engagement and retention intervention for suicidal clients, as rated by clients receiving the intervention and peer specialists delivering the intervention on an assessment adapted from Treatment Acceptability and Preference Questionnaire
2 secondary outcomes
Perceived Effectiveness
Time frame: 1 month
Engagement
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa B. Dixon, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment engagement and retention intervention for suicidal clients in people with Suicide, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (Adapted From the Treatment Acceptability and Preference Questionnaire) (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.