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| ID | Type | Description | Link |
|---|---|---|---|
| R56MH112139 | U.S. NIH Grant/Contract | View source | |
| 8320 | Other Identifier | New York State Psychiatric Institute Institutional Review Board | |
| 1383713 | Other Identifier | WCG Institutional Review Board |
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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.
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment engagement and retention intervention for suicidal clients | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Engagement |
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Inclusion Criteria (clients receiving pilot intervention):
Inclusion Criteria (peer specialists delivering pilot intervention):
Exclusion criteria (all participants):
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| Name | Affiliation | Role |
|---|---|---|
| Lisa B. Dixon, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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No participants progressed beyond Phase 1 (qualitative interviews)
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Engagement and Retention Intervention for Suicidal Clients | 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). Treatment engagement and retention intervention for suicidal clients: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Staff Participants | Staff members who completed Phase 1 qualitative interviews |
| BG001 | Phase 1 Client Participants | Clients who completed Phase 1 qualitative interviews. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The study was terminated before participants could receive the intervention, therefore no data was collected for this outcome. | Posted | 1 month |
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During qualitative interviews, up to 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Engagement and Retention Intervention for Suicidal Clients | 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). Treatment engagement and retention intervention for suicidal clients: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa B. Dixon, MD, MPH | Columbia University | 646 774 8420 | Lisa.Dixon@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2025 | Nov 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2024 | Nov 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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).
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N/A - Open pilot trial
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Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims
| 1 month |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary | 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 | The study was terminated before participants could receive the intervention, therefore no data was collected for this outcome. | Posted | 1 month |
|
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| Primary | 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 | The study was terminated before participants could receive the intervention, therefore no data was collected for this outcome. | Posted | 1 month |
|
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| Secondary | 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 | The study was terminated before participants could receive the intervention, therefore no data was collected for this outcome. | Posted | 1 month |
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| Secondary | Engagement | Rate of return after the first OBH visit for clients assigned to the suicide care pathway, as assessed by Medicaid claims | The study was terminated before participants could receive the intervention, therefore no data was collected for this outcome. | Posted | 1 month |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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