Zero Suicide Implementation in Outpatient Mental Health Clinics

NCT05587530 | Terminated Results DMC

• 4 other identifiers: AAAV1378R56MH11213983201383713
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Suicide

Keywords

Suicide Prevention; Engagement; Retention; Outpatient behavioral health

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Perceived Effectiveness

  1 month

• Engagement

  1 month

Study Arms (1)

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).

Behavioral: Treatment engagement and retention intervention for suicidal clients

Interventions

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.

Treatment engagement and retention intervention for suicidal clients

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Lacks capacity to consent
• Not fluent to read, write, and/or speak in English

Sponsors & Collaborators

• Columbia University: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Lisa B. Dixon, MD, MPH
• Organization: Columbia University

Lisa.Dixon@nyspi.columbia.edu

646 774 8420

Study Officials

• Lisa B. Dixon, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A - Open pilot trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edna L. Edison Professor of Psychiatry

Model Details: 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).

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: October 20, 2022
• Study Start: November 20, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)