Clinical trial NCT05922670: The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth
Official title: The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Suicide
Engagement, Patient
Keywords: Sexual and Gender Minority Youth
Suicide Prevention Program
Effectiveness-Implementation Hybrid
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Drexel University
name: Mazzoni Health Center
name: Thomas Jefferson University
name: Carilion Clinic
name: Diversity Camp, Inc.
First posted: 2023-06-28
Enrollment: 260
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Behavioral health-Works (BH-Works) is a systems-level, multicomponent suicide prevention program designed for youth populations. The program includes two primary components, comprehensive web-based behavioral health screening (BHS), and an electronic referral system. This project will adapt and import this program into lesbian, gay, bisexual, transgender, and queer (LGBTQ) organizations. This project builds upon robust partnerships with two diverse LGBTQ organizations in Philadelphia, Pennsylvania and in rural Roanoke, Virginia and their behavioral health partners.
Primary purpose: PREVENTION

Brief summary: Youth suicide is a serious public health concern. Compared to their heterosexual and cisgender peers, sexual and gender minority (SGM) adolescents report higher rates of suicidal ideation and suicide attempts. Unfortunately, many barriers complicate the implementation of suicide prevention in SGM communities. SGM youth often report feeling unwelcome in traditional behavioral health service organizations. Consequently, treatment attendance and retention remain low. Instead, this population generally seeks mental health services in community organizations for lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth. These organizations are often unprepared for this clinical challenge. The Behavioral Health-Works (BH-Works) suicide risk management system may offer a potential solution to this problem. BH-Works is an evidence-based, comprehensive youth suicide prevention program. It offers support for policy development, staff training, suicide and behavioral health screening, technology-assisted safety planning, an electronic patient referral system, real-time data analytics for program monitoring, and a learning collaborative structure to support sustainability. All functions are supported on a web-based software platform that facilitates cross-system communication, implementation, adoption, and expansion. In this project, the investigators will adapt this program for LGBTQ organizations and test feasibility, acceptability and preliminary effectiveness. This project builds upon robust partnerships with two diverse LGBTQ organizations in Philadelphia, Pennsylvania and rural Southwest, Virginia) and their respective behavioral health (BH) partnering sites. To facilitate BH-Works adaptation for SGM adolescents, the investigators will employ the Enhancing Engagement trajectory from Lau's cultural adaptation framework. To pilot the program within LGBTQ organizations and their partners, the investigators will use an Effectiveness-Implementation Hybrid Type 2 design with a historical comparison group. Informed by the Consolidated Framework for Implementation Research, the investigators will also pilot test a sequenced implementation strategy. This strategy focuses on promoting engagement, building partnerships, and creating sustainability. In Years 1 and 2, the investigators will collect treatment as usual data, and work with their partners to adapt BH-Works policy, content, practices, and workflow. The investigators will also train staff/providers in suicide risk management, family engagement and affirmative care. In Years 3 and 4, the investigators will test the adapted SGM BH-Works Program and examine several essential program targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification).

Detailed description: Suicide is the second leading cause of death for 15-to-24-year-olds in the United States (U.S.). Yet, only 14% of youth with suicidal ideation and 22% of those who make a suicide attempt, report receiving mental health services. The circumstances that sexual and gender minority (SGM) youth face are particularly alarming. Compared to their heterosexual and cisgender peers, SGM adolescents report far higher rates of suicidal ideation and suicide attempts. Consequently, adoption of effective suicide prevention programs, that increase identification and referral in organizations serving this population, are sorely needed.

Unfortunately, many barriers complicate the implementation of suicide prevention for SGM communities. SGM youth often report feeling unwelcome and misunderstood in traditional behavioral health service organizations. Consequently, treatment attendance and retention remain low. Instead, this population generally seeks mental health services in community organizations for lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth. Unfortunately, these organizations are often unprepared for this clinical challenge. Specifically, they lack a) training in risk assessment, b) standardized screening tools, and c) access to behavioral health (BH) services that staff trust. In addition, staff in LGBTQ organizations express concern that many BH providers lack the SGM-sensitivity needed to work with this high risk, vulnerable population. Given these challenges, suicide prevention for SGM youth requires a multi-faceted program aimed to improve resources within these organizations and relationships between service systems.

A potential solution to this challenge is the Behavioral Health-Works (BH-Works) suicide risk management system. Similar to the identify, treat and refer structure of screening, brief intervention, and referral to treatment (SBIRT) for substance use, BH-Works includes support for policy development, staff training, suicide and behavioral health screening, technology-assisted safety planning, an electronic patient referral system, real-time data management for program monitoring, and a learning collaborative structure to support sustainability. All functions are supported on a web-based platform that facilitates cross-system communication, implementation, adoption, and expansion. BH-Works has been used in both clinical and non-clinical settings. In this project, the investigators will adapt BH-Works for SGM adolescents presenting in LGBTQ organizations and use data from the web-based screening and EMR systems to measure targets and outcomes. The investigators will employ the Enhancing Engagement trajectory, from Lau's cultural adaptation framework for this purpose. Lau recommends that adaptation of evidence-based treatments (EBTs) is necessary when contextual processes (e.g. discrimination, caregiver support, mistrust of health systems) contribute to unique vulnerabilities in specific populations, particularly those living in contexts where fewer specialized services exist. This project builds upon partnerships with two LGBTQ organizations in Philadelphia, and rural Southwest, Virginia) and their respective behavioral health (BH) partners.

The investigators will use an Effectiveness-Implementation Hybrid Type 2 design, with a historical comparison group, to test the feasibility, acceptability, and preliminary effectiveness of BH-Works within the LGBTQ organizations and their BH partners. Informed by the Consolidated Framework for Implementation Research (CFIR), the investigators will pilot test a sequenced implementation strategy. This strategy focuses on building partnerships and involves a) promoting engagement, b) strengthening relationships, and c) creating sustainability. In Year 1, the investigators will collect treatment as usual data, and work with stakeholders to adapt BH-Works policy, content, practices, and workflow. The investigators will also train staff in suicide risk management, family engagement, and affirmative care. In Years 2 and 3, the investigators will test the adapted SGM BH-Works Program and examine several essential program targets and outcomes, which are outlined in the aims.

Three aims focus on engagement, adaptation, and feasibility/acceptability of SGM BH-Works. Aim #1: Engage LGBTQ organization staff and partnering behavioral health providers. This aim focuses on: a) engaging a stakeholder advisory group, and b) initiating the implementation strategy. Aim #2: Adapt and pilot the BH-Works Program for LGBTQ organizations and partnering behavioral health sites. The adapted BH-Works Program will be implemented into LGBTQ organizations' workflow for a one-month open trial. Qualitative and quantitative data will be collected to evaluate initial feasibility and acceptability as well as to explore barriers and facilitators to usability in urban and rural organizations. The manual will undergo revisions. Aim #3: Test the feasibility, acceptability, and preliminary effectiveness of the SGM BH-Works Program compared to a historical control group. This quasi-experimental design will test the relationships between targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification). The proposed research responds to the growing national need to identify and refer vulnerable youth at risk for suicide.

Timeline: Control group data will be collected from month 5-18, while the investigators do manual and program adaptation (Aim #1). In months 19-24, the investigators will conduct the Zero Suicide evaluation, conduct trainings with LGBTQ organizations and BH site staff, pilot the program for a month, and gather initial feedback (focus groups) on the program to make final adaptations to the manual. Training consultations with staff will proceed bi-monthly through month 41 (Aim #2). In months 25-41, the investigators will run the program and collect satisfaction (consumers), feasibility, acceptability, and preliminary effectiveness data (Aim #3). In months 42-44, the investigators will do closing focus groups with staff, administrators, caregivers, and patients at all sites. Following this, the investigators will write up manuscripts and an R01 to test the SGM BH-Works program on a larger scale. Research aims for this three-year project will be completed with the addition of a fourth no cost extension year.

Procedure: Procedures are broken down by aim.

Aim #1: Engage LGBTQ organization staff and partnering behavioral health providers. This aim focuses on: a) engaging a stakeholder advisory group, and b) initiating the implementation strategy.

Administrative stakeholder participants have already agreed to participate in this research and serve as Co-Is on the project. LGBTQ staff/behavioral health provider participants will be recruited by leadership to participate in this project. The investigators expect to include 4-8 staff/providers/administrators at each site. Consenting processes will occur immediately before initial evaluation activities and the first trainings begins. Each agency reports having at least 4 to 6 intake workers and all will be trained in the program. These staff members will complete assessments at the beginning of the study and then five times over the course of years 2-4. They will participate in a final interview after the one month pilot period and at the end of the study.

Engage advisory board and workgroup. A local and national advisory board will serve as project collaborators. This group includes academics, educators, administrators, practicing professionals, and community members who are committed to SGM health (see letters of support and commitment). The principal investigator's partners at will assist in identifying SGM youth and their caregivers to serve on the board. The investigators' collaboration with an organizing body for LGBTQ community centers in the world, will have a central role in steering this project. A smaller workgroup will consist of project investigators, leadership from partnering sites, and an implementation consultant. The advisory board meets every two-three months throughout the project.

Aim #2: Adapt and pilot the BH-Works Program for LGBTQ organizations and partnering behavioral health sites. The adapted BH-Works Program will be implemented into LGBTQ organizations' workflow for a one-month open trial. Qualitative and quantitative data will be collected to evaluate initial feasibility and acceptability as well as to explore barriers and facilitators to usability in urban and rural organizations. The manual will undergo revisions.

Adaptation process. The investigators will employ Lau's framework for the cultural adaptations of evidence-based treatments (EBTs). Lau recommends that adaptation of EBTs is necessary when contextual processes (e.g. discrimination, caregiver support, mistrust of health systems) contribute to unique vulnerabilities in specific populations, such as SGM youth (particularly those living in rural contexts where fewer specialized LGBTQ services exist). In this project, the investigators focus on Lau's Enhancing Engagement trajectory of adaptation work. As such, the workgroup will focus on generating BH-Works program adaptations that will increase social validity, a potential target for increasing engagement. The role of the workgroup is essential in the adaptation process. The investigators expect this group will increase the social validity of the program by helping us adapt the screening language to be more affirmative, better manage matters of pronoun use, and address concerns about discrimination in standard operating procedures.

Adolescent, emerging adult, and caregiver participation in the pilot process mirrors what is described below in Aim #3. Following the Aim #2 pilot of the BH-Works program, organization staff, patients and caregivers will be invited to participate in a focus group to discuss features of the BH-Works program that they find appealing and unappealing, as well as suggestions for improvement. Responses will be consolidated across group and location type (urban vs. rural).

Aim #3: Test the feasibility, acceptability, and preliminary effectiveness of the SGM BH-Works Program compared to a historical control group. This quasi-experimental design will test the relationships between targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification). The proposed research responds to the growing national need to identify and refer vulnerable youth at risk for suicide.

Treatment as usual data will be extracted as de-identified medical records data at the LGBTQ organizations. Data will be collected on the number of patients who were a) assessed for suicide, b) identified as at risk for suicide, and c) referred for behavioral health services. As part of standard care procedures, staff currently conduct a one week follow up call on any patient referred for services, asking if they attended and about their experience. To facilitate comparison with the intervention group, the investigators will ask LGTBQ staff members to include 4-item Acceptability of Intervention Measure on their experience with a) the referral process, and b) their first behavioral health appointment (see measures section).

Treatment as usual data for the control group will be extracted as de-identified records data at the LGBTQ organizations in Years 1 and 2. Data will be collected on the number of patients who were a) assessed for suicide, b) identified as at risk for suicide, and c) referred for behavioral health services. To facilitate comparison with the intervention group, the investigators will ask LGTBQ staff members to include 4-item Acceptability of Intervention Measure (AIM) on their experience with a) the referral process, and b) their first behavioral health appointment.

Once the BH-Works program is implemented in Years 2 and 3, adolescent consent will begin at the point of screening. The BH-Works screening tool will be included in the standard of care procedures. However, the principal investigator's Institution Review Board (IRB) has approved a brief consent at the beginning of the screen asking permission to use de-identified screening data for research; 90% of patients agree to participate. At the end of the BHS, participants complete a brief satisfaction measure about their experience with the screening tool. This is included as part of the screening process for ongoing quality improvement (QI) purposes. In investigators' past studies, if patients endorse any level of current suicidal ideation, a consent form is automatically presented at the end of the screening asking permission to follow up with the adolescent in one week and one month to see if services were recommended and obtained. However, in this study, the LGBTQ agencies already do a standard of care follow up call to see if patients went to services. As such, they will ask if the research team can call to follow up with them about participating in an interview about seeking services. Consent for participation in this follow-up assessment will occur in the first part of the meeting. In both PA and VA, youth, ages 14 and older, can seek their own mental health services without parental consent. At partnering LGBTQ organizations, many adolescents do not want their parents involved. These youth can still participate in this project without involving their parent, even though caregiver engagement will be encouraged.

Caregivers will be recruited in a similar fashion as adolescent patients. After receiving family engagement training, it is expected that staff will be able to engage approximately 50-60% patients' caregivers in the referral process. If caregivers have been engaged, staff will ask if the research team can contact them about participating in a follow up research assessment about seeking help. As with patient participants, caregivers will be contacted to set up a 60-minute meeting a week after their child was screened and referred. Caregivers will provide consent at the beginning of the meeting. The investigators will not exclude caregivers from participation if their adolescent chooses not to participate (and vice versa). It is likely these individual participants can offer important perspectives on screening and referral processes.

Eligibility criteria: Inclusion Criteria:

1. youth must be seeking services at the participating LGBTQ organizations.
2. youth must endorse current suicidal ideation on the BHS.

Exclusion Criteria:

1. youth lack enough English-language proficiency to complete the BH-Works program
2. youth are not capable of understanding the requirements for study participation

Primary outcomes:
measure: Successful Referral (Youth attends a first behavioral health session with a behavioral health provider at the recommendation of LGBTQ organization staff)
timeFrame: Self and staff report (medical records) collected within one week to one month after participant enrolls in study and completes the behavioral health screen.
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Self report collected within one week to one month after participant enrolls in study and completes the behavioral health screen.
measure: Caregiver Involvement (Caregiver was observed by LGBTQ organization staff as being involved in the screening and referral process with their youth)
timeFrame: Staff report collected within one week to one month after participant enrolls in study and completes the behavioral health screen.
measure: Behavioral Health Screen Suicide Subscale
timeFrame: Collected at time of study enrollment.
Secondary outcomes:
measure: Gatekeeper Behavior Scale (Adapted Version)
timeFrame: Completed pre- and post- training during year 2, and every 6 months during the 18-month experimental phase.
measure: Partnership Development Items
timeFrame: Completed pre- and post- training during year 2, and every 6 months during the 18-month experimental phase.
measure: Software Usability Survey
timeFrame: Completed pre- and post- training during year 2, and every 6 months during the 18-month experimental phase.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mazzoni Center
state: Pennsylvania
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Roanoke
country: United States
facility: Diversity Camp, Inc.
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Jody M. Russon, PhD
role: PRINCIPAL_INVESTIGATOR
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