The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth

NCT05922670 | Terminated Results DMC

• 1 other identifier: 22-079
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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 de-identified treatment as usual data gathered by participating centers, and work with their advisory board and partners to adapt BH-Works policy, content, practices, and workflow. Starting in Year 2, the investigators will train staff/providers in suicide risk management, family engagement and affirmative care. In Years 3 and 4 (no cost extension year), 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).

Conditions

Suicide; Engagement, Patient

Keywords

Sexual and Gender Minority Youth; Suicide Prevention Program; Effectiveness-Implementation Hybrid

Outcome Measures

Primary Outcomes (4)

• Successful Referral (Youth and Staff Report on Youth's Attendance at a First Behavioral Health Session With a Behavioral Health Provider at the Recommendation of LGBTQ Organization Staff)

  Youth and staff report (medical records) indicate that the youth has attended a first behavioral health appointment at the behavioral health site that LGBTQ organization staff referred them to. This data is to be recorded dichotomously (no= 0; yes=1).

  Youth self-report and staff report (medical records) to be collected within one week to one month after participant enrolled in study and completed the behavioral health screen.

• Acceptability of Intervention Measure (Youth Self-report)

  The Acceptability of Intervention Measure (AIM) examine intervention or program acceptability. Youth will complete this measure within one week to one month after they enroll in the study and complete the behavioral health screen. The AIM includes 4-items and has a 5-point Likert response scale (1 = completely disagree, 5 = completely agree) for each item. To calculate the total scale score for the measure, responses from the 4-items are averaged for a total score of 1-5. Higher scores indicate greater program satisfaction.

  Youth self-report measure to be collected within one week to one month after participant enrolls in study and completes the behavioral health screen.

• Caregiver Involvement (Staff Report on Caregiver Involvement in the Screening and Referral Process With Their Youth)

  LGBTQ organization staff will indicate whether a caregiver has been involved in the screening and referral process taking place at LGBTQ organizations. This data will be recorded dichotomously (no= 0; yes=1).

  Staff report to be collected within one week to one month after participant enrolls in study and the youth completes the behavioral health screen.

• Behavioral Health Screen Suicide Subscale (Youth Self-report)

  The suicide subscale of the behavioral health screen consists of four items asking youth about suicidal ideation and behavior. The response format is dichotomous (yes/no) for each item. The total subscale score uses established clinical cut-offs to indicate those participants who are at risk for suicide.

  To be collected from youth at time of study enrollment.

Secondary Outcomes (4)

• Gatekeeper Behavior Scale (Administrator/Staff Training Impact)

  Completed pre- and post- training, then was slated to be re-assessed and every 6 months during the 18-month experimental phase. Pre- and post-training timepoints were collected prior to project termination.

• Family Engagement Scale (Administrator/Staff Training Impact)

  Completed pre- and post- training, then was slated to be re-assessed and every 6 months during the 18-month experimental phase. Pre- and post-training timepoints were collected prior to project termination.

• Partnership Development Items (Administrator/Staff)

  Completed pre- and post- training, then was slated to be re-assessed at every 6 months during the 18-month experimental phase. Pre- and post-training timepoints were collected prior to project termination.

• Software Usability Survey (Administrator/Staff)

  To be collected at post-training, at start of pilot period once staff/administrators begin using program software. Then, to be re-assessed every 6 months during the 18-month experimental phase. This survey was not collected prior to project termination.

Study Arms (1)

SGM BH-Works Implementation

EXPERIMENTAL

For this phase of the study, the adapted version of the BH-works program (SGM BH-Works) will be implemented into LGBTQ+ Community Organizations. The BH-Works program offers screening, training, and referral coordination.

Behavioral: The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth

Interventions

The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth BEHAVIORAL

BH-Works is a web-based, comprehensive program for suicide prevention. The BH-Works program is a systems-level intervention that provides tools and resources to make organization adoption more feasible.

Also known as: SGM BH-Works

SGM BH-Works Implementation

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Mazzoni Health Center: collaborator
• Thomas Jefferson University: collaborator
• Carilion Clinic: collaborator
• Diversity Camp, Inc.: collaborator

Study Sites (4)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Mazzoni Center

Philadelphia, Pennsylvania, 19147, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Diversity Camp, Inc.

Roanoke, Virginia, 24016, United States

Location

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MeSH Terms

Conditions

Suicide; Patient Participation; Coitus

Interventions

Sex

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Jody Russon
• Organization: Virginia Tech

jrusson@vt.edu

540-231-4235

Study Officials

• Jody M. Russon, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Behavioral health-Works (BH-Works) is a systems-level, multicomponent suicide prevention program designed for youth populations. The program 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 was adapted for the constituent groups and workflows of LGBTQ organizationsm, becoming SGM BH-Works.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 28, 2023
• Study Start: July 24, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: If funded, within 6 months of the Notice of Award date the investigators will submit a Data Submission Agreement signed by the principal investigator and an institutional business official, as well as define and complete the Data Expected section of this project. Uploads of all initial demographic and clinical data will be completed by the next submission cycle deadline following the initiation of data collection of clinical assessments outlined in the timeline for this project. Clinical data collection, therefore, will occur when the pilot phase begins, month 11 (July 2023) of the project. The next submission cycle deadline following July 2023 would be January 15th, 2024. Subsequent data uploads will be harmonized, validated, and submitted biannually on the standard January 15th and July 15th submission deadlines.

Locations

US (4)