SuicideNCT05922670
The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth
A study testing The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth in people with Suicide and Engagement, Patient, run by Virginia Polytechnic Institute and State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Suicide, Engagement, Patient
- What is being tested?
- The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jul 2024to 21 Mar 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth must be seeking services at the participating LGBTQ organizations.
- youth must endorse current suicidal ideation on the BHS.
Who cannot join
- youth lack enough English-language proficiency to complete the BH-Works program
- youth are not capable of understanding the requirements for study participation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mazzoni Center
Philadelphia, Pennsylvania, 19147
Carilion Clinic
Roanoke, Virginia, 24014
Diversity Camp, Inc.
Roanoke, Virginia, 24016
About this study
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).
Read the 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 de-identified treatment as usual data gathered by participating centers, and work with stakeholders to adapt BH-Works policy, content, practices, and workflow. Starting in Year 2, the investigators will also train staff 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 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 during the first two years, while the investigators do manual and program adaptation (Aim #1). In year 2, the investigators will conduct the Zero Suicide evaluation, and begin conducting trainings with LGBTQ organizations and BH site staff. The program will then be piloted for a month, and the investigators will gather initial feedback (focus groups) on the program to make final adaptations to the manual. Training consultations with staff will proceed bi-monthly through years 3 and 4, once the program is implemented (Aim #2). In years 3 and 4, the investigators will run the program and collect satisfaction (consumers), feasibility, acceptability, and preliminary effectiveness data (Aim #3). At the end of year 4, 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 from the participating 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. As part of standard care procedures, staff currently conduct a 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 encourage LGTBQ staff members to include the 4-item Acceptability of Intervention Measure on their experience with a) the referral process, and b) their first behavioral health appointment.
Once the BH-Works program is implemented, 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.
- Conditions
- Suicide, Engagement, Patient
- Being tested
- The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth
- Keywords
- Sexual and Gender Minority Youth, Suicide Prevention Program, Effectiveness-Implementation Hybrid
- Medical subject headings
- Suicide, Patient Participation, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority YouthBehavioural
Also called SGM BH-Works
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: To be collected from youth at time of study enrollment.
Secondary outcomes (4)
Gatekeeper Behavior Scale (Administrator/Staff Training Impact)
The gatekeeper behavior scale (GBS) was adapted for the purposes of the study. Preparedness, likelihood, and self-efficacy GBS subscales were examined. These subscales include between 2 and 4 items each. The response format for each item is a likert scale and ranges from 1 (very low) to 5 (very high). The total subscale scores for preparedness, liklihood, and self-efficacy were determined by calculating the mean of all item responses within each subscale. Higher scores on each subscale indicate greater training impact.
Measured: 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)
The family engagement scale was developed by the investigators and modeled from the items on the gatekeeper behavior scale. The family engagement scale includes two items evaluating: 1) confidence talking with caregivers' about their youth's suicide risk; and 2) knowing how to motivate a caregiver to take their youth to services. The response format is a likert scale and ranges from 1 (strongly disagree) to 6 (strongly agree). The total scale score is determined by calculating the mean of all item responses. Higher scores indicate greater training impact.
Measured: 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)
Partnership development items were developed by the research team and examined administrator/staff reported confidence in their partnering site's ability to work affirmatively with LGBTQ youth (affirmative item) and help youth with suicidal thoughts and behavior (STB item). They also reported on items assessing liklihood of referring LGBTQ youth to their partnering site (referring item) and reaching out to their partnering site for consultation (consultation item). Partnership development items were completed post-training once administrators/staff were introduced and initiated their cross-site working relationship. The items have a 5-point Likert response scale (1 = very low confidence/liklihood, 5 = very high confidence/liklihood). Higher scores on each item indicate a stronger partnership on the areas assessed.
Measured: 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)
The Software Usability Measurement Interview (SUMI) will be used to measure usability of the BH-Works program portal for administrators/staff, once software use is initiated following training. The SUMI has 50 Likert scale items (i.e., attitude statements requiring participants to respond with "agree," "undecided" and "disagree") and addresses a standard set of usability factors consisting of: Affect, Control, Helpfulness, Learnability, and Efficiency. The quantitative goal is for each factor to achieve a score of at least 80% of the maximum possible score. Progress over the course of the study period will be tracked. The SUMI is scored and interpreted with reference to a standardization database representing mixed software products. This database is updated yearly. The global usability score is set to an average score of 50 with scores above 50 indicating more user-friendly and below as less user-friendly.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start24 Jul 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Why it stopped: A grant termination notification was recieved on 3/21/25 stating that the project no longer affectuates agency priorities. Recruitment was halted upon recieving the termination notice.
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.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mazzoni Health Center, Thomas Jefferson University, Carilion Clinic, Diversity Camp, Inc.
- Responsible party
- Principal investigator, Jody Russon, PhD, LMFT, Virginia Polytechnic Institute and State University
- Investigators
- Jody M. Russon, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922670
- Sponsor's protocol ID
- 22-079
- Status last verified
- Apr 2026
- First submitted
- 16 May 2023
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All youth participants will agree to the sharing of data results with the (National Institute of Mental Health (NIMH) Data Archive (NDA). All data will be de-identified prior to receipt by the repository, but the information needed to generate a (global unique identifier) GUID will be collected for each participant. The proposed research will also involve collecting data from approximately 50-60% of caregivers whose adolescents participate in the research. Demographic information from these participating caregivers will be shared using the procedures described for adolescent participants above.
Publications
Education Development Center (EDC). (2017, January 11). Zero Suicide Organizational Self-Study (Version 1.11.17) [PDF]. Zero Suicide.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Albright GL, Davidson J, Goldman R, Shockley KM, Timmons-Mitchell J. Development and Validation of the Gatekeeper Behavior Scale. Crisis. 2016 Jul;37(4):271-280. doi: 10.1027/0227-5910/a000382. Epub 2016 Jun 1.
PubMed 27245815Bidell MP. The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS): Establishing a New Interdisciplinary Self-Assessment for Health Providers. J Homosex. 2017;64(10):1432-1460. doi: 10.1080/00918369.2017.1321389.
PubMed 28459378Hoyert DL, Xu J. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012 Oct 10;61(6):1-51.
PubMed 24984457Lau AS. Making the case for selective and directed cultural adaptations of evidence-based treatments: Examples from parent training. Clinical psychology: Science and practice. 2006;13(4):295.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
PubMed 23303463Bauer GR, Scheim AI, Pyne J, Travers R, Hammond R. Intervenable factors associated with suicide risk in transgender persons: a respondent driven sampling study in Ontario, Canada. BMC Public Health. 2015 Jun 2;15:525. doi: 10.1186/s12889-015-1867-2.
PubMed 26032733Haas AP, Eliason M, Mays VM, Mathy RM, Cochran SD, D'Augelli AR, Silverman MM, Fisher PW, Hughes T, Rosario M, Russell ST, Malley E, Reed J, Litts DA, Haller E, Sell RL, Remafedi G, Bradford J, Beautrais AL, Brown GK, Diamond GM, Friedman MS, Garofalo R, Turner MS, Hollibaugh A, Clayton PJ. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi: 10.1080/00918369.2011.534038.
PubMed 21213174Perez-Brumer A, Day JK, Russell ST, Hatzenbuehler ML. Prevalence and Correlates of Suicidal Ideation Among Transgender Youth in California: Findings From a Representative, Population-Based Sample of High School Students. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):739-746. doi: 10.1016/j.jaac.2017.06.010. Epub 2017 Jul 5.
PubMed 28838578Toomey RB, Syvertsen AK, Shramko M. Transgender Adolescent Suicide Behavior. Pediatrics. 2018 Oct;142(4):e20174218. doi: 10.1542/peds.2017-4218. Epub 2018 Sep 11.
PubMed 30206149Guss CE, Woolverton GA, Borus J, Austin SB, Reisner SL, Katz-Wise SL. Transgender Adolescents' Experiences in Primary Care: A Qualitative Study. J Adolesc Health. 2019 Sep;65(3):344-349. doi: 10.1016/j.jadohealth.2019.03.009. Epub 2019 Jun 18.
PubMed 31227384Qureshi RI, Zha P, Kim S, Hindin P, Naqvi Z, Holly C, Dubbs W, Ritch W. Health Care Needs and Care Utilization Among Lesbian, Gay, Bisexual, and Transgender Populations in New Jersey. J Homosex. 2018;65(2):167-180. doi: 10.1080/00918369.2017.1311555. Epub 2017 May 8.
PubMed 28481718Olson-Kennedy J, Cohen-Kettenis PT, Kreukels BP, Meyer-Bahlburg HF, Garofalo R, Meyer W, Rosenthal SM. Research priorities for gender nonconforming/transgender youth: gender identity development and biopsychosocial outcomes. Curr Opin Endocrinol Diabetes Obes. 2016 Apr;23(2):172-9. doi: 10.1097/MED.0000000000000236.
PubMed 26825472
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth
- ClinicalTrials.gov ID
- NCT05922670
- Acronym / sponsor ID
- 22-079
- Conditions
- Suicide, Engagement, Patient
- Keywords
- Sexual and Gender Minority Youth, Suicide Prevention Program, Effectiveness-Implementation Hybrid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A grant termination notification was recieved on 3/21/25 stating that the project no longer affectuates agency priorities. Recruitment was halted upon recieving the termination notice.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Mazzoni Health Center, Thomas Jefferson University, Carilion Clinic, Diversity Camp, Inc.
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 de-identified treatment as usual data gathered by participating centers, and work with stakeholders to adapt BH-Works policy, content, practices, and workflow. Starting in Year 2, the investigators will also train staff 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 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 during the first two years, while the investigators do manual and program adaptation (Aim #1). In year 2, the investigators will conduct the Zero Suicide evaluation, and begin conducting trainings with LGBTQ organizations and BH site staff. The program will then be piloted for a month, and the investigators will gather initial feedback (focus groups) on the program to make final adaptations to the manual. Training consultations with staff will proceed bi-monthly through years 3 and 4, once the program is implemented (Aim #2). In years 3 and 4, the investigators will run the program and collect satisfaction (consumers), feasibility, acceptability, and preliminary effectiveness data (Aim #3). At the end of year 4, 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 from the participating 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. As part of standard care procedures, staff currently conduct a 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 encourage LGTBQ staff members to include the 4-item Acceptability of Intervention Measure on their experience with a) the referral process, and b) their first behavioral health appointment.
Once the BH-Works program is implemented, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SGM BH-Works Implementation | Experimental | Behavioral: The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority YouthFor 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- youth must be seeking services at the participating LGBTQ organizations.
- youth must endorse current suicidal ideation on the BHS.
Key exclusion criteria (2 listed)
- youth lack enough English-language proficiency to complete the BH-Works program
- youth are not capable of understanding the requirements for study participation
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 |
|---|---|---|
| The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority YouthAlso: SGM BH-WorksBH-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. | Behavioural | SGM BH-Works Implementation |
Primary outcome
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)
Time frame: 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.
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).
Acceptability of Intervention Measure (Youth Self-report)
Time frame: Youth self-report measure to be collected within one week to one month after participant enrolls in study and completes the behavioral health screen.
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.
Caregiver Involvement (Staff Report on Caregiver Involvement in the Screening and Referral Process With Their Youth)
Time frame: Staff report to be collected within one week to one month after participant enrolls in study and the youth completes the behavioral health screen.
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).
Behavioral Health Screen Suicide Subscale (Youth Self-report)
Time frame: To be collected from youth at time of study enrollment.
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.
4 secondary outcomes
Gatekeeper Behavior Scale (Administrator/Staff Training Impact)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundEducation Development Center (EDC). (2017, January 11). Zero Suicide Organizational Self-Study (Version 1.11.17) [PDF]. Zero Suicide.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 27245815Albright GL, Davidson J, Goldman R, Shockley KM, Timmons-Mitchell J. Development and Validation of the Gatekeeper Behavior Scale. Crisis. 2016 Jul;37(4):271-280. doi: 10.1027/0227-5910/a000382. Epub 2016 Jun 1.
- Background: PubMed 28459378Bidell MP. The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS): Establishing a New Interdisciplinary Self-Assessment for Health Providers. J Homosex. 2017;64(10):1432-1460. doi: 10.1080/00918369.2017.1321389.
- Background: PubMed 24984457Hoyert DL, Xu J. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012 Oct 10;61(6):1-51.
- BackgroundLau AS. Making the case for selective and directed cultural adaptations of evidence-based treatments: Examples from parent training. Clinical psychology: Science and practice. 2006;13(4):295.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 23303463Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
- Background: PubMed 26032733Bauer GR, Scheim AI, Pyne J, Travers R, Hammond R. Intervenable factors associated with suicide risk in transgender persons: a respondent driven sampling study in Ontario, Canada. BMC Public Health. 2015 Jun 2;15:525. doi: 10.1186/s12889-015-1867-2.
- Background: PubMed 21213174Haas AP, Eliason M, Mays VM, Mathy RM, Cochran SD, D'Augelli AR, Silverman MM, Fisher PW, Hughes T, Rosario M, Russell ST, Malley E, Reed J, Litts DA, Haller E, Sell RL, Remafedi G, Bradford J, Beautrais AL, Brown GK, Diamond GM, Friedman MS, Garofalo R, Turner MS, Hollibaugh A, Clayton PJ. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi: 10.1080/00918369.2011.534038.
- Background: PubMed 28838578Perez-Brumer A, Day JK, Russell ST, Hatzenbuehler ML. Prevalence and Correlates of Suicidal Ideation Among Transgender Youth in California: Findings From a Representative, Population-Based Sample of High School Students. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):739-746. doi: 10.1016/j.jaac.2017.06.010. Epub 2017 Jul 5.
- Background: PubMed 30206149Toomey RB, Syvertsen AK, Shramko M. Transgender Adolescent Suicide Behavior. Pediatrics. 2018 Oct;142(4):e20174218. doi: 10.1542/peds.2017-4218. Epub 2018 Sep 11.
- Individual participant dataSharing planned: Yes. All youth participants will agree to the sharing of data results with the (National Institute of Mental Health (NIMH) Data Archive (NDA). All data will be de-identified prior to receipt by the repository, but the information needed to generate a (global unique identifier) GUID will be collected for each participant. The proposed research will also involve collecting data from approximately 50-60% of caregivers whose adolescents participate in the research. Demographic information from these participating caregivers will be shared using the procedures described for adolescent participants above.
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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.
Jody M. Russon, PhD principal investigator
Virginia Polytechnic Institute and State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth in people with Suicide and Engagement, Patient, run by Virginia Polytechnic Institute and State University at 4 sites 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 2 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 27 Apr 2026). 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?
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) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922670, which also lists 40 linked publications.
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 27 Apr 2026.