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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.
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| Name | Class |
|---|---|
| Mazzoni Health Center | UNKNOWN |
| Thomas Jefferson University | OTHER |
| Carilion Clinic | OTHER |
| Diversity Camp, Inc. |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jody M. Russon, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States | ||
| Mazzoni Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Education Development Center (EDC). (2017, January 11). Zero Suicide Organizational Self-Study (Version 1.11.17) [PDF]. Zero Suicide. | ||
| 28851459 | Background | 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. | |
| 27245815 |
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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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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.
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No participants were slated to be randomized in this study. All administrator and staff participants were enrolled in the same condition (SGM BH-Works staff training). This study was designed to include youth and caregiver participants as well as administrator and staff participants; however, no youth or caregiver participants were enrolled prior to study termination.
We enrolled staff and administrators (n=18) across participating LGBTQ sites and their behavioral health partners. Enrollment occurred between July 2024 and February 2025. Baseline characteristics were assessed for those who completed pre-training assessments (n=17). Training outcomes were assessed for those who completed all training activities and post-training assessments (n=15).
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| ID | Title | Description |
|---|---|---|
| FG000 | SGM BH-Works Implementation | The adapted version of the BH-works program (SGM BH-Works) staff training was implemented into LGBTQ+ community organizations. The original BH-Works training curriculum was adapted for the purposes of this project and included a newly developed affirmative care module designed by this research team in collaboration with a partnering LGBTQ site. The training was 1.5 days in length and included information about the BH-Works platform technology, affirmative care, suicide awareness, safety planning, and family engagement. Case studies, roleplay, and discussions were also designed and embedded into the training materials. The training was delivered on two separate occasions for the sites in each region (Philadelphia and Southwest Virginia). Per our implementation strategy, this allowed for those at LGBTQ organizations and their partnering behavioral health sites to build a relationship. Non-participant leadership and support staff were also invited to participate in relevant aspects of the training. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2024 |
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| UNKNOWN |
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.
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| To be collected from youth at time of study enrollment. |
| 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. | 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. | 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. | 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. |
| Philadelphia |
| Pennsylvania |
| 19147 |
| United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Diversity Camp, Inc. | Roanoke | Virginia | 24016 | United States |
| Background |
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| Background | Substance Abuse and Mental Health Services Administration. (2012). Screening, Brief Intervention, and Referral to Treatment (SBIRT). U.S. Department of Health and Human Services. https://www.samhsa.gov/sbirt |
| 19664226 | Background | Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. |
| Background | Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in psychology. 2006 Jan 1;3(2):77-101. |
| Background | Diamond GM, Shilo G, Jurgensen E, D'Augelli A, Samarova V, White K. How depressed and suicidal sexual minority adolescents understand the causes of their distress. Journal of Gay & Lesbian Mental Health. 2011 Mar 31;15(2):130-51. |
| 35662798 | Background | Diamond G, Kodish T, Ewing ESK, Hunt QA, Russon JM. Family processes: Risk, protective and treatment factors for youth at risk for suicide. Aggress Violent Behav. 2022 May-Jun;64:101586. doi: 10.1016/j.avb.2021.101586. Epub 2021 Mar 9. |
| 24437432 | Background | Asarnow JR, Miranda J. Improving care for depression and suicide risk in adolescents: innovative strategies for bringing treatments to community settings. Annu Rev Clin Psychol. 2014;10:275-303. doi: 10.1146/annurev-clinpsy-032813-153742. Epub 2014 Jan 16. |
| Background | Coleman N. SUMI (Software Usability Measurement Inventory) as a knowledge elicitation tool for improving usability. 1993; Unpublished BA Honours thesis, Dept. Applied Psychology, University College Cork, Ireland. |
| 33074740 | Background | Fish JN. Future Directions in Understanding and Addressing Mental Health among LGBTQ Youth. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):943-956. doi: 10.1080/15374416.2020.1815207. Epub 2020 Oct 19. |
| Background | Guo W, Ratcliffe SJ, Have TT. A random pattern-mixture model for longitudinal data with dropouts. Journal of the American Statistical Association. 2004 Dec 1;99(468):929-37. |
| Background | Hedeker D, Gibbons RD. Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychological methods. 1997 Mar;2(1):64. |
| 26769889 | Background | Kano M, Silva-Banuelos AR, Sturm R, Willging CE. Stakeholders' Recommendations to Improve Patient-centered "LGBTQ" Primary Care in Rural and Multicultural Practices. J Am Board Fam Med. 2016 Jan-Feb;29(1):156-60. doi: 10.3122/jabfm.2016.01.150205. |
| Background | Raudenbush SW, Bryk AS. Hierarchical linear models: Applications and data analysis methods. sage; 2002. |
| 34447940 | Background | Richards JE, Simon GE, Boggs JM, Beidas R, Yarborough BJH, Coleman KJ, Sterling SA, Beck A, Flores JP, Bruschke C, Grumet JG, Stewart CC, Schoenbaum M, Westphal J, Ahmedani BK. An implementation evaluation of "Zero Suicide" using normalization process theory to support high-quality care for patients at risk of suicide. Implement Res Pract. 2021 Jan 1;2. doi: 10.1177/26334895211011769. Epub 2021 May 24. |
| 34046893 | Background | Russon J, Smithee L, Simpson S, Levy S, Diamond G. Demonstrating Attachment-Based Family Therapy for Transgender and Gender Diverse Youth with Suicidal Thoughts and Behavior: A Case Study. Fam Process. 2022 Mar;61(1):230-245. doi: 10.1111/famp.12677. Epub 2021 May 27. |
| 28865597 | Background | Taliaferro LA, Muehlenkamp JJ. Nonsuicidal Self-Injury and Suicidality Among Sexual Minority Youth: Risk Factors and Protective Connectedness Factors. Acad Pediatr. 2017 Sep-Oct;17(7):715-722. doi: 10.1016/j.acap.2016.11.002. |
| 20147663 | Background | Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10. |
| Staff & Administrator Baseline Assessment |
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| Staff & Administrator Post-Training Assessment |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 18 administrators (n=4) and staff (n=14) were enrolled across sites. While 18 staff and administrators were enrolled in the study, only 17 completed baseline assessments prior to termination. All participants were assigned to the same condition, SGM BH-Works (staff training). No youth or caregiver participants were enrolled in the study before project termination, as such, baseline measures only include staff/administrator participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | SGM BH-Works Implementation | 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. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Leadership Commitment: Zero Suicide Self-Study Assessment | This items asks: "What type of commitment has leadership made to reduce suicide and provide suicide prevention services?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Staffing Committment: Zero Suicide Self-Study Assessment | This items asks: "What type of formal commitment has leadership in your organization made regarding staffing to reduce suicide and to provide safer suicide prevention and intervention?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Role of Survivors: Zero Suicide Self-Study Assessment | This item asks: "What is the role of suicide attempt and suicide loss survivors in the organization's design, implementation, and improvement of suicide prevention and intervention policies and services?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Staff Assessment: Zero Suicide Self-Study Assessment | This item asks: "How does the organization formally assess staff on their perception of their confidence, skills, and perceived support to identify and care for individuals at risk for suicide?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Staff Trainings: Zero Suicide Self-Study Assessment | This item asks: "What trainings on identifying people at risk for suicide or providing suicide prevention and intervention services have been provided to staff?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Screening Policies or Procedures: Zero Suicide Self-Study Assessment | This item asks: "What are the organization's policies or procedures for screening for suicide risk among individuals you serve?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Screen for Suicide: Zero Suicide Self-Study Assessment | This item asks: "How does the organization screen for suicide risk in the people it serves?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Suicide Assessments: Zero Suicide Self-Study Assessment | This item asks: "How does the organization ensure assessments for suicide risk are arranged for individuals who screen positive?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Supporting and Tracking: Zero Suicide Self-Study Assessment | This item asks: "Which best describes the organization's approach to supporting and tracking individuals at risk for suicide?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Collaborative Safety Planning: Zero Suicide Self-Study Assessment | This item asks: "What is the organization's approach to collaborative safety planning when an individual is at risk for suicide?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Lethal Means Safety: Zero Suicide Self-Study Assessment | This item asks: "What is the organization's approach to lethal means safety?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Referring for Treatment: Zero Suicide Self-Study Assessment | This item asks: "What is the organization's approach to referring individuals for treatment of suicidal thoughts and behaviors?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Engaging: Zero Suicide Self-Study Assessment | This item asks: "What is the organization's approach to engaging hard-to-reach individuals or those who are at risk and don't show for expected services?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Quality Improvement: Zero Suicide Self-Study Assessment | This item asks: "What is the organization's approach to quality improvement efforts related to suicide prevention services?" Items from the Zero Suicide Organizational Self-Study measure organizational suicide prevention readiness in multiple, overarching domains (lead, train, identify, engage, treat, transition, improve) on a rating scale with anchors from 1 to 5. Higher ratings indicate that the organization has embedded greater suicide care with regard to the domain. | Respondents who indicated "I don't know" or "I prefer not to answer" on this item are not included in the mean. | Mean | Standard Deviation | Scores on a scale |
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| Prior Participation in Suicide Readiness Modules | Count of staff/administrator participants who had already recieved portions of the suicide readiness modules to be provided in the training for the program under study. These participants only were required to attend the portions they had not recieved. | Count of Participants | Participants |
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| Participant Education | Number of participants with a master's degree or higher. | Count of Participants | Participants |
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| Participant Prior Suicide Prevention Training | Number of participants who reporting attending a prior training on suicide prevention before participating in the training for the program under study. | Count of Participants | Participants |
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| Clinical Experience | Number of participants reporting six or more years in clinical practice. | Count of Participants | Participants |
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| Professional Experience with LGBTQ Youth | Number of participants reporting two or more years of working with LGBTQ youth professionally. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | While staff/administrator participants were enrolled in the study, no youth or caregiver participants were enrolled by the time of project termination. SGM BH-Works was in the process of being implemented and staff/administrators were completing training. | Posted | 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. |
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| Primary | 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. | While staff/administrator participants were enrolled, no youth or caregiver participants were enrolled by the time of project termination. SGM BH-Works was in the process of being implemented and staff/administrators were completing training. | Posted | Youth self-report measure to be collected within one week to one month after participant enrolls in study and completes the behavioral health screen. |
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| Primary | 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). | While staff/administrator participants were enrolled, no youth or caregiver participants were enrolled by the time of project termination. SGM BH-Works was in the process of being implemented and staff/administrators were completing training. | Posted | Staff report to be collected within one week to one month after participant enrolls in study and the youth completes the behavioral health screen. |
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| Primary | 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. | While staff/administrator participants were enrolled, no youth or caregiver participants were enrolled by the time of project termination. SGM BH-Works was in the process of being implemented and staff/administrators were completing training. | Posted | To be collected from youth at time of study enrollment. |
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| Secondary | 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. | While 18 staff and administrators were enrolled in the study, 17 completed the first timepoint (pre-training) when the Gatekeeper Behavior Scale was first administered. Related-samples tests only included data from those participants who completed all training activities as well as pre- and post-training assessments. Some participants were in the process of completing training activities at the time of project termination. | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | 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. | While 18 staff and administrators were enrolled in the study, 17 completed the first timepoint (pre-training) when the family engagement scale was first administered. Related-samples tests only included data from those participants who completed all training activities as well as pre- and post-training assessments. Some participants were in the process of completing training activities at the time of project termination. | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Post-Hoc | Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (Administrator/Staff Training Impact) | The Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS) is a self report measure used to examine clinical preparedness, attitudes, and knowledge with regard to treating LGBT patients. In this study, the total scale score (mean of all individual items) was used. Scores range from 1-7, where higher values represent greater levels of preparedness for working with LGBT patients. | While 18 staff and administrators were enrolled in the study, 17 completed the first timepoint (pre-training) when this measure was first administered. Related-samples tests only included data from those participants who completed all training activities as well as pre- and post-training assessments. Some participants were in the process of completing training activities at the time of project termination. | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | 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. | While 18 staff and administrators were enrolled in the study, 14-17 completed both the pre and post-training timepoints (depending on the item). Some participants were in the process of completing training activities at the time of project termination. | Posted | Mean | Standard Deviation | Scores on a scale | 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. |
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| Secondary | 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. | The software usability survey was slated to be administered once staff/administrators initiated their use of the program platform at post-training and at the start of the pilot period. This survey was not collected prior to project termination. | Posted | 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. |
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| Post-Hoc | Acceptability, Feasibility, and Appropriateness of Intervention Measures (Administrator/Staff) | The Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM) examine intervention or program acceptability, feasibility, and appropriateness. Administrators and staff completed these measure at the post-training timepoint, after they had learned about the SGM BH-Works program. Each measure 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 each measure, responses from the 4-items are averaged for a total score of 1-5. Higher scores indicate greater program acceptability, feasibility, or appropriateness. | While 18 staff and administrators were enrolled in the study, 15 completed the second timepoint (post-training) when these measures were administered to administrators/staff after they learned about the details of BH-Works program. Some participants were in the process of completing training activities at the time of project termination. | Posted | Mean | Standard Deviation | Scores on a scale | Completed at the second (post- training) timepoint (after introduced to BH-Works), 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. |
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Adverse events were to be monitored for youth and caregiver participants for the duration of their participation in the active phase of the trial (approximately one month following enrollment). Youth and caregiver participants were not enrolled prior to project termination. Adverse events for staff and administrator participants were monitored for a period of less than a year prior to termination, but were slated to be monitored for 24 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SGM BH-Works Implementation | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Russon | Virginia Tech | 540-231-4235 | jrusson@vt.edu |
| Aug 25, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2025 | Aug 25, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D010358 | Patient Participation |
| D003075 | Coitus |
| ID | Term |
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| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D012725 | Sexual Behavior |
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| ID | Term |
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| D012723 | Sex |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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