- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922670
The BH-Works Suicide Prevention Program for Sexual and Gender Minority Youth
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, United States, 19147
- Mazzoni Center
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Virginia
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Roanoke, Virginia, United States, 24014
- Carilion Clinic
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Roanoke, Virginia, United States, 24016
- Diversity Camp, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- youth must be seeking services at the participating LGBTQ organizations.
- youth must endorse current suicidal ideation on the BHS.
Exclusion Criteria:
- youth lack enough English-language proficiency to complete the BH-Works program
- youth are not capable of understanding the requirements for study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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).
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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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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.
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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.
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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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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.
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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).
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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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Behavioral Health Screen Suicide Subscale (Youth Self-report)
Time Frame: To be collected from youth at time of study enrollment.
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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.
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To be collected from youth at time of study enrollment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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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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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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.
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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.
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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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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.
|
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.
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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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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.
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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.
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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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jody M. Russon, PhD, Virginia Polytechnic Institute and State University
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
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Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
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University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
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Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
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University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
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Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
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Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
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VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
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Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityActive, not recruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
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Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
Clinical Trials on The Behavioral Health-Works Suicide Prevention Program for Sexual and Gender Minority Youth
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University of MichiganNational Institute of Mental Health (NIMH); Children's Hospital of Michigan; ...RecruitingBehavioral Symptoms | Suicide | Self-Injurious Behavior | Behavior | Suicide PreventionUnited States
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University of MichiganNational Institute of Mental Health (NIMH); Children's Hospital of Michigan; ...CompletedSuicide PreventionUnited States
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University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
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University of Texas at AustinNational Institute of Nursing Research (NINR)Recruiting
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Hanoi Medical UniversityNational Geriatric HospitalCompletedStroke | Cerebrovascular Disorders | Brain Ischemia | Cerebral Infarction | Brain InfarctionVietnam