Clinical Research Directory

Safety Planning Intervention for Autistic Youth: A Randomized Controlled Trial With Providers in Developmental-Behavioral Pediatric Clinics

The goal of this clinical trial is to examine the initial feasibility, acceptability, and effectiveness of Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) for providers serving autistic youth in outpatient settings. The main question aims to answer: * Assess whether CIPP-A is feasible and acceptable to providers in development behavioral pediatric clinics? * Assess whether CIPP-A shows initial effectiveness in increasing providers confidence in managing suicide risk in autistic youth? If there is a comparison group: Researchers will compare CIPP-A to general safety planning intervention (SPI) on feasibility, acceptability, and initial effectiveness. Participants will be randomized to receive training in SPI or CIPP-A and complete online surveys and interviews over 6-months to measure feasibility, acceptability, and initial effectiveness.

Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities

Suicide is one of the leading causes of early death worldwide. In Brazil, suicide rates have been rising steadily over the past two decades, and most suicides occur in low- and middle-income countries where access to specialized care is limited. There is an urgent need for fast-acting, practical interventions that can be delivered in public emergency settings. Two promising approaches have emerged: esketamine, a medication that can rapidly reduce suicidal thoughts within hours, and Crisis Response Planning (CRP), a brief session in which a trained clinician works with the person to create a personalized written plan for managing future suicidal crises. The goal of this clinical trial is to learn if esketamine or Crisis Response Planning (CRP), each added to enhanced treatment as usual (eTAU), can prevent future suicide-related events compared to eTAU alone in adolescents and adults aged 14 years or older who recently attempted suicide or have severe suicidal thoughts. The main questions it aims to answer are: Does a single esketamine infusion plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Does a single session of Crisis Response Planning plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Which approach leads to faster or more lasting improvements in suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life? Are these interventions feasible, acceptable, and cost-effective within a public health system? Researchers will compare three groups to see which approach works best to prevent suicide attempts, suicide-related hospitalizations, and suicide deaths over one year. A total of 468 participants will be randomly assigned in equal numbers (156 per group) to one of three groups: Esketamine group: receive a single intravenous esketamine infusion (0.50 mg/kg given over 40 minutes) in a monitored medical setting with continuous heart rate, blood pressure, and oxygen monitoring, plus eTAU. A physician will be present throughout. Participants will be observed for up to 24 hours before discharge. Crisis Response Planning group: complete one 20-to-45-minute session with a trained clinician to build a personal crisis plan that includes warning signs, coping strategies, reasons for living, support contacts, and emergency resources. Participants will leave with a written and digital copy of their plan, plus eTAU. Enhanced treatment as usual (eTAU) group: receive standard emergency care, safety counseling about access to lethal means, connection to the local mental health network (including Psychosocial Care Centers and primary care), and a scheduled psychiatric follow-up appointment within 7 days. Participants will: Complete health questionnaires about suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life at 11 time points over one year (at enrollment, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year) Provide a blood sample at the start of the study for exploratory analyses of biological markers that may be related to treatment response Use a smartphone app to report their mood, thoughts, and emotions four times a day for four weeks after enrollment Be monitored for safety and adverse events throughout the entire study period The study takes place in the public emergency network of Indaiatuba, São Paulo, Brazil (population approximately 256,000), and is designed to reflect real-world clinical conditions. Participants who experience a new suicide-related event during the study will be offered an open-label rescue treatment combining esketamine and Crisis Response Planning, and will continue to be followed for the remainder of the year. The study also includes an evaluation of how well these interventions can be adopted and sustained within Brazil's public mental health system, including assessments of acceptability, feasibility, and cost-effectiveness.

Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk: Aim 2b

This is a second pilot study being completed based on lessons learned from the Aim 2a feasibility pilot study (NCT06941311). Following modifications, the investigators are testing the acceptability, feasibility, and preliminary effectiveness of the combination of two psychosocial interventions, Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and the computer-assisted version of the Youth-Nominated Support Team (eYST). In this phase of the study, CBT-SP + eYST will be tested in an open trial (number of youth = 15). Investigators will recruit Black adolescents (ages 12-17) that come to an urban acute care setting for suicidal thoughts and/or self-injurious behaviors to receive the intervention in an outpatient community mental health agency. Participants will receive 12-14 sessions of CBT-SP in addition to YST. Participants will nominate up to 5 caring adults in their lives to serve as support persons. These support persons will attend an education/orientation session to learn more about their role and how to support the youth. Support persons will have weekly contact with the youth and weekly follow up contacts from the youth's clinician/YST intervention specialist. Youth will be assessed at baseline, 6 weeks, and 14 weeks. Parents will be assessed at baseline and 14 weeks. Support persons will be assessed at baseline and 14 weeks. Fidelity assessments will be completed by clinicians after each session, after the YST psycho-ed session, and weekly to document contact with the support team.

Career Enhancement Training Study Delivered Across Career Phases

This trial tests the effectiveness of the Wingman-Connect Program delivered by USAF personnel on individual suicide risk. Randomization will be among classes at Initial Technical Training, in which 396 classes of USAF personnel will be randomized to Wingman-Connect or to an active control training (N=2,970 Airmen) and followed for one year. These classes send a proportion of graduates to Air Force Global Strike Command (AFGSC) \& Air Mobility Command (AMC) operational bases.

Pilot Testing Suicide Risk Prediction Algorithms in Primary Care

The goal of this pilot study is to learn whether the use of suicide risk prediction algorithms in primary care can help identify people who may benefit from extra mental health monitoring. Specifically, this study aims to measure how use of the suicide risk prediction algorithm to prompt extra mental health monitoring among adult primary care patients impacts proportions of patients identified at risk of suicide and engaged in safety planning. Secondarily, we plan to measure proportions of patients identified at risk of suicide via mental health monitoring (irrespective of engagement in safety planning).

Caring Connections Youth Suicide Detection and Intervention Study

The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include: Is Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth? For the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and/or Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.

Adapting a Telehealth Intervention for Suicide Prevention Among Patients With Alcohol Use Disorder in Tanzania

Together, alcohol use and suicide account for approximately 4 million deaths per year, with a considerable burden on low and middle-income countries. Tanzania is among the world's most underserved nations for mental health treatment, with very little capacity to treat suicidality or alcohol use disorders. In this study, the researchers will adapt an evidence-based intervention for suicide prevention to address the unique needs of people with alcohol use disorders in Tanzania, and rigorously pilot test the intervention to assess its feasibility and acceptability in a Tanzanian emergency department.

IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.

A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

Virtual Reality Lethal Means Safety Training

The goal of this randomized clinical trial is to determine whether a virtual reality (VR) training program can help healthcare providers improve their skills in discussing suicide prevention and safe storage of firearms and medications with Veterans. The study will test whether VR training increases providers' self-efficacy, confidence, and comfort in conducting lethal means safety counseling, and whether it improves their intention to use these counseling practices in their clinical work. Researchers will compare healthcare providers who complete the VR training to those who complete a 2D video training to determine whether the VR approach is more effective. Participants will complete online surveys before and after the training and again three months later. They will be randomly assigned to one of two groups: VR training group: Participants use a VR headset to interact with a virtual Veteran patient in a simulated rural clinic and practice suicide prevention counseling skills; Video training group: Participants use the same headset to watch a \~10-minute 2D video depicting the lethal means safety counseling session. After the training, participants will also provide feedback about their experience, including how realistic and useful they found the training.

Online Suicide Prevention and Intervention Training for Secondary School Counselors

The aim of this study is to develop and evaluate the effectiveness of the Online Suicide Prevention and Intervention Training Program (Çevrimiçi İntihar Önleme ve Müdahale Eğitim Programı - ÇİÖMEP) for school counselors working in secondary education. Suicide is a major public health concern among adolescents, and school counselors play a vital role in early identification and intervention. This research uses a randomized controlled trial (RCT) design to determine if the training improves counselors' knowledge, perceived competence, and attitudes toward suicide prevention while reducing the stigma associated with suicidal behavior.

HAVEN-Connect Youth Suicide Prevention

HAVEN=CONNECT is a comprehensive depression and suicide prevention intervention that is designed to be integrated into predominantly Black churches, a strategically ideal location for mental health intervention for Black youth. HAVEN=CONNECT has three components: (1) Church Community Engagement: an interactive process of introducing the program to key church leaders and stakeholder groups. (2) Faith-Based Curriculum: educational overview for pastors, other ministerial staff and youth lay leaders on how to integrate the program into the church using communication mediums that have cultural and religious relevance in the Black Church context. (3) Youth-Connect Intervention: The goals of this project are to test the impact of HAVEN=CONNECT (HAVEN) on key intervention targets, hypothesized mediators, and build a research-informed implementation strategy for future large-scale testing.

Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)

This study will test whether a novel intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings.

Population Impact of Wingman-Connect Implemented by the US Air Force

This study involves collection of implementation data and analysis of USAF de-identified administrative data on base-level suicide attempt rates following US Air Force (USAF) delivery of Wingman-Connect training at 8 operational AF bases, as part of a force-wide scale out of the program. Implementation of Wingman-Connect by the USAF will occur over 51 months. The AF has agreed to stagger implementation based on a randomized stepped-wedge design. Once Wingman-Connect has been initiated at each base, all entering first-term Airmen will receive Wingman-Connect, with \~17,400 total Airmen receiving Wingman-Connect across all bases. Implementation. The study will directly collect data from USAF prevention personnel who are involved in the delivery of the intervention to measure fidelity and measure implementation barriers and facilitators. These base-level data are essential to test Wingman-Connect impact on suicide attempt rates in a general USAF population, to study Wingman-Connect diffusion, and to refine implementation processes and tools. Suicide Rates. Bases routinely provide their base-wide suicide attempt rates to the Air Force Medical Readiness Agency (AFMRA). AFMRA will provide these routinely-collected aggregate administrative data to this study in order to analyze changes in base-level suicide attempt rates (USAF administrative data) among the 8 bases.

Native-RISE (Risk Identification for Suicide and Enhanced Care)

The goal of this research is to test a systems-level suicide prevention strategy, Native-RISE (Risk Identification for Suicide and Enhanced care), that combines predictive analytics and brief contact interventions (BCIs) to reduce suicide in health systems serving Native Americans (NAs). This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and Shiprock) already implementing suicide prevention programs and serving the White Mountain Apache Tribe (WMAT) and Navajo Nation (NN).

Brief Skills for Safer Living (Brief-SfSL)

The goal of this project is to assess the efficacy of Brief-Skills for Safer Living (Brief-SfSL) in a randomized control trial. The investigators will be testing 150 participants Canada-wide, half of which will be randomized to receive Brief-SfSL (B-TAU) and the other half will be randomized to receive Brief-SfSL after a 3 month waitlist (WL-TAU). The main questions this study seeks to answer are: * Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months? * Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity, anxiety, and anhedonia? * Is B-TAU more efficacious than WL-TAU at 3 months for improving social connectedness, emotional regulation, functioning (work, life, social), executive control and social problem-solving? * Are adverse events equivalent between B-TAU and WL-TAU at 3 months?

Implementation of a Suicide Prevention Gatekeeper Program in the University Setting

The goal of this clinical trial is to assess the effectiveness of a suicide prevention training program (Gatekeepers) tailored to university students in Spain. The main questions it aims to answer are: * Does the training program improve suicide-related knowledge, attitudes, perceived behavioral control, and gatekeeper behaviors among students? * Are there differences in training outcomes by gender, and how do they affect program engagement and effectiveness? Researchers will compare a Immediate Intervention Group (GTK-IG), which will receive the full training immediately, with a 2) the Delayed Intervention Group (GTK-DG), which will be a waitlist control during the first phase of the study, to evaluate the program's short- and medium-term impact, using both in-person and online formats. which will be a waitlist control during the first phase of the study. Participants will: * Be randomly assigned to the intervention or control group, choosing between in-person or online training * Complete online surveys at three timepoints: before the program (T0), immediately after (T1), 2-3 months later (T2), and 9-12 months follow-up (T3). * Attend two 3-hour training sessions covering key suicide prevention competencies * Participate in a follow-up session with focus group discussion to qualitatively assess retention and use of learned skills * Complete validated questionnaires on suicide prevention literacy, attitudes, stigma, and self-reported gatekeeper behaviors This trial includes validation of the Spanish versions of the WISE (Willingness to Intervene Against Suicide Enhanced Questionnaire) and ACT as Gatekeeper measures. The study is registered at ClinicalTrials.gov and follows CONSORT and SPIRIT guidelines. Ethical approval was granted by the Human Research Ethics Committee at the University of Valencia.

Life Skills Training for Soldiers Arriving at Their First Duty Location

This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Soldiers arriving at their first duty location will be randomized to receive either Level Up or a single session Army bystander intervention program. Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury

The study purpose is to test the effect of Crisis Response Planning (CRP) when used as the second method of suicide prevention in military service members who are at risk for suicide due to mild traumatic brain injury (mTBI). CRP will be compared to usual treatment. The treatment will be a 30 to 60 minute session to one person at a time either in-person or using telehealth.

Evaluating Primary Suicide Prevention in Adolescents With Risk Factors

Suicide is one of the main causes of death among teenagers. Because it is preventable, primary prevention of suicide has become a public health priority, with encouraging results in promoting suicide awareness and reducing suicidal thoughts among adolescents. However, the lack of studies conducted among vulnerable populations (i.e., marginalised, disengaged and disadvantaged) is a major gap, even though these populations present an increased risk of suicidal behaviour. The aim of this project is to test the effectiveness of a brief primary suicide prevention intervention for vulnerable adolescents, using a randomised controlled trial. Vulnerable adolescents include those 1) detained in juvenile detention centres, 2) at risk of dropping out of school, 3) undergoing treatment for psychiatric disorders, 4) belonging to a sexual or gender diversity, 5) affected by chronic conditions, or 6) with relational/familial problems. The main aim is to test the effectiveness of the intervention on a composite measure of suicide awareness, psychological distress and suicidal thoughts. The project will also explore other issues that present challenges for vulnerable populations: access to primary suicide prevention and non-response bias. The study will provide relevant results to address the current lack of high-quality evidence for primary suicide prevention in adolescents.

Suicidal Ideation Framework: Grounded Theory Study, Catalonia

This doctoral project aims to develop a comprehensive theoretical model of the process through which the suicidal ideation framework is configured as a symbolic, narrative, and relational expression, adopting a multiperspective approach that spans the suicide attempt and the stages of care and recovery. Moving away from biomedical reductionisms, this investigation seeks to identify shared meaning-making nuclei and discursive fractures that reflect the inherent conflictuality of the suicidal act. Grounded in the integration of the theoretical frameworks previously outlined, this study adopts an interpretive-constructivist approach. Phase 1 will include studies conducted in OECD countries, providing a broad and conceptually diverse interpretive foundation. Phase 2, conducted in Catalonia, will deepen situated configurations, assuming that local sociocultural frameworks act as interpretive prisms for globally relevant phenomena. Overall, this theoretical-methodological architecture not only ensures conceptual robustness and coherence, but also articulates an ethical and epistemic commitment to understanding suicide through the complexity of its human textures. By centering suffering, listening to historically silenced voices, honoring the singularity of each life trajectory, and grounding the inquiry in an ethics of care, this study aims to transcend a merely technical-instrumental logic of knowledge.

Syncing Screening and Services for Suicide Prevention Across Health and Justice Systems

This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

Safety Planning and Cognitive Behavioral Therapy for Adolescent Suicide Prevention in Mozambique

This implementation research project aims to test the effectiveness and implementation outcomes of suicide safety planning along and a transdiagnostic cognitive behavioral intervention for suicide prevention on decreasing suicidal behaviors in secondary school students in Mozambique. This study will also result in hypothesized mechanisms of intervention effects, costs and cost-effectiveness.

Suicide Prevention After Community Care Discharge

The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.