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and treatment of mental illnesses.

Suicide Prevention

Learn more about Suicide Prevention.

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Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.


Just-in-time Interventions for Reducing Short-term Suicide Risk 

Study Type: INTERVENTIONAL
Start Date: November 19, 2024
Eligibility: 18 Years to , f
Location(s): Mass General Brigham, Boston, Massachusetts, United States

The goal of this study is to test the effects of just-in-time intervention strategies aimed to promote implementation of the safety plan and its components at different levels of suicidal urges and intent. The main questions the investigators aim to answer are:

1. What is the acceptability and feasibility of the just-in-time intervention strategies? 2. What are the proximal effects of just-in-time intervention strategies aimed to promote use of the safety plan and its components? 3. What internal and external contextual factors moderate the just-in-time intervention effects?

Participants (adults hospitalized for suicidal thoughts or behaviors) will:

* Answer questions about current suicidal thoughts on their smartphone up to 4 times each day during both hospitalization and the 4 weeks after they leave the hospital * Each time they submit a survey, be immediately randomized to receive (or not receive) a just-in-time intervention tailored to their level of current suicidal thoughts * Answer brief follow-up questions on their smartphone within a couple hours of each randomization * Provide feedback on their experience with the just-in-time interventions


Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression 

Study Type: INTERVENTIONAL
Start Date: November 6, 2024
Eligibility: 18 Years to 70 Years, f
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.

Objective:

To test a study drug (HNK) in people with MDD.

Eligibility:

People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.

Design:

Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.

HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:

They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.

They will receive no drugs for 2 to 3 weeks.

They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.

One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.

...


Efficacy-Implementation Study for PC CARES in Rural Alaska 

Study Type: INTERVENTIONAL
Start Date: September 12, 2024
Eligibility: 12 Years to , t
Location(s): Rural Human Services Program, Fairbanks, Alaska, United States; University of Michigan, Ann Arbor, Michigan, United States

This participatory, pragmatic efficacy-implementation trial evaluates the impact of Promoting Community Conversations About Research to End Suicide (PC CARES) to evaluate Learning Circle (LC) participant outcomes (AIM#1), community-wide diffusion effects, and efficacy by tracking youth impact (AIM#2), while finding sustainable ways to scale PC CARES to other Alaska Native (AN) communities (AIM#3).


Natural History of Depression, Bipolar Disorder and Suicide Risk 

Study Type: OBSERVATIONAL
Start Date: September 9, 2024
Eligibility: 18 Years to 120 Years, f
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.

People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.

This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.

Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.


Participatory Research for Suicide Prevention in Autism 

Study Type: INTERVENTIONAL
Start Date: September 5, 2024
Eligibility: 18 Years to , t
Location(s): University of Utah, Salt Lake City, Utah, United States

The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are:

* Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people? * What feedback do participants have to help improve the intervention?

Participants will:

* engage in a four-part virtual educational intervention * answer questions via online survey before, after, and 3-months after the intervention * participate in an optional interview to provide feedback


A Digitally Assisted Risk Reduction Platform for Youth At High Risk for Suicide 

Study Type: INTERVENTIONAL
Start Date: August 14, 2024
Eligibility: 13 Years to 18 Years, f
Location(s): Columbia University, New York, New York, United States

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.


Real-time Examination of Skills and Coping Use in Teen's Everyday Lives 

Study Type: INTERVENTIONAL
Start Date: July 29, 2024
Eligibility: 13 Years to 18 Years, f
Location(s): University of Utah, Salt Lake City, Utah, United States

The goal of this clinical trial is to compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are:

Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention.

The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation.

Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.


The Effects of SAINT® Neuromodulation System on Explicit and Implicit Suicidal Cognition 

Study Type: INTERVENTIONAL
Start Date: June 30, 2024
Eligibility: 18 Years to 75 Years, f
Location(s): University of Iowa, Iowa City, Iowa, United States; Medical University of South Carolina (MUSC), Charleston, South Carolina, United States; University of Texas, Austin, Austin, Texas, United States

This multi-site, double-blind, randomized, sham-controlled mechanistic trial aims to test the effects of Magnus Neuromodulation System (MNS) with Stanford Accelerated Intermittent Neuromodulation Therapy (SAINT®) Technology on the neural circuitry of suicidal cognitions in psychiatrically hospitalized patients with Major Depressive Disorder (MDD) and active suicidal ideation (SI). This will be accomplished by applying the MNS with SAINT to a customized target within the left dorsolateral prefrontal cortex (L-DLPFC) identified with fMRI for five consecutive days and measuring resting-state functional connectivity (RS FC) between the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN) at baseline and immediate-post visit. The relationship between changes in RS FC and changes in both Explicit and Implicit Suicidal Cognitions (ESC and ISC, respectively) will be determined. This study will also determine the relationship between changes in RS FC in neural networks underlying mediators of suicidal cognitions and changes in such mediators with active versus sham SAINT.


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

Study Type: INTERVENTIONAL
Start Date: June 24, 2024
Eligibility: 18 Years to , f
Location(s): HealthPartners Institute, Bloomington, Minnesota, United States

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.


Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide 

Study Type: INTERVENTIONAL
Start Date: June 15, 2024
Eligibility: 12 Years to 18 Years, t
Location(s): Michele Berk, Stanford, California, United States

The proposed research addresses the urgent need to reduce suicide rates among teens. This will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical Behavior Therapy, \[DBT\]) with an evidence-based treatment protocol for insomnia (a digital version of Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone.

Participants will be randomly assigned to receive 6 months of DBT plus CBT-I or to DBT alone and will complete research assessments measuring suicidal ideation, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. Participants will also wear a device on their wrist (like a Fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.


Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial 

Study Type: INTERVENTIONAL
Start Date: June 12, 2024
Eligibility: 18 Years to 70 Years, f
Location(s): Brown University, Providence, Rhode Island, United States; Butler Hospital, Providence, Rhode Island, United States

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.


Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior 

Study Type: INTERVENTIONAL
Start Date: May 25, 2024
Eligibility: 13 Years to 21 Years, f
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

The goal of this study is to understand why some people act more impulsively when feeling negative emotions, which is called negative urgency. The researchers hope to understand how negative urgency relates to the way networks of brain cells communicate with one another. The researchers will measure negative urgency and brain signals in adolescents aged 13-21 years with depression and suicidal thoughts and behaviors.

The main questions it aims to answer are:

* Whether a type of brain signaling called cortical inhibition is related to negative urgency * Whether depressed adolescents with suicidal behavior have more problems with cortical inhibition than depressed adolescents with suicidal thoughts only * Whether the relationship between negative urgency and cortical inhibition changes over time

Adolescents who participate in the study will complete the following activities at the time they join the study, as well as 6 months and 12 months later:

* Interviews with researchers and questionnaires to learn about their thoughts, emotions, and symptoms * A questionnaire about impulsive behaviors and negative urgency * Computerized games that measure brain functions * An MRI scan of the brain * Transcranial magnetic stimulation with electroencephalography (TMS-EEG), a way to measure how brain cells communicate (cortical inhibition) using a magnet placed outside of the head and recording brain signals


Suicide Prevention Integration Into Task-shifted Mental Health Interventions 

Study Type: INTERVENTIONAL
Start Date: May 13, 2024
Eligibility: FEMALEs, 18 Years to , t
Location(s): Islamabad Capital Territory, Islamabad, Pakistan

Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.


Testing an Intergenerational Model of Suicide Risk in Mother-child Dyads 

Study Type: INTERVENTIONAL
Start Date: April 1, 2024
Eligibility: Age N/A, f
Location(s): University of Pittsburgh, Pittsburgh, Pennsylvania, United States

The investigators are interested in learning more about how the role of mothers' emotions has on the transmission of suicide risk to children. Eligible participants will be invited to participate in a baseline assessment, and 4 follow-up assessments in the next year. This research study is a randomized control trial. Participants that choose to enroll are randomly assigned, that is by chance (like by flipping a coin) to receive DBT Skills Training or treatment as usual (TAU). Participants may also be selected for DBT skills training, it which would occur once a week for 6 months.


Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care 

Study Type: INTERVENTIONAL
Start Date: March 26, 2024
Eligibility: 25 Years to 100 Years, t
Location(s): BMS at Yard 56, Baltimore, Maryland, United States

The objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in Latinx youth, particularly those in immigrant families with parents who have limited English proficiency (LEP). The investigators will focus on the use of trained community health workers (CHWs) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination.

Specific aims are 1: To develop site-specific implementation protocols for the integration of CHWs into SIB screening and safety planning for Latinx youth and the youths families; 2: To pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: To engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings.

Parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the study.


Improving Care, Accelerating Recovery and Education 

Study Type: INTERVENTIONAL
Start Date: February 29, 2024
Eligibility: 12 Years to 17 Years, f
Location(s): Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States; University of Vermont Medical Center, Burlington, Vermont, United States

The goal of this clinical trial is to test the I-CARE program in children who are in a medical hospital awaiting inpatient mental health treatment. The main questions it aims to answer are:

* Can the I-CARE program be used at the medical hospitals and do the patients and hospital staff like the program? * Does the I-CARE program lower patients' emotional distress, thoughts about suicide or suicide attempts?

Patients will complete as many of the 7 I-CARE videos as possible during their stay at the medical hospital and fill out online surveys. There are workbook activities that go with each I-CARE video. A hospital staff member will help the patient do the videos and workbook activities.


Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part a 

Study Type: INTERVENTIONAL
Start Date: February 23, 2024
Eligibility: 18 Years to , f
Location(s): UMass Memorial Health, Worcester, Massachusetts, United States

This Study will comprehensively evaluate a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide.

A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used


Digital Youth-Nominated Support Team (YST) Program 

Study Type: INTERVENTIONAL
Start Date: November 27, 2023
Eligibility: 13 Years to 17 Years, f
Location(s): Michigan Medicine, Ann Arbor, Michigan, United States

The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth.


Development and Testing of ImHere4U: a Digital Suicide Prevention Intervention for Cyberbullied Adolescents 

Study Type: INTERVENTIONAL
Start Date: November 21, 2023
Eligibility: 12 Years to 17 Years, f
Location(s): University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents.

The specific aims are to:

Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \>35% underserved youth).

H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates \> 80% and imHere4U engagement \> 70%.

H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period.

Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \> 6.


Risk and Resilience to Suicide Following Late-Life Spousal Bereavement 

Study Type: INTERVENTIONAL
Start Date: November 20, 2023
Eligibility: 65 Years to , f
Location(s): University of Pittsburgh (UPMC), Pittsburgh, Pennsylvania, United States

The purpose of the RISE study is to examine how the 24-hour rhythm of sleep and social activity relate to mood and suicidal ideation among older adults that recently lost a spouse or life partner.


Swift Outpatient Alternatives for Rapid Stabilization 

Study Type: INTERVENTIONAL
Start Date: November 9, 2023
Eligibility: 13 Years to 21 Years, f
Location(s): Seattle Children's, Seattle, Washington, United States

The goal of this clinical trial is to improve the effective outpatient management of acute youth suicide risk by optimizing intervention components to build an efficient, evidence-based intervention that is responsive to the needs of, and coordinated with, providers in primary care settings. The main questions are:

1. What is the strongest combination of SOARS components associated with reduction in youth suicidal thoughts and behavior (STB)? 2. Do age and STB history moderate the impact of the effects of the SOARS intervention components? 3. Do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth STBs? 4. What helps medical outpatient providers refer to SOARS and continue care after SOARS?


Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality 

Study Type: INTERVENTIONAL
Start Date: September 18, 2023
Eligibility: 50 Years to 80 Years, f
Location(s): Weill Cornell Medicine, New York, New York, United States

The investigators hypothesized that during the 9-week course of Engage \& Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.


Supplementing Brief Psychotherapy With a Mobile App 

Study Type: INTERVENTIONAL
Start Date: September 14, 2023
Eligibility: 18 Years to , f
Location(s): Rutgers University Behavioral Healthcare, Piscataway, New Jersey, United States

Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide


Stepped Approach to Reducing Risk of Suicide in Primary Care 

Study Type: INTERVENTIONAL
Start Date: August 8, 2023
Eligibility: 12 Years to 17 Years, f
Location(s): Eastglen Pediatrics, Columbus, Ohio, United States; Hilliard Pediatrics, Hilliard, Ohio, United States

Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care.

STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability.

The main questions the study aims to answer are:

* Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?


iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide 

Study Type: INTERVENTIONAL
Start Date: June 1, 2023
Eligibility: 15 Years to , f
Location(s): Evidence-Based Practice Institute, Seattle, Washington, United States; University of Maryland, Baltimore, Baltimore, Maryland, United States

This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.


Study 1: Social Engage Coaching R61 Phase 

Study Type: INTERVENTIONAL
Start Date: June 1, 2023
Eligibility: 60 Years to , f
Location(s): University of Rochester, Rochester, New York, United States

The purpose of this study is to test whether an individual coaching program called Social Engage Coaching (or 'Engage Coaching' for short) helps adults age 60 and older feel more connected to other people in ways that matter to them. Procedures include participating in a Social Engage Coaching program, research assessments with surveys, and assessments completed on a cell phone. Engage Coaching involves individual sessions with a trained Engage Coach (up to 10 sessions) that are designed to help participants improve social relationships and well-being. All subjects will receive the scheduled baseline and follow-up interviews by the research team. These interviews will be conducted at study start, mid-way through the program at 8 weeks and after completing the program at 16 weeks. Interviews will be via Zoom/phone as well as surveys done online.


Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial) 

Study Type: INTERVENTIONAL
Start Date: April 10, 2023
Eligibility: 15 Years to 29 Years, t
Location(s): San Diego State University, San Diego, California, United States

The overarching goal of this study is to evaluate a newly-developed suicide prevention program for sexual and gender minority youth and emerging adults. After development of the intervention program, a randomized controlled trial will be conducted to test its preliminary efficacy in lowering the risk for suicide attempts.


Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization 

Study Type: INTERVENTIONAL
Start Date: March 31, 2023
Eligibility: 12 Years to 19 Years, f
Location(s): Franciscan Hospital For Children, Inc., Brighton, Massachusetts, United States

Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.


Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention 

Study Type: INTERVENTIONAL
Start Date: January 26, 2023
Eligibility: 12 Years to 18 Years, f
Location(s): Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC, McMurray, Pennsylvania, United States; UPMC Center for Adolescent and Young Adult Health, Pittsburgh, Pennsylvania, United States

This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cybervictimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.


Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care 

Study Type: INTERVENTIONAL
Start Date: November 7, 2022
Eligibility: 13 Years to 17 Years, f
Location(s): University of Michigan's (Child and Adolescent Psychiatric Inpatient Program), Ann Arbor, Michigan, United States

This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.


Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents 

Study Type: INTERVENTIONAL
Start Date: October 3, 2022
Eligibility: 13 Years to 18 Years, f
Location(s): UT Southwestern Medical Center, Dallas, Texas, United States

This project aims to examine the efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.

The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.


Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD) 

Study Type: INTERVENTIONAL
Start Date: October 1, 2022
Eligibility: 18 Years to 65 Years, f
Location(s): Palo Alto University, Palo Alto, California, United States

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.


Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents 

Study Type: INTERVENTIONAL
Start Date: October 1, 2022
Eligibility: 10 Years to 24 Years, t
Location(s): UAB Huntsville Regional Medical Campus, Huntsville, Alabama, United States; University of Alabama at Birmingham, Birmingham, Alabama, United States

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.


Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2 

Study Type: INTERVENTIONAL
Start Date: September 1, 2022
Eligibility: 18 Years to 65 Years, f
Location(s): University of Michigan, Ann Arbor, Michigan, United States

Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.


Ketamine Treatment of Youth Suicide Attempters 

Study Type: INTERVENTIONAL
Start Date: June 27, 2022
Eligibility: 14 Years to 30 Years, f
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States; The Cleveland Clinic, Cleveland, Ohio, United States

Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 140 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk \< 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).


Culture and Well-Being for Latinos 

Study Type: INTERVENTIONAL
Start Date: June 1, 2022
Eligibility: 18 Years to , f
Location(s): University of Rochester Medical Center, Rochester, New York, United States

The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.


Mental Health in Primary Care 

Study Type: INTERVENTIONAL
Start Date: April 26, 2022
Eligibility: 12 Years to 16 Years, t
Location(s): UHealth Pediatrics at Kendall, Miami, Florida, United States; UM UHealth Pediatrics at the Professional Arts Center, Miami, Florida, United States; Borinquean Medical Centers, Miami, Florida, United States; Belkys Bravo Clinic, Miami, Florida, United States; Nicklaus Children Hospital, Miami, Florida, United States; Pediatric Consultants of Kendall, P.A., Miami, Florida, United States; South Florida Pediatric Partners, Miami, Florida, United States; Community Health of South Florida, Miami, Florida, United States; Jessie Trice Community Health Center, Miami, Florida, United States; UM Pediatric Mobile Clinic, Miami, Florida, United States; Pediatric Mobile Clinic, Miami, Florida, United States; Mailman for Child Devlopment, Miami, Florida, United States; Care Resource, Miami, Florida, United States; Prime Care Health, Miami, Florida, United States; Medlife Clinical Research, Miami, Florida, United States

The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.


WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt 

Study Type: INTERVENTIONAL
Start Date: April 22, 2022
Eligibility: 50 Years to 90 Years, f
Location(s): Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, New York, United States

The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).


Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation 

Study Type: INTERVENTIONAL
Start Date: April 4, 2022
Eligibility: 12 Years to 18 Years, f
Location(s): Mayo Clinic in Rochester, Rochester, Minnesota, United States

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.


Long-term Observation of Participants With Mood Disorders 

Study Type: OBSERVATIONAL
Start Date: August 17, 2021
Eligibility: 18 Years to 99 Years, t
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments.

Objective:

To learn the long-term impact of depression, bipolar disorder, and suicide risk.

Eligibility:

Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago.

Design:

This study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact.

In Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview.

In Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH.

In both phases, participants can skip any questions they do not want to answer.

The online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours.

The information that participants give in this study may be linked to their other NIH research records.


Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders 

Study Type: OBSERVATIONAL
Start Date: July 15, 2021
Eligibility: 8 Years to 17 Years, f
Location(s): Nationwide Children's Hospital/ Ohio State University, Columbus, Ohio, United States; National Institutes of Health Clinical Center, Bethesda, Maryland, United States; Kennedy Krieger Institute/Johns Hopkins University, Baltimore, Maryland, United States

Background:

Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Also, youth with ASD/NDD are often excluded from many research studies. Because of this, researchers need more data. They want to make sure they are asking the best questions for young people in clinics such as the National Institute of Mental Health (NIMH) clinic. They want to make sure they have the best data to determine if a person is at risk for hurting or killing himself or herself.

Objective:

To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD.

Eligibility:

Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD

Design:

Participants will fill out 4 questionnaires during a 1-hour meeting with study staff. They will answer questions about how they have been feeling. They will be asked if they think about or plan to hurt or kill themselves. They will also be asked if they have ever thought about it or planned it in the past. Other questions will assess their understanding of death. Participants can take a break if needed.

Parents of the participants will be asked similar questions.

Parents will be informed if their child has current thoughts of suicide.

About 1 week after the initial assessment, parents will be contacted to fill out a follow-up questionnaire. It will take about 10 minutes to complete.


Telehealth to Improve Prevention of Suicide (TIPS) 

Study Type: INTERVENTIONAL
Start Date: July 12, 2021
Eligibility: 18 Years to , f
Location(s): UMass Chan Medical School, Worcester, Massachusetts, United States

The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.


Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention 

Study Type: INTERVENTIONAL
Start Date: March 5, 2021
Eligibility: 18 Years to 65 Years, f
Location(s): Yale University, New Haven, Connecticut, United States; Emory University, Atlanta, Georgia, United States; UAB Medicine | Heersink School of Medicine, Birmingham, Alabama, United States

This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine.


MicroRNA Correlates of Childhood Maltreatment and Suicidality 

Study Type: OBSERVATIONAL
Start Date: February 26, 2021
Eligibility: 18 Years to 60 Years, t
Location(s): UAB Huntsville Regional Medical Campus, Huntsville, Alabama, United States; University of Alabama at Birmingham, Birmingham, Alabama, United States

This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA \[MiRNA\]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.


Suicide in Urban Natives: Detection and Networks to Combat Events 

Study Type: INTERVENTIONAL
Start Date: March 15, 2020
Eligibility: 18 Years to 34 Years, f
Location(s): First Nations Community HealthSource, Albuquerque, New Mexico, United States

This study compares the effectiveness of a program to detect and manage suicide risk among American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase engagement, social connectedness, and resilience in at-risk youth. The other half will receive usual care that does not include the caring text messages.


Wakȟáŋyeža (Little Holy One) 

Study Type: INTERVENTIONAL
Start Date: November 18, 2019
Eligibility: 18 Years to , t
Location(s): Fort Peck Tribal Head Start, Poplar, Montana, United States

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.


Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska 

Study Type: INTERVENTIONAL
Start Date: September 12, 2019
Eligibility: 15 Years to , t
Location(s): University of Michigan, Ann Arbor, Michigan, United States

This intervention study measures the outcomes of the PC CARES (Promoting Community Conversations about Research to End Suicide) project implemented in remote rural Alaskan villages. Researchers worked with local service providers and other partners to recruit facilitators who were trained to implement the 5-session PC CARES curriculum. The study will compare pre-post data from intervention participants to non-participants, and will analyze social networks related to suicide prevention behavior in each village.


A Novel Cognitive Reappraisal Intervention for Suicide Prevention 

Study Type: INTERVENTIONAL
Start Date: March 28, 2017
Eligibility: 50 Years to 90 Years, f
Location(s): Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, New York, United States

The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).


Neurobiology of Suicide 

Study Type: INTERVENTIONAL
Start Date: December 1, 2015
Eligibility: 18 Years to 70 Years, t
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.

Objective:

To understand what happens in the brain when someone has thought about or attempted suicide.

Eligibility:

Group 1: Adults ages 18 70 who have thought about or attempted suicide recently

Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past

Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide

Group 4: Healthy volunteers the same ages.

Design:

Participants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.

Phase 1: 1 week in hospital. Participants will have:

Physical exam.

Questions about thoughts and feelings.

Thinking and memory tests and simple tasks.

Blood and urine tests.

Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.

Sleep test. Disks and bands will be placed on the body to monitor it during sleep.

Magnetic detectors on their head while they perform tasks.

A wrist monitor for activity and sleep.

Lumbar puncture (optional). A needle will collect fluid from the back.

Shock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.

Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.

Phase 3: up to 4 more ketamine doses over 2 weeks.

Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.


Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships 

Study Type: INTERVENTIONAL
Start Date: March 31, 2008
Eligibility: FEMALEs, 18 Years to 64 Years, f
Location(s): Grady Hospital, Atlanta, Georgia, United States

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.