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Background Adolescent suicidality currently ranks as the third leading cause of death among adolescents, affecting global adolescent population, particularly in low- and middle-income countries (LMICs) like Nepal. This study explores the assessment of suicidality as an adverse event in adolescent mental health research in Nepal and outlines practical strategies for integrating suicide management protocols into mental health surveys in LMICs. It offers guidance on suicide risk assessment and referral pathways for vulnerable adolescents and contribute to suicide prevention efforts. Methods This study, a part of a cross-sectional survey with 490 adolescents aged 13–15 in public secondary schools in Kathmandu valley, used a three step approach of the Suicide Management Protocol (SMP) to identify and manage participants at risk of suicidality. Using the specific item under the measurement of mental health among adolescents and young people at the population level (MMAPP) tool followed by administering the suicide screening tool, those at risk of suicidality were identified by the researchers. Clinical assessments were then conducted by the psychosocial counsellor to categorize risk levels using Beck Suicide Intent Scale (BSIS) and provided appropriate management according to the severity. Results Of total 490 participants, while the single item under the MMAPP assessment identified 33 (6.7%) participants at risk, further screening using the suicide screening tool confirmed 25(5.1%) as positives, by the researchers. The psychosocial counsellor clinically assessed the 25 participants screened as suicide risk positive and found that 10 (40%) as high risk, 8 (32%) as moderate, and 7 (28%) as low risk. The clinical management of the cases at a differing level of risk was then managed as per the designated clinical pathways by developing protective behavior and reducing suicide related risk factors. All the participants were found to be safe and functioning normally through the course of clinical management, ranging from 2 to 6 sessions. Conclusions Overall, integrating suicidality measures in mental health surveys was found to be effective suicide assessment and preventive strategy for adolescents in Nepal. Developing suicide management protocols within mental health surveys is essential and feasible for real-time monitoring and response to suicidal behavior among at-risk populations in LMICs, including Nepal.

Background Suicide and risk management protocols in mental health research aim to ensure patient safety, provide vital information on how to assess suicidal ideation, manage risk, and respond to unexpected and expected situations. However, there is a lack of literature that identifies specific components and strategies to include in suicide and risk management protocols (SRMPs) for mental health research. The goal of this scoping review was to review academic and grey literature to determine core components and associated strategies, which can be used to inform SRMPs in mental health research. Methods and analysis The methodological framework outlined by Arksey and O’Malley was used for this scoping review. The search strategy, conducted by a medical librarian, was multidisciplinary and included seven databases. Two reviewers independently assessed eligibility criteria in each document and used a standardized charting form to extract relevant data. The extracted data were then examined using qualitative content analysis. Specifically, summative content analysis was used to identify the core components and strategies used in SRMPs. The data synthesis process was iterative. Results This review included 36 documents, specifically 22 peer-reviewed articles and 14 documents from the grey literature. Five core components of SRMPs emerged from the reviewed literature including: training; educational resources for research staff; educational resources for research participants; risk assessment and management strategies; and clinical and research oversight. Potentials strategies for risk mitigation within each of the core components are outlined. Conclusions The five core components and associated strategies for inclusion in SRMPs will assist mental health researchers in conducting research safely and rigorously. Findings can inform the development of SRMPs and how to tailor them across various research contexts.

Pembrolizumab prolongs progression-free and overall survival among patients with advanced melanoma and recurrence-free survival in resected stage III disease. KEYNOTE-716 assessed pembrolizumab as adjuvant therapy in patients with completely resected, high-risk, stage II melanoma. We report results from the planned first and second interim analyses for recurrence-free survival. In this double-blind, randomised, placebo-controlled phase 3 study, involving 160 academic medical centres and hospitals in 16 countries (Australia, Belgium, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Poland, South Africa, Spain, Switzerland, the UK, and the USA), patients aged 12 years or older with newly diagnosed, completely resected stage IIB or IIC melanoma (TNM stage T3b or T4 with a negative sentinel lymph node biopsy) were recruited. Eligible patients were randomly assigned (1:1), in blocks of four and stratified by T-category (3b, 4a, and 4b) and paediatric status (age 12–17 years vs ≥18 years), using an interactive response technology system to intravenous pembrolizumab 200 mg (2 mg/kg in paediatric patients) or placebo every 3 weeks for 17 cycles or until disease recurrence or unacceptable toxicity. All patients, clinical investigators, and analysts were masked to treatment assignment. The primary endpoint was investigator-assessed recurrence-free survival (defined as time from randomisation to recurrence or death) in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment). The primary endpoint was met if recurrence-free survival was significantly improved for pembrolizumab versus placebo at either the first interim analysis (after approximately 128 patients had events) or second interim analysis (after 179 patients had events) under multiplicity control. Safety was assessed in all patients randomly assigned to treatment who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03553836, and is closed to accrual. Between Sept 23, 2018, and Nov 4, 2020, 1182 patients were screened, of whom 976 were randomly assigned to pembrolizumab (n=487) or placebo (n=489; ITT population). The median age was 61 years (IQR 52–69) and 387 (40%) patients were female and 589 (60%) were male. 874 (90%) of 976 patients were White and 799 (82%) were not Hispanic or Latino. 483 (99%) of 487 patients in the pembrolizumab group and 486 (99%) of 489 in the placebo group received assigned treatment. At the first interim analysis (data cutoff on Dec 4, 2020; median follow-up of 14·4 months [IQR 10·2–18·7] in the pembrolizumab group and 14·3 months [10·1–18·7] in the placebo group), 54 (11%) of 487 patients in the pembrolizumab group and 82 (17%) of 489 in the placebo group had a first recurrence of disease or died (hazard ratio [HR] 0·65 [95% CI 0·46–0·92]; p=0·0066). At the second interim analysis (data cutoff on June 21, 2021; median follow-up of 20·9 months [16·7–25·3] in the pembrolizumab group and 20·9 months [16·6–25·3] in the placebo group), 72 (15%) patients in the pembrolizumab group and 115 (24%) in the placebo group had a first recurrence or died (HR 0·61 [95% CI 0·45–0·82]). Median recurrence-free survival was not reached in either group at either assessment timepoint. At the first interim analysis, grade 3–4 treatment-related adverse events occurred in 78 (16%) of 483 patients in the pembrolizumab groups versus 21 (4%) of 486 in the placebo group. At the first interim analysis, four patients died from an adverse event, all in the placebo group (one each due to pneumonia, COVID-19-related pneumonia, suicide, and recurrent cancer), and at the second interim analysis, one additional patient, who was in the pembrolizumab group, died from an adverse event (COVID-19-related pneumonia). No deaths due to study treatment occurred. Pembrolizumab as adjuvant therapy for up to approximately 1 year for stage IIB or IIC melanoma resulted in a significant reduction in the risk of disease recurrence or death versus placebo, with a manageable safety profile. Merck Sharp & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.

Intimate partner violence (IPV) is strongly linked to suicidal behaviors (ideation, plans, attempts), affecting 1 in 3 women globally, with prevalence varying across regions. Sociocultural and economic factors shape IPV and SB risk differently. This review will estimate prevalence, risk factors, and associations of IPV and SBs among women of reproductive age in Asia to provide region-specific evidence for targeted interventions. We will systematically search PubMed, Scopus, PsycINFO, Web of Science, EMBASE, CINAHL, and Google Scholar for studies published up to 30 November 2025, following PRISMA guidelines. The search will also include grey literature and citation chaining, using keyword truncation, string searches, and standardized indexing terms. Cross-sectional observational studies among Asian women (19–45 years) exposed to intimate partner violence (physical, psychological, sexual) will be included, reporting suicidal behaviors (ideation, plans, attempts) compared with unexposed women. Only English-language, peer-reviewed studies will be considered, while reviews, abstracts, and unpublished studies will be excluded. Two independent reviewers will screen studies for the central concepts of “Intimate Partner Violence (IPV)” and “Suicidal Behaviors (SB)”, with disagreements resolved by a third reviewer. Data on prevalence, associated factors, mediator variables, and numerical estimates of IPV–SB associations will be extracted. Meta-analysis using a random-effects model will be conducted alongside a narrative synthesis. Findings will be visualized with forest and funnel plots, heterogeneity assessed using the Q Cochrane statistic and I² index, and subgroup and sensitivity analyses performed. Risk of bias will be evaluated using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist. Early identification of psychological distress using culturally validated tools, combined with understanding context-specific drivers of IPV, is essential for preventing suicidal behaviors among Asian women of reproductive age. Findings from this review will inform targeted interventions, guide policy, and address gender norms that perpetuate violence and elevate mental health risks.

Background Suicide attempts (SA) constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Methods/Design Multicentre randomized controlled trial. We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters) and «Crisis card» (effective only in first-attempters). Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards». Discussion ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy. Trial Registration The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174.

Background This study is built on a long-standing research partnership between the Johns Hopkins Center for American Indian Health and the White Mountain Apache Tribe to identify effective interventions to prevent suicide and promote resilience among American Indian (AI) youth. The work is founded on a tribally-mandated, community-based suicide surveillance system with case management by local community mental health specialists (CMHSs) who strive to connect at-risk youth to treatment and brief, adjunctive interventions piloted in past research. Methods Our primary aim is to evaluate which brief interventions, alone or in combination, have the greater effect on suicide ideation (primary outcome) and resilience (secondary outcome) among AI youth ages 10–24 ascertained for suicide-related behaviors by the tribal surveillance system. We are using a Sequential Multiple Assignment Randomized Trial with stratified assignment based on age and suicidal-behavior type, and randomizing N =  304 youth. Brief interventions are delivered by AI CMHSs, or by Elders with CMHS support, and include: 1) New Hope, an evidence-based intervention to reduce immediate suicide risk through safety planning, emotion regulation skills, and facilitated care connections; and 2) Elders’ Resilience, a culturally-grounded intervention to promote resilience through connectedness, self-esteem and cultural identity/values. The control condition is Optimized Case Management, which all study participants receive. We hypothesize that youth who receive: a) New Hope vs. Optimized Case Management will have significant reductions in suicide ideation; b) Elders’ Resilience vs. Optimized Case Management will have significant gains in resilience; c) New Hope followed by Elders’ Resilience will have the largest improvements on suicide ideation and resilience; and d) Optimized Case Management will have the weakest effects of all groups. Our secondary aim will examine mediators and moderators of treatment effectiveness and sequencing. Discussion Due to heterogeneity of suicide risk/protective factors among AI youth, not all youth require the same types of interventions. Generating evidence for what works, when it works, and for whom is paramount to AI youth suicide prevention efforts, where rates are currently high and resources are limited. Employing Native paraprofessionals is a means of task-shifting psychoeducation, culturally competent patient support and continuity of care. Trial registration Clinical Trials NCT03543865 , June 1, 2018.

Background Suicide among young people in Alaska Native (AN) communities was nearly unheard of through the establishment of statehood in 1959, but from 1960–1995, the suicide rate increased by approximately 500% during this period of rapid, imposed social transition. These disruptions increased conditions associated with suicide risk (e.g., substance use disorders, cultural disconnection), and challenged the community-level social safety net of youth protective factors. The purpose of this paper is to outline development and evaluation methodology for a comparative effectiveness trial of two virtual, culturally grounded, brief interventions to address suicide prevention among AN young people. The proposed study addresses significant gaps in culturally appropriate evidence-based programming to address suicide prevention among AN young people by comparing effectiveness of these two interventions. Findings from this study have potential to expand the range of accessible, critically important services to this population. Methods Our interventions will be targeted toward AN young people ages 14–24 who present with suicide attempt, ideation, or associated risk behaviors, including alcohol-related injury in the Yukon-Kuskokwim region or the Interior of Alaska. In this randomized controlled comparative effectiveness trial, 14–24-year-old AN individuals will receive either BeWeL (Because We Love You) which will comprise a 45-min virtual wisdom talk addressing family strengths and increasing protective factors ( n  = 185), or BeWeL + MISN (plus motivational interviewing about social networks), which will include an additional 15 min focused on discussion of the individual’s social networks ( n  = 185). Both interventions will have two follow-up visits at 2 and 6 weeks. We will evaluate changes in both intervention groups from the baseline survey at 3, 6, and 12 months on primary outcomes of suicide-intent risk, depression, anxiety, frequency of alcohol use, and alcohol consequences and compare effectiveness between the two interventions. In our secondary aim, we will evaluate changes in both groups from the baseline survey at 3, 6, and 12 months on individual and community protective factors, social networks, and awareness of connectedness and compare effectiveness between the two interventions. Discussion This project has the potential to expand the range and effectiveness of suicide prevention services for AN young people and will help meet the need in Alaska to link clinical behavioral health services to AN community-based networks, and to engage local cultural resources in aftercare for individuals at risk for suicide. Findings have potential to provide practical information to advance the field of suicide prevention and enhance protective factors and resiliency among this population. Trial registration ClinicalTrials.gov Identifier: NCT05360888; Registered December 22, 2022. https://clinicaltrials.gov/study/NCT05360888 .

Suicide and suicidal behavior during adolescence have been steadily increasing over the past two decades. The preponderance of interventions focuses on crisis intervention, underlying psychiatric disorders, regulating negative affect, and reducing cognitive distortions. However, low positive affectivity may be a mechanism that contributes to adolescent suicidal ideation and behaviors independent of other risk factors. Skills to Enhance Positivity (STEP) is an acceptance-based intervention, designed to increase attention to, and awareness of, positive affect and positive experiences. Results from a pilot RCT demonstrated engagement of the target (positive affect) and a decrease in clinical outcomes (suicidal events; i.e., either a suicide attempt or an emergency intervention for an acute suicidal crisis), providing support to test the clinical effectiveness of STEP in a larger clinical trial with clinical staff implementing the intervention. To test the effectiveness of STEP, compared to Enhanced Treatment as Usual (ETAU), in reducing suicidal events and ideation in adolescents admitted to inpatient psychiatric care due to suicide risk. We hypothesize that those randomized to STEP, compared to ETAU, will have lower rates of suicide events, active suicidal ideation (SI), and depressed mood over the 6-month follow-up period. We hypothesize that those randomized to STEP, compared to ETAU, will demonstrate greater improvement in the hypothesized mechanisms of attention to positive affect stimuli and gratitude and satisfaction with life. Participants will be randomized to either STEP or ETAU. STEP consists of four in-person sessions focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent via text messaging daily for the first month post-discharge and every other day for the following two months. The ETAU condition will receive text-delivered reminders to use a safety plan provided at discharge from the hospital and healthy habits messages, matched in frequency to the STEP group. This trial was registered on 6 August 2021 (ClinicalTrials.gov NCT04994873). The STEP protocol was approved by the National Institute of Mental Health (NIMH) Data and Safety Monitoring Board on March 4, 2022. The RCT is currently in progress. The STEP protocol is an innovative, adjunctive treatment that has the potential to have positive effects on adolescent suicidal ideation and attempts beyond that found for standard treatment alone.

Background The post-discharge period following psychiatric hospitalization is a high-risk period for suicide attempts. This risk is substantially higher for patients admitted for suicidal behavior. Despite the urgent need for effective countermeasures, evidence-based interventions specifically designed to prevent suicide reattempts in this high-risk population remain limited. Although assertive case management is recognized as an effective intervention, its feasibility, safety, and efficacy for patients in psychiatric hospitals remain uninvestigated. The ACTION-JP study aims to evaluate the feasibility, safety, and efficacy of such an intervention adapted for patients in Japan admitted to psychiatric hospitals following a suicide attempt. Methods The ACTION-JP study is a multicenter, single-arm clinical trial. A total of 220 adult patients admitted to participating psychiatric hospitals following a suicide attempt will be enrolled. The intervention comprises two main components: a psychoeducation program conducted during hospitalization and an 18-month structured assertive case management follow-up. The primary outcome is the change from baseline in the Columbia-Suicide Severity Rating Scale total score at the 6-month follow-up. Secondary outcomes include the incidence of suicide reattempts and self-harm, as well as changes in Beck Depression Inventory-II and Global Assessment of Functioning Scale scores. Discussion This study protocol describes the essential first step in developing an evidence-based suicide prevention strategy for psychiatric inpatients. This study will provide important data on the intervention’s feasibility, safety, and efficacy. The findings are expected to offer important insights into the potential effectiveness of assertive case management for reducing suicide risk post-discharge. The successful implementation of this study will provide the necessary basis for designing a future large-scale randomized controlled trial that may help to establish a new standard of care in psychiatric hospitals. Trial registration This trial was registered on the University Hospital Medical Information Network clinical trials registry: UMIN000057009 (Date of registration: April 1, 2025) and the Japan Registry for Clinical Trials: jRCT1010250041 (Date of registration: October 20, 2025).

IntroductionSuicide is a significant public health issue worldwide. Many deaths by suicide occur in moments of crisis. Therefore, interventions which support individuals to manage moments of acute distress are needed. Safety Planning Interventions (SPI) are a group of brief interventions which aim to reduce imminent risk of suicide through the collaborative creation of a written set of coping strategies a person can use when suicidal ideation and/or urges occur. A number of studies, including systematic reviews, have supported the efficacy of SPIs in reducing suicidal behaviour, and sometimes ideation. However, there is notable heterogeneity in SPI effectiveness research. Our review aims to synthesise and critically examine the methodological characteristics of research on SPI effectiveness and to provide recommendations for the reporting of future research.Method and analysisA predetermined search strategy will be used to search six electronic databases. Eligible studies will examine the effectiveness of SPIs for suicidality in adults aged 18+. There will be no restrictions to inclusion based on study design, study setting and participant characteristics. Two independent reviewers will perform study selection, data extraction and quality assessment. Disagreements between reviewers will be resolved by a third reviewer. Data gathered will include study design, participant characteristics, study setting, type of SPI delivered, theoretical approach used to guide research, outcomes measured and results reported. A narrative synthesis of the methodological characteristics of the included studies will be provided. Recommendations for the development and reporting of future research will be provided. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-Analysis guidance.Ethics and disseminationEthical approval is not required as no original data will be collected. Findings will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberThis protocol has been registered on Prospero (registration ID CRD42025641027).