Study protocol: Development and evaluation of an Interpersonal Counseling-based Stratified Stepped-Care intervention for suicide prevention among children and adolescents. A Randomized Controlled Trial

Background: While suicide rates have stabilized or declined in many regions, there is a concerning global rise in non-fatal suicidal behaviors (STBs) among youth, placing immense strain on mental healthcare systems. This has resulted in a surge in youth psychiatric emergency department visits and a systemic crisis of extended wait times and low treatment engagement. Given that the period following a suicidal crisis carries the highest risk for repeat attempts, there is an urgent need for innovative, scalable service delivery models that can provide rapid, effective, and sustained care. This study proposes a novel, stratified stepped-care (SSC) model that integrates non-specialist mental health professionals (MHPPs) to deliver low-intensity, evidence-based counseling for youth with STBs. Methods: This study protocol details the design and methodology of a randomized controlled trial (RCT) that will evaluate the efficacy and implementation outcomes of the proposed SSC model. We will compare the SSC intervention to care as usual (CAU) for youth (ages 6–18) with STBs. The SSC model utilizes a standardized triage system and a tiered intervention approach: low-intensity Interpersonal Counseling adapted for suicide crisis intervention (IPC-A-SCI) delivered by non-specialists for mild to moderate STBs, and brief IPT-A-SCI by licensed professionals for severe cases. Primary outcome will be the reduction of STBs, measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), while secondary outcomes include changes in depression, anxiety, trauma symptoms, and functioning. We will also estimate key implementation outcomes, including waiting time, accessibility, acceptability, and cost-effectiveness. Discussion: We anticipate that this RCT will demonstrate not only the effectiveness of the SSC model in reducing STBs and related symptoms but also its feasibility and accessibility within a public mental health setting. The anticipated outcomes of decreased wait times and increased treatment engagement will provide a crucial blueprint for health policymakers and clinicians. Successful implementation of this SSC model could offer a scalable solution for closing the treatment gap and reducing high-risk periods following suicidal crises, potentially transforming how accessible and effective mental health services are delivered to youth. Trial Registration: The trial was registered at ClinicalTrials.gov (registration number: NCT[07321171])