NCT07321171

Stepped-Care for Suicidal Youth and Children

Examining the Efficacy of a Stratified-Stepped-Care Model for Brief Interpersonal Couseling (IPC) in Youth With Imminent Suicidal Risk: A Prospective, Randomized Controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Shira Barzilay · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this RCT study is to test the efficacy of a stratified stepped-care (SSC) model in reducing suicidal thoughts and behaviors (STB) in children and adolescents. The main questions it aims to answer are: 1. Does the SSC model effectively reduce STB and mental health symptoms? 2. Can the SSC model improve access to treatment and be cost-effective? Researchers will compare the SSC model to Care as Usual (CAU). The SSC model includes low-intensity counseling delivered by non-specialists for mild STB and professional-delivered therapy for more severe cases. The CAU group will receive standard clinic treatment, which consists of a waitlist for brief therapy and follow-up. Participants will be recruited from a clinic at Schneider Children's Medical Center, randomly assigned to either the SSC group or the CAU group, and Complete assessments at the start of the study and at 1, 3, and 6 months.

Detailed description

Detailed Study Description This study is aimed at improving the care provided to children and adolescents experiencing suicidal thoughts and behaviors (STB). It addresses the significant public health challenge of rising suicide rates among youth and the systemic issues within mental health services, such as long waiting times and a shortage of professional staff. The research aims to develop a new, effective model of care that can be integrated into existing health systems. The investigators will conduct a randomized controlled trial (RCT) comparing a new SSC model to the current standard of care, Care as Usual (CAU). The goal is to determine if the SSC model is more effective in reducing suicidal symptoms and improving mental health outcomes. 1. Provider Training: A key component of this model is the use of non-specialist mental health providers. The investigators will train a group of individuals, primarily psychology and community mental health graduate students with relevant experience, to deliver a low-intensity, evidence-based intervention. This intervention, Interpersonal Counseling for Suicidal Crisis Intervention (IPC-A-SCI), is a manualized protocol adapted for this study. The training will be conducted in a hybrid format (in-person and online), and the investigators will include weekly group supervision by a senior clinical psychologist. This training emphasizes the ethical and safety considerations necessary when working with this vulnerable population. 2. Participant Treatment and Data Collection: Upon entering the study, senior clinicians will conduct a baseline assessment of each participant, including a diagnostic interview and a suicide risk evaluation. Participants will then be randomly assigned to one of two groups: Intervention Group (SSC): Participants in this group will receive care based on their initial clinical assessment. Those with mild-to-moderate STB will receive the low-intensity IPC-A-SCI intervention from the newly trained non-specialist providers. If a patient's condition worsens, they can "step up" to a higher level of care, receiving brief IPT-A-SCI (Interpersonal Psychotherapy for Adolescents) from a professional therapist. Control Group (CAU): Participants in this group will receive the standard treatment currently provided at the clinic. This typically involves an initial psychiatric assessment followed by placement on a waitlist for brief therapy. Assessments to measure outcomes, including STB, depression, anxiety, and trauma, will be conducted at the beginning of the study and again at one, three, and six months. The investigators will analyze this data to compare the effectiveness of the two care models.

Conditions

• Suicidal Ideation and Behavior

Interventions

Type	Name	Description
BEHAVIORAL	IPC-A-SCI (Interpersonal Counseling for Suicide Crisis Intervention)	The IPC-A-SCI is a manualized, low-intensity intervention adapted for adolescents experiencing suicidal thoughts and behaviors. It is based on Interpersonal Psychotherapy (IPT) principles but is designed to be delivered in a limited number of sessions by trained non-specialists. The protocol focuses on identifying and addressing interpersonal problems that may trigger or maintain suicidal behaviors. It includes core components such as safety planning, building interpersonal skills, and emotional processing, with a specific emphasis on involving parents in the treatment process. The intervention is a key component of the overall stratified stepped-care (SSC) model, which aims to provide targeted, effective, and accessible care in a public health setting.
BEHAVIORAL	IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention)	The IPT-A-SCI is a crisis-focused psychotherapeutic intervention developed for adolescents with suicidal thoughts and behaviors. It is based on the principles of Interpersonal Psychotherapy (IPT).

Timeline

• Start date: 2024-05-07
• Primary completion: 2027-12-01
• Completion: 2027-12-31
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Israel