Stepped-Care for Suicidal Youth and Children

NCT07321171 | Recruiting DMC

• 2 other identifiers: 0021-24-RMC2023/333
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the SSC model effectively reduce STB and mental health symptoms?
2. 2.Can the SSC model improve access to treatment and be cost-effective?

Conditions

Suicidal Ideation and Behavior

Keywords

suicide prevention; youth; adolescent; inter personal counseling; stepped care; Suicide thoughts; paraprofessional; IPT; treatment

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Suicidal Thoughts and Behaviors (STB) as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).

  This primary outcome measure assesses the change in the severity of suicidal thoughts and behaviors (STB) among participants over time, relative to their initial state at baseline. Data for this measure will be collected using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a standardized, clinician-administered tool that consists of a series of questions designed to identify, classify, and quantify the severity of a person's suicidal thoughts and behaviors. The scale addresses five types of suicidal ideation (e.g., thoughts of suicide without a plan or intent) and six types of suicidal behaviors (e.g., actual suicide attempts). The assessment is conducted at multiple time points. The change in C-SSRS scores between these time points will be used to compare the intervention group with the control group, determining whether the new treatment is more effective in reducing suicidal risk in children and adolescents.

  Baseline, Week 4, Week 8, 12 Weeks Follow-up

• Feasibility of SSC Model Integration

  This measure evaluates the feasibility and fidelity of implementing the Stratified-Stepped-Care (SSC) model into the existing clinic workflow. Feasibility will be measured by calculating the percentage of adherence to the study protocol for both providers and participants (e.g., percentage of sessions completed, percentage of core protocol elements delivered). Fidelity will also be assessed via direct observation and completion of a standardized Protocol Adherence Checklist. Higher percentages indicate greater feasibility and fidelity to the SSC model and a better outcome.

  From randomization up to one year after baseline.

Secondary Outcomes (13)

• Depression: Measured by the Mood and Feelings Questionnaire (MFQ).

  Baseline, Week 4, Week 8, 12 Weeks Follow-up

• Total Cost of Mental Health Service Delivery per Participant

  From randomization up to 6 months post-baseline.

• Time (in Days) from Initial Intake to First Therapeutic Session

  Initial Intake (Day 1) up up to first session of intervention

• Change from Baseline in Anxiety Symptoms as measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED).

  Baseline, Week 4, Week 8, 12 Weeks Follow-up

• Outcome Rating Scale (ORS) /Child Outcome Rating Scale (CORS)

  Baseline, Week 4, Week 8, 12 Weeks Follow-up

Study Arms (2)

Intervention Arm: Stratified Stepped Care (SSC)

EXPERIMENTAL

The role of this arm is to test the efficacy of a new, tiered model for treating suicidal thoughts and behaviors (STB) in youth. Participants in this group will receive an intervention that is tailored to their specific needs and level of risk, as determined by an initial clinical assessment. Low-Intensity Treatment: Participants with mild-to-moderate STB will receive an adapted form of Interpersonal Counseling (IPC-A-SCI) delivered by a trained non-specialist. This intervention focuses on safety planning and improving interpersonal skills. High-Intensity Treatment: Participants with more severe STB, or those whose condition worsens, will receive Interpersonal Psychotherapy (IPT-A-SCI) from a professional therapist. This provides a clear "step-up" pathway to a more intensive level of care.

Behavioral: IPC-A-SCI (Interpersonal Counseling for Suicide Crisis Intervention); Behavioral: IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention)

Control Arm: Care as Usual (CAU)

ACTIVE COMPARATOR

The role of this arm is to serve as a comparison group to the SSC model. It represents the standard of care currently available in a public outpatient clinic in Israel. Standard Treatment: Participants in this arm will receive an initial psychiatric assessment. They will then be placed on a waitlist for a brief IPT intervention. Follow-up assessments will be conducted every three months. After completing the brief IPT, some participants may be referred to community services, and a small percentage may receive longer-term psychotherapy.

Behavioral: IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention)

Interventions

IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention) BEHAVIORAL

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).

Control Arm: Care as Usual (CAU); Intervention Arm: Stratified Stepped Care (SSC)

IPC-A-SCI (Interpersonal Counseling for Suicide Crisis Intervention) BEHAVIORAL

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.

Intervention Arm: Stratified Stepped Care (SSC)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must be between 6 and 18 years old, inclusive.
• Participants currently exhibit various forms of STB, including suicidal thoughts, gestures, behaviors, or attempted suicide.

You may not qualify if:

• Acute medical conditions.
• Current psychotic disorders.
• Non-fluency in Hebrew (language of intervention and assessment).
• Diagnosed intellectual disability.
• Diagnosed neurodevelopmental disorders (other than those that commonly co-occur with STB and are deemed manageable by the study team).
• Inability to provide informed consent (participant) or parental permission (parent/guardian).

Sponsors & Collaborators

• Shira Barzilay: lead
• Schneider Children's Medical Center, Israel: collaborator

Study Sites (1)

Shneider children's Medical Center

Petah Tikva, 4920235, Israel

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Suicide Prevention

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Shira Barzilay, Principal Investigator, Phd

CONTACT

972-54-5309759; bshira@haifa.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Although the therapists are aware of the type of treatment they are providing, the participants themselves are not aware of which research arm they belong to (the SSC group or the CAU group) at the time of allocation. They know that they are participating in a study to compare treatment methods, but the identity of the specific treatment they receive is only revealed to them upon the start of the treatment. This makes them "masked" for a certain period to prevent bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator Dr Shira Barzilay

Model Details: This study uses a parallel-group, randomized controlled trial (RCT) design. This means that after a baseline assessment, participants will be randomly assigned to one of two distinct, independent groups. Each group will receive a different intervention for the duration of the study, and their outcomes will be compared. The core of this model is the comparison between a novel, multi-layered treatment approach (Stratified Stepped-Care - SSC) and the existing standard of care (Care as Usual - CAU). The two groups are completely separate, with no participants switching between them. This design is robust for evaluating the effectiveness of a new intervention against an established one, as it minimizes bias and allows for a direct comparison of outcomes.

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: January 6, 2026
• Study Start: May 7, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after the publication of the primary manuscript, for a period of 3 years following the initial release date.
• Access Criteria: Access to the Individual Participant Data (IPD) will be granted only to qualified researchers outside of the immediate study team. Access requires that the requesting researcher submit a methodologically sound proposal for secondary analysis, and this proposal must be approved by the study's scientific review committee or the Institutional Review Board (IRB) to ensure the proposed use is ethical and aligned with participant consent. The following study documents and data will be made available: * De-identified Individual Participant Data (IPD) * Study Protocol * Statistical Analysis Plan (SAP) * Informed Consent Form (ICF) Access is contingent upon the requester signing a formal Data Access Agreement (DAA), which legally mandates adherence to privacy protocols and ensures protection of the sensitive nature of the data (suicide risk in minors).The de-identified dataset and supporting files will be delivered via a secured, password-protected electronic platform.

Locations

IL (1)