Stepped-Care for Suicidal Youth and Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorShira Barzilay

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Acute medical conditions.

Current psychotic disorders.

Non-fluency in Hebrew (language of intervention and assessment).

Diagnosed intellectual disability.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Intervention Arm: Stratified Stepped Care (SSC)Experimental treatment 2 interventions
Group B: Control Arm: Care as Usual (CAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 4, Week 8, 12 Weeks Follow-up
2

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.

Time frame
From randomization up to one year after baseline.

Secondary outcomes

1

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

This outcome measure assesses the change in depression levels among participants over time, relative to their initial state at baseline. Depression is measured using a standardized self-report questionnaire called the Mood and Feelings Questionnaire (MFQ). The MFQ is a standard tool for measuring the severity of depressive symptoms in children and adolescents. Participants are asked to rate the frequency of various depressive symptoms (such as feeling sad, hopeless, or losing interest in activities) on a rating scale. A higher score on the questionnaire indicates greater depression severity. The assessment is conducted at multiple time pointsץ

Time frame
Baseline, Week 4, Week 8, 12 Weeks Follow-up
2

Total Cost of Mental Health Service Delivery per Participant

Costs in US Dollars will include direct service costs (e.g., provider salaries, training, supervision, facility costs) and indirect costs (e.g., costs associated with hospitalizations or emergency room visits related to STB). These components will be aggregated to provide a single value for the total cost of care for the study period. Lower total costs indicate greater economic efficiency and a better outcome.

Time frame
From randomization up to 6 months post-baseline.
3

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

The waiting time will be measured as the number of days from a participant's initial intake at the clinic to their first therapeutic session. This data will be collected for both the SSC group and the Care as Usual (CAU) group and will be compared to demonstrate whether the new model improves access. From Initial Intake (Day 1) through the start of the first therapeutic session for each participant. A lower number of days indicates reduced waiting time and a better outcome for access to care.

Time frame
Initial Intake (Day 1) up up to first session of intervention
4

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

his outcome measure assesses the change in anxiety levels among participants over time, relative to their initial state at baseline. Anxiety is measured using a standardized self-report questionnaire called the Screen for Child Anxiety Related Emotional Disorders (SCARED). The SCARED is a standardized questionnaire that screens for five main types of anxiety disorders: panic disorder, generalized anxiety disorder, separation anxiety disorder, social anxiety, and school avoidance. Participants are asked to rate how true specific symptoms have been for them in the last three months, using a rating scale. A higher score on the questionnaire indicates greater anxiety severity.

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

Other outcomes

Sponsors and contacts

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Shira Barzilay

Lead sponsor

University of Haifa

Sponsor institution

Schneider Children's Medical Center, Israel

Collaborator