Stepped-Care for Suicidal Youth and Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IPC-A-SCI (Interpersonal Counseling for Suicide Crisis Intervention), IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention).
- Who it may be relevant to
- Registry conditions: Suicidal Ideation and Behavior. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Interventions
- 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 - 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).
Primary outcome measures
- Change from Baseline in Suicidal Thoughts and Behaviors (STB) as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- Feasibility of SSC Model Integration [Time frame: From randomization up to one year after baseline.]
Secondary outcome measures (12)
- Depression: Measured by the Mood and Feelings Questionnaire (MFQ). [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- Total Cost of Mental Health Service Delivery per Participant [Time frame: From randomization up to 6 months post-baseline.]
- Time (in Days) from Initial Intake to First Therapeutic Session [Time frame: 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). [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- Outcome Rating Scale (ORS) /Child Outcome Rating Scale (CORS) [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- Staff Survey of Acceptability (Adapted) [Time frame: up to 1 year post initial training]
- change in emotional and behavioral difficulties and prosocial strengths among participants. It is measured using the Strengths and Difficulties Questionnaire (SDQ), [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- the severity of Post-Traumatic Stress Disorder (PTSD) symptoms among participants. It is measured using the self-report questionnaire Child PTSD Symptom Scale (CPSS). [Time frame: baseline]
- Difficulties in Emotion Regulation Scale - State (DERS-State) [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- The Deliberate Self-Harm Inventory (DASH-I), a self-report tool specifically designed for adolescents. [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- The Children's Global Assessment Scale (CGAS) [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
- The Clinical Global Improvement (CGI) [Time frame: Baseline, Week 4, Week 8, 12 Weeks Follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Shneider children's Medical Center — Petah Tikva
Identifiers
NCT: NCT07321171 · 0021-24-RMC · 2023/333