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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change from Baseline in Suicidal Thoughts and Behaviors (STB) as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
研究概览
简要总结
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:
- Does the SSC model effectively reduce STB and mental health symptoms?
- 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.
详细描述
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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Intervention Arm: Stratified Stepped Care (SSC)
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.
干预措施: IPC-A-SCI (Interpersonal Counseling for Suicide Crisis Intervention) (Behavioral)
Intervention Arm: Stratified Stepped Care (SSC)
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.
干预措施: IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention) (Behavioral)
Control Arm: Care as Usual (CAU)
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.
干预措施: IPT-A-SCI (Interpersonal Psychotherapy for Adolescents with Suicidal Crisis Intervention) (Behavioral)
结局指标
主要结局
Change from Baseline in Suicidal Thoughts and Behaviors (STB) as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
时间窗: Baseline, Week 4, Week 8, 12 Weeks Follow-up
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.
Feasibility of SSC Model Integration
时间窗: From randomization up to one year after baseline.
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.
次要结局
- 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)
- Staff Survey of Acceptability (Adapted)(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),(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).(baseline)
- Difficulties in Emotion Regulation Scale - State (DERS-State)(Baseline, Week 4, Week 8, 12 Weeks Follow-up)
- The Deliberate Self-Harm Inventory (DASH-I), a self-report tool specifically designed for adolescents.(Baseline, Week 4, Week 8, 12 Weeks Follow-up)
- The Children's Global Assessment Scale (CGAS)(Baseline, Week 4, Week 8, 12 Weeks Follow-up)
- The Clinical Global Improvement (CGI)(Baseline, Week 4, Week 8, 12 Weeks Follow-up)
- Client Satisfaction Questionnaire (CSQ-4) Score(immediately after the intervention)
研究者
Shira Barzilay
Principal Investigator Dr Shira Barzilay
University of Haifa