Stepped-Care for Suicidal Youth and Children (SURE-CARE)

Shira Barzilay

Status: Enrolling

Conditions: Suicidal Ideation and Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07321171

0021-24-RMC

2023/333 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups

Intervention Arm: Stratified Stepped Care (SSC)

Experimental group

Description:

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.

Treatment:

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

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

Control Arm: Care as Usual (CAU)

Active Comparator group

Description:

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.

Treatment:

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