Outpatient Alternatives for Youth Suicide Risk

(SOARS Trial)

Overseen By Molly Adrian

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Psychosis, Eating disorder, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4-8 weeks

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to assist youth with acute suicidal thoughts or those who have attempted suicide in the past month. It compares several treatment combinations, including short therapy sessions, caregiver coaching, and safety planning, to determine which most effectively reduces suicidal thoughts and behaviors. One treatment under evaluation is the Swift Outpatient Alternatives for Rapid Stabilization (SOARS) program. The trial aims to develop a reliable outpatient program that integrates well with primary care settings. It seeks participants who have recently experienced serious suicidal thoughts or a suicide attempt and are open to therapy. As an unphased trial, this study provides a unique opportunity to contribute to developing effective treatments for youth in crisis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CAMS (Collaborative Assessment and Management of Suicidality) approach is both well-received and effective in managing suicide risk among teenagers. Studies have found CAMS to be successful in lowering suicide risk in teens by using tools like the Suicide Status Form to understand and address suicidal thoughts.

In this trial, the CAMS Single Session Consultation has reduced suicide risk. This method, supported by evidence, has been safely used in many settings. Training for caregivers and skills training for teens, which includes emotional and communication skills, strengthen the treatment. These components are based on well-known therapies like Dialectical Behavior Therapy (DBT) and Cognitive Behavioral Therapy (CBT), which are proven to be safe and effective.

Lethal Means Safety, which involves limiting access to items that could be used for self-harm, is also a crucial part of these treatments. This strategy has been shown to lower suicide risk by increasing the time and distance between a person and harmful means.

Overall, these treatments are considered safe and have been effectively used in similar situations to help reduce suicide risk in young people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to managing youth suicide risk. Unlike traditional treatments that might primarily focus on medication or long-term therapy, this trial combines brief, targeted interventions with skill-building. The treatments focus on immediate engagement through a single session of CAMS (Collaborative Assessment and Management of Suicidality), followed by either caregiver skills training, youth-focused skills training, or both. Additionally, some arms emphasize lethal means safety, providing families with tools to manage home safety. These approaches aim to stabilize crises quickly and equip both youth and caregivers with practical skills, potentially transforming the way we address acute suicide risk in young people.

What evidence suggests that this trial's treatments could be effective for youth suicide risk?

Research shows that the Collaborative Assessment and Management of Suicidality (CAMS) approach effectively reduces suicidal thoughts. Studies have found that CAMS can quickly decrease these thoughts in just 6 to 8 sessions. In this trial, participants will receive different combinations of interventions. One arm includes skills training for caregivers, which has shown positive results in helping families communicate better and handle crises. Another arm focuses on Lethal Means Safety, which involves limiting access to items that could be used for self-harm, thereby reducing suicide risks. By combining these methods, especially with skills training for both young people and their caregivers, this trial aims to provide a comprehensive solution to youth suicide risk. Various clinical studies support this combination, showing a decrease in suicidal thoughts and behaviors among adolescents. ^{1 2 3 6 7}

Who Is on the Research Team?

Molly Adrian, Ph.D.

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for young people who have recently had suicidal thoughts or attempted suicide, as indicated by positive responses on the Ask Suicide Screening Questionnaire. It's designed to help improve outpatient care for acute youth suicide risk.

Inclusion Criteria

You have reported acute suicidal thoughts or a suicide attempt in the past thirty days on the Ask Suicide Screening Questionnaire (ASQ).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a minimum of 1 session and a maximum of 8 sessions of CAMS and additional components like coping skills training, caregiver skills, and lethal means safety

4-8 weeks

1 to 8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 1 month, and 2 months

2 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Swift Outpatient Alternatives for Rapid Stabilization

Trial Overview

The study tests a combination of interventions: CAMS Single Session Consultation, Driver Focused Skills Training, Lethal Means Safety, and Caregiver Skills Training. The goal is to find the most effective mix of these components to reduce suicidal thoughts and behaviors in youth.

How Is the Trial Designed?

Group I: CAMS Single Session Consultation (SSC) Active Control 1 Intervention

CAMS is a clinical intervention designed to modify how clinicians engage, assess and plan treatment with suicidal patients. The foundational brief intervention that all participants will receive includes 1 90-minute session of CAMS assessment and planning interview with follow-up care navigation.

Group II: CAMS SSC + Caregiver Skills Building Active Control 2 Interventions

Caregivers will receive 3, 30-minute modules across 3 sessions that provide explicit coaching in several skills. Module content will include 1) psychoeducation on suicidality and the escalation cycle and creation of a communication plan related to responding to youth suicidality (i.e., Crisis Escalation and Communication Plan); 2) positive communication and relationship building strategies including reflective listening, validation, and how to implement regular teen-directed one-on-one time; and 3) setting up behavioral expectations, house rules, and using positive reinforcement based contingency management in the home (i.e., targeted praise, using rewards to promote more effective behaviors). All modules will include didactic skill building, role-play of skill use with the therapist, and a check-in with the youth and youth therapist to collaboratively problem-solve barriers to use of skills.

Group III: CAMS SSC + Driver-Focused Skills Training Active Control 2 Interventions

Specific skills are taught to youth based on CAMS drivers/case conceptualization of suicidality. Based on our pilot work, the common components of treatment include explicit coaching in skills informed by evidence-based treatments like Dialectical Behavior Therapy (DBT), Cognitive Behavioral Therapy (CBT), and Behavioral Activation (BA). Skills are drawn from the following 3 domains: emotion regulation and crisis survival skills (e.g., paced breathing, use of temperature and exercise to alter mood, Hope Box), behavioral activation strategies (e.g., goal-directed behavior, scheduling of activities, problem-solving) and communication skills (communication around suicidality, validation of self and others, making clear requests/DEAR MAN). Youth assigned to the Ongoing CAMS Intervention condition will receive three, 50-minute sessions that include the interim SSF and driver focused treatment encompassing skills instruction, in-session practice, and assigned homework.

Group IV: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety Active Control 4 Interventions

This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.

Group V: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety Active Control 3 Interventions

This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.

Group VI: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety Active Control 3 Interventions

The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.

Group VII: CAMS SSC + Lethal Means Safety Active Control 2 Interventions

The CAMS Therapeutic Assessment incorporates low levels of lethal means restriction (see above). Experimental Intervention Component 4 will provide a high level of lethal means restriction that includes the evaluation of the need for a lock box, the provision of a lock box if needed, structured process for evaluating home safety in each room of the house, specific directives to accomplish, follow up with the clinician, and problem-solving barriers to lethal means restriction over two, 30-minute modules delivered across 2 sessions.

Group VIII: CAMS SSC + Driver Focused Skills Training + Caregiver training Active Control 3 Interventions

This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 286 suicidal adolescents aged 12 to 17, those receiving rapid-response outpatient follow-up had a significantly lower hospitalization rate (18%) compared to the control group (43%) at six months, indicating the effectiveness of this treatment model.

Both groups showed similar improvements in functioning and reductions in suicidality, suggesting that rapid-response outpatient care can effectively support suicidal adolescents without the need for hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rapid-response outpatient model for reducing hospitalization rates among suicidal adolescents. Greenfield, B., Larson, C., Hechtman, L., et al.[2022]

The Crisis Stabilization Program successfully reduced the reliance on state psychiatric facilities for children and adolescents by providing immediate support through a dedicated crisis team and after-hours assistance.

This program highlights the effectiveness of community-based services in addressing mental health crises, demonstrating a proactive approach to mental health care for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crisis stabilization services for children and adolescents: a brokerage model to reduce admissions to state psychiatric facilities. Ruffin, JE., Spencer, HR., Abel, A., et al.[2019]

The establishment of an outpatient psychiatric Emergency Room Follow-up Team (ERFUT) led to a 16% reduction in hospitalization rates for suicidal adolescents, indicating improved management of youth in crisis.

Importantly, there was no increase in the number of patients returning to the Emergency Room, and none of the adolescents in the experimental group died during a 3-year follow-up, suggesting that intensive outpatient care can be both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term efficacy of interventions by a youth crisis team. Greenfield, B., Hechtman, L., Tremblay, C.[2022]

The Behavioral Health Crisis Care Clinic (CCC) model was found to be highly feasible and acceptable for youth in crisis, with a satisfaction score exceeding benchmarks, indicating it effectively meets the needs of young individuals experiencing suicidal thoughts or behaviors.

Participants in the CCC showed significant reductions in self-reported suicide risk, with a low rate of emergency department usage during and after treatment, and over 88% of those without prior outpatient care were successfully connected to ongoing mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A unique model of care for youth in crisis: A pilot open trial. Adrian, M., Twohy, E., Babeva, K., et al.[2023]

In a study of 181 youth suicide attempters in emergency departments, key factors influencing the decision to admit or discharge included the specific ED site, the presence of a suicide plan, and parental reports of problems.

Hospitalization was linked to better connections to outpatient treatment and increased use of intensive services, highlighting the importance of inpatient care for improving outcomes in high-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Psychiatric Hospitalization in Youth Presenting to the Emergency Department with Suicidality. Hughes, JL., Anderson, NL., Wiblin, JL., et al.[2022]

An intensive outpatient program (IOP) for suicidal adolescents showed high feasibility and acceptability, with 81% of the 364 enrolled participants completing an average of nine sessions and over 95% reporting satisfaction with the program.

Participants demonstrated significant improvements in depressive symptoms and suicidal ideation by the time of discharge, although 8.7% reported a suicide attempt and 27.3% experienced a suicidal event within six months post-discharge, indicating the need for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Feasibility Outcomes of a Youth Suicide Prevention Intensive Outpatient Program. Kennard, B., Mayes, T., King, J., et al.[2022]

The study is a three-arm randomized controlled trial involving youth who have experienced acute care for suicidality, testing the effectiveness of two interventions, Safety Planning Intervention with structured follow-up (SPI+) and Collaborative Assessment and Management of Suicidality (CAMS), against enhanced usual care over approximately 8 weeks.

The primary outcome will focus on reducing suicidal events, including death by suicide and suicide attempts, while secondary outcomes will assess the number of attempts and severity of suicidal ideation, aiming to establish safe and effective treatment strategies for youth in crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial. Adrian, M., McCauley, E., Gallop, R., et al.[2023]

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The Collaborative Assessment and Management of Suicidality (CAMS) is an evidence-based approach to treating people suffering from serious thoughts of self-harm.

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Here's how to adapt the CAMS Framework® to treat and prevent suicidal thoughts and ideation in children, teens, and young adults.