Swift Outpatient Alternatives for Rapid Stabilization
SOARS
2 other identifiers
interventional
184
1 country
1
Brief Summary
The goal of this clinical trial is to improve the effective outpatient management of acute youth suicide risk by optimizing intervention components to build an efficient, evidence-based intervention that is responsive to the needs of, and coordinated with, providers in primary care settings. The main questions are:
- 1.What is the strongest combination of SOARS components associated with reduction in youth suicidal thoughts and behavior (STB)?
- 2.Do age and STB history moderate the impact of the effects of the SOARS intervention components?
- 3.Do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth STBs?
- 4.What helps medical outpatient providers refer to SOARS and continue care after SOARS?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
November 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 27, 2025
March 1, 2025
4.1 years
June 19, 2023
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Harkavy-Asnis Suicide Scale
This measure assesses the frequency of suicidal ideation on a 5-point Likert scale, with 0 indicating "never" and 4 indicating "most or all of the time". Higher scores reflect higher severity and frequency of suicidal ideation.
baseline, 1, and 2 month follow up
Secondary Outcomes (1)
Columbia Suicide Severity Rating Scale (C-SSRS)
baseline, 1, & 2 month follow up
Study Arms (8)
CAMS Single Session Consultation (SSC)
ACTIVE COMPARATORCAMS 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.
CAMS SSC + Driver-Focused Skills Training
ACTIVE COMPARATORSpecific 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.
CAMS SSC + Caregiver Skills Building
ACTIVE COMPARATORCaregivers 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.
CAMS SSC + Lethal Means Safety
ACTIVE COMPARATORThe 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.
CAMS SSC + Driver Focused Skills Training + Caregiver training
ACTIVE COMPARATORThis arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
ACTIVE COMPARATORThis arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
ACTIVE COMPARATORThe arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
ACTIVE COMPARATORThis arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
Interventions
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. CAMS is based around a model of STB which states that youth become suicidal in response to overwhelming pain, and treatment identifies and targets the drivers of suicide as the primary focus of assessment and intervention.
The CAMS approach focuses on therapeutic assessment, collaborative identification and treatment of the patient-defined STB drivers (i.e., the problems that make suicide compelling to the patient) and utilizes problem-focused treatment sessions to address the drivers in order to reduce the wish to die. In the SOARS brief intervention model, specific skills are taught to youth based on CAMS drivers/case conceptualization of suicidality.
Caregivers will receive 3, 30-minute modules across 3 sessions that provide explicit coaching in several skills adapted from evidence-based treatments for youth suicidality including DBT and CBT.48,49 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.
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 safety over two, 30-minute modules delivered across 2 sessions.
Eligibility Criteria
You may qualify if:
- Acute suicidal thoughts or past month suicide attempt as reported on positive responses to the Ask Suicide Screening Questionnaire (ASQ),
You may not qualify if:
- urgent medical care secondary to self-injurious behavior, psychosis, eating disorder that requires full or partial inpatient care, or
- intellectual disability warranting a different treatment pathway;
- limited English, Spanish, Vietnamese, or Chinese proficiency that would interfere with ability to complete study assessments;
- unwillingness to participate in psychotherapy,
- caregiver unwilling or ineligible to participate;
- and previous enrollment in SOARS program or other P50 project as to not confuse longitudinal follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seattle Children's
Seattle, Washington, 98199, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Molly Adrian, Ph.D.
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
June 19, 2023
First Posted
August 18, 2023
Study Start
November 9, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share