Swift Outpatient Alternatives for Rapid Stabilization

Suicidal Ideation Clinical Trial

— SOARS  

Official title:

Swift Outpatient Alternatives for Rapid Stabilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996172
• Other study ID #: STUDY00016898
• Secondary ID: P50MH129708
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: January 2028

Study information

• Verified date: December 2023
• Source: University of Washington
• Contact: Molly Adrian
• Phone: 206-987-7183
• Email: molly.adrian[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

The investigators are comparing different treatment sequences for suicidal thoughts and behaviors. The treatment package families are assigned will be determined by randomization. All participants will receive 1 session of Collaborative Assessment and Management of Suicidality (CAMS) and care management. CAMS treatment primarily focuses on working with a therapist to understand the reasons why the participants are thinking about suicide Additional components which the participant may be randomly assigned to receive include coping skills training for youth, skills training for parents, and additional safety strategies. Each treatment type is designed to help adolescents and young adults with suicide risk. Participants will be randomly assigned to an intervention sequence for a minimum of 1 session (120 minutes) and maximum of 8 sessions (440 minutes, divided across separate youth and caregiver components). Caregivers will receive at least 1 session and a maximum of 4 sessions. Depending on the randomization, caregivers may be assigned to receive skills related to caregiving and safe storage of items that could be used for harm. To see how the treatment is going participants will receive study assessments at the beginning of the study, 1-month, and 2-months. Study assessments will ask about demographics, suicide attempts, suicidal ideation, non-suicidal self-injury, experiences with treatment, substance use, and social experiences. The research team will also collect information from medical records.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: January 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

Inclusion Criteria:

• Acute suicidal thoughts or past month suicide attempt as reported on positive responses to the Ask Suicide Screening Questionnaire (ASQ),

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

Behavioral:
• CAMS Single Session Consultation
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.
• Driver Focused Skills Training
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.
• Caregiver Skills Training
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.
• Lethal Means Safety
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.

Locations

Country	Name	City	State
United States	Seattle Children's	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Columbia Suicide Severity Rating Scale (C-SSRS)	ASuicidal thoughts and behaviors. Suicide ideation is rated on a scale of 1 to 5, with higher numbers reflecting more severe ideation. Suicidal behaviors are count measures, with higher numbers reflecting more attempts.	baseline, 1, & 2 month follow up