Swift Outpatient Alternatives for Rapid Stabilization

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Suicide Attempt

• Registration Number: NCT05996172
• Lead Sponsor: University of Washington

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?

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-18
• Study Start: 2023-11-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-12
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Harkavy-Asnis Suicide Scale	baseline, 1, and 2 month follow up	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.

Secondary Outcome Measures

Name	Time	Method
Columbia Suicide Severity Rating Scale (C-SSRS)	baseline, 1, & 2 month follow up	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.

Trial Locations

Locations (1)

Seattle Children's; 🇺🇸 Seattle, Washington, United States