Clinical trial NCT05996172: Swift Outpatient Alternatives for Rapid Stabilization
Official title: Swift Outpatient Alternatives for Rapid Stabilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide Attempt
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-18
Enrollment: 184
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Harkavy-Asnis Suicide Scale
timeFrame: baseline, 1, and 2 month follow up
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline, 1, & 2 month follow up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: University of Washington
name: Molly Adrian, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: