Swift Outpatient Alternatives for Rapid Stabilization

NCT05996172 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-03-27

No results posted yet for this study

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?

Conditions

Interventions

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Molly Adrian, Ph.D. · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996172 on ClinicalTrials.gov