Swift Outpatient Alternatives for Rapid Stabilization

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05996172
Status
Recruiting
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Conditions

  • Suicidal Ideation
  • Suicide Attempt

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • CAMS Single Session Consultation — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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?

Key Dates

Start date
Nov 9, 2023
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CAMS Single Session Consultation (SSC)
    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.
  • Active Comparator: CAMS SSC + Driver-Focused Skills Training
    Specific 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.
  • Active Comparator: CAMS SSC + Caregiver Skills Building
    Caregivers 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.
  • Active Comparator: CAMS SSC + 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 restriction over two, 30-minute modules delivered across 2 sessions.
  • Active Comparator: CAMS SSC + Driver Focused Skills Training + Caregiver training
    This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
  • Active Comparator: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
    This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
  • Active Comparator: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
    The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
  • Active Comparator: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
    This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.

Primary Outcome Measure

Harkavy-Asnis Suicide Scale [ Time Frame: baseline, 1, and 2 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children'sSeattleWashington98199
Molly C Adrian
[email protected]

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