Swift Outpatient Alternatives for Rapid Stabilization

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Suicide Attempt
• Interventions: Behavioral: CAMS Single Session Consultation; Behavioral: Driver Focused Skills Training; Behavioral: Lethal Means Safety; Behavioral: Caregiver Skills Training

• 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: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-12
• 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),

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CAMS SSC + Driver-Focused Skills Training	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.
CAMS SSC + Lethal Means Safety	CAMS Single Session Consultation	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.
CAMS SSC + Lethal Means Safety	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.
CAMS SSC + Driver Focused Skills Training + Lethal Means Safety	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.
CAMS Single Session Consultation (SSC)	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 SSC + Driver-Focused Skills Training	CAMS Single Session Consultation	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.
CAMS SSC + Driver Focused Skills Training + Caregiver training	CAMS Single Session Consultation	This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
CAMS SSC + Caregiver Skills Building	CAMS Single Session Consultation	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.
CAMS SSC + Driver Focused Skills Training + Lethal Means Safety	Driver Focused Skills Training	This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
CAMS SSC + Caregiver Skills Training + Lethal Mean Safety	Caregiver Skills Training	The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety	Driver Focused Skills Training	This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
CAMS SSC + Caregiver Skills Building	Caregiver Skills Training	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.
CAMS SSC + Driver Focused Skills Training + Caregiver training	Driver Focused Skills Training	This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
CAMS SSC + Driver Focused Skills Training + Lethal Means Safety	CAMS Single Session Consultation	This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
CAMS SSC + Caregiver Skills Training + Lethal Mean Safety	CAMS Single Session Consultation	The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety	CAMS Single Session Consultation	This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver training	Caregiver Skills Training	This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
CAMS SSC + Caregiver Skills Training + Lethal Mean Safety	Lethal Means Safety	The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety	Caregiver Skills Training	This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety	Lethal Means Safety	This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.

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