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Swift Outpatient Alternatives for Rapid Stabilization (SOARS)

Primary Purpose

Suicidal Ideation, Suicide Attempt

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAMS Single Session Consultation
Driver Focused Skills Training
Caregiver Skills Training
Lethal Means Safety
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    CAMS Single Session Consultation (SSC)

    CAMS SSC + Driver-Focused Skills Training

    CAMS SSC + Caregiver Skills Building

    CAMS SSC + Lethal Means Safety

    CAMS SSC + Driver Focused Skills Training + Caregiver training

    CAMS SSC + Driver Focused Skills Training + Lethal Means Safety

    CAMS SSC + Caregiver Skills Training + Lethal Mean Safety

    CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety

    Arm Description

    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.

    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.

    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.

    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.

    This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.

    This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.

    The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.

    This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.

    Outcomes

    Primary Outcome Measures

    Columbia Suicide Severity Rating Scale (C-SSRS)
    Suicidal 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.

    Secondary Outcome Measures

    Suicidal Ideation Questionnaire Junior
    Assesses severity of suicidal thoughts. Scores range from 0 to 90, with higher scores reflecting more severe ideation.

    Full Information

    First Posted
    June 19, 2023
    Last Updated
    August 15, 2023
    Sponsor
    University of Washington
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05996172
    Brief Title
    Swift Outpatient Alternatives for Rapid Stabilization
    Acronym
    SOARS
    Official Title
    Swift Outpatient Alternatives for Rapid Stabilization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2027 (Anticipated)
    Study Completion Date
    January 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: What is the strongest combination of SOARS components associated with reduction in youth suicidal thoughts and behavior (STB)? Do age and STB history moderate the impact of the effects of the SOARS intervention components? Do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth STBs? 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation, Suicide Attempt

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CAMS Single Session Consultation (SSC)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CAMS SSC + Driver-Focused Skills Training
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CAMS SSC + Caregiver Skills Building
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CAMS SSC + Lethal Means Safety
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CAMS SSC + Driver Focused Skills Training + Caregiver training
    Arm Type
    Active Comparator
    Arm Description
    This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
    Arm Title
    CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
    Arm Type
    Active Comparator
    Arm Description
    This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
    Arm Title
    CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
    Arm Type
    Active Comparator
    Arm Description
    The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
    Arm Title
    CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
    Arm Type
    Active Comparator
    Arm Description
    This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CAMS Single Session Consultation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Driver Focused Skills Training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Caregiver Skills Training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lethal Means Safety
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Columbia Suicide Severity Rating Scale (C-SSRS)
    Description
    Suicidal 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.
    Time Frame
    baseline, 1, and 2 month follow up
    Secondary Outcome Measure Information:
    Title
    Suicidal Ideation Questionnaire Junior
    Description
    Assesses severity of suicidal thoughts. Scores range from 0 to 90, with higher scores reflecting more severe ideation.
    Time Frame
    baseline, 1, & 2 month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Molly Adrian
    Phone
    206-987-7183
    Email
    molly.adrian@seattlechildrens.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Molly Adrian, Ph.D.
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Swift Outpatient Alternatives for Rapid Stabilization

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