xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996172</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016898</org_study_id>
      <secondary_id>P50MH129708</secondary_id>
      <nct_id>NCT05996172</nct_id>
    </id_info>
    <brief_title>Swift Outpatient Alternatives for Rapid Stabilization</brief_title>
    <acronym>SOARS</acronym>
    <official_title>Swift Outpatient Alternatives for Rapid Stabilization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to improve the effective outpatient management of acute&#xD;
        youth suicide risk by optimizing intervention components to build an efficient,&#xD;
        evidence-based intervention that is responsive to the needs of, and coordinated with,&#xD;
        providers in primary care settings. The main questions are:&#xD;
  &#xD;
          1. What is the strongest combination of SOARS components associated with reduction in youth&#xD;
             suicidal thoughts and behavior (STB)?&#xD;
  &#xD;
          2. Do age and STB history moderate the impact of the effects of the SOARS intervention&#xD;
             components?&#xD;
  &#xD;
          3. Do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth&#xD;
             STBs?&#xD;
  &#xD;
          4. What helps medical outpatient providers refer to SOARS and continue care after SOARS?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators are comparing different treatment sequences for suicidal thoughts and&#xD;
        behaviors. The treatment package families are assigned will be determined by randomization.&#xD;
  &#xD;
        All participants will receive 1 session of Collaborative Assessment and Management of&#xD;
        Suicidality (CAMS) and care management. CAMS treatment primarily focuses on working with a&#xD;
        therapist to understand the reasons why the participants are thinking about suicide&#xD;
        Additional components which the participant may be randomly assigned to receive include&#xD;
        coping skills training for youth, skills training for parents, and additional safety&#xD;
        strategies. Each treatment type is designed to help adolescents and young adults with suicide&#xD;
        risk.&#xD;
  &#xD;
        Participants will be randomly assigned to an intervention sequence for a minimum of 1 session&#xD;
        (120 minutes) and maximum of 8 sessions (440 minutes, divided across separate youth and&#xD;
        caregiver components).&#xD;
  &#xD;
        Caregivers will receive at least 1 session and a maximum of 4 sessions. Depending on the&#xD;
        randomization, caregivers may be assigned to receive skills related to caregiving and safe&#xD;
        storage of items that could be used for harm.&#xD;
  &#xD;
        To see how the treatment is going participants will receive study assessments at the&#xD;
        beginning of the study, 1-month, and 2-months. Study assessments will ask about demographics,&#xD;
        suicide attempts, suicidal ideation, non-suicidal self-injury, experiences with treatment,&#xD;
        substance use, and social experiences. The research team will also collect information from&#xD;
        medical records.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
      <time_frame>baseline, 1, and 2 month follow up</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Suicidal Ideation Questionnaire Junior</measure>
      <time_frame>baseline, 1, &amp; 2 month follow up</time_frame>
      <description>Assesses severity of suicidal thoughts. Scores range from 0 to 90, with higher scores reflecting more severe ideation.</description>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">184</enrollment>
    <condition>Suicidal Ideation</condition>
    <condition>Suicide Attempt</condition>
    <arm_group>
      <arm_group_label>CAMS Single Session Consultation (SSC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Driver-Focused Skills Training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Caregiver Skills Building</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Lethal Means Safety</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Lethal Means Safety</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Caregiver Skills Training + Lethal Mean Safety</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CAMS Single Session Consultation</intervention_name>
      <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.</description>
      <arm_group_label>CAMS SSC + Caregiver Skills Building</arm_group_label>
      <arm_group_label>CAMS SSC + Caregiver Skills Training + Lethal Mean Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver training</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver-Focused Skills Training</arm_group_label>
      <arm_group_label>CAMS SSC + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS Single Session Consultation (SSC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Driver Focused Skills Training</intervention_name>
      <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.</description>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver training</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver-Focused Skills Training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Caregiver Skills Training</intervention_name>
      <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.</description>
      <arm_group_label>CAMS SSC + Caregiver Skills Building</arm_group_label>
      <arm_group_label>CAMS SSC + Caregiver Skills Training + Lethal Mean Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Lethal Means Safety</intervention_name>
      <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.</description>
      <arm_group_label>CAMS SSC + Caregiver Skills Training + Lethal Mean Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Driver Focused Skills Training + Lethal Means Safety</arm_group_label>
      <arm_group_label>CAMS SSC + Lethal Means Safety</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Acute suicidal thoughts or past month suicide attempt as reported on positive&#xD;
               responses to the Ask Suicide Screening Questionnaire (ASQ),&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  urgent medical care secondary to self-injurious behavior, psychosis, eating disorder&#xD;
               that requires full or partial inpatient care, or&#xD;
  &#xD;
            -  intellectual disability warranting a different treatment pathway;&#xD;
  &#xD;
            -  limited English, Spanish, Vietnamese, or Chinese proficiency that would interfere with&#xD;
               ability to complete study assessments;&#xD;
  &#xD;
            -  unwillingness to participate in psychotherapy,&#xD;
  &#xD;
            -  caregiver unwilling or ineligible to participate;&#xD;
  &#xD;
            -  and previous enrollment in SOARS program or other P50 project as to not confuse&#xD;
               longitudinal follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Molly Adrian, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Molly Adrian</last_name>
      <phone>206-987-7183</phone>
      <email>molly.adrian@seattlechildrens.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Molly Adrian</investigator_full_name>
      <investigator_title>Associate Professor, Psychiatry and Behavioral Sciences</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Suicidal Ideation</mesh_term>
      <mesh_term>Suicide, Attempted</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996172
  org study id: STUDY00016898
  secondary id: P50MH129708
  nct id: NCT05996172
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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?
  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.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Columbia Suicide Severity Rating Scale (C-SSRS)
  time frame: baseline, 1, and 2 month follow up
  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.
  measure: Suicidal Ideation Questionnaire Junior
  time frame: baseline, 1, & 2 month follow up
  description: Assesses severity of suicidal thoughts. Scores range from 0 to 90, with higher scores reflecting more severe ideation.
  arm group label: CAMS Single Session Consultation (SSC)
  arm group type: Active Comparator
  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 group label: CAMS SSC + Driver-Focused Skills Training
  arm group type: Active Comparator
  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 group label: CAMS SSC + Caregiver Skills Building
  arm group type: Active Comparator
  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 group label: CAMS SSC + Lethal Means Safety
  arm group type: Active Comparator
  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 group label: CAMS SSC + Driver Focused Skills Training + Caregiver training
  arm group type: Active Comparator
  description: This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
  arm group label: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
  arm group type: Active Comparator
  description: This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
  arm group label: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
  arm group type: Active Comparator
  description: The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
  arm group type: Active Comparator
  description: This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
  intervention type: Behavioral
  intervention name: CAMS Single Session Consultation
  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.
  arm group label: CAMS SSC + Caregiver Skills Building
  arm group label: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver training
  arm group label: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
  arm group label: CAMS SSC + Driver-Focused Skills Training
  arm group label: CAMS SSC + Lethal Means Safety
  arm group label: CAMS Single Session Consultation (SSC)
  intervention type: Behavioral
  intervention name: Driver Focused Skills Training
  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.
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver training
  arm group label: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
  arm group label: CAMS SSC + Driver-Focused Skills Training
  intervention type: Behavioral
  intervention name: Caregiver Skills Training
  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.
  arm group label: CAMS SSC + Caregiver Skills Building
  arm group label: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver training
  intervention type: Behavioral
  intervention name: Lethal Means Safety
  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.
  arm group label: CAMS SSC + Caregiver Skills Training + Lethal Mean Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means Safety
  arm group label: CAMS SSC + Driver Focused Skills Training + Lethal Means Safety
  arm group label: CAMS SSC + Lethal Means Safety
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 21 Years
  healthy volunteers: No
  last name: Molly Adrian, Ph.D.
  role: Principal Investigator
  affiliation: University of Washington
  last name: Molly Adrian
  phone: 206-987-7183
  email: molly.adrian@seattlechildrens.org
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Molly Adrian
  investigator title: Associate Professor, Psychiatry and Behavioral Sciences
  mesh term: Suicide
  mesh term: Suicidal Ideation
  mesh term: Suicide, Attempted