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Suicidal IdeationSOARSNCT05996172

Swift Outpatient Alternatives for Rapid Stabilization

A study testing CAMS Single Session Consultation, Driver Focused Skills Training and Caregiver Skills Training in people with Suicidal Ideation and Suicide Attempt, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 21 years
Conditions the study is for
Suicidal Ideation, Suicide Attempt
What is being tested?
CAMS Single Session Consultation, Driver Focused Skills Training and Caregiver Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteUnited States
Study dates
9 Nov 2023to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Acute suicidal thoughts or past month suicide attempt as reported on positive responses to the Ask Suicide Screening Questionnaire (ASQ),

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Seattle Children's

    Seattle, Washington, 98199

    Molly C Adrian, molly.adrian@seattlechildrens.org

    Recruiting

Other trials in United States

About this study

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?
Read the 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.

Being tested
CAMS Single Session Consultation, Driver Focused Skills Training, Caregiver Skills Training, Lethal Means Safety
Medical subject headings
Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAMS Single Session ConsultationBehavioural

    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 TrainingBehavioural

    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 TrainingBehavioural

    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 SafetyBehavioural

    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 groups in NCT05996172
Study groupRoleWhat they receive
CAMS Single Session Consultation (SSC)Active comparatorCAMS 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.
Receives: Behavioral: CAMS Single Session Consultation
CAMS SSC + Driver-Focused Skills TrainingActive comparatorSpecific 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.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Driver Focused Skills Training
CAMS SSC + Caregiver Skills BuildingActive comparatorCaregivers 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.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Caregiver Skills Training
CAMS SSC + Lethal Means SafetyActive comparatorThe 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.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Lethal Means Safety
CAMS SSC + Driver Focused Skills Training + Caregiver trainingActive comparatorThis arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Driver Focused Skills Training; Behavioral: Caregiver Skills Training
CAMS SSC + Driver Focused Skills Training + Lethal Means SafetyActive comparatorThis arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Driver Focused Skills Training; Behavioral: Lethal Means Safety
CAMS SSC + Caregiver Skills Training + Lethal Mean SafetyActive comparatorThe arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Caregiver Skills Training; Behavioral: Lethal Means Safety
CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means SafetyActive comparatorThis arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
Receives: Behavioral: CAMS Single Session Consultation; Behavioral: Driver Focused Skills Training; Behavioral: Caregiver Skills Training; Behavioral: Lethal Means Safety

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Harkavy-Asnis Suicide Scale

    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.

    Measured: baseline, 1, and 2 month follow up

Secondary outcomes (1)
  1. Columbia Suicide Severity Rating Scale (C-SSRS)

    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.

    Measured: baseline, 1, & 2 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start9 Nov 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996172
Sponsor's protocol ID
STUDY00016898
Other IDs
P50MH129708
Acronym
SOARS
Status last verified
Mar 2025
First submitted
19 Jun 2023
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CAMS Single Session Consultation, Driver Focused Skills Training and Caregiver Skills Training in people with Suicidal Ideation and Suicide Attempt, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Molly Adrian (206-987-7183, molly.adrian@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Harkavy-Asnis Suicide Scale (time frame: baseline, 1, and 2 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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