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CAMS SSC + Driver Focused Skills Training + Caregiver training for Suicidal Thoughts (SOARS Trial)
N/A
Recruiting
Led By Molly Adrian, Ph.D.
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute suicidal thoughts or past month suicide attempt as reported on positive responses to the Ask Suicide Screening Questionnaire (ASQ)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, & 2 month follow up
Awards & highlights
SOARS Trial Summary
This trial aims to create an effective outpatient way to manage youth suicide risk, through a combination of components and understanding how age, history, alliance, and self-efficacy play a role.
Who is the study for?
This trial is for young people who have recently had suicidal thoughts or attempted suicide, as indicated by positive responses on the Ask Suicide Screening Questionnaire. It's designed to help improve outpatient care for acute youth suicide risk.Check my eligibility
What is being tested?
The study tests a combination of interventions: CAMS Single Session Consultation, Driver Focused Skills Training, Lethal Means Safety, and Caregiver Skills Training. The goal is to find the most effective mix of these components to reduce suicidal thoughts and behaviors in youth.See study design
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects are not applicable. However, participants may experience emotional discomfort during sessions that address sensitive topics like suicidal thoughts and past attempts.
SOARS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOARS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1, & 2 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1, & 2 month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Harkavy-Asnis Suicide Scale
Secondary outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS)
SOARS Trial Design
8Treatment groups
Active Control
Group I: CAMS SSC + Driver Focused Skills Training + Caregiver trainingActive Control3 Interventions
This arm includes CAMS SSC, 3 sessions of youth facing driver focused skills, and 3 sessions of caregiver skills training.
Group II: CAMS SSC + Caregiver Skills Training + Lethal Mean SafetyActive Control3 Interventions
The arm includes the CAMS single session intervention, 3 sessions caregiver skills training and lethal means safety.
Group III: CAMS SSC + Driver Focused Skills Training + Caregiver Skills + Lethal Means SafetyActive Control4 Interventions
This arm includes the single session intervention, youth skills training, caregiver skills training and lethal means safety.
Group IV: CAMS Single Session Consultation (SSC)Active Control1 Intervention
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.
Group V: CAMS SSC + Driver Focused Skills Training + Lethal Means SafetyActive Control3 Interventions
This arm includes the CAMS single session intervention, 3 sessions of skills training for the youth, and lethal means safety for caregiver.
Group VI: CAMS SSC + Driver-Focused Skills TrainingActive Control2 Interventions
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.
Group VII: CAMS SSC + Caregiver Skills BuildingActive Control2 Interventions
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.
Group VIII: CAMS SSC + Lethal Means SafetyActive Control2 Interventions
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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,576 Total Patients Enrolled
1 Trials studying Suicidal Thoughts
40 Patients Enrolled for Suicidal Thoughts
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,525 Total Patients Enrolled
1 Trials studying Suicidal Thoughts
240 Patients Enrolled for Suicidal Thoughts
Molly Adrian, Ph.D.Principal InvestigatorUniversity of Washington
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over the age of fifty-five qualified to participate in this experiment?
"This research project has an age requirement for participants: applicants must be between 13 and 21 years old."
Answered by AI
Is the research initiative still open to participants?
"Absolutely. The records on clinicaltrials.gov signpost that this research is currently recruiting - the trial was initially posted on 9th November 2023, and its information has been updated as recently as 6th December 2023. This venture requires 184 participants to be sourced from one medical facility only."
Answered by AI
Can I qualify to join this experiment?
"This investigation is looking for 184 adolescent patients with a history of suicidal ideation or recent attempts. To be eligible, candidates must answer positively to the Ask Suicide Screening Questionnaire (ASQ)."
Answered by AI
How many participants are admitted to the clinical trial?
"Affirmative, the clinical trial is still recruiting participants. Its inaugural posting was on November 9th 2023 and it has been revised as recently as December 6th of that same year. 184 individuals are needed at a single medical site for this experiment."
Answered by AI
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