Youth Suicide Prevention: CAMS-BI vs. Safety Planning in a Randomized Trial

NCT07628192 | Not Yet Recruiting

• 1 other identifier: IRB 26-129
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study outlines a randomized controlled trial evaluating two brief suicide-specific interventions for adolescents aged 12-17 who are hospitalized for suicidal ideation or attempts. Suicide remains a leading cause of death among youth, and many adolescents are discharged from inpatient care without targeted, suicide-focused treatment, contributing to high rates of readmission and ongoing risk. This study seeks to address that gap by comparing the effectiveness of the Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) with the Stanley-Brown Safety Planning Intervention (SPI), both delivered as single-session interventions during inpatient hospitalization. Participants (N=118) will be randomly assigned to receive either CAMS-BI or SPI. CAMS-BI is a therapeutic, collaborative framework that focuses on identifying and addressing the underlying psychological drivers of suicidality, while SPI is a structured, practical approach that emphasizes immediate safety through coping strategies, support systems, and means restriction. Following the intervention, participants will be monitored for 90 days post-discharge, with follow-ups at 30, 60, and 90 days. The primary outcome is the rate of psychiatric readmissions and suicide-related emergency department visits within 90 days of discharge. Secondary outcomes include changes in suicidal ideation, measured by the Beck Scale for Suicide Ideation, and caregiver confidence in managing their child's safety. Additional measures include distress levels, hopelessness, treatment satisfaction, and engagement. The study hypothesizes that CAMS-BI will result in lower readmission rates, greater reductions in suicidal ideation, and improved caregiver confidence compared to SPI. Both interventions produce individualized safety or stabilization plans that are shared with patients and caregivers and incorporated into discharge planning to support continuity of care. Safety protocols are emphasized throughout the study, given the high-risk population. Participants receive standard clinical care, crisis resources, and close monitoring, with procedures in place to address any escalation in suicide risk. Data will be collected using secure systems, and confidentiality will be maintained through de-identification and controlled access. Overall, this study aims to determine whether a rapid, inpatient, suicide-focused intervention can improve short-term outcomes for high-risk youth and reduce the likelihood of rehospitalization, ultimately informing scalable approaches to suicide prevention in clinical settings.

Conditions

Suicidal Ideation; Suicide Attempt; Safety Plan; Depression / Major Depressive Disorder; Hopelessness

Keywords

Youth suicide; Suicide ideation; Suicide attempt; Suicidal behavior; Depression; CAMS therapy; Safety plan; Hopelessness

Outcome Measures

Primary Outcomes (1)

• Reduction of inpatient psychiatry readmissions for suicide risk following CAMS-Brief Intervention VS Stanley-Brown Planning Intervention

  To compare CAMS-Brief Intervention VS Stanley-Brown Planning Intervention in reducing psychiatric readmissions and suicide-related emergency department (ED) visits within 90 days after discharge.

  90 days following discharge

Secondary Outcomes (2)

• Intensity of the Beck Scale for Suicide Ideation

  90 days after discharge

• Improving caregiver confidence pre and post intervention using a 'Caregiver Confidence' 2 question scale

  90 days post discharge

Study Arms (2)

CAMS-BI

ACTIVE COMPARATOR

Participants randomized to receive CAMS-BI intervention

Behavioral: CAMS Brief Intervention

Stanley Brown

ACTIVE COMPARATOR

Participants randomized to Stanley Brown Safety Plan

Behavioral: Stanley-Brown Safety Planning Intervention

Interventions

CAMS Brief Intervention BEHAVIORAL

CAMS-BI is a brief, structured, suicide-focused psychotherapy delivered during inpatient hospitalization that uses the Suicide Status Form to collaboratively identify and directly target the patient's specific psychological drivers of suicidality (e.g., hopelessness, psychological pain, agitation, and self-hate). It emphasizes a strong therapeutic alliance and shared formulation to reduce suicidal risk and support linkage to ongoing care after discharge.

CAMS-BI

Stanley-Brown Safety Planning Intervention BEHAVIORAL

The Stanley-Brown Safety Planning Intervention (SPI) is a brief, structured, collaborative session in which the adolescent and clinician create a personalized written safety plan to use during future suicidal crises. The plan outlines warning signs, internal coping strategies, social supports, professional resources, and steps for restricting access to lethal means to help reduce immediate risk.

Stanley Brown

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents aged 12-17 years.
• Admitted to inpatient psychiatry for suicide attempt or active suicidal ideation.
• English-speaking patient and parent/guardian.
• Ability to understand and the willingness to sign a written informed assent document with a parent/guardian willing and able to sign a written informed consent.

You may not qualify if:

• Moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time).
• Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis.
• In custody of Children's Services.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Tatiana Falcone, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina A Deisz, LISW-S

CONTACT

(440) 225-6193; deiszc@ccf.org

Tatiana Falcone, M.D.

CONTACT

(216) 444-7459; falcont1@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research Behavioral Health and Neurological Science, Child and Adolescent Psychiatrist, Assistant Professor of Medicine, Principal Investigator

Model Details: This single-site randomized controlled trial compares two brief inpatient suicide-specific interventions for adolescents (ages 12-17) hospitalized for suicidal ideation or suicide attempts: Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) and the Stanley-Brown Safety Planning Intervention (SPI). Participants (N≈118) are randomized 1:1 and receive one 60-90 minute session during hospitalization. CAMS-BI targets psychological drivers of suicidality through collaborative assessment and structured treatment planning, while SPI focuses on developing a personalized six-step safety plan. Primary outcomes are psychiatric readmission and suicide-related emergency department visits at 30, 60, and 90 days post-discharge. Secondary outcomes include suicidal ideation, hopelessness, distress, caregiver confidence, and treatment engagement. The study evaluates whether CAMS-BI improves post-discharge outcomes compared to SPI, with follow-up assessments through 90 day

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (1)