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

Innovating Suicide Preventative Care for Youth; A Randomized Trial of CAMS- BI Versus Stanley- Brown Safety Planning Intervention in Preventing Suicide Driven Readmission

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Hopelessness; Suicide Attempt; Depression / Major Depressive Disorder; Safety Plan
• Intervention / Treatment: Behavioral: CAMS Brief Intervention; Behavioral: Stanley-Brown Safety Planning Intervention

Detailed Description

This single-site randomized controlled trial evaluates two brief suicide-specific interventions for adolescents hospitalized for suicidal ideation or suicide attempts at Cleveland Clinic Children's. The study compares the Collaborative Assessment and Management of Suicidality-Brief Intervention (CAMS-BI) with the Stanley-Brown Safety Planning Intervention (SPI) to determine their effectiveness in reducing suicide-related psychiatric readmissions and emergency department utilization following inpatient psychiatric hospitalization.

Adolescent suicide remains a major public health concern and is one of the leading causes of death among youth ages 10-24 years. Psychiatric hospitalization provides an important opportunity to intervene following suicidal crises; however, many adolescents are discharged without receiving a structured suicide-focused therapeutic intervention beyond standard stabilization and discharge planning. Brief, scalable interventions that can be delivered during hospitalization may improve continuity of care and reduce recurrent suicidal crises after discharge.

Participants are adolescents ages 12-17 years admitted for suicidal ideation or suicide attempts. Eligible participants are randomized in a 1:1 ratio to receive either CAMS-BI or SPI during their inpatient admission. Randomization is stratified by gender and implemented using REDCap block randomization procedures.

CAMS-BI is a collaborative, suicide-focused therapeutic intervention adapted from the Collaborative Assessment and Management of Suicidality framework. The intervention uses the Suicide Status Form (SSF) to identify and target the psychological drivers of suicidality, including hopelessness, psychological pain, agitation, and self-hate. Sessions emphasize collaborative assessment, treatment planning, and therapeutic alliance.

SPI is a structured suicide prevention intervention focused on developing an individualized safety plan to support crisis management after discharge. The intervention includes identification of warning signs, coping strategies, supportive contacts, professional resources, and means restriction planning.

Participants complete study assessments at baseline, following the intervention, and during follow-up at 30, 60, and 90 days after discharge. Clinical outcomes include psychiatric readmissions, suicide-related emergency department visits, suicidal ideation severity, distress, hopelessness, caregiver confidence in crisis management, and participant satisfaction with the intervention.

Intervention fidelity is monitored through clinician training, structured supervision, and review of recorded intervention sessions using standardized fidelity measures specific to each intervention.

All participants continue to receive standard inpatient psychiatric treatment and discharge planning throughout study participation. Safety monitoring procedures are in place for escalation of suicide risk, including access to crisis intervention resources and clinical evaluation as needed. Study data are maintained in secure HIPAA-compliant systems.

The study is designed to determine whether a brief suicide-focused therapeutic intervention targeting the underlying drivers of suicidality provides additional benefit compared with structured safety planning alone in reducing short-term suicide-related outcomes among high-risk adolescents.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Falcone, M.D.; Phone Number: (216) 444-7459; Email: falcont1@ccf.org
• Study Contact Backup: Name: Christina A Deisz, LISW-S; Phone Number: (440) 225-6193; Email: deiszc@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
      • Contact: Tatiana Falcone, M.D.; Phone Number: (216) 444-7459; Email: falcont1@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAMS-BI; Participants randomized to receive CAMS-BI intervention	Behavioral: CAMS Brief Intervention; 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.
Active Comparator: Stanley Brown; Participants randomized to Stanley Brown Safety Plan	Behavioral: Stanley-Brown Safety Planning Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of the Beck Scale for Suicide Ideation	To compare interventions' effects on suicidal ideation intensity using the Beck Scale for Suicide Ideation (min 0, max 38)(higher scoring = more severe).	90 days after discharge
Improving caregiver confidence pre and post intervention using a 'Caregiver Confidence' 2 question scale	To assess changes in caregiver confidence pre- and post-intervention in supporting suicidal youth and maintaining home safety using a 2 question scale.	90 days post discharge

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Tatiana Falcone, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Suicidal behavior; Hopelessness; Suicide attempt; Suicide ideation; Safety plan; Youth suicide; CAMS therapy
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Mood Disorders; Suicide; Depressive Disorder; Behavior; Suicidal Ideation; Depression; Depressive Disorder, Major; Suicide, Attempted
• Other Study ID Numbers: IRB 26-129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No