The Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT07628192
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.
Trial opening soon.
Get Notified12 year–17 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 90 days following discharge
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.
Time frame: 90 days after discharge
To compare interventions' effects on suicidal ideation intensity using the Beck Scale for Suicide Ideation (min 0, max 38)(higher scoring = more severe).
Time frame: 90 days post discharge
To assess changes in caregiver confidence pre- and post-intervention in supporting suicidal youth and maintaining home safety using a 2 question scale.
Contact information is provided by the study sponsor or research team.
Christina A Deisz, LISW-S
CONTACT
Tatiana Falcone, M.D.
CONTACT
The Cleveland Clinic
Other
Innovating Suicide Preventative Care for Youth; A Randomized Trial of CAMS- BI Versus Stanley- Brown Safety Planning Intervention in Preventing Suicide Driven Readmission
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07568054
Behavior, Behavioral Symptoms
Cleveland, Ohio, United States
View Trial DetailsNCT06686901
Behavior, Behavioral Symptoms
Boston, Massachusetts, United States
View Trial DetailsNCT07618208
Anxiety Disorders, Behavior
View Trial DetailsNCT05977439
Behavior, Behavioral Symptoms
Charleston, South Carolina, United States
View Trial Details