Suicidal IdeationNCT07628192
Youth Suicide Prevention: CAMS-BI vs. Safety Planning in a Randomized Trial
A study testing CAMS Brief Intervention and Stanley-Brown Safety Planning Intervention in people with Suicidal Ideation and Suicide Attempt, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation, Suicide Attempt, Safety Plan
- What is being tested?
- CAMS Brief Intervention and Stanley-Brown Safety Planning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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
The Cleveland Clinic
Cleveland, Ohio, 44195
Tatiana Falcone, M.D., (216) 444-7459, falcont1@ccf.org
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Suicidal Ideation, Suicide Attempt, Safety Plan, Depression / Major Depressive Disorder, Hopelessness
- Being tested
- CAMS Brief Intervention, Stanley-Brown Safety Planning Intervention
- Keywords
- Youth suicide, Suicide ideation, Suicide attempt, Suicidal behavior, Depression, CAMS therapy, Safety plan, Hopelessness
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMS Brief InterventionBehavioural
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.
Stanley-Brown Safety Planning InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CAMS-BI | Active comparator | Participants randomized to receive CAMS-BI intervention Receives: Behavioral: CAMS Brief Intervention |
| Stanley Brown | Active comparator | Participants randomized to Stanley Brown Safety Plan Receives: Behavioral: Stanley-Brown Safety Planning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days following discharge
Secondary outcomes (2)
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).
Measured: 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.
Measured: 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Falcone, MD, The Cleveland Clinic
- Investigators
- Tatiana Falcone, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628192
- Sponsor's protocol ID
- IRB 26-129
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovating Suicide Preventative Care for Youth; A Randomized Trial of CAMS- BI Versus Stanley- Brown Safety Planning Intervention in Preventing Suicide Driven Readmission
- ClinicalTrials.gov ID
- NCT07628192
- Acronym / sponsor ID
- IRB 26-129
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| CAMS-BI | Active comparator | Behavioral: CAMS Brief InterventionParticipants randomized to receive CAMS-BI intervention |
| Stanley Brown | Active comparator | Behavioral: Stanley-Brown Safety Planning InterventionParticipants randomized to Stanley Brown Safety Plan |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMS Brief InterventionCAMS-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. | Behavioural | CAMS-BI |
| Stanley-Brown Safety Planning InterventionThe 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. | Behavioural | Stanley Brown |
Primary outcome
Reduction of inpatient psychiatry readmissions for suicide risk following CAMS-Brief Intervention VS Stanley-Brown Planning Intervention
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.
2 secondary outcomes
Intensity of the Beck Scale for Suicide Ideation
Time frame: 90 days after discharge
Improving caregiver confidence pre and post intervention using a 'Caregiver Confidence' 2 question scale
Time frame: 90 days post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Suicidal Ideation
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
Deep TMS for PTSD With Suicidal Ideation
Post Traumatic Stress Disorder PTSD, Suicidal Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tatiana Falcone, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMS Brief Intervention and Stanley-Brown Safety Planning Intervention in people with Suicidal Ideation and Suicide Attempt, run by The Cleveland Clinic 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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 Christina A Deisz, LISW-S ((440) 225-6193, deiszc@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of inpatient psychiatry readmissions for suicide risk following CAMS-Brief Intervention VS Stanley-Brown Planning Intervention (time frame: 90 days following discharge). 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 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.