Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
1 other identifier
interventional
1,000
1 country
6
Brief Summary
The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), a suicide-specific intervention that helps people prevent suicidal crises from escalating, and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI), a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting. This project focuses on suicidal youth ages 12-24 in five ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and Northern Manhattan/lower Bronx/eastern Queens communities in New York City, New York.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedStudy Start
First participant enrolled
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 14, 2028
May 4, 2026
April 1, 2026
3.6 years
November 21, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Suicidal ideation as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
Suicidal thoughts: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scores for suicidal ideation range from 0 to 5, with higher scores indicating more serious suicidal ideation, where 0 = "no suicidal thoughts"; 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan".
baseline, 3 months, 6 months, 12 months
Change in Suicidal behavior as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
Suicidal behavior with intent to die: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scored 0 to 1, with 1 indicating a suicide attempt since last assessment.
baseline, 3 months, 6 months, 12 months
Number of Suicides
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
12 months
Secondary Outcomes (10)
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
baseline, 3 months, 6 months, 12 months
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)
baseline, 3 months, 6 months, 12 months
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)
baseline, 3 months, 6 months, 12 months
Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).
baseline, 3 months, 6 months, 12 months
Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
baseline, 3 months, 6 months, 12 months
- +5 more secondary outcomes
Study Arms (2)
Safety Planning Intervention
ACTIVE COMPARATORThe SPI is a brief, evidence- based intervention that provides people with an individualized set of steps that can be used progressively to both reduce risk and maintain safety when suicide ideation (SI) emerges. Safety plans are developed collaboratively between providers, at risk youth, and family members when possible. Core SPI components include recognizing warning signs of an imminent suicidal crisis (e.g., changes in mood, thoughts or behaviors); using internal coping skills to reduce distress; using people or places in the individual's support network as a means of distraction from SI; reaching out to family or friends to help manage the crisis; contacting health professionals or emergency services; and reducing access to lethal means. SPI+ includes a brief follow-up component post- discharge that includes contacting the patient for a mood and risk check-in; reviewing and revising the safety plan; and facilitating connection with community mental health services.
Ultra-Brief Crisis IPT-A
ACTIVE COMPARATORInterpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) is a scalable, flexible, and extensively examined mental health treatment developed to reduce depressive symptoms and improve interpersonal functioning, and has been adapted for use in adolescents (IPT-A SCI) and shown to be effective in treating depression and reducing associated suicide risk. Interpersonal problems are often at the core of suicidal thinking and behavior in youths including minority youths.
Interventions
Stanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge
Five session crisis focused version of IPT for adolescents.
Eligibility Criteria
You may qualify if:
- Suicide Risk During Acute Care Visit (At least one item in risk assessment is required; check all that apply): \_\_\_ Chief complaint of suicide-related concern (via Medical Record/Other), \_\_\_ Active suicidal ideation endorsed in past 1 month on validated suicide screener, \_\_\_ Suicidal behavior in the past 3 months on validated suicide screener, \_\_\_ Clinician indicated SI in past month or SA in past 3 months.
- Have access to a cellular phone with the ability to receive phone calls and text messages over the 12-month follow- up period
- Adolescent must be verbally fluent and can communicate, understand, and read in either English or Spanish
- Adolescent has been/will be discharged from a higher level of care (i.e. inpatient, day hospital, partial hospitalization program (PHP), or residential treatment program) and back in the community within 4 weeks of their acute care visit. \[Note: this criterion does not apply to all patients - select N/A if this is the case.
You may not qualify if:
- Significant cognitive or developmental delays that prevent understanding or using SPI+ or IPT-A-SCI (includes inability to communicate verbally)
- Altered mental status (acute psychosis, intoxication, or mania)
- Unable or unwilling to provide informed consent (adults), assent (minors), or permission (parents/caregivers)
- The services offered through the study are not in the best clinical interest of the patient (e.g., presenting problem requires a different level of care or treatment approach).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Johns Hopkins All Children's Hospitalcollaborator
- Children's Hospital of Philadelphiacollaborator
- Reichman Universitycollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- Columbia Universitycollaborator
Study Sites (6)
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Columbia University Irving Medical Center (CUMC)
New York, New York, 10032, United States
Weill-Cornell Medicine
New York, New York, 10065, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.
PMID: 29998307RESULTHaruvi Catalan L, Levis Frenk M, Adini Spigelman E, Engelberg Y, Barzilay S, Mufson L, Apter A, Benaroya Milshtein N, Fennig S, Klomek AB. Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI) Pilot Study Results. Front Psychiatry. 2020 Dec 9;11:553422. doi: 10.3389/fpsyt.2020.553422. eCollection 2020.
PMID: 33362595RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly C Wilcox, PhD
Johns Hopkins Bloomberg School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 30, 2023
Study Start
March 10, 2025
Primary Completion (Estimated)
October 14, 2028
Study Completion (Estimated)
October 14, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share