NCT06151158 · Johns Hopkins University
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
What this study is about
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 the usual treatment 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)
Stanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge
BEHAVIORAL
Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
Five session crisis focused version of IPT for adolescents.
Primary outcome measures
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
Time frame: baseline, 3 months, 6 months, 12 months
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".
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
Time frame: baseline, 3 months, 6 months, 12 months
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.
Number of Suicides
Time frame: 12 months
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Where
- St. Petersburg, Florida
- Baltimore, Maryland
- New York, New York
- Chapel Hill, North Carolina
- Philadelphia, Pennsylvania
Collaborators
Johns Hopkins All Children's Hospital, Children's Hospital of Philadelphia, Reichman University, Patient-Centered Outcomes Research Institute, Columbia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations