Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06151158

Conditions

Suicide, Attempted

Suicide Ideation

Suicide

Suicide Prevention

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

Interventions

Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)

Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)

Study Details

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.

Conditions

Suicide, Attempted

Suicide Ideation

Suicide

Suicide Prevention

Study ID

NCT06151158

Start date

Mar 10, 2025

Status verified date

Jul, 2026

Completion date

Aug 15, 2029

Anticipated

Primary completion date

Jul 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

484 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Safety Planning Intervention

The 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.

active comparator: Ultra-Brief Crisis IPT-A

Interpersonal 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 Intervention and Follow-up Contacts (SPI+)

Stanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge

Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)

Five session crisis focused version of IPT for adolescents.

Primary outcome measure

  • 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 ]
  • 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 ]
  • Number of Suicides [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Holly C Wilcox, PhD

4103700081hwilcox1@jhmi.edu

Catherine Grela

2408058868agrelam1@jh.edu

Locations

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Jennifer Katzenstein, PhD

727-767-7439jkatzen7@jhmi.edu

Antonika Ford

7277677439aford38@jh.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Holly C. Wilcox, PhD

410-370-0081hwilcox1@jhmi.edu

Catherine Grela

2408058868agrelam1@jh.edu

Principal Investigator:

Holly C Wilcox, PhD

Columbia University Irving Medical Center (CUMC)

Recruiting

New York, New York, United States, 10032

Contacts

Laura Mufson, PhD

646-774-5791Lhm3@cumc.columbia.edu

Christa Labouliere, PhD

646-774-8467Christa.Labouliere@nyspi.columbia.edu

Weill-Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Shannon Bennett, PhD

646-962-2820smb9017@med.cornell.edu

University of North Carolina Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Danielle Lowe, MD, PhD

919-445-0870Danielle_Lowe@med.unc.edu

Rachel Ear, PhD

919-445-0870earr@unc.edu

Childrens Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Tami Benton, MD

609-351-2637BENTONT@chop.edu

Juan Zambonini, PhD

2158396617zamboninij@email.chop.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Safety Planning Intervention
  • Ultra-Brief Crisis
  • Interpersonal Psychotherapy for Adolescents
  • Emergency Department
  • Suicide Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.