Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings

NCT ID: NCT06151158

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2028-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 12-19 in three ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; and upper Manhattan/lower Bronx in New York City.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Emergency department (ED) visits for suicide-related concerns have been increasing in youth over the past decade, a trend potentially exacerbated by the COVID-19 pandemic. Also, youth suicidal thoughts and attempts have increased with the 2019 Centers for Disease Control and Prevention (CDC) Youth Risk Behavior Surveillance System (YRBSS) finding that 18.8 percent of high school students have seriously considered suicide and 8.9 percent had attempted suicide in the past year. Furthermore, suicide rates are increasing more rapidly in Latino/Latina, Black, and multiracial youth, especially Black youth as compared to White youth. Similar increases in suicide risk are seen in lesbian, gay, bisexual, transgender, queer and other sexually minority (LGBTQ+) youth. This project focuses on suicidal youth ages 12-19 in three ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; and upper Manhattan/lower Bronx in New York City.

There is limited evidence about which interventions are most helpful for suicidal youth in acute care settings such as EDs. Interventions like safety planning (Safety Planning Intervention with follow-up contacts) are delivered primarily in ED settings while others like Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) are provided primarily in outpatient settings. Furthermore, safety planning focuses on deescalating suicidal crises when beginning to occur, while IPT-A SCI focuses on developing skills to prevent crises from occurring. While both approaches have an evidence base, it is not yet known which one is more effective and acceptable in a diverse youth population. Determining which intervention is more effective has implications for dissemination and resource allocation to EDs or outpatient settings.

The research team includes a group of ethnically and racially diverse partners and advisors, advocates, researchers, ED physicians, nurses, and social workers, some of whom have lived experience of suicide attempts and suicide loss. This team has provided feedback about crucial elements of this proposal, e.g., recruitment, intervention approaches, and follow-up approaches and will continue active involvement in all stages of this project.

The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the SPI+, a suicide-specific intervention that helps people prevent suicidal crises from escalating, and 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide, Attempted Suicide Ideation Suicide Suicide Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Five session crisis focused version of IPT for adolescents.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

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

Five session crisis focused version of IPT for adolescents.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Acute care visit for suicide-related concern or screen positive on a suicide risk screener (serious SI as indicated by a C-SSRS screening endorsing question two "Have you actually had any thoughts of killing yourself?" in past four weeks or SA in past four weeks);
* Has a cell phone with ability to receive phone calls and text messages over the 12-month follow-up;
* Ability to speak, understand, and read in English or Spanish

Exclusion Criteria

* Significant cognitive or developmental delays that prevent understanding or using SPI or IPT-A SCI. Participants must be verbally fluent and have the ability to communicate verbally. This will, in part, be determined by notes in Epic and/or by asking one of the patient's parents/clinicians;
* Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania);
* Unable to provide informed consent (adults); assent (minors); permission (parents/caregivers).
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Reichman University

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Holly C Wilcox, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status NOT_YET_RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Columbia University Irving Medical Center (CUMC)

New York, New York, United States

Site Status NOT_YET_RECRUITING

Weill-Cornell Medicine

New York, New York, United States

Site Status NOT_YET_RECRUITING

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Holly C Wilcox, PhD

Role: CONTACT

4103700081

Taylor Ryan, MA

Role: CONTACT

4846835824

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jennifer Katzenstein, PhD

Role: primary

727-767-7439

Antonika Ford

Role: backup

7277677439

Holly C. Wilcox, PhD

Role: primary

410-370-0081

Taylor Ryan

Role: backup

4846835824

Laura Mufson, PhD

Role: primary

646-774-5791

Christa Labouliere, PhD

Role: backup

646-774-8467

Shannon Bennett, PhD

Role: primary

646-962-2820

Danielle Lowe, MD, PhD

Role: primary

919-445-0870

Rachel Ear, PhD

Role: backup

919-445-0870

Tami Benton, MD

Role: primary

609-351-2637

Juan Zambonini, PhD

Role: backup

2158396617

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 29998307 (View on PubMed)

Haruvi 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.

Reference Type RESULT
PMID: 33362595 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.pcori.org/research-results/2022/preventing-suicidal-behavior-diverse-high-risk-youth-acute-care-settings

Patient-Centered Outcomes Research Institute (PCORI) website description of study

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00408733

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.