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Verhinderung von suizidalem Verhalten bei verschiedenen Hochrisikojugendlichen in der Akutversorgung (Project HOPE)

2. November 2026 aktualisiert von: Johns Hopkins University

This multisite randomized controlled trial will compare two brief interventions for youth and young adults ages 12-24 following an acute care visit for suicide risk: the Stanley-Brown Safety Planning Intervention with follow-up contacts (SPI+) and Interpersonal Psychotherapy for Adolescents-Ultra Short Crisis Intervention (IPT-A SCI). The study will evaluate which approach is more effective in reducing suicidal ideation and suicide events. Findings will help patients, families, and clinicians make informed decisions about care following a suicide-related emergency department visit.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Youth and young adults who present to emergency departments (EDs) with suicide-related concerns need timely access to effective interventions and follow-up care. However, evidence is limited regarding which brief interventions are most effective for this population. This study focuses on youth and young adults ages 12-24 receiving care in five racially and ethnically diverse geographic areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and New York City, New York.

This multisite randomized controlled trial compares two brief interventions: the Safety Planning Intervention with follow-up contacts (SPI+) and Interpersonal Psychotherapy for Adolescents-Ultra Short Crisis Intervention (IPT-A SCI). SPI+ is a suicide-specific intervention that helps participants recognize warning signs and identify coping strategies and sources of support to prevent suicidal crises from escalating. It combines safety planning in the acute care setting with follow-up contacts. IPT-A SCI is a brief psychotherapy intervention delivered primarily in outpatient settings that addresses interpersonal problems associated with suicidal crises and helps participants develop communication and interpersonal problem-solving skills.

The study will examine the comparative effectiveness of these interventions in reducing suicidal ideation and suicide events among youth and young adults following an acute care visit for suicide risk. Although both approaches are intended to support participants during periods of elevated risk, the approaches differ in focus, intensity, and delivery setting. Understanding comparative effectiveness can help guide treatment decisions, implementation, and resource allocation across acute care and outpatient settings.

The research team works with a racially and ethnically diverse group of partners and advisors, including advocates, researchers, ED physicians, nurses, social workers, and individuals with lived experience of suicide attempts or suicide loss. Partners and advisors have contributed to recruitment strategies, intervention approaches, and follow-up procedures and will continue to inform study conduct, interpretation of findings, and dissemination.

Findings from this study will help inform care for youth and young adults presenting to EDs with suicide-related concerns and support the implementation of effective, brief interventions across diverse clinical settings.

Studientyp

Interventionell

Einschreibung (Geschätzt)

484

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Catherine Grela
  • Telefonnummer: 667-217-4303
  • E-Mail: agrelam1@jh.edu

Studienorte

  • Vereinigte Staaten
    • Florida
      • St. Petersburg, Florida, Vereinigte Staaten, 33701
        • Rekrutierung
        • Johns Hopkins All Children's Hospital
        • Kontakt:
        • Kontakt:
          • Jasmine Niazi, M.S.
          • Telefonnummer: 727-767-2389
          • E-Mail: jniazi1@jh.edu
        • Hauptermittler:
          • Jennifer Katzenstein, PhD
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21205
        • Rekrutierung
        • Johns Hopkins University
        • Kontakt:
        • Hauptermittler:
          • Holly C Wilcox, PhD
        • Kontakt:
    • New York
      • New York, New York, Vereinigte Staaten, 10032
        • Rekrutierung
        • Columbia University Irving Medical Center (CUMC)
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Laura Mufson, PhD
        • Unterermittler:
          • Christa Labouliere, PhD
      • New York, New York, Vereinigte Staaten, 10065
        • Rekrutierung
        • Weill-Cornell Medicine
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Shannon Bennett, PhD
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27514
        • Rekrutierung
        • University of North Carolina Medical Center
        • Kontakt:
        • Kontakt:
          • Rachel Ear, PhD
          • Telefonnummer: 919-445-0870
          • E-Mail: earr@unc.edu
        • Hauptermittler:
          • Danielle Lowe, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Rekrutierung
        • Childrens Hospital of Philadelphia
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Tami Benton, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Suicide Risk During Acute Care Visit (At least one item must apply: Chief complaint of suicide-related concern, Active suicidal ideation endorsed in past 1 month on validated suicide screener, Suicidal behavior in the past 3 months on validated suicide screener, and/or 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 the acute care visit.

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Safety Planning Intervention (SPI)

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.
Verhalten: 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
Aktiver Komparator: Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI)

Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (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.
Verhalten: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)

Five session crisis focused version of IPT for adolescents.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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".
baseline, 3 months, 6 months, 12 months
Suicide events: measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Service Assessment for Children and Adolescents (SACA) Recent
Zeitfenster: baseline, 3 months, 6 months, 12 months

Suicide event is defined as the presence of a suicide attempt, an aborted or interrupted attempt (as identified on the C-SSRS), or a visit to the emergency department, crisis stabilization acute care facility, or psychiatric hospitalization for suicide-related concerns (as identified on the SACA) occurring anytime during the follow-up period.
baseline, 3 months, 6 months, 12 months
Number of Suicides
Zeitfenster: 12 months

Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
Zeitfenster: baseline, 3 months, 6 months, 12 months

Services Assessment for Children and Adolescents (SACA) use of inpatient, outpatient, school services since last assessment. Items are dichotomous (yes/no) and the scale ranges from 0 (no services) to 3 (3 types of services), higher numbers indicate more services.
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)
Zeitfenster: baseline, 3 months, 6 months, 12 months

Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L) for young adults. The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
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)
Zeitfenster: baseline, 3 months, 6 months, 12 months

Quality of Life will be assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y). The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
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).
Zeitfenster: baseline, 3 months, 6 months, 12 months

Generalized Anxiety Disorder will be assessed by the GAD 7 question scale. The Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 total score ranges from 0 to 21 with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
baseline, 3 months, 6 months, 12 months
Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
Zeitfenster: baseline, 3 months, 6 months, 12 months

The nine-item Patient Health Questionnaire is a depressive symptom scale and diagnostic tool that assesses the presence and severity of depressive symptoms and a possible depressive disorder. The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
baseline, 3 months, 6 months, 12 months
Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).
Zeitfenster: baseline, 3 months, 6 months, 12 months

The Conflict Behavior Questionnaire (CBQ) reliably assesses the adolescent's perception of the relationship with the participant's parents. The CBQ total score ranges from 0-20, with higher scores indicating greater conflict with each parent.
baseline, 3 months, 6 months, 12 months
Change in social interactions with peers as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Peer Relationships scale.
Zeitfenster: baseline, 3 months, 6 months, 12 months

The PROMIS (Patient-Reported Outcomes Measurement Information System) scale assesses social interactions with peers. The Pediatric Peer Relationships scale has a possible score between 1 and 40, with higher scores indicating greater social interactions with peers.
baseline, 3 months, 6 months, 12 months
Change in social interactions with family as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships scale.
Zeitfenster: baseline, 3 months, 6 months, 12 months

The Patient-Reported Outcomes Measurement Information System (PROMIS) scale assesses social interactions with family. The Pediatric Family Relationships scale has a possible score between 1 and 40, with higher scores indicating greater social interactions with family.
baseline, 3 months, 6 months, 12 months
Change in skill use derived from the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) arm
Zeitfenster: 3 months, 6 months, 12 months

Project-created a self-report of Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) skill use during follow-up, indicating feasibility/acceptability of SPI, helpfulness of different skills/sections of the safety plan, and frequency of use for different skills/sections of the safety plan.
3 months, 6 months, 12 months
Change in skill use derived from the Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) arm
Zeitfenster: 3 months, 6 months, 12 months

Project created a self-report of Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) skill use during follow-up indicating which components adolescents have used. The self-report survey scoring will be a summation and then taking an average of the sum to be the score. Higher scores closer to 5 indicate adolescents learned a lot of from the intervention, and the lower scores indicate adolescents learned few skills.
3 months, 6 months, 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Johns Hopkins University

Mitarbeiter

Patient-Centered Outcomes Research Institute
Children's Hospital of Philadelphia
Columbia University
Johns Hopkins All Children's Hospital
Reichman University

Ermittler

  • Hauptermittler: Holly C Wilcox, PhD, Johns Hopkins Bloomberg School of Public Health

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. März 2025

Primärer Abschluss (Geschätzt)

15. Juni 2028

Studienabschluss (Geschätzt)

15. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

21. November 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. November 2023

Zuerst gepostet (Tatsächlich)

30. November 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00408733

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