Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Itsemurhakäyttäytymisen ehkäiseminen erilaisten riskialttiiden nuorten kanssa akuuttihoidossa (Project HOPE)

maanantai 2. marraskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

484

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Holly C Wilcox, PhD
  • Puhelinnumero: 410-370-0081
  • Sähköposti: hwilcox1@jhmi.edu

Tutki yhteystietojen varmuuskopiointi

  • Nimi: Catherine Grela
  • Puhelinnumero: 667-217-4303
  • Sähköposti: agrelam1@jh.edu

Opiskelupaikat

  • Yhdysvallat
    • Florida
      • St. Petersburg, Florida, Yhdysvallat, 33701
        • Rekrytointi
        • Johns Hopkins All Children's Hospital
        • Ottaa yhteyttä:
          • Jennifer Katzenstein, PhD
          • Puhelinnumero: 727-767-7439
          • Sähköposti: jkatzen7@jhmi.edu
        • Ottaa yhteyttä:
          • Jasmine Niazi, M.S.
          • Puhelinnumero: 727-767-2389
          • Sähköposti: jniazi1@jh.edu
        • Päätutkija:
          • Jennifer Katzenstein, PhD
    • Maryland
      • Baltimore, Maryland, Yhdysvallat, 21205
        • Rekrytointi
        • Johns Hopkins University
        • Ottaa yhteyttä:
        • Päätutkija:
          • Holly C Wilcox, PhD
        • Ottaa yhteyttä:
          • Catherine Grela
          • Puhelinnumero: 667-217-4303
          • Sähköposti: agrelam1@jh.edu
    • New York
      • New York, New York, Yhdysvallat, 10032
        • Rekrytointi
        • Columbia University Irving Medical Center (CUMC)
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
        • Päätutkija:
          • Laura Mufson, PhD
        • Alatutkija:
          • Christa Labouliere, PhD
      • New York, New York, Yhdysvallat, 10065
        • Rekrytointi
        • Weill-Cornell Medicine
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
        • Päätutkija:
          • Shannon Bennett, PhD
    • North Carolina
      • Chapel Hill, North Carolina, Yhdysvallat, 27514
        • Rekrytointi
        • University of North Carolina Medical Center
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
          • Rachel Ear, PhD
          • Puhelinnumero: 919-445-0870
          • Sähköposti: earr@unc.edu
        • Päätutkija:
          • Danielle Lowe, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19104
        • Rekrytointi
        • Childrens Hospital of Philadelphia
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
        • Päätutkija:
          • Tami Benton, PhD

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta - 24 vuotta (Lapsi, Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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).

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: 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.
Käyttäytyminen: 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
Active Comparator: 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.
Käyttäytyminen: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)

Five session crisis focused version of IPT for adolescents.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 12 months

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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).
Aikaikkuna: 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).
Aikaikkuna: 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).
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Johns Hopkins University

Yhteistyökumppanit

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

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Lauantai 15. maaliskuuta 2025

Ensisijainen valmistuminen (Arvioitu)

Torstai 15. kesäkuuta 2028

Opintojen valmistuminen (Arvioitu)

Sunnuntai 15. heinäkuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 21. marraskuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 21. marraskuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Torstai 30. marraskuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 4. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. marraskuuta 2026

Viimeksi vahvistettu

Sunnuntai 1. marraskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • IRB00408733

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa