Clinical trial NCT06151158: Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Official title: Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicide Ideation
Suicide
Suicide Prevention
Keywords: Safety Planning Intervention
Ultra-Brief Crisis
Interpersonal Psychotherapy for Adolescents
Emergency Department
Suicide Prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins All Children's Hospital
name: Children's Hospital of Philadelphia
name: Reichman University
name: Patient-Centered Outcomes Research Institute
name: Columbia University
First posted: 2023-11-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
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
timeFrame: baseline, 3 months, 6 months, 12 months
measure: 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
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Suicides
timeFrame: 12 months
Secondary outcomes:
measure: Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in social interactions with peers as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Peer Relationships scale.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in social interactions with family as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships scale.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Change in skill use derived from the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) arm
timeFrame: 3 months, 6 months, 12 months
measure: Change in skill use derived from the Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) arm
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Columbia University Irving Medical Center (CUMC)
state: New York
city: New York
country: United States
facility: Weill-Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Holly C Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.