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NCT Number: NCT06151158

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

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.

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Key information

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins All Children's Hospital, St. Petersburg, Florida, United States

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About this study

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 12-24 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Behavioral

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)

Behavioral

Five session crisis focused version of IPT for adolescents.

Primary outcomes

  1. 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

    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".

  2. 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

    Suicidal behavior with intent to die: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scored 0 to 1, with 1 indicating a suicide attempt since last assessment.

  3. Number of Suicides

    Time frame: 12 months

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

Secondary outcomes

  1. Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)

    Time frame: 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.

  2. Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)

    Time frame: 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).

  3. Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)

    Time frame: 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).

  4. Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).

    Time frame: 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).

  5. Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).

    Time frame: 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).

  6. Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).

    Time frame: baseline, 3 months, 6 months, 12 months

    The Conflict Behavior Questionnaire (CBQ) reliably assesses the adolescent's perception of their relationship with their parents. The CBQ total score ranges from 0-20, with higher scores indicating greater conflict with each parent.

  7. Change in social interactions with peers as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Peer Relationships scale.

    Time frame: 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.

  8. Change in social interactions with family as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships scale.

    Time frame: 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.

  9. Change in skill use derived from the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) arm

    Time frame: 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.

  10. Change in skill use derived from the Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) arm

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Grela

CONTACT

[email protected]

2408058868

Holly C Wilcox, PhD

CONTACT

[email protected]

4103700081

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 30, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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