An interventional study of Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) in Suicide, Attempted, Suicide Ideation and Suicide, sponsored by Johns Hopkins University. Recruiting at 6 sites in United States. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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.
281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.
This study's planned enrollment of 484 is above the median of 129 across 224 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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The criteria were revised on the registry on Nov 4, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)
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.
Behavioral: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
Stanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge
Five session crisis focused version of IPT for adolescents.
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
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".
Time frame: 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
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Suicides
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
Time frame: 12 months
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
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.
Time frame: 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)
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).
Time frame: 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)
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).
Time frame: 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).
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).
Time frame: baseline, 3 months, 6 months, 12 months
Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
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).
Time frame: baseline, 3 months, 6 months, 12 months
Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 3 months, 6 months, 12 months
Plan to share: No
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