Suicide, AttemptedProject HOPENCT06151158
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
A study testing Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) in people with Suicide, Attempted and Suicide Ideation, run by Johns Hopkins University at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Suicide, Attempted, Suicide Ideation, Suicide
- What is being tested?
- Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Mar 2025to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Holly C. Wilcox, PhD, 410-370-0081, hwilcox1@jhmi.edu
Catherine Grela, 667-217-4303, agrelam1@jh.edu
- Recruiting
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
Danielle Lowe, MD, PhD, 919-445-0870, Danielle_Lowe@med.unc.edu
Rachel Ear, PhD, 919-445-0870, earr@unc.edu
- Recruiting
Columbia University Irving Medical Center (CUMC)
New York, New York, 10032
Laura Mufson, PhD, 646-774-5791, Lhm3@cumc.columbia.edu
Christa Labouliere, PhD, 646-774-8467, Christa.Labouliere@nyspi.columbia.edu
- Recruiting
Weill-Cornell Medicine
New York, New York, 10065
Shannon Bennett, PhD, 646-962-2820, smb9017@med.cornell.edu
Gail Harrison, 929-646-0627, gah4007@med.cornell.edu
- Recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Tami Benton, MD, 609-351-2637, bentont@chop.edu
Juan Zambonini, PhD, 215-839-6617, zamboninij@email.chop.edu
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Jennifer Katzenstein, PhD, 727-767-7439, jkatzen7@jhmi.edu
Jasmine Niazi, M.S., 727-767-2389, jniazi1@jh.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Suicide, Attempted, Suicide Ideation, Suicide, Suicide Prevention
- Being tested
- Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
- Keywords
- Safety Planning Intervention, Ultra-Brief Crisis, Interpersonal Psychotherapy for Adolescents, Emergency Department, Suicide Prevention
- Medical subject headings
- Suicide, Attempted, Suicide, Suicide Prevention, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)Behavioural
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)Behavioural
Five session crisis focused version of IPT for adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention (SPI) | Active comparator | 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. Receives: Behavioral: Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) |
| Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI) | Active comparator | 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. Receives: Behavioral: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start15 Mar 2025
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins All Children's Hospital, Children's Hospital of Philadelphia, Reichman University, Patient-Centered Outcomes Research Institute, Columbia University
- Responsible party
- Sponsor
- Investigators
- Holly C Wilcox, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151158
- Sponsor's protocol ID
- IRB00408733
- Acronym
- Project HOPE
- Status last verified
- Nov 2026
- First submitted
- 21 Nov 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29998307Haruvi 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.
PubMed 33362595
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
- ClinicalTrials.gov ID
- NCT06151158
- Acronym / sponsor ID
- Project HOPE / IRB00408733
- Conditions
- Suicide, Attempted, Suicide Ideation, Suicide, Suicide Prevention
- Keywords
- Safety Planning Intervention, Ultra-Brief Crisis, Interpersonal Psychotherapy for Adolescents, Emergency Department, Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins All Children's Hospital, Children's Hospital of Philadelphia, Reichman University, Patient-Centered Outcomes Research Institute, Columbia University
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention (SPI) | Active comparator | Behavioral: Stanley Brown Safety Planning Intervention and Follow-up Contacts (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. |
| Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI) | Active comparator | Behavioral: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Safety Planning Intervention (SPI) |
| Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)Five session crisis focused version of IPT for adolescents. | Behavioural | Ultra-Brief Crisis Interpersonal Psychotherapy for Suicidal Children and Adolescents (IPT-A-SCI) |
Primary outcome
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".
Suicide events: measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) and the Service Assessment for Children and Adolescents (SACA) Recent
Time frame: 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.
Number of Suicides
Time frame: 12 months
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
10 secondary outcomes
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
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
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
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
Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).
Time frame: baseline, 3 months, 6 months, 12 months
Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).
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.
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.
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
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
Time frame: 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 29998307Stanley 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.
- Results publication: PubMed 33362595Haruvi 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.
- Patient-Centered Outcomes Research Institute (PCORI) website description of studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly C Wilcox, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) in people with Suicide, Attempted and Suicide Ideation, run by Johns Hopkins University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly C Wilcox, PhD (410-370-0081, hwilcox1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: baseline, 3 months, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06151158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.