Safety Planning + Interpersonal Therapy for Suicide Prevention

Recruiting at 5 trial locations

Overseen By Taylor Ryan, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive delays, Altered mental status, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Safety Planning + Interpersonal Therapy for Suicide Prevention safe for humans?

Preliminary results from a pilot study on an ultra-brief crisis intervention based on Interpersonal Psychotherapy (IPT) for suicidal children and adolescents suggest that the treatment is safe, feasible, and acceptable. ^{1 2 3 4 5}

How is the treatment Safety Planning + Interpersonal Therapy for Suicide Prevention different from other treatments for suicide prevention?

This treatment is unique because it combines Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) with the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), focusing on enhancing coping strategies and social support while removing dangerous means for suicide. It is designed to be flexible, applicable in various settings, and effective in reducing suicidal behavior. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) and Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) for suicide prevention?

Research shows that Interpersonal Psychotherapy (IPT) is effective for treating depression in adolescents, and a pilot study of the ultra-brief crisis intervention version (IPT-A SCI) showed promising results in reducing suicidal thoughts. The study found meaningful trends in reducing suicidal ideation, suggesting that this approach could be beneficial for adolescents at risk. ^{4 5 9 10 11}

Who Is on the Research Team?

Holly C Wilcox, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for diverse high-risk youth aged 12-19 who have visited acute care for suicide-related concerns or screened positive for suicidal thoughts or attempts in the past month. Participants must have a cell phone and be able to communicate in English or Spanish.

Inclusion Criteria

I've had a recent acute care visit for suicide concerns or scored high on a suicide risk test.

I've had thoughts of suicide or attempted it in the last four weeks.

I have a cell phone that can make calls and receive texts for the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) or Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) to prevent suicidal crises.

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in suicidal behavior, quality of life, anxiety, and depression.

12 months

Assessments at baseline, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
• Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)

Trial Overview The study compares two interventions: SPI+, which helps prevent escalation of suicidal crises, and IPT-A SCI, a psychotherapy that teaches skills to avoid such crises and tackles interpersonal issues leading to them. It aims to set future care standards for at-risk youth.

How Is the Trial Designed?

Group I: Ultra-Brief Crisis IPT-A Active Control 1 Intervention

Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (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.

Group II: Safety Planning Intervention Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Johns Hopkins All Children's Hospital

Collaborator

Trials

47

Recruited

5,009,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

Reichman University, Israel

Collaborator

Trials

1

Recruited

1,000+

Johns Hopkins All Childrens Hospital

Collaborator

Trials

1

Recruited

1,000+

Childrens Hospital of Philadelphia

Collaborator

Trials

1

Recruited

1,000+

Reichman University

Collaborator

Published Research Related to This Trial

An ultra-brief acute crisis intervention based on Interpersonal Psychotherapy (IPT) was developed for children and adolescents at risk of suicide, consisting of five weekly sessions and monthly follow-ups over three months.

Preliminary results from a pilot study with 26 adolescents showed promising trends in reducing suicidal ideation, indicating that the intervention is safe, feasible, and acceptable, although further research is needed due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI) Pilot Study Results. Haruvi Catalan, L., Levis Frenk, M., Adini Spigelman, E., et al.[2020]

Over 90% of adolescents recently hospitalized for suicide risk reported having access to their safety plans after discharge, indicating high retention and potential for use during critical periods.

While safety plan use and suicidal ideation both declined over time, the relationship between them varied by sex: girls showed a correlation in changes, while boys' safety plan use decreased regardless of their suicidal ideation changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. May, AM., Al-Dajani, N., Ballard, ED., et al.[2023]

A meta-analysis of 6 studies involving 3536 participants found that safety planning-type interventions (SPTIs) significantly reduce suicidal behavior, with a relative risk of 0.570 compared to control groups, indicating they are effective in preventing suicide attempts.

However, the same analysis showed no significant effect of SPTIs on reducing suicidal ideation, suggesting that while SPTIs are beneficial for preventing actions, additional strategies may be necessary to address thoughts of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety planning-type interventions for suicide prevention: meta-analysis. Nuij, C., van Ballegooijen, W., de Beurs, D., et al.[2022]

Interpersonal psychotherapy (IPT) was successfully integrated into a psychiatry residency program over a 5-year period, highlighting its effectiveness as a brief, evidence-based treatment for acute major depression.

The implementation process not only enhanced the training of residents in evidence-based treatment approaches but also helped convey essential psychotherapy concepts, indicating its value in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing interpersonal psychotherapy in a psychiatry residency training program. Lichtmacher, J., Eisendrath, SJ., Haller, E.[2006]

The Safety Planning Intervention (SPI) is a structured six-step action plan designed to help individuals at risk of suicide by enhancing their coping strategies and social support, and by removing access to means of self-harm.

Research shows that SPI is highly effective in reducing suicidal behavior, making it a valuable tool in various settings such as emergency rooms and outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. Perlstein, J., Katzir, N., Lotan, A., et al.[2022]

A systematic review of 22 studies found that suicide safety planning (SSP) is effective in reducing suicidal behavior and ideation, highlighting its importance as a suicide prevention strategy.

SSP can be delivered in various formats, including standard, enhanced, and electronically, but more research is needed to explore its impact on mental illness symptoms and resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. Marshall, CA., Crowley, P., Carmichael, D., et al.[2023]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Randomized study of school-based intensive interpersonal psychotherapy for depressed adolescents with suicidal risk and parasuicide behaviors. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI) Pilot Study Results. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Problem Area on Outcomes Among Adolescents Treated With Interpersonal Psychotherapy for Depression. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy group (IPT-G) for depression. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy for adolescent depression: description of modification and preliminary application. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety planning-type interventions for suicide prevention: meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Implementing interpersonal psychotherapy in a psychiatry residency training program. [2006]

9. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]