SAFETY-A + CLASP for Youth Suicide Prevention

(SAFE STEPS Trial)

Recruiting at 4 trial locations

Overseen By Jocelyn I Meza, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Disqualifiers: Active psychosis, Drug dependence, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Immediate intervention during ED visit

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which approach is more effective for young people experiencing suicidal thoughts or behaviors: a combined method using SAFETY-A and CLASP follow-up contacts, or SAFETY-A with standard emergency care. SAFETY-A focuses on safety planning and stabilization, while CLASP provides ongoing support after hospital discharge. Teens and young adults aged 13-24 who have experienced suicidal thoughts or plans in the past week may be suitable for this study. The researchers aim to assess how these treatments help over time, with evaluations at 3, 6, and 12 months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant mental health advancements.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the SAFETY-A program, formerly known as the Family Intervention for Suicide Prevention (FISP), is safe for young people. Studies indicate it reduces suicidal thoughts and actions without major side effects. The program focuses on creating a safety plan and providing stability during emergency room visits.

For the combined treatment, which includes SAFETY-A and the CLASP (Coping Long Term with Active Suicidality Program) follow-up, research also suggests safety. Early results show it helps manage suicidal behavior. The CLASP program includes brief follow-up calls to support participants, which have proven effective without serious negative effects.

Both treatments aim to offer extra care and support to help young people in crisis, and existing studies suggest they are safe and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAFETY-A and CLASP approach because it offers a fresh take on youth suicide prevention by integrating therapeutic follow-up with emergency department care. Unlike standard treatments that often end at the hospital, this method includes ongoing support through the Coping Long Term with Active Suicidality Program (CLASP). This continuous engagement aims to provide stability and support, addressing gaps in care after an initial crisis. Additionally, SAFETY-A integrates safety planning into emergency care, potentially improving immediate stabilization and family involvement. These features could lead to more comprehensive and effective prevention strategies compared to traditional, short-term interventions.

What evidence suggests that this trial's treatments could be effective for youth suicide prevention?

Research has shown that the SAFETY-A method, used in emergency care, can reduce the risk of future suicidal thoughts and actions in young people. Studies found it led to fewer repeat visits to the emergency room and less self-harm. In this trial, one group of participants will receive SAFETY-A integrated within usual ED care. Another group will receive a combined approach that includes both SAFETY-A and the CLASP program, which adds follow-up support with therapy and case management. The CLASP program has also reduced suicidal behaviors. When combined with SAFETY-A, this approach improves mental health and safety over time. Together, these treatments have led to better outcomes for many young people dealing with suicidal thoughts. ^{3 6 7 8 9}

Who Is on the Research Team?

Joan R Asarnow, PhD

Principal Investigator

University of California, Los Angeles

David Goldston, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for young people aged 15-24 who have recently experienced suicidal thoughts or behaviors. They must be able to give informed consent and engage in the study, which means they can't have conditions like active psychosis or drug dependence that would interfere. Participants and their parents must speak English fluently, with parents also having the option of Spanish.

Inclusion Criteria

I am between 15 and 24 years old.

Past-week suicidal behavior or ideation with plan or intent

Exclusion Criteria

Youth not fluent in English

My parent does not speak English or Spanish fluently.

Symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis, drug dependence, no locator information)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAFETY-A integrated within usual ED Care, with or without additional therapeutic follow-up contacts using the CLASP model

Immediate intervention during ED visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

3 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts
• SAFETY-A within usual ED Care

Trial Overview

The trial compares two approaches for emergency care: SAFETY-A within usual ED Care versus a combination of SAFETY-A and CLASP Therapeutic Follow-Up Contacts. The effectiveness will be monitored over time with follow-up assessments at 3, 6, and 12 months after initial treatment.

How Is the Trial Designed?

Group I: Combined Active Control 1 Intervention

The combined treatment arm includes both 1) SAFETY-A integrated within usual ED Care, and 2) therapeutic follow-up contacts using the Coping Long Term with Active Suicidality Program (CLASP) model.

Group II: SAFETY-Acute within Usual ED Care Active Control 1 Intervention

The SAFETY-Acute (A) approach to safety planning and stabilization will be integrated within usual ED Care. SAFETY-A was formerly called the Family Intervention for Suicide Prevention, FISP.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Olive View-UCLA Education & Research Institute

Collaborator

Trials

34

Recruited

880,000+

RAND

Collaborator

Trials

145

Recruited

617,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A redesigned electronic case sheet and computer-assisted interventions were implemented in an emergency department to enhance medication safety, showing positive user acceptance over a 6-month period.

Physicians found the new system more useful and supportive compared to traditional paper-based methods, although usage varied significantly among the different alert steps, indicating a need for further optimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication safety and knowledge-based functions: a stepwise approach against information overload. Patapovas, A., Dormann, H., Sedlmayr, B., et al.[2021]

Transition interventions, which include follow-up care after emergency department visits, significantly reduce the risk of subsequent suicide and improve adherence to treatment, as shown by a study with 10 trials involving pediatric patients.

An ED-based discharge planning intervention was effective in increasing the number of attended post-ED treatment sessions, highlighting the importance of structured follow-up care in preventing future suicide-related incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric suicide-related presentations: a systematic review of mental health care in the emergency department. Newton, AS., Hamm, MP., Bethell, J., et al.[2023]

The SPARC Trial is a randomized controlled study involving 1,510 participants (720 adolescents and 790 adults) at risk for suicide, aiming to compare the effectiveness of two follow-up support models: Instrumental Support Calls (ISC) and Caring Contacts (CC) via text messages.

The primary goal is to assess which intervention better reduces suicidal ideation and behavior over 6 months, using the Columbia Suicide Severity Rating Scale (C-SSRS), thereby providing critical insights into effective suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of safety planning intervention with instrumental support calls (ISC) versus safety planning intervention with two-way text message caring contacts (CC) in adolescents and adults screening positive for suicide risk in emergency departments and primary care clinics: Protocol for a pragmatic randomized controlled trial. Radin, AK., Shaw, J., Brown, SP., et al.[2023]

In a study of 100 adolescents aged 11 to 18 who were discharged from a pediatric ED after suicidal ideation or attempts, 66% successfully followed up with a mental health provider, especially those with a prior psychiatric diagnosis.

Despite successful follow-up for many, a significant number returned to the ED within 2 months, with 92% of those requiring inpatient psychiatric admission, highlighting the need for targeted interventions for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health follow-up among adolescents with suicidal behaviors after emergency department discharge. Sobolewski, B., Richey, L., Kowatch, RA., et al.[2022]

An estimated 158,520 children and adolescents visit emergency departments annually due to adverse drug events (ADEs), with nearly half of these cases occurring in children aged 1 to 4 years.

Unintentional overdoses are the most common cause of these ADEs, highlighting the need for targeted interventions to prevent such incidents, especially for medications frequently prescribed to young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. Cohen, AL., Budnitz, DS., Weidenbach, KN., et al.[2018]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

The study analyzes follow-up attempts for adverse event reports, focusing on spontaneous reports, patient support programs, and literature, using data from the European Economic Area during the pre-pandemic period.

It highlights the need for a risk-based approach to Individual Case Safety Report follow-ups, encouraging discussions among industry and regulatory authorities to improve safety monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance. Vemula, GK., Badale, P., Mavrogenis, P., et al.[2023]

Pediatric patients in emergency departments are at a higher risk for errors and adverse events, particularly young children and those with high-acuity conditions, due to a lack of standardized safety practices.

Implementing a culture of safety, enhancing team training, and improving organizational systems can significantly reduce medication errors and improve overall care quality, ultimately decreasing morbidity and mortality in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric patient safety in the prehospital/emergency department setting. Barata, IA., Benjamin, LS., Mace, SE., et al.[2013]

Two user-friendly apps were developed to assist patients at risk of suicide in emergency departments: a web app for creating safety plans during their visit and a smartphone app for post-discharge support, which includes self-care resources and tracking follow-up appointments.

Usability testing showed high satisfaction scores for both apps, with significant improvements after refinements, indicating that these digital tools could effectively support patients and enhance the implementation of evidence-based interventions in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReachCare Mobile Apps for Patients Experiencing Suicidality in the Emergency Department: Development and Usability Testing Using Mixed Methods. Larkin, C., Djamasbi, S., Boudreaux, ED., et al.[2023]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The introduction of the SAFEST rubric significantly improved the quality of patient safety reports among residents, with a notable increase in reporting the 'staff involved' and 'standard of care' elements.

After training, residents were 2.2 times more likely to include information about the staff involved in incidents and 1.8 times more likely to describe the standard of care, indicating that structured education can enhance the consistency of safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFEST: Use of a Rubric to Teach Safety Reporting to Pediatric House Officers. Keefer, P., Helms, L., Warrier, K., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A comprehensive educational program was developed for nurses to prevent safety accidents among hospitalized children, covering seven key areas such as falls, poisoning, and medical device safety, based on expert input from 18 specialists.

Nurses recognized the importance of child safety education (average score of 4.18) but reported lower actual performance in delivering this education (average score of 3.72), highlighting a significant gap that needs to be addressed to improve safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Educational Content for Nurses to Prevent Safety Accidents of Hospitalized Children: Delphi Approach. Lee, YS., Oh, WO.[2022]

Over a three-year period, a total of 31,817 safety events were reported in an academic medical center, with the majority (77.3%) classified as precursor events that resulted in minimal or no harm to patients.

Serious safety events, which resulted in moderate to severe harm or death, were very rare, making up only 0.1% of all reported events, indicating that while safety events are common, severe outcomes are infrequent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive Epidemiology of Safety Events at an Academic Medical Center. Marra, AR., Algwizani, A., Alzunitan, M., et al.[2020]

The ED-SAFE 2 study aims to enhance suicide prevention in emergency departments by implementing a continuous quality improvement (CQI) approach, focusing on universal suicide risk screening and a new Safety Planning Intervention (SPI) over a 24-month period across eight emergency departments.

By using data-driven methods to refine care processes, the study seeks to improve the identification of at-risk patients and the effectiveness of interventions, potentially leading to better outcomes in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department safety assessment and follow-up evaluation 2: An implementation trial to improve suicide prevention. Boudreaux, ED., Haskins, BL., Larkin, C., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5047846/

The Coping with Long Term Active Suicide Program (CLASP)

This paper presents a description and pilot data for a new adjunctive intervention designed to reduce suicidal behavior among high-risk individuals.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11209847/

Coping Long Term with Active Suicide in Adolescents

We adapted CLASP for adolescents (CLASP-A) because of its specific focus on suicidal behavior and favorable preliminary results, as well as its transdiagnostic ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01748760

Coping Long Term With Attempted Suicide - Adolescents ...

The goals of CLASP-A are to reduce continued suicidal behavior and ideation, reduce risk behaviors for suicide, and improve adherence to psychosocial and ...

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researchgate.net

researchgate.net/publication/363004931_The_Coping_Long_Term_with_Active_Suicide_Program_CLASP_A_Multi-Modal_Intervention_for_Suicide_PreventionA_Multi-Modal_Intervention_for_Suicide_Prevention

The Coping Long Term with Active Suicide Program (CLASP)

CLASP is a multifaceted, adjunctive intervention designed to target suicidality through a combination of case management, individual psychotherapy, and ...

5.

hsrd.research.va.gov

hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=3590

The Coping Long-Term with Active Suicide Program (CLASP ...

Presenters will discuss suicide risk factors, challenges in suicide prevention over care transitions, and will present efficacy data on CLASP. Intended ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3979300/

The Emergency Department Safety Assessment and Follow ...

ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multiphase, quasi-experimental design.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032723014878

Longitudinal risk of suicide outcomes in people with severe ...

Participants with SMI were at higher risk for suicide outcomes than participants with other psychiatric diagnoses. CLASP was efficacious among ...

8.

psychiatrictimes.com

psychiatrictimes.com/view/researchers-address-youth-suicide-prevention-in-virtual-panel

Researchers Address Youth Suicide Prevention in Virtual ...

This study focuses on Safety-Acute(A), which is an ED crisis therapy session focused on patient safety (formerly known as Family Intervention ...

9.

flbhimpact.org

flbhimpact.org/wp-content/uploads/2020/09/jamapsychiatry_miller_2017_oi_170023.pdf

Suicide Prevention in an Emergency Department Population ...

The CLASP-ED protocol consisted of up to 7 brief (10- to 20-minute) telephone calls to the participant and up to 4 calls to an SO identified by ...