SAFETY-A + CLASP for Youth Suicide Prevention

(YPIC-SP 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

Trial Summary

What is the purpose of this trial?

This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 \& 12 month follow-up assessments.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment SAFETY-A + CLASP for Youth Suicide Prevention?

Research shows that follow-up support after emergency department visits, like the Safety Planning Intervention, can significantly reduce suicidal thoughts and attempts. This suggests that similar follow-up treatments, like SAFETY-A + CLASP, may also be effective in preventing youth suicide. ^{1 2 3 4 5}

Is the SAFETY-A + CLASP treatment generally safe for humans?

The research highlights the importance of using multiple methods to detect adverse events (unwanted effects from treatment) in suicide prevention studies, suggesting that careful monitoring is crucial. However, there is no specific safety data available for the SAFETY-A + CLASP treatment itself. ^{6 7 8 9 10}

How is the SAFETY-A + CLASP treatment for youth suicide prevention different from other treatments?

The SAFETY-A + CLASP treatment is unique because it combines emergency department care with therapeutic follow-up contacts, focusing on both immediate safety and ongoing support, which is not a standard approach in youth suicide prevention. ^{11 12 13 14 15}

Research Team

Joan R Asarnow, PhD

Principal Investigator

University of California, Los Angeles

David Goldston, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

ReachCare Mobile Apps for Patients Experiencing Suicidality in the Emergency Department: Development and Usability Testing Using Mixed Methods. [2023]

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

Emergency department safety assessment and follow-up evaluation 2: An implementation trial to improve suicide prevention. [2022]

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

Pediatric suicide-related presentations: a systematic review of mental health care in the emergency department. [2023]

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mental health follow-up among adolescents with suicidal behaviors after emergency department discharge. [2022]

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

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. [2018]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

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

A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance. [2023]

10. England 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. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Development of Educational Content for Nurses to Prevent Safety Accidents of Hospitalized Children: Delphi Approach. [2022]

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

SAFEST: Use of a Rubric to Teach Safety Reporting to Pediatric House Officers. [2022]

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

Pediatric patient safety in the prehospital/emergency department setting. [2013]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Descriptive Epidemiology of Safety Events at an Academic Medical Center. [2020]

15. England pubmed.ncbi.nlm.nih.gov

Medication safety and knowledge-based functions: a stepwise approach against information overload. [2021]