Safer Still Intervention for Suicide Prevention

Recruiting at 1 trial location

Overseen By Nikhitha Kakarala, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jeff Bridge

Disqualifiers: Non-English speakers, No digital device

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The long-term goal is to decrease suicide and suicidal behaviors in at-risk youth through preventative interventions. Investigators propose to develop an interactive intervention ("Safer Still") to help promote safe storage of firearms during the critical period immediately following high-risk care transitions. The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the Safer Still treatment for suicide prevention?

Research on the Safety Planning Intervention (SPI), which is similar to Safer Still, shows it can help reduce suicidal thoughts and behaviors, decrease depression and hopelessness, and improve treatment attendance. This suggests that Safer Still might also be effective in preventing suicide. ^{1 2 3 4 5}

What safety data exists for the Safer Still Intervention for Suicide Prevention?

The research highlights challenges in defining and reporting adverse events (unwanted effects) in suicide prevention studies, making it hard to evaluate safety. It emphasizes the need for clear definitions and consistent reporting to improve safety assessments in such interventions. ^{6 7 8 9 10}

How does the Safer Still Intervention for Suicide Prevention treatment differ from other treatments for suicide prevention?

The Safer Still Intervention is unique because it enhances traditional safety planning with motivational interviewing strategies, which aim to increase motivation and self-efficacy (confidence in one's ability to execute a plan) for using the safety plan. This approach is particularly focused on adolescents at risk for suicide, addressing the common issue of safety plans not being used during high-risk periods after hospital discharge. ^{5 11 12 13 14}

Research Team

Jeff Bridge

Principal Investigator

Nationwide Children's Hospital

Jack Stevens, Ph.D.

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for adolescents aged 12-17 who have been discharged from psychiatric hospitals and live in homes with unsafely stored firearms. It aims to prevent suicide by promoting safe firearm storage.

Inclusion Criteria

Participants' child must be receiving inpatient, crisis, or emergency treatment on the CAPI or YCSU Nationwide Children's Hospital

Participants must indicate that at least one firearm is located in or around the residence of the adolescent and is stored unlocked, loaded, or both unlocked and loaded

I am the only one in my household joining this study.

Exclusion Criteria

Participants will be excluded for inability to speak/read English

Participants will be excluded for lacking access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Safer Still intervention, which includes weekly prompts about means restriction and normative feedback.

3 months

Weekly prompts (virtual)

Follow-up

Participants are monitored for changes in firearm storage practices and readiness to change.

3 months

Follow-up assessments at 1 month and 3 months (virtual)

Treatment Details

Interventions

• Safer Still

Trial Overview The 'Safer Still' interactive intervention, designed to encourage secure firearm storage post-hospital discharge, is being tested alongside Enhanced Usual Care (EUC) as a potential method for reducing suicidal behaviors in at-risk youth.

Participant Groups

Group I: Safer Still Intervention Experimental Treatment 1 Intervention

Investigators will present parents with suggested alternatives for restricting lethal means, particularly firearms and medications with high toxicity in overdose. Investigators will present multiple options for restricting access as opposed to just one alternative that may be deemed unreasonable by a family. Investigators will generate these options based upon the expertise of the study's lethal means consultant. Second, the mobile technology platform will provide weekly prompts about means restriction. Parents who have not restricted access to lethal means will be asked to document their reasons for inaction-a justification for not following safe storage practices. Third, the mobile technology platform will provide descriptive normative data regarding means restriction to those who have not secured these items

Group II: Enhanced Usual Care (EUC) Placebo Group 1 Intervention

Families randomly assigned to the control condition will receive a psychological placebo that will feature an education only website developed by NCH's web design team. This website will cover warning signs for suicide, the leading methods of suicide - so that both conditions have content that features information about firearms - and locating professional help. Like the intervention Safer Still web-based program, the control website will be branded with a Nationwide Children's Hospital affiliation, as opposed to an outside organization that will be less familiar to the central Ohio sample. The control website will NOT feature these three behavioral economic strategies--namely (a) multiple suggested alternatives for means restriction, (b) requests to justify inaction regarding means restriction, and (c) normative feedback about means restriction.

Who Is Running the Clinical Trial?

Jeff Bridge

Lead Sponsor

Trials

2

Recruited

270+

Ohio Chapter American Academy of Pediatrics

Collaborator

Trials

1

Recruited

80+

Findings from Research

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]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[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]

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 pharmacovigilance analysis of over 85,000 cases from the FDA's Adverse Event Reporting System identified specific drug combinations and indications that may increase the risk of suicide, highlighting the complexity of suicide risk factors.

The study suggests that certain demographic groups may be more affected by these drug combinations, indicating a need for further research to validate these findings and improve suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. Ding, T., Chen, ES.[2020]

Safety planning is a crucial intervention for adolescents at risk of suicide, but many do not utilize their plans after leaving psychiatric hospitals, highlighting a need for improved strategies.

The article proposes enhancing safety planning with motivational interviewing techniques to boost adolescents' motivation and confidence in using their safety plans, aiming to reduce the risk of recurrent suicidal crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing motivation and self-efficacy for safety plan use: Incorporating motivational interviewing strategies in a brief safety planning intervention for adolescents at risk for suicide. Micol, VJ., Prouty, D., Czyz, EK.[2023]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

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]

References

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

Predicting suicidal risk in schizophrenic and schizoaffective patients in a prospective two-year trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of mental health service recommendations in England and Wales and suicide rates, 1997-2006: a cross-sectional and before-and-after observational study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Results of a clinico-experimental evaluation of suicide prevention programs]. [2022]

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

Predicting and preventing suicide: do we know enough to do either? [2022]

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

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

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

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. [2023]

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

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

8. 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]

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

Mining Drugs and Indications for Suicide-Related Adverse Events. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A systematic review of validated suicide outcome classification in observational studies. [2020]

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

Enhancing motivation and self-efficacy for safety plan use: Incorporating motivational interviewing strategies in a brief safety planning intervention for adolescents at risk for suicide. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A comparison of multi-component systems approaches to suicide prevention. [2022]

14. Israel pubmed.ncbi.nlm.nih.gov

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