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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to reduce suicide and suicidal behaviors in at-risk youth by developing "Safer Still," an interactive program that promotes safe firearm storage. This intervention complements traditional care for adolescents discharged from psychiatric hospitals who live in homes with unsecured firearms. The trial will test two groups: one using the Safer Still program and another receiving standard educational care. It seeks participants with a child aged 12-17 who is currently receiving psychiatric care and has at least one unsecured firearm in their home. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for enhancing youth safety.

Will I have to stop taking my current medications?

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

What prior data suggests that the Safer Still intervention is safe for adolescents?

Research shows that the Safer Still program uses proven methods to reduce the risk of suicide. Studies have found that limiting access to dangerous items, like guns, effectively prevents suicide. Similar programs, known as Safety Planning Interventions, have successfully reduced suicidal thoughts and actions and encouraged adherence to treatment.

Although specific data on the safety of Safer Still is limited, its approach is based on these effective strategies. Since this trial does not involve drugs or medical procedures, the risks remain generally low. The program focuses on education and behavior change through a mobile app, which participants typically find easy to use. Overall, the program should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safer Still intervention for suicide prevention because it takes a novel approach to reducing access to lethal means, which is a critical factor in preventing suicide. Unlike traditional methods that might suggest a single solution, Safer Still offers multiple options for families to safely store potentially dangerous items like firearms and medications. This flexibility can make it easier for families to adopt safer practices. Additionally, the intervention utilizes a mobile technology platform to provide ongoing support and prompts, helping parents stay engaged and accountable in their efforts to secure lethal means. This combination of personalized options and continuous support is what sets Safer Still apart from existing treatments.

What evidence suggests that the Safer Still intervention is effective for suicide prevention in at-risk youth?

Research has shown that safety planning can help reduce suicidal thoughts and actions. Studies have found that these plans, especially when paired with follow-up support, lead to fewer suicide attempts. In this trial, the Safer Still program is one of the interventions being tested. It builds on existing strategies by promoting the safe storage of firearms, which is crucial to prevent impulsive actions during risky times. By offering various ways to limit access to dangerous items and encouraging families to take action, Safer Still aims to reduce the risk of suicide among at-risk youth. Early results indicate that involving families in these prevention strategies can significantly improve safety during critical times. ^{4 6 7 8 9}

Who Is on the Research Team?

Jeff Bridge

Principal Investigator

Nationwide Children's Hospital

Jack Stevens, Ph.D.

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116169/

The effect of the SAFE intervention on post-discharge suicidal ... During the six months of follow-up, a total of 570 suicide attempts and 25 suicides occurred. The rate of suicide attempt was 11,652 per 100,000 ...

2. zerosuicide.edc.org zerosuicide.edc.org/evidence/evidence-base

Evidence Base | Zero Suicide - edc.org Current research suggests that no single approach will reduce suicide among individuals who are in care. Comprehensive, multi-component, system-wide approaches ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834522

Peer Support for Suicide Prevention in Michigan: RCT The percentage of suicide attempts at 6 months after randomization was 14.9% for peer support recipients (including 2 deaths by suicide) vs 17.2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000661

Safety planning intervention for suicidal individuals in ED Studies conducted in the Department of Veteran Affairs' (VA) EDs found that SPI plus follow-up calls (SPI+) resulted in lower suicidal behavior rates and ...

6. withpower.com withpower.com/trial/phase-suicide-7-2024-1876c

Safer Still Intervention for Suicide Prevention The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468266724001579

Series Restriction of access to means used for suicide One of the most effective public health measures to prevent suicide is the restriction of access to means used in suicidal acts.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092896/

Improving Suicide Prevention Through Evidenced-Based ... These findings indicate the benefit for suicide was found in the intervention counties and confined to the demographic group targeted by the intervention.

9. academic.oup.com academic.oup.com/epirev/article/46/1/1/7602966

A systematic review of lethal means safety counseling ... Only 3 studies reported data on suicidal SDV behavior after LMSC, 2 of which were rated as high risk of bias and 1 was rated moderate. All 3 of these studies ...