Safety Planning Intervention for Suicide Prevention

Overseen By Kristen J Wells, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Immediate suicide intention

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program aimed at preventing suicide among sexual and gender minority youth and emerging adults. The study evaluates the effectiveness of two support methods: one uses only the Safety Planning Intervention (SPI), while the other combines SPI with additional navigation services for support and resources. Suitable participants include individuals aged 15-29 who identify as LGBTQ+, have recently experienced suicidal thoughts, have a history of a suicide attempt, and live in Southern California. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could influence future support programs for LGBTQ+ youth.

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 prior data suggests that this intervention is safe for sexual and gender minority youth and emerging adults?

Research shows that the Safety Planning Intervention (SPI) is generally safe and easy for people to manage. Studies have found that SPI can help reduce suicidal thoughts and actions, providing crucial support for those at risk and decreasing the likelihood of self-harm.

For the version with Navigation Services, past research highlights additional benefits. These services connect participants with useful resources and support groups. This combination has shown promise in keeping people engaged in their care, further reducing their risk of suicide.

Overall, both interventions focus on providing support and coping strategies, which are essential for mental health and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safety Planning Intervention (SPI) with Navigation Services because it offers a tailored approach to suicide prevention for sexual and gender minority (SGM) youth and emerging adults. Unlike traditional treatments that may rely on medication or lengthy therapy sessions, this intervention combines a single-session safety planning strategy with ongoing patient navigation. This means participants receive not only immediate coping strategies but also continuous support and connection to mental health and social resources. This dual approach aims to decrease feelings of isolation and improve coping skills, addressing the root factors that contribute to suicidal thoughts and behaviors in this vulnerable group.

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

Research has shown that the Safety Planning Intervention (SPI), a treatment in this trial, effectively reduces suicidal thoughts and actions. It creates a personalized plan to stay safe during a crisis. This brief intervention lowers hospital visits and increases follow-up care. Another treatment arm in this trial includes the Safety Planning Intervention with Navigation Services, offering extra support by connecting individuals to mental health and community resources. This combination reduces feelings of isolation and improves coping skills, which are crucial for preventing suicide. Overall, both versions of the intervention in this trial show promising results in supporting those at risk. ^{1 3 6 7 8}

Who Is on the Research Team?

Arjan van der Star, Ph.D.

Principal Investigator

San Diego State University

Aaron J Blashill, Ph.D.

Principal Investigator

San Diego State University

Kristen J Wells, Ph.D.

Principal Investigator

San Diego State University

Are You a Good Fit for This Trial?

This trial is for young people aged 15-29 in San Diego who identify as part of the sexual and gender minority community, have experienced suicidal thoughts recently, and can consent to participate. It's not for those with an immediate intention to attempt suicide.

Inclusion Criteria

Speaks English

Reports suicidal ideation over the past two weeks, as indicated by the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version

Reports a lifetime history of one or more suicide attempts

Exclusion Criteria

Individuals with immediate intention to attempt suicide will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Safety Planning Intervention with Navigation Services (PN+SPI) or the Safety Planning Intervention (SPI) alone

12 months

Frequent contact for motivational enhancement and problem-solving

Follow-up

Participants are monitored for changes in suicidal ideation, thwarted belongingness, and coping skills

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Safety Planning Intervention
• Safety Planning Intervention with Navigation Services

Trial Overview The study tests a new suicide prevention program tailored for sexual and gender minority youth. Participants will be randomly assigned to receive either Safety Planning Intervention with Navigation Services or just Safety Planning Intervention.

How Is the Trial Designed?

Group I: Safety Planning Intervention with Navigation Services Experimental Treatment 1 Intervention

A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention integrates a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to mental health and social support resources (e.g., SGM-specific support groups within the community).

Group II: Safety Planning Intervention Active Control 1 Intervention

The Safety Planning Intervention (SPI) is a single-session, empirically supported, suicide prevention intervention. The patient navigator will deliver the SPI.

Safety Planning Intervention is already approved in United States for the following indications:

Approved in United States as Safety Planning Intervention for:

• Suicide prevention in general population

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

Individuals with mental illness face a heightened risk of suicide, especially after being discharged from psychiatric hospitalization.

Safety planning intervention (SPI) has shown promising results in emergency departments, but there is a significant gap in research regarding its implementation during psychiatric hospitalization at discharge, indicating a need for more widespread use of SPI in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning: Why It Is Essential on the Day of Discharge From In-patient Psychiatric Hospitalization in Reducing Future Risks of Suicide. Schuster, H., Jones, N., Qadri, SF.[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]

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]

In a study of 1,602 veterans, 30% of safety plans for suicide prevention were missing social contacts for distraction or help, which is crucial during a crisis.

Notably, veterans without a help contact were over twice as likely to attempt suicide or die by suicide in the following year, highlighting the importance of including social support in safety plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Importance of Social Contacts on U.S. Veteran Suicide Safety Plans. Chalker, SA., Parrish, EM., Martinez Ceren, CS., et al.[2023]

A self-administered, Web-based safety planning application was developed and tested with 30 suicidal patients, showing strong usability ratings and enabling 90% of participants to complete at least 5 out of 6 safety planning steps.

Participants reported a significant decrease in suicidal ideation intensity after using the application, with pre-application scores averaging 5.11 and post-application scores averaging 4.46, indicating the potential effectiveness of this tool in enhancing coping abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. Boudreaux, ED., Brown, GK., Stanley, B., et al.[2023]

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]

The study successfully implemented the Safety Planning Intervention (SPI) for adolescent suicidality in emergency services, showing that training significantly improved providers' attitudes and knowledge about the intervention.

Collaboration with stakeholders and brief training were effective strategies for integrating structured safety planning into pediatric emergency settings, which is crucial for enhancing care for suicidal youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning Intervention for Adolescents: Provider Attitudes and Response to Training in the Emergency Services Setting. Bettis, AH., Donise, KR., MacPherson, HA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33913799/

The Effectiveness of the Safety Planning Intervention for ... Primary measures included: suicidality (ideation, behavior, deaths; 10 studies), suicide-related outcomes (depression, hopelessness; 5 studies) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789424001187

Evaluating the Effectiveness of Safety Plans for Mitigating ... SP quality was associated with reduced risk for suicide outcomes. · SP quality issues were common; nearly all contained at least one poor-quality item. · Higher ...

3. 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).

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ... This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide ...

5. pcori.org pcori.org/research-results/2019/comparing-two-ways-provide-safety-planning-follow-support-adults-and-teens-risk-suicide-sparc-trial

Comparing Two Ways to Provide Safety Planning Follow- ... This study compares two approaches to providing safety planning with follow-up support for adults and adolescents who screen positive for suicide risk.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11071175/

Safety Planning Intervention and Follow-up: A Telehealth ... Brief, evidence-based interventions during or following ED visits can reduce suicide risk, decrease hospitalizations, and increase outpatient engagement [15].

7. researchgate.net researchgate.net/publication/351199333_The_Effectiveness_of_the_Safety_Planning_Intervention_for_Adults_Experiencing_Suicide-Related_Distress_A_Systematic_Review

The Effectiveness of the Safety Planning Intervention for ... Safety Planning Interventions (SPI) have shown positive outcomes in reducing suicidal ideation and attempts, hopelessness, and psychiatric ...

8. mental.jmir.org mental.jmir.org/2024/1/e52763/

Translating Suicide Safety Planning Components Into the ... Objective: This study aims to evaluate the extent to which apps integrated components of the safety planning intervention (SPI), and if so, how ...