Safety Planning 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: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test a program to prevent suicide among young people who identify as sexual and gender minorities. The program combines a Safety Planning Intervention, which helps manage suicidal thoughts, with Navigation Services that connect participants to support and mental health resources. It seeks participants aged 15 to 29 who identify with non-heterosexual or diverse gender identities, live in San Diego County, and have experienced suicidal thoughts or attempts. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for mental health challenges in the community.

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 program is safe for sexual-and-gender-minority youth and emerging adults?

Research has shown that the Safety Planning Intervention (SPI) is generally safe for individuals experiencing suicidal thoughts. Studies have found it effective in reducing suicidal behavior and thoughts. Many participants also report improvements in depression and hopelessness.

The SPI is a brief intervention, requiring little time to complete. It helps individuals create a personal plan for managing a crisis. This plan includes recognizing warning signs, finding coping strategies, and identifying contacts for support during distress.

Studies have reported no major safety issues, indicating that the treatment is well-tolerated. For those considering joining a trial involving SPI, current research provides reassuring evidence of its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safety Planning Intervention with Navigation Services because it offers a more personalized and proactive approach to suicide prevention for sexual and gender minority youth. Unlike standard treatments that might focus solely on therapy or medication, this intervention combines a single-session safety planning technique with ongoing support from a patient navigator. This unique combination aims to decrease feelings of isolation and improve coping skills by connecting participants to tailored social support and mental health resources. The approach not only addresses immediate safety concerns but also builds a community support network, which could lead to more sustainable mental health improvements.

What evidence suggests that the Safety Planning Intervention with Navigation Services is effective for suicide prevention in sexual-and-gender-minority youth?

Research has shown that the Safety Planning Intervention (SPI), provided to participants in this trial, effectively reduces suicidal thoughts and actions. Studies indicate that SPI helps lessen feelings of hopelessness and depression, often linked to suicide. By guiding individuals to create a personalized plan for crisis safety, SPI has successfully prevented suicide attempts. In this trial, the intervention combines with Navigation Services, which connect participants to community support and mental health resources. Together, these strategies aim to improve coping skills and reduce feelings of isolation. ^{1 2 4 5 6}

Who Is on the Research Team?

Aaron 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?

Inclusion Criteria

1) age 15 to 29 years; 2) identifies as gay, lesbian, bisexual, transgender, genderqueer, asexual, pansexual, non-binary, or another non-exclusively heterosexual identity, and/or reports same-gender romantic attraction, and/or reports same-gender sexual behavior in the past 12 months; 3) resides in San Diego County, California; 4) speaks English; 5) is willing and able to provide informed consent; 6) reports suicidal ideation over the past two weeks, as indicated by the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version; and 7) reports a lifetime history of one or more suicide attempts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Safety Planning Intervention with Navigation Services (PN+SPI) designed to reduce suicide attempts among SGM youth and emerging adults

6 months

Frequent contact for motivational enhancement and problem-solving

Follow-up

Participants are monitored for changes in thwarted belongingness and suicide-related coping skills

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Safety Planning Intervention with Navigation Services

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 will integrate 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 social support and mental health resources (e.g., SGM-specific support groups within the community).

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

In a study involving 3,189 patients (1,995 with breast abnormalities and 1,194 with cervical abnormalities), the presence of barriers significantly delayed the time to diagnostic resolution, with adjusted hazard ratios of 0.744 for breast and 0.792 for cervical participants, indicating that barriers negatively impact timely care.

Patient navigators played a crucial role in addressing these barriers by arranging appointments, making referrals, and providing education, suggesting that effective navigation can enhance access to cancer care and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. Katz, ML., Young, GS., Reiter, PL., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

The NavSTAR intervention, which provided patient navigation for hospitalized patients with comorbid substance use disorders, resulted in significant cost savings of $17,780 per participant by reducing emergency department visits and inpatient hospital stays over a 12-month period.

The study suggests that implementing patient navigation services can be an effective strategy for healthcare payors and policymakers to lower hospital costs associated with patients suffering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. Orme, S., Zarkin, GA., Dunlap, LJ., et al.[2023]

Citations

1. 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).

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

The Effectiveness of the Safety Planning Intervention for ... The safety planning intervention (SPI) is gaining momentum in suicide prevention practice and research. This systematic review sought to ...

3. withpower.com withpower.com/trial/safety-planning-intervention-for-suicide-prevention-f754d

Safety Planning Intervention for Suicide Prevention Research shows that the Safety Planning Intervention (SPI) is effective in reducing suicidal behavior and improving outcomes like depression and hopelessness.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1482924/full

a qualitative systematic review and meta-synthesis While the meta-analysis of six safety planning type studies (19) also found reduced suicidal behaviour among intervention participants compared to treatment as ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S2368795924000295

Translating Suicide Safety Planning Components Into the ... Suicide safety planning is an evidence-based approach used to help individuals identify strategies to keep themselves safe during a mental health crisis.

6. 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 ...