Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)

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

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a support program for young people from sexual and gender minority groups who are at high risk of suicide. The program combines safety planning with ongoing guidance to help participants feel more connected and teach them how to cope with suicidal thoughts. Attachment-based family therapy (ABFT) has been adapted to address the needs of transgender and gender diverse youth experiencing suicidal thoughts and behavior.

Will I have to stop taking my current medications?

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

How is the Safety Planning Intervention with Navigation Services treatment different from other treatments?

The Safety Planning Intervention with Navigation Services is unique because it combines personalized safety planning with navigation services to help individuals access necessary resources and support, which is not typically included in standard treatments for similar conditions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Safety Planning Intervention with Navigation Services?

Research shows that patient navigation services can help reduce hospital visits for people with substance use disorders and improve timely care for cancer patients by overcoming barriers to treatment. This suggests that similar navigation services might also support the effectiveness of Safety Planning Interventions by helping patients access and complete necessary care. ^{6 7 8 9 10}

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

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]

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]

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]

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]

Citations

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

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. [2023]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care. [2021]

4. England 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. [2022]

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

Patient navigation to facilitate early intervention referral completion among poor urban children. [2022]

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

The effectiveness of screening and brief intervention on reducing driving while intoxicated citations. [2016]

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

Parenting interventions and the prevention of unintentional injuries in childhood: systematic review and meta-analysis. [2022]

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

A randomized controlled trial of a web-based early intervention for children and their parents following unintentional injury. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The role of organizations in community participation--prevention of accidental injuries in a rural Swedish municipality. [2019]

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

Implementation fidelity of the 'Stay One Step Ahead' home safety intervention: a mixed-methods analysis. [2023]