Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial)

Suicide Clinical Trial

Official title:

Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669976
• Other study ID #: HS-2022-0204
• Secondary ID: R33MH120236
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: San Diego State University
• Contact: Aaron J Blashill, Ph.D.
• Phone: 619-594-2245
• Email: ajblashill[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this study is to evaluate a newly-developed suicide prevention program for sexual and gender minority youth and emerging adults. After development of the intervention program, a randomized controlled trial will be conducted to test its preliminary efficacy in lowering the risk for suicide attempts.

Description:

Suicide is the 10th leading cause of death among all U.S. citizens, and is the 2nd leading cause of death among youth and emerging adults between the ages of 15 and 34. Moreover, U.S. representative data indicate increasing trends in suicide attempts and death by suicide. In addition to the immense psychological burden experienced by the family and friends of individuals who attempt and complete suicide, the costs of death by suicide and suicide attempts in 2013 were estimated at $93.5 billion. One group that is particularly vulnerable to suicide is sexual and gender minorities (SGMs). SGM is an umbrella term used to describe individuals who identify as non-exclusively heterosexual (e.g., gay, lesbian, bisexual) and/or as transgender/non-binary (e.g., identify as a gender different from their birth sex). Extant research consistently notes substantial mental health disparities among SGMs in comparison to their heterosexual and cis-gender counterparts. In 2017, in the U.S., 23% of sexual minority youth reported one or more suicide attempts (in the past 12 months) vs. 5.4% of heterosexual youth. This disparity has also been noted in a meta-analysis of population-based longitudinal studies, with sexual minority adolescents and emerging adults reporting 2.26 increased odds of suicide attempts compared to their heterosexual counterparts. Prevalence of lifetime suicide attempts among gender minorities is also substantially elevated compared to the general population, with 45% of 18-24-year-old transgender individuals reporting history of one or more suicide attempts. Despite these substantial health disparities in suicide among SGM youth/emerging adults, no known suicide prevention programs exist for this highly vulnerable population. Given this crucial gap in the literature, the proposed study will adapt and test 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 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 social support and mental health resources (e.g., SGM-specific support groups within the community). After completing the development of the PN+SPI intervention during a previous phase of the project, this study will accomplish the following specific aims: Specific Aim 2: To conduct a pilot randomized controlled trial of the integrated PN+SPI by comparing it to the safety planning intervention alone to assess feasibility, acceptability, and preliminary efficacy. We plan to randomize 170 SGM youth/emerging adults to either the PN+SPI or SPI alone and follow participants for 12 months. It is expected that the pilot trial will provide additional information about the feasibility and acceptability of the PN+SPI intervention and study methods, in preparation for a future full-scale efficacy trial. In addition, the pilot test will evaluate its preliminary impact on suicide attempts. It is hypothesized that participants assigned to the PN+SPI intervention will demonstrate lower suicide attempts in comparison to participants assigned to the SPI alone condition. Specific Aim 3: To conduct longitudinal analysis of the mechanisms of action of the integrated PN+SPI. To understand the mechanisms of change in the PN+SPI intervention, we will assess the theoretical purported targets (i.e., decreases in thwarted belongingness and increases in suicide-related coping skills). We hypothesize that participants assigned to the PN+SPI intervention will demonstrate clinically meaningful changes in the target variables relative to participants assigned to the SPI alone condition. Subsequently, these changes in proposed targets will predict changes in suicidal attempts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 29 Years

Eligibility

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 or cisgender identity, and/or reports same-gender romantic attraction, and/or reports same-gender sexual behavior in the past 12 months; 3) resides in Southern 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. Exclusion Criteria: 1) Individuals with immediate intention to attempt suicide will be excluded.

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

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

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Cramer RJ, Kapusta ND. A Social-Ecological Framework of Theory, Assessment, and Prevention of Suicide. Front Psychol. 2017 Oct 9;8:1756. doi: 10.3389/fpsyg.2017.01756. eCollection 2017. — View Citation

Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/ — View Citation

Ivey-Stephenson AZ, Crosby AE, Jack SPD, Haileyesus T, Kresnow-Sedacca MJ. Suicide Trends Among and Within Urbanization Levels by Sex, Race/Ethnicity, Age Group, and Mechanism of Death - United States, 2001-2015. MMWR Surveill Summ. 2017 Oct 6;66(18):1-16. doi: 10.15585/mmwr.ss6618a1. — View Citation

Kann L, McManus T, Harris WA, Shanklin SL, Flint KH, Queen B, Lowry R, Chyen D, Whittle L, Thornton J, Lim C, Bradford D, Yamakawa Y, Leon M, Brener N, Ethier KA. Youth Risk Behavior Surveillance - United States, 2017. MMWR Surveill Summ. 2018 Jun 15;67(8):1-114. doi: 10.15585/mmwr.ss6708a1. — View Citation

Labouliere CD, Stanley B, Lake AM, Gould MS. Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. Suicide Life Threat Behav. 2020 Feb;50(1):29-41. doi: 10.1111/sltb.12554. Epub 2019 May 21. — View Citation

Miranda-Mendizabal A, Castellvi P, Pares-Badell O, Almenara J, Alonso I, Blasco MJ, Cebria A, Gabilondo A, Gili M, Lagares C, Piqueras JA, Roca M, Rodriguez-Marin J, Rodriguez-Jimenez T, Soto-Sanz V, Vilagut G, Alonso J. Sexual orientation and suicidal behaviour in adolescents and young adults: systematic review and meta-analysis. Br J Psychiatry. 2017 Aug;211(2):77-87. doi: 10.1192/bjp.bp.116.196345. Epub 2017 Mar 2. — View Citation

Olfson M, Blanco C, Wall M, Liu SM, Saha TD, Pickering RP, Grant BF. National Trends in Suicide Attempts Among Adults in the United States. JAMA Psychiatry. 2017 Nov 1;74(11):1095-1103. doi: 10.1001/jamapsychiatry.2017.2582. — View Citation

Shepard DS, Gurewich D, Lwin AK, Reed GA Jr, Silverman MM. Suicide and Suicidal Attempts in the United States: Costs and Policy Implications. Suicide Life Threat Behav. 2016 Jun;46(3):352-62. doi: 10.1111/sltb.12225. Epub 2015 Oct 29. — View Citation

Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Assess presence or absence of suicide attempts (i.e., actual, interrupted, or aborted) over the twelve-month follow-up period	Presence or absence of suicide attempts in the full twelve-month following-up period
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Assess suicidal ideation severity (5 items [yes/no]; scores range from 0 to 5 with higher scores indicating more severe suicidal ideation)	Change from baseline suicidal ideation severity scores at 3 months, 6 months, and 12 months
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Assess suicidal ideation intensity (5 items on 5-point scales; scores range from 0 to 25 with higher scores indicating more intense suicidal ideation)	Change from baseline suicidal ideation intensity scores at 3 months, 6 months, and 12 months
Secondary	The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness	Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)	Change from baseline thwarted belongingness scores at 3 months, 6 months, and 12 months
Secondary	Suicide-Related Coping Scale (SRCS) - Internal Coping Skills	Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better internal coping)	Change from baseline suicide-related internal coping scores at 3 months, 6 months, and 12 months
Secondary	Suicide-Related Coping Scale (SRCS) - External Coping Skills	Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping)	Change from baseline suicide-related external coping scores at 3 months, 6 months, and 12 months

External Links

•   10 Leading Causes of Death, United States: 2016, All Races, Both Sexes
•   Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk