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

NCT05669976 | Active Not Recruiting DMC

• 2 other identifiers: HS-2022-0204R33MH120236
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide

Keywords

Sexual and gender minority youth; Prevention; Patient Navigation; Safety Planning Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Change from baseline suicidal ideation severity scores at 3 months, 6 months, and 12 months

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Change from baseline suicidal ideation intensity scores at 3 months, 6 months, and 12 months

• The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness

  Change from baseline thwarted belongingness scores at 3 months, 6 months, and 12 months

• Suicide-Related Coping Scale (SRCS) - Internal Coping Skills

  Change from baseline suicide-related internal coping scores at 3 months, 6 months, and 12 months

• Suicide-Related Coping Scale (SRCS) - External Coping Skills

  Change from baseline suicide-related external coping scores at 3 months, 6 months, and 12 months

Study Arms (2)

Safety Planning Intervention with Navigation Services

EXPERIMENTAL

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).

Behavioral: Safety Planning Intervention with Navigation Services

Safety Planning Intervention

ACTIVE COMPARATOR

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

Behavioral: Safety Planning Intervention

Interventions

Safety Planning Intervention with Navigation Services BEHAVIORAL

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).

Also known as: PN+SPI

Safety Planning Intervention with Navigation Services

Safety Planning Intervention BEHAVIORAL

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

Also known as: SPI

Safety Planning Intervention

Eligibility Criteria

• Age: 15 Years - 29 Years
• Gender Eligibility Details: Identify 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.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \) Individuals with immediate intention to attempt suicide will be excluded.

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (9)

• 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.

  PMID: 28903161 BACKGROUND

• 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.

  PMID: 28981481 BACKGROUND

• 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.

  PMID: 26511788 BACKGROUND

• 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/

  PMID: 22013611 BACKGROUND

• 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.

  PMID: 29902162 BACKGROUND

• 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.

  PMID: 28254960 BACKGROUND

• 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.

  PMID: 29998307 BACKGROUND

• 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.

  PMID: 31112330 BACKGROUND

• 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.

  PMID: 29062296 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Suicide; Coitus

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Sexual Behavior

Study Officials

• Aaron J Blashill, Ph.D.

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Kristen J Wells, Ph.D.

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Arjan van der Star, Ph.D.

  San Diego State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (for primary endpoint: suicide attempts) will be masked for randomized study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective participants will be recruited within Southern California and requested to fill out a brief online survey. A trained member of the study team will contact each potential participant to explain the study, obtain verbal consent for pre-enrollment screening, and conduct the screening process. For those who meet screening criteria, a trained member of the study team will provide more information about the study and engage in an informed consent process during a virtual appointment. Following informed consent, participants will complete self-report questionnaires and clinician-based interviews. When eligible, participants will be randomized to either receive the PN+SPI intervention or SPI alone and offered virtual appointments. At baseline, 3-month, 6-month, and 12-month follow-ups, participants will complete clinical interviews to assess for suicidal ideation and suicidal behaviors and complete measures of suicidal coping and thwarted belongingness.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: April 10, 2023
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)