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

January 26, 2024 updated by: Aaron Blashill, San Diego State University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kristen J Wells, Ph.D.
  • Phone Number: 619-594-1919
  • Email: kwells@sdsu.edu

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182
        • Recruiting
        • San Diego State University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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).
Other Names:
  • PN+SPI
Active Comparator: Safety Planning Intervention
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
The Safety Planning Intervention (SPI) is a single-session, empirically supported, suicide prevention intervention. The patient navigator will deliver the SPI.
Other Names:
  • SPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Presence or absence of suicide attempts in the full twelve-month following-up period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Change from baseline suicidal ideation severity scores at 3 months, 6 months, and 12 months
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
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Change from baseline suicidal ideation intensity scores at 3 months, 6 months, and 12 months
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
The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
Time Frame: Change from baseline thwarted belongingness scores at 3 months, 6 months, and 12 months
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
Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Time Frame: Change from baseline suicide-related internal coping scores at 3 months, 6 months, and 12 months
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
Suicide-Related Coping Scale (SRCS) - External Coping Skills
Time Frame: Change from baseline suicide-related external coping scores at 3 months, 6 months, and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kristen J Wells, Ph.D., San Diego State University
  • Principal Investigator: Aaron J Blashill, Ph.D., San Diego State University
  • Study Director: Arjan van der Star, Ph.D., San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-2022-0204
  • R33MH120236 (U.S. NIH Grant/Contract: National Institute of Mental Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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