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

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning Intervention with Navigation Services
Safety Planning Intervention
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Sexual and gender minority youth, Prevention, Patient Navigation, Safety Planning Intervention

Eligibility Criteria

15 Years - 29 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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 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. Exclusion Criteria: 1) Individuals with immediate intention to attempt suicide will be excluded.

Sites / Locations

  • San Diego State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Safety Planning Intervention with Navigation Services

Safety Planning Intervention

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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)
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)

Full Information

First Posted
December 20, 2022
Last Updated
April 10, 2023
Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05669976
Brief Title
Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial)
Official Title
Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Sexual and gender minority youth, Prevention, Patient Navigation, Safety Planning Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective participants will be recruited within the greater San Diego 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 in-person or 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.
Masking
Outcomes Assessor
Masking Description
Outcome assessors (for primary endpoint: suicide attempts) will be masked for randomized study condition.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Planning Intervention with Navigation Services
Arm Type
Experimental
Arm Description
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).
Arm Title
Safety Planning Intervention
Arm Type
Active Comparator
Arm Description
The Safety Planning Intervention (SPI) is a single-session, empirically supported, suicide prevention intervention. The patient navigator will deliver the SPI.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning Intervention with Navigation Services
Other Intervention Name(s)
PN+SPI
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning Intervention
Other Intervention Name(s)
SPI
Intervention Description
The Safety Planning Intervention (SPI) is a single-session, empirically supported, suicide prevention intervention. The patient navigator will deliver the SPI.
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Assess presence or absence of suicide attempts (i.e., actual, interrupted, or aborted) over the twelve-month follow-up period
Time Frame
Presence or absence of suicide attempts in the full twelve-month following-up period
Secondary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Assess suicidal ideation severity (5 items [yes/no]; scores range from 0 to 5 with higher scores indicating more severe suicidal ideation)
Time Frame
Change from baseline suicidal ideation severity scores at 3 months, 6 months, and 12 months
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Assess suicidal ideation intensity (5 items on 5-point scales; scores range from 0 to 25 with higher scores indicating more intense suicidal ideation)
Time Frame
Change from baseline suicidal ideation intensity scores at 3 months, 6 months, and 12 months
Title
The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
Description
Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)
Time Frame
Change from baseline thwarted belongingness scores at 3 months, 6 months, and 12 months
Title
Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Description
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)
Time Frame
Change from baseline suicide-related internal coping scores at 3 months, 6 months, and 12 months
Title
Suicide-Related Coping Scale (SRCS) - External Coping Skills
Description
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)
Time Frame
Change from baseline suicide-related external coping scores at 3 months, 6 months, and 12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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. Exclusion Criteria: 1) Individuals with immediate intention to attempt suicide will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron J Blashill, Ph.D.
Phone
619-594-2245
Email
ajblashill@sdsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen J Wells, Ph.D.
Phone
619-594-1919
Email
kwells@sdsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron J Blashill, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristen J Wells, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arjan van der Star, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Study Director
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron J Blashill, Ph.D.
Phone
619-594-2245
Email
ablashil@mail.sdsu.edu
First Name & Middle Initial & Last Name & Degree
Kristen J Wells, Ph.D.
Phone
619-594-1919
Email
kwells@sdsu.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
28903161
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.
Results Reference
background
PubMed Identifier
28981481
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.
Results Reference
background
PubMed Identifier
26511788
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.
Results Reference
background
PubMed Identifier
22013611
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/
Results Reference
background
PubMed Identifier
29902162
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.
Results Reference
background
PubMed Identifier
28254960
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.
Results Reference
background
PubMed Identifier
29998307
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.
Results Reference
background
PubMed Identifier
31112330
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.
Results Reference
background
PubMed Identifier
29062296
Citation
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/nchs/products/databriefs/db293.htm
Description
10 Leading Causes of Death, United States: 2016, All Races, Both Sexes
URL
https://doi.org/10.1016/j.cbpra.2011.01.001
Description
Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk

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

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