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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MH120236-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The overarching goal of this study is to develop a suicide prevention program for sexual-and-gender-minority youth and emerging adults. After development of the intervention program, an open phase trial will be conducted to test its feasibility, acceptability, and preliminary impact on three intervention targets.
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 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). This study will accomplish the following specific aims:
Specific Aim 1: To adapt and test an integrated PN+SPI designed to reduce suicide attempts among SGM youth and emerging adults. In this open-phase trial (N = 30), within-person changes in thwarted belongingness and suicide-related coping skills will be tested. It is hypothesized that PN+SPI participants will display decreases in thwarted belongingness and increases in suicide-related coping skills. Feasibility and acceptability of the PN+ SPI intervention will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 and 6 months |
| 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 and 6 months |
| Suicide-Related Coping Scale (SRCS) - External Coping Skills | Assess suicide-related external 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 and 6 months |
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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.
Exclusion Criteria:
Identify 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.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Blashill, Ph.D. | San Diego State University | Principal Investigator |
| Kristen J Wells, Ph.D. | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | San Diego | California | 92182 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28903161 | Background | 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. | |
| 28981481 | 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. |
| Label | URL |
|---|---|
| 10 Leading Causes of Death, United States: 2016, All Races, Both Sexes | View source |
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November 2021 through May 2022; San Diego County.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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). 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 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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). 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 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline thwarted belongingness scores at 3 and 6 months |
|
Six months
An adverse event is defined as any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign, symptom, or disease, temporally associated with participant's study participation, whether or not considered related to participant's study participation; it encompasses both physical and psychological harm. This study also included non-medical events that may be behavioral (i.e., self-harm) or social (e.g., child protective services involvement with the family).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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). 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 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization Following Method Research | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | A school system detected that the subject searched for attempt method on school-owned computer. Subject was hospitalized for nine days and enrolled in an intensive outpatient program. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concerns Following Interview Questions | Investigations | US DHHS OHRP | Systematic Assessment | After signing informed consent, subject was deemed ineligible and referred to higher levels of care. They expressed concerns about clinical interview questions putting them at risk for suicide. Case was deemed anticipated, related but not serious. |
The study was conducted to assess the feasibility and acceptability of a newly developed suicide prevention intervention. By design, the quantitative outcome measurement was not sufficiently powered to evaluate preliminary efficacy and/or mechanistic target engagement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Blashill | San Diego State University | 619-594-2245 | ajblashill@sdsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Jan 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2022 | Jan 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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A broad recruitment strategy will be used to recruit participants within the greater San Diego. Potential participants will be requested to contact study personnel via email or telephone. 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 at an in-person appointment. Following informed consent, participants will complete self-report questionnaires and clinician-based interviews in person. At baseline, 3-month, and 6-month follow-ups, participants will be asked to complete measures of suicidal coping and thwarted belongingness. At the 3- and 6-month follow-up, satisfaction with mental health services and satisfaction with interpersonal relationship with patient navigator will be assessed.
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| 26511788 | 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. |
| 22013611 | 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/ |
| 29902162 | 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. |
| 28254960 | 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. |
| 29998307 | 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. |
| 31112330 | 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. |
| 29062296 | 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. |
| Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk | View source |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual Orientation | Count of Participants | Participants |
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| Primary | 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) | 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline suicide-related internal coping scores at 3 and 6 months |
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|
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| Primary | Suicide-Related Coping Scale (SRCS) - External Coping Skills | Assess suicide-related external coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping) | 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline suicide-related external coping scores at 3 and 6 months |
|
|
|
| 0 |
| 31 |
| 2 |
| 31 |
| 4 |
| 31 |
|
| Suicide Attempt | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | Subject engaged in a suicide attempt by walking into traffic. |
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| Hospitalization Following Symptom Worsening | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | Subject was hospitalized for two days for reasons of severe depression and eating disorder symptoms. |
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| Suicide Attempt | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | Subject engaged in a suicide attempt by attempting to strangle themselves. |
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| Interrupted Suicide Attempt | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | Subject engaged in an interrupted suicide attempt |
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| Hospitalization for Sciatica | Nervous system disorders | US DHHS OHRP | Systematic Assessment | Subject was hospitalized for sciatica. |
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| Emergency Room Visit | Psychiatric disorders | US DHHS OHRP | Systematic Assessment | Subject went to emergency room for panic-like symptoms and suicidal ideation without plan. |
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| 6 Months |
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| 6 Months |
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