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Suicide Prevention for Sexual and Gender Minority Youth (Case Series)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04757649
Recruitment Status : Active, not recruiting
First Posted : February 17, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Aaron Blashill, San Diego State University

Brief Summary:
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, a case series trial will be conducted to test the feasibility and acceptability of the intervention and study methods.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Safety Planning Intervention with Navigation Services Not Applicable

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 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 case series trial (N = 10), feasibility and acceptability of the PN+ SPI intervention will be assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 and 3-month follow-up, participants will be asked to complete measures of suicidal coping and thwarted belongingness. At the 3-month follow-up, satisfaction with mental health services and satisfaction with interpersonal relationship with patient navigator will be assessed.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Suicide Prevention for Sexual and Gender Minority Youth (Case Series)
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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 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).
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 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).
Other Name: PN+SPI Intervention




Primary Outcome Measures :
  1. The Interpersonal Needs Questionnaire-15 (INQ-15) [ Time Frame: Change from baseline thwarted belongingness scores at 3 months ]
    Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)

  2. Suicide-Related Coping Scale (SRCS) [ Time Frame: Change from baseline suicide-related coping scores at 3 months ]
    Assess suicide-related coping (17 items on 5-point scales; scores range from 0 to 68 with higher scores indicating better coping)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 15 to 29 years
  • 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
  • Resides in San Diego County, California
  • Speaks English
  • Is willing and able to provide informed consent
  • Reports suicidal ideation over the past two weeks, as indicated by the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version
  • Reports a lifetime history of one or more suicide attempts

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757649


Locations
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United States, California
San Diego State University
San Diego, California, United States, 92182
Sponsors and Collaborators
San Diego State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Aaron J Blashill San Diego State University
Principal Investigator: Kristen J Wells San Diego State University
Additional Information:
Publications:

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Responsible Party: Aaron Blashill, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT04757649    
Other Study ID Numbers: HS-2020-0076 (1)
1R61MH120236-01 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aaron Blashill, San Diego State University:
Sexual and gender minority youth
Patient Navigation
Safety Planning Intervention
Prevention
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms