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Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)

Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05087966
Enrollment
31
Registered
2021-10-21
Start date
2021-11-08
Completion date
2022-12-02
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

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

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, an open phase trial will be conducted to test its feasibility, acceptability, and preliminary impact on three intervention targets.

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 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.

Interventions

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).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
San Diego State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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, 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.

Eligibility

Sex/Gender
ALL
Age
15 Years to 29 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

MeasureTime frameDescription
The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted BelongingnessChange from baseline thwarted belongingness scores at 3 and 6 monthsAssess 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 SkillsChange from baseline suicide-related internal coping scores at 3 and 6 monthsAssess 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 SkillsChange from baseline suicide-related external coping scores at 3 and 6 monthsAssess suicide-related external coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping)

Countries

United States

Participant flow

Recruitment details

November 2021 through May 2022; San Diego County.

Participants by arm

ArmCount
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).
31
Total31

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1
Overall StudyWithdrawal by Subject5

Baseline characteristics

CharacteristicSafety Planning Intervention With Navigation Services
Age, Categorical
<=18 years
5 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
18 Participants
Region of Enrollment
United States
31 participants
Sex/Gender, Customized
Gender Identity
Agender
0 Participants
Sex/Gender, Customized
Gender Identity
Female
13 Participants
Sex/Gender, Customized
Gender Identity
Gender Fluid
4 Participants
Sex/Gender, Customized
Gender Identity
Gender Non-Conforming
1 Participants
Sex/Gender, Customized
Gender Identity
Genderqueer
1 Participants
Sex/Gender, Customized
Gender Identity
Male
4 Participants
Sex/Gender, Customized
Gender Identity
Non-Binary
6 Participants
Sex/Gender, Customized
Gender Identity
Other Gender Identity
1 Participants
Sex/Gender, Customized
Gender Identity
Trans Man
1 Participants
Sex/Gender, Customized
Gender Identity
Trans Woman
0 Participants
Sexual Orientation
Asexual
1 Participants
Sexual Orientation
Bisexual
4 Participants
Sexual Orientation
Gay/Lesbian
10 Participants
Sexual Orientation
Other Sexual Orientation
2 Participants
Sexual Orientation
Pansexual
6 Participants
Sexual Orientation
Queer
8 Participants
Sexual Orientation
Straight/Heterosexual
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 31
other
Total, other adverse events
4 / 31
serious
Total, serious adverse events
2 / 31

Outcome results

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)

Time frame: Change from baseline suicide-related external coping scores at 3 and 6 months

Population: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - External Coping SkillsBaseline18.35 score on a scaleStandard Deviation 3.56
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - External Coping Skills3 Months19.79 score on a scaleStandard Deviation 3.39
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - External Coping Skills6 Months19.48 score on a scaleStandard Deviation 2.22
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)

Time frame: Change from baseline suicide-related internal coping scores at 3 and 6 months

Population: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - Internal Coping SkillsBaseline17.26 score on a scaleStandard Deviation 3.03
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - Internal Coping Skills3 Months18.83 score on a scaleStandard Deviation 2.96
Safety Planning Intervention With Navigation ServicesSuicide-Related Coping Scale (SRCS) - Internal Coping Skills6 Months18.20 score on a scaleStandard Deviation 2.61
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)

Time frame: Change from baseline thwarted belongingness scores at 3 and 6 months

Population: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Safety Planning Intervention With Navigation ServicesThe Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted BelongingnessBaseline30.83 score on a scaleStandard Deviation 9.31
Safety Planning Intervention With Navigation ServicesThe Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness3 Months28.13 score on a scaleStandard Deviation 10.32
Safety Planning Intervention With Navigation ServicesThe Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness6 Months29.36 score on a scaleStandard Deviation 9.57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026