Trial Outcomes & Findings for Suicide Prevention for Sexual and Gender Minority Youth (Open Trial) (NCT NCT05087966)
NCT ID: NCT05087966
Last Updated: 2024-03-19
Results Overview
Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Change from baseline thwarted belongingness scores at 3 and 6 months
Results posted on
2024-03-19
Participant Flow
November 2021 through May 2022; San Diego County.
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
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31
|
|
Overall Study
COMPLETED
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25
|
|
Overall Study
NOT COMPLETED
|
6
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Reasons for withdrawal
| Measure |
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).
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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5
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Baseline Characteristics
Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)
Baseline characteristics by cohort
| Measure |
Safety Planning Intervention With Navigation Services
n=31 Participants
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).
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|---|---|
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Age, Categorical
<=18 years
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5 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Male
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4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Female
|
13 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Trans Man
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Trans Woman
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Non-Binary
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Genderqueer
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Gender Non-Conforming
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Gender Fluid
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4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Agender
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0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Other Gender Identity
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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31 participants
n=5 Participants
|
|
Sexual Orientation
Gay/Lesbian
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10 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
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4 Participants
n=5 Participants
|
|
Sexual Orientation
Straight/Heterosexual
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0 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual
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6 Participants
n=5 Participants
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|
Sexual Orientation
Asexual
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1 Participants
n=5 Participants
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|
Sexual Orientation
Queer
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8 Participants
n=5 Participants
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|
Sexual Orientation
Other Sexual Orientation
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2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline thwarted belongingness scores at 3 and 6 monthsPopulation: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.
Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)
Outcome measures
| Measure |
Safety Planning Intervention With Navigation Services
n=31 Participants
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).
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|---|---|
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The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
Baseline
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30.83 score on a scale
Standard Deviation 9.31
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The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
3 Months
|
28.13 score on a scale
Standard Deviation 10.32
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The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
6 Months
|
29.36 score on a scale
Standard Deviation 9.57
|
PRIMARY outcome
Timeframe: Change from baseline suicide-related internal coping scores at 3 and 6 monthsPopulation: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.
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)
Outcome measures
| Measure |
Safety Planning Intervention With Navigation Services
n=31 Participants
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).
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|---|---|
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Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
3 Months
|
18.83 score on a scale
Standard Deviation 2.96
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Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
6 Months
|
18.20 score on a scale
Standard Deviation 2.61
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Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Baseline
|
17.26 score on a scale
Standard Deviation 3.03
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PRIMARY outcome
Timeframe: Change from baseline suicide-related external coping scores at 3 and 6 monthsPopulation: 31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.
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)
Outcome measures
| Measure |
Safety Planning Intervention With Navigation Services
n=31 Participants
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).
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|---|---|
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Suicide-Related Coping Scale (SRCS) - External Coping Skills
Baseline
|
18.35 score on a scale
Standard Deviation 3.56
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Suicide-Related Coping Scale (SRCS) - External Coping Skills
3 Months
|
19.79 score on a scale
Standard Deviation 3.39
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Suicide-Related Coping Scale (SRCS) - External Coping Skills
6 Months
|
19.48 score on a scale
Standard Deviation 2.22
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Adverse Events
Safety Planning Intervention With Navigation Services
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Planning Intervention With Navigation Services
n=31 participants at risk
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).
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|---|---|
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Psychiatric disorders
Hospitalization Following Method Research
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3.2%
1/31 • Number of events 1 • 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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Psychiatric disorders
Suicide Attempt
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3.2%
1/31 • Number of events 1 • 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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Psychiatric disorders
Hospitalization Following Symptom Worsening
|
3.2%
1/31 • Number of events 1 • 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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Other adverse events
| Measure |
Safety Planning Intervention With Navigation Services
n=31 participants at risk
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).
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|---|---|
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Investigations
Concerns Following Interview Questions
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3.2%
1/31 • Number of events 1 • 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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Psychiatric disorders
Interrupted Suicide Attempt
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3.2%
1/31 • Number of events 1 • 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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Nervous system disorders
Hospitalization for Sciatica
|
3.2%
1/31 • Number of events 1 • 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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Psychiatric disorders
Emergency Room Visit
|
3.2%
1/31 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place