Trial Outcomes & Findings for Suicide Prevention for Sexual and Gender Minority Youth (Case Series) (NCT NCT04757649)
NCT ID: NCT04757649
Last Updated: 2024-01-29
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
9 participants
Primary outcome timeframe
Cohen's d effect size as change from baseline thwarted belongingness scores at 3 months (0.00-0.49 small effect; 0.50-0.79 medium effect; 0.80-1.00 large effect)
Results posted on
2024-01-29
Participant Flow
May 2021 through July 2021; 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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9
|
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Overall Study
COMPLETED
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7
|
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Overall Study
NOT COMPLETED
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2
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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
Withdrawal by Subject
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1
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Suicide Prevention for Sexual and Gender Minority Youth (Case Series)
Baseline characteristics by cohort
| Measure |
Safety Planning Intervention With Navigation Services
n=9 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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2 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex/Gender, Customized
Gender Identity · Male
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2 Participants
n=5 Participants
|
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Sex/Gender, Customized
Gender Identity · Female
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2 Participants
n=5 Participants
|
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Sex/Gender, Customized
Gender Identity · Trans Man
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1 Participants
n=5 Participants
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Sex/Gender, Customized
Gender Identity · Trans Woman
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1 Participants
n=5 Participants
|
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Sex/Gender, Customized
Gender Identity · Non-Binary
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1 Participants
n=5 Participants
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Sex/Gender, Customized
Gender Identity · Genderqueer
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1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Gender Non-Conforming
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0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Gender Fluid
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1 Participants
n=5 Participants
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Sex/Gender, Customized
Gender Identity · Agender
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0 Participants
n=5 Participants
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Sex/Gender, Customized
Gender Identity · Other Gender
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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9 participants
n=5 Participants
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Sexual Orientation
Gay/Lesbian
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3 Participants
n=5 Participants
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Sexual Orientation
Bisexual
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5 Participants
n=5 Participants
|
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Sexual Orientation
Straight/Heterosexual
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0 Participants
n=5 Participants
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Sexual Orientation
Pansexual
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1 Participants
n=5 Participants
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Sexual Orientation
Asexual
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0 Participants
n=5 Participants
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Sexual Orientation
Questioning/I don't know
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0 Participants
n=5 Participants
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Sexual Orientation
Other Sexual Orientation
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Cohen's d effect size as change from baseline thwarted belongingness scores at 3 months (0.00-0.49 small effect; 0.50-0.79 medium effect; 0.80-1.00 large effect)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=7 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
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-0.29 Cohen's d effect size
Interval -1.42 to 0.85
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PRIMARY outcome
Timeframe: Cohen's d effect size as change from baseline suicide-related internal coping scores at 3 months (0.00-0.49 small effect; 0.50-0.79 medium effect; 0.80-1.00 large effect)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=7 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
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0.67 Cohen's d effect size
Interval -0.5 to 1.83
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PRIMARY outcome
Timeframe: Cohen's d effect size as change from baseline suicide-related external coping scores at 3 months (0.00-0.49 small effect; 0.50-0.79 medium effect; 0.80-1.00 large effect)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=7 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
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0.86 Cohen's d effect size
Interval -0.32 to 2.05
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Adverse Events
Safety Planning Intervention With Navigation Services
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Planning Intervention With Navigation Services
n=9 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
Distress with increased suicidal ideation and emergency services involvement
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11.1%
1/9 • Number of events 1 • Three 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=9 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
Increased Anxiety
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11.1%
1/9 • Number of events 1 • Three 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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Social circumstances
Arrest
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11.1%
1/9 • Number of events 1 • Three 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