Trial Outcomes & Findings for Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities (NCT NCT05018143)
NCT ID: NCT05018143
Last Updated: 2025-02-17
Results Overview
The Columbia-Suicide Severity Rating Scale is an interview-rated measure that will be completed by a blind independent evaluator. The Columbia-Suicide Severity Rating Scale includes a measure of suicidal ideation (range 0-5: higher scores indicate more severe ideation). The measure has strong psychometric properties, including inter-rater reliability and internal consistency. The suicidal behavior and the suicidal ideation subscales have been shown to predict future suicidal behavior.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Change from baseline to 6 months
Results posted on
2025-02-17
Participant Flow
Recruitment occurred through a targeted social media campaign.
Participants complete the safety planning intervention prior to randomization.
Participant milestones
| Measure |
STARS
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
STARS
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
Baseline characteristics by cohort
| Measure |
STARS
n=32 Participants
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
n=32 Participants
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Continuous
|
21 Mean
STANDARD_DEVIATION 1.983 • n=32 Participants
|
21.8125 Mean
STANDARD_DEVIATION 1.595 • n=32 Participants
|
21.40 Mean
STANDARD_DEVIATION 1.83 • n=64 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=29 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
27 Participants
n=32 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
48 Participants
n=61 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
|
Sex: Female, Male
Male
|
8 Participants
n=29 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
5 Participants
n=32 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
13 Participants
n=61 Participants • One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
7 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=32 Participants
|
26 Participants
n=32 Participants
|
55 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=32 Participants
|
11 Participants
n=32 Participants
|
20 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=32 Participants
|
4 Participants
n=32 Participants
|
7 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=32 Participants
|
15 Participants
n=32 Participants
|
33 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
32 participants
n=32 Participants
|
64 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Participants with past month suicidal ideation
The Columbia-Suicide Severity Rating Scale is an interview-rated measure that will be completed by a blind independent evaluator. The Columbia-Suicide Severity Rating Scale includes a measure of suicidal ideation (range 0-5: higher scores indicate more severe ideation). The measure has strong psychometric properties, including inter-rater reliability and internal consistency. The suicidal behavior and the suicidal ideation subscales have been shown to predict future suicidal behavior.
Outcome measures
| Measure |
STARS
n=32 Participants
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
n=32 Participants
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Suicidal Ideation and Behavior
6 months
|
1.000 Mean Units on the CSSRS SI scale
Standard Deviation 1.101946
|
1.103448 Mean Units on the CSSRS SI scale
Standard Deviation 1.31868
|
|
Suicidal Ideation and Behavior
Baseline
|
2.625 Mean Units on the CSSRS SI scale
Standard Deviation .870669
|
2.34375 Mean Units on the CSSRS SI scale
Standard Deviation 1.180743
|
|
Suicidal Ideation and Behavior
2 months
|
1.37931 Mean Units on the CSSRS SI scale
Standard Deviation 1.115277
|
1.064516 Mean Units on the CSSRS SI scale
Standard Deviation .9286364
|
|
Suicidal Ideation and Behavior
4 months
|
1.37931 Mean Units on the CSSRS SI scale
Standard Deviation 1.2653
|
.8333333 Mean Units on the CSSRS SI scale
Standard Deviation 1.147211
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Participants with past month suicidal ideation
Support from family respectively, will be measured through the Procidano and Heller Perceived Social Support from Family Scale. This five-item emotional support scale is rated on a 5-point scale (1=Not True; 5=Very True), where higher scores indicate greater social support. The measure has strong convergent and divergent validity, as well a strong test-retest reliability and internal consistency.
Outcome measures
| Measure |
STARS
n=32 Participants
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
n=32 Participants
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Social Support
Baseline
|
3.42 Mean score on family support
Standard Deviation 1.14
|
3.36 Mean score on family support
Standard Deviation 1.27
|
|
Social Support
2 months
|
3.61 Mean score on family support
Standard Deviation 0.96
|
3.43 Mean score on family support
Standard Deviation 1.20
|
|
Social Support
4 months
|
3.34 Mean score on family support
Standard Deviation 0.86
|
3.2 Mean score on family support
Standard Deviation 0.92
|
|
Social Support
6 months
|
3.45 Mean score on family support
Standard Deviation 0.96
|
3.23 Mean score on family support
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Every 2 months until 6 monthsPopulation: Participants with past month suicidal ideation
Self-reported use of their safety plan
Outcome measures
| Measure |
STARS
n=32 Participants
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
n=32 Participants
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Number of Participants Who Used Their Safety Plant at Least 1 Time
2 months
|
22 Participants
|
18 Participants
|
|
Number of Participants Who Used Their Safety Plant at Least 1 Time
4 months
|
20 Participants
|
18 Participants
|
|
Number of Participants Who Used Their Safety Plant at Least 1 Time
6 months
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Participants with past month suicidal ideation
Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation.
Outcome measures
| Measure |
STARS
n=32 Participants
The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.
STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
|
Control Condition
n=32 Participants
The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.
Control condition: In this intervention, participants will receive the safety planning intervention.
|
|---|---|---|
|
Beck Scale for Suicide Ideation
4 months
|
5.48 Score on the scale
Standard Deviation 5.70
|
5.15 Score on the scale
Standard Deviation 5.68
|
|
Beck Scale for Suicide Ideation
6 months
|
4.15 Score on the scale
Standard Deviation 5.48
|
5.88 Score on the scale
Standard Deviation 7.20
|
|
Beck Scale for Suicide Ideation
Baseline
|
7.41 Score on the scale
Standard Deviation 6.30
|
7.56 Score on the scale
Standard Deviation 7.41
|
|
Beck Scale for Suicide Ideation
2 months
|
5.79 Score on the scale
Standard Deviation 5.79
|
6.10 Score on the scale
Standard Deviation 6.96
|
Adverse Events
STARS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place