Suicide
Conditions
Keywords
Sexual minority, Suicide, Emerging adults
Brief summary
Emerging adult sexual minorities (EASM) are vulnerable to stressors that increase risk for suicidal ideation and behaviors. The investigators will examine a mobile application that leverages skills coaching and peer mentoring to reduce suicide risk for EASM. The online life skills intervention (iREACH) was developed to reduce a variety of negative health outcomes using telehealth with peer mentors. In Supporting Transitions to Adulthood and Reducing Suicide (STARS), investigators' interdisciplinary team will adapt iREACH to reduce suicidal ideation and behaviors among EASM. Then, investigators will pilot test STARS using in a racially/ethnically diverse sample of EASM with suicidal ideation. Participants will be randomized to receive an in-person brief, evidence-based safety planning protocol or to receive safety planning plus access to STARS. This project will identify the potential clinical utility of STARS for suicide prevention in a vulnerable, marginalized, population to inform a future larger efficacy RCT.
Detailed description
Investigators will use the ADAPT-ITT framework to adapt a life skills intervention to increase the desire to live and reduce suicide ideation among at-risk emerging adult sexual minorities. STARS will embed components of the Safety Plan Intervention as well as modules focused on promoting coping with discrimination, social support, and positive affect. Investigators will pilot test STARS using a Type 1 Effectiveness-Implementation Hybrid Design in a racially/ethnically diverse sample of 60 EASM who report past-month suicidal ideation. Investigators will recruit EASM through social media advertising and invite them to an in-person screening. Eligible participants will provide informed consent and complete a Safety Planning Intervention with a licensed clinician, given the high-risk nature of the sample. They then will be randomized to the control condition (CC, n = 30) or STARS (n = 30). Participants will be assessed at 2, 4, and 6 months. Primary outcomes will be preliminary efficacy outcomes of suicidal ideation and behavior and hypothesized mechanisms of change (improved coping with discrimination, social support, positive affect) to estimate critical parameters for a future trial. Secondary outcomes will be RE-AIM framework indicators (reach, adoption, implementation, maintenance). Our aims are: Aim 1: To conduct a systematic suicide prevention adaptation of a life skills intervention (STARS) that incorporates safety planning content and targets coping, social support, and positive affect using the ADAPT-ITT framework. Aim 2: To examine preliminary efficacy (suicidal ideation and behaviors) and mechanisms of action of STARS, relative to our control condition (safety planning protocol alone), using a prospective RCT design. Aim 3: Using RE-AIM metrics, to examine whether STARS has preliminary evidence for impacting intervention implementation outcomes among EASM compared to the control arm.
Interventions
BEHAVIORALSTARS
This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
BEHAVIORALControl condition
In this intervention, participants will receive the safety planning intervention.
Sponsors
National Institute of Mental Health (NIMH)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes evaluator will be blinded to randomization.
Intervention model description
The investigators will adapt a life skills intervention to increase the desire to live and reduce suicide ideation among at-risk emerging adult sexual minorities (EASM). STARS will embed components of the Safety Plan Intervention and modules to promote coping with discrimination, social support, and positive affect. We will pilot test STARS in a racially/ethnically diverse sample of 60 EASM who report past-month suicidal ideation. Eligible participants will provide informed consent and complete a Safety Planning Intervention with a licensed clinician. They then will be randomized to the control condition (CC, n = 30) or STARS (n = 30). The investigators will follow participants for 6 months, with evaluations at 2, 4, and 6 months. Primary outcomes will be preliminary efficacy outcomes of suicidal ideation and behavior and hypothesized mechanisms of change (improved coping with discrimination, social support, positive affect) to estimate critical parameters for a future trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
1. Identifies as a sexual minority 2. Lives in the Philadelphia Metropolitan Area; 3. Report suicide ideation in the prior month as verified in clinical interview; 4. Is aged 18-24 years (inclusive) 5. Daily use of a smartphone 6. Does not plan to move out of the region for the next 6 months 7. Consents to the study procedures
Exclusion criteria
1. Does not live in the Philadelphia Metropolitan Area; 2. Does not meet clinical criteria for suicide ideation in the prior month; 3. Is not between the ages of 18-24 years (inclusive) 4. Does not own a smartphone 5. Plan to move out of the region for the next 6 months 6. Does not consent to study procedures 7. Meets criteria for an unmanaged psychotic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Ideation and Behavior | Change from baseline to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support | Change from baseline to 6 months | 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. |
| Number of Participants Who Used Their Safety Plant at Least 1 Time | Every 2 months until 6 months | Self-reported use of their safety plan |
| Beck Scale for Suicide Ideation | Change from baseline to 6 months | Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred through a targeted social media campaign.
Pre-assignment details
Participants complete the safety planning intervention prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | STARS | Control Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 32 Participants | 64 Participants |
| Age, Continuous | 21 Mean STANDARD_DEVIATION 1.983 | 21.8125 Mean STANDARD_DEVIATION 1.595 | 21.40 Mean STANDARD_DEVIATION 1.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 26 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 15 Participants | 33 Participants |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 21 Participants | 27 Participants | 48 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Suicidal Ideation and Behavior
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.
Time frame: Change from baseline to 6 months
Population: Participants with past month suicidal ideation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STARS | Suicidal Ideation and Behavior | Baseline | 2.625 Mean Units on the CSSRS SI scale | Standard Deviation 0.870669 |
| STARS | Suicidal Ideation and Behavior | 2 months | 1.37931 Mean Units on the CSSRS SI scale | Standard Deviation 1.115277 |
| STARS | Suicidal Ideation and Behavior | 4 months | 1.37931 Mean Units on the CSSRS SI scale | Standard Deviation 1.2653 |
| STARS | Suicidal Ideation and Behavior | 6 months | 1.000 Mean Units on the CSSRS SI scale | Standard Deviation 1.101946 |
| Control Condition | Suicidal Ideation and Behavior | 6 months | 1.103448 Mean Units on the CSSRS SI scale | Standard Deviation 1.31868 |
| Control Condition | Suicidal Ideation and Behavior | Baseline | 2.34375 Mean Units on the CSSRS SI scale | Standard Deviation 1.180743 |
| Control Condition | Suicidal Ideation and Behavior | 4 months | .8333333 Mean Units on the CSSRS SI scale | Standard Deviation 1.147211 |
| Control Condition | Suicidal Ideation and Behavior | 2 months | 1.064516 Mean Units on the CSSRS SI scale | Standard Deviation 0.9286364 |
Secondary
Beck Scale for Suicide Ideation
Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation.
Time frame: Change from baseline to 6 months
Population: Participants with past month suicidal ideation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STARS | Beck Scale for Suicide Ideation | Baseline | 7.41 Score on the scale | Standard Deviation 6.3 |
| STARS | Beck Scale for Suicide Ideation | 2 months | 5.79 Score on the scale | Standard Deviation 5.79 |
| STARS | Beck Scale for Suicide Ideation | 4 months | 5.48 Score on the scale | Standard Deviation 5.7 |
| STARS | Beck Scale for Suicide Ideation | 6 months | 4.15 Score on the scale | Standard Deviation 5.48 |
| Control Condition | Beck Scale for Suicide Ideation | 6 months | 5.88 Score on the scale | Standard Deviation 7.2 |
| Control Condition | Beck Scale for Suicide Ideation | Baseline | 7.56 Score on the scale | Standard Deviation 7.41 |
| Control Condition | Beck Scale for Suicide Ideation | 4 months | 5.15 Score on the scale | Standard Deviation 5.68 |
| Control Condition | Beck Scale for Suicide Ideation | 2 months | 6.10 Score on the scale | Standard Deviation 6.96 |
Secondary
Number of Participants Who Used Their Safety Plant at Least 1 Time
Self-reported use of their safety plan
Time frame: Every 2 months until 6 months
Population: Participants with past month suicidal ideation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STARS | Number of Participants Who Used Their Safety Plant at Least 1 Time | 2 months | 22 Participants |
| STARS | Number of Participants Who Used Their Safety Plant at Least 1 Time | 4 months | 20 Participants |
| STARS | Number of Participants Who Used Their Safety Plant at Least 1 Time | 6 months | 14 Participants |
| Control Condition | Number of Participants Who Used Their Safety Plant at Least 1 Time | 2 months | 18 Participants |
| Control Condition | Number of Participants Who Used Their Safety Plant at Least 1 Time | 4 months | 18 Participants |
| Control Condition | Number of Participants Who Used Their Safety Plant at Least 1 Time | 6 months | 11 Participants |
Secondary
Social Support
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.
Time frame: Change from baseline to 6 months
Population: Participants with past month suicidal ideation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STARS | Social Support | Baseline | 3.42 Mean score on family support | Standard Deviation 1.14 |
| STARS | Social Support | 2 months | 3.61 Mean score on family support | Standard Deviation 0.96 |
| STARS | Social Support | 4 months | 3.34 Mean score on family support | Standard Deviation 0.86 |
| STARS | Social Support | 6 months | 3.45 Mean score on family support | Standard Deviation 0.96 |
| Control Condition | Social Support | 6 months | 3.23 Mean score on family support | Standard Deviation 1.19 |
| Control Condition | Social Support | Baseline | 3.36 Mean score on family support | Standard Deviation 1.27 |
| Control Condition | Social Support | 4 months | 3.2 Mean score on family support | Standard Deviation 0.92 |
| Control Condition | Social Support | 2 months | 3.43 Mean score on family support | Standard Deviation 1.2 |