SuicideNCT04757649
Suicide Prevention for Sexual and Gender Minority Youth (Case Series)
A study testing Safety Planning Intervention with Navigation Services in people with Suicide, run by San Diego State University at 1 site in United States.
Trial 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, a case series trial will be conducted to test the feasibility and acceptability of the intervention and study methods. Read more about this study
- Who is it for?
- Ages 15 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Safety Planning Intervention with Navigation Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15 to 29 years
- 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
- Resides in San Diego County, California
- Speaks English
- Is willing and able to provide informed consent
- Reports suicidal ideation over the past two weeks, as indicated by the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version
- Reports a lifetime history of one or more suicide attempts
Who cannot join
- Individuals with immediate intention to attempt suicide will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
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, a case series trial will be conducted to test the feasibility and acceptability of the intervention and study methods.
Read the 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 case series trial (N = 9), feasibility and acceptability of the PN+ SPI intervention will be assessed.
- Conditions
- Suicide
- Being tested
- Safety Planning Intervention with Navigation Services
- Keywords
- Sexual and gender minority youth, Patient Navigation, Safety Planning Intervention, Prevention
- Medical subject headings
- Suicide, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning Intervention with Navigation ServicesBehavioural
Also called PN+SPI Intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention with Navigation Services | Experimental | 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). Receives: Behavioral: Safety Planning Intervention with Navigation Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start13 May 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 and 3-month follow-up, participants will be asked to complete measures of suicidal coping and thwarted belongingness. At the 3-month follow-up, satisfaction with mental health services and satisfaction with interpersonal relationship with patient navigator will be assessed.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Aaron Blashill, San Diego State University
- Investigators
- Aaron J Blashill, Principal investigator, San Diego State UniversityKristen J Wells, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757649
- Sponsor's protocol ID
- HS-2020-0076 (1)
- Other IDs
- 1R61MH120236-01
- Status last verified
- Jan 2024
- First submitted
- 11 Feb 2021
- Last updated
- 29 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olfson M, Blanco C, Wall M, Liu SM, Saha TD, Pickering RP, Grant BF. National Trends in Suicide Attempts Among Adults in the United States. JAMA Psychiatry. 2017 Nov 1;74(11):1095-1103. doi: 10.1001/jamapsychiatry.2017.2582.
PubMed 28903161Ivey-Stephenson AZ, Crosby AE, Jack SPD, Haileyesus T, Kresnow-Sedacca MJ. Suicide Trends Among and Within Urbanization Levels by Sex, Race/Ethnicity, Age Group, and Mechanism of Death - United States, 2001-2015. MMWR Surveill Summ. 2017 Oct 6;66(18):1-16. doi: 10.15585/mmwr.ss6618a1.
PubMed 28981481Shepard DS, Gurewich D, Lwin AK, Reed GA Jr, Silverman MM. Suicide and Suicidal Attempts in the United States: Costs and Policy Implications. Suicide Life Threat Behav. 2016 Jun;46(3):352-62. doi: 10.1111/sltb.12225. Epub 2015 Oct 29.
PubMed 26511788Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/
PubMed 22013611Kann L, McManus T, Harris WA, Shanklin SL, Flint KH, Queen B, Lowry R, Chyen D, Whittle L, Thornton J, Lim C, Bradford D, Yamakawa Y, Leon M, Brener N, Ethier KA. Youth Risk Behavior Surveillance - United States, 2017. MMWR Surveill Summ. 2018 Jun 15;67(8):1-114. doi: 10.15585/mmwr.ss6708a1.
PubMed 29902162Miranda-Mendizabal A, Castellvi P, Pares-Badell O, Almenara J, Alonso I, Blasco MJ, Cebria A, Gabilondo A, Gili M, Lagares C, Piqueras JA, Roca M, Rodriguez-Marin J, Rodriguez-Jimenez T, Soto-Sanz V, Vilagut G, Alonso J. Sexual orientation and suicidal behaviour in adolescents and young adults: systematic review and meta-analysis. Br J Psychiatry. 2017 Aug;211(2):77-87. doi: 10.1192/bjp.bp.116.196345. Epub 2017 Mar 2.
PubMed 28254960Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.
PubMed 29998307Labouliere CD, Stanley B, Lake AM, Gould MS. Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. Suicide Life Threat Behav. 2020 Feb;50(1):29-41. doi: 10.1111/sltb.12554. Epub 2019 May 21.
PubMed 31112330Cramer RJ, Kapusta ND. A Social-Ecological Framework of Theory, Assessment, and Prevention of Suicide. Front Psychol. 2017 Oct 9;8:1756. doi: 10.3389/fpsyg.2017.01756. eCollection 2017.
PubMed 29062296van der Star A, Randall A, Salgin L, Brady JP, Albright C, Mitzner J, Alexander J, Williams K, Weersing VR, Calzo JP, Rojas SA, Ramers CB, Wells KJ, Blashill AJ. Development of a Suicide Prevention Intervention for Sexual and Gender Minority Youth and Young Adults: Rationale, Design, and Evidence of Feasibility and Acceptability. Suicide Life Threat Behav. 2025 Apr;55(2):e70014. doi: 10.1111/sltb.70014.
PubMed 40179218
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention for Sexual and Gender Minority Youth (Case Series)
- ClinicalTrials.gov ID
- NCT04757649
- Acronym / sponsor ID
- HS-2020-0076 (1)
- Conditions
- Suicide
- Keywords
- Sexual and gender minority youth, Patient Navigation, Safety Planning Intervention, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, a case series trial will be conducted to test the feasibility and acceptability of the intervention and study methods.
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 case series trial (N = 9), feasibility and acceptability of the PN+ SPI intervention will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 and 3-month follow-up, participants will be asked to complete measures of suicidal coping and thwarted belongingness. At the 3-month follow-up, satisfaction with mental health services and satisfaction with interpersonal relationship with patient navigator will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention with Navigation Services | Experimental | Behavioral: Safety Planning Intervention with Navigation ServicesA 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). |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 15 to 29 years
- 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
- Resides in San Diego County, California
- Speaks English
- Is willing and able to provide informed consent
Key exclusion criteria (1 listed)
- Individuals with immediate intention to attempt suicide will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Planning Intervention with Navigation ServicesAlso: PN+SPI InterventionA 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). | Behavioural | Safety Planning Intervention with Navigation Services |
Primary outcome
The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness
Time frame: 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)
Suicide-Related Coping Scale (SRCS) - Internal Coping Skills
Time frame: 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)
Suicide-Related Coping Scale (SRCS) - External Coping Skills
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28903161Olfson M, Blanco C, Wall M, Liu SM, Saha TD, Pickering RP, Grant BF. National Trends in Suicide Attempts Among Adults in the United States. JAMA Psychiatry. 2017 Nov 1;74(11):1095-1103. doi: 10.1001/jamapsychiatry.2017.2582.
- Background: PubMed 28981481Ivey-Stephenson AZ, Crosby AE, Jack SPD, Haileyesus T, Kresnow-Sedacca MJ. Suicide Trends Among and Within Urbanization Levels by Sex, Race/Ethnicity, Age Group, and Mechanism of Death - United States, 2001-2015. MMWR Surveill Summ. 2017 Oct 6;66(18):1-16. doi: 10.15585/mmwr.ss6618a1.
- Background: PubMed 26511788Shepard DS, Gurewich D, Lwin AK, Reed GA Jr, Silverman MM. Suicide and Suicidal Attempts in the United States: Costs and Policy Implications. Suicide Life Threat Behav. 2016 Jun;46(3):352-62. doi: 10.1111/sltb.12225. Epub 2015 Oct 29.
- Background: PubMed 22013611Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/
- Background: PubMed 29902162Kann L, McManus T, Harris WA, Shanklin SL, Flint KH, Queen B, Lowry R, Chyen D, Whittle L, Thornton J, Lim C, Bradford D, Yamakawa Y, Leon M, Brener N, Ethier KA. Youth Risk Behavior Surveillance - United States, 2017. MMWR Surveill Summ. 2018 Jun 15;67(8):1-114. doi: 10.15585/mmwr.ss6708a1.
- Background: PubMed 28254960Miranda-Mendizabal A, Castellvi P, Pares-Badell O, Almenara J, Alonso I, Blasco MJ, Cebria A, Gabilondo A, Gili M, Lagares C, Piqueras JA, Roca M, Rodriguez-Marin J, Rodriguez-Jimenez T, Soto-Sanz V, Vilagut G, Alonso J. Sexual orientation and suicidal behaviour in adolescents and young adults: systematic review and meta-analysis. Br J Psychiatry. 2017 Aug;211(2):77-87. doi: 10.1192/bjp.bp.116.196345. Epub 2017 Mar 2.
- Background: PubMed 29998307Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.
- Background: PubMed 31112330Labouliere CD, Stanley B, Lake AM, Gould MS. Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. Suicide Life Threat Behav. 2020 Feb;50(1):29-41. doi: 10.1111/sltb.12554. Epub 2019 May 21.
- Background: PubMed 29062296Cramer RJ, Kapusta ND. A Social-Ecological Framework of Theory, Assessment, and Prevention of Suicide. Front Psychol. 2017 Oct 9;8:1756. doi: 10.3389/fpsyg.2017.01756. eCollection 2017.
- Derived from this study: PubMed 40179218van der Star A, Randall A, Salgin L, Brady JP, Albright C, Mitzner J, Alexander J, Williams K, Weersing VR, Calzo JP, Rojas SA, Ramers CB, Wells KJ, Blashill AJ. Development of a Suicide Prevention Intervention for Sexual and Gender Minority Youth and Young Adults: Rationale, Design, and Evidence of Feasibility and Acceptability. Suicide Life Threat Behav. 2025 Apr;55(2):e70014. doi: 10.1111/sltb.70014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron J Blashill principal investigator
San Diego State University
Kristen J Wells principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning Intervention with Navigation Services in people with Suicide, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757649, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.