NCT04757649

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 3, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

February 11, 2021

Results QC Date

February 23, 2023

Last Update Submit

January 26, 2024

Conditions

Suicide

Keywords

Sexual and gender minority youthPatient NavigationSafety Planning InterventionPrevention

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    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)

Study Arms (1)

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).

Behavioral: Safety Planning Intervention with Navigation Services

Interventions

Safety Planning Intervention with Navigation ServicesBEHAVIORAL

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).

Also known as: PN+SPI Intervention
Safety Planning Intervention with Navigation Services

Eligibility Criteria

Age15 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentify 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with immediate intention to attempt suicide will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (10)

  • 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.

    PMID: 28903161BACKGROUND

  • Ivey-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.

    PMID: 28981481BACKGROUND

  • Shepard 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.

    PMID: 26511788BACKGROUND

  • Institute 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/

    PMID: 22013611BACKGROUND

  • Kann 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.

    PMID: 29902162BACKGROUND

  • Miranda-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.

    PMID: 28254960BACKGROUND

  • Stanley 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.

    PMID: 29998307BACKGROUND

  • Labouliere 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.

    PMID: 31112330BACKGROUND

  • Cramer 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.

    PMID: 29062296BACKGROUND

  • van 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.

    PMID: 40179218DERIVED

MeSH Terms

Conditions

SuicideCoitus

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorSexual Behavior

Limitations and Caveats

The study was conducted to assess the feasibility and acceptability of a newly developed suicide prevention intervention. By design, the quantitative outcome measurement was not sufficiently powered to evaluate preliminary efficacy and/or mechanistic target engagement.

Results Point of Contact

Title
Dr. Aaron Blashill
Organization
San Diego State University
ajblashill@sdsu.edu
619-594-2245

Study Officials

  • Aaron J Blashill

    San Diego State University

    PRINCIPAL INVESTIGATOR

  • Kristen J Wells

    San Diego State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

May 13, 2021

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

January 29, 2024

Results First Posted

May 3, 2023

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)