Implementation of a Suicide Prevention Gatekeeper Program in the University Setting

NCT07052240 | Enrolling By Invitation DMC

• 1 other identifier: 2024-PSILOG-3746002
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effectiveness of a suicide prevention training program (Gatekeepers) tailored to university students in Spain. The main questions it aims to answer are:

• Does the training program improve suicide-related knowledge, attitudes, perceived behavioral control, and gatekeeper behaviors among students?
• Are there differences in training outcomes by gender, and how do they affect program engagement and effectiveness? Researchers will compare a Immediate Intervention Group (GTK-IG), which will receive the full training immediately, with a 2) the Delayed Intervention Group (GTK-DG), which will be a waitlist control during the first phase of the study, to evaluate the program's short- and medium-term impact, using both in-person and online formats. which will be a waitlist control during the first phase of the study. Participants will:
• Be randomly assigned to the intervention or control group, choosing between in-person or online training
• Complete online surveys at three timepoints: before the program (T0), immediately after (T1), 2-3 months later (T2), and 9-12 months follow-up (T3).
• Attend two 3-hour training sessions covering key suicide prevention competencies
• Participate in a follow-up session with focus group discussion to qualitatively assess retention and use of learned skills
• Complete validated questionnaires on suicide prevention literacy, attitudes, stigma, and self-reported gatekeeper behaviors This trial includes validation of the Spanish versions of the WISE (Willingness to Intervene Against Suicide Enhanced Questionnaire) and ACT as Gatekeeper measures. The study is registered at ClinicalTrials.gov and follows CONSORT and SPIRIT guidelines. Ethical approval was granted by the Human Research Ethics Committee at the University of Valencia.

Conditions

Suicide Prevention; Suicide Awareness; Suicide Behavior

Keywords

Suicide Prevention; Gatekeeper Training; University Students; Mental Health Literacy; Suicide Awareness; Stigma Reduction; Help-Seeking Behavior

Outcome Measures

Primary Outcomes (2)

• Change in Willingness to Intervene Against Suicide (WISE) Score from Baseline to 2-Month Follow-Up

  The Willingness to Intervene Against Suicide Enhanced Questionnaire (WISE) assesses four constructs from the Theory of Planned Behavior: (1) attitudes toward intervening in suicidal behavior, (2) subjective norms, (3) perceived behavioral control, and (4) intentions to intervene. The scale consists of multiple items rated on Likert-type scales. Higher scores indicate greater willingness and preparedness to act as a suicide prevention gatekeeper. The Spanish version of the WISE will be used, following a translation and back-translation process, and will be validated within this study.

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3)

• Self-Reported Gatekeeper Behaviors Using ACT as Gatekeeper Scale from Baseline to 2-Month Follow-Up

  The ACT as Gatekeeper scale evaluates the frequency of suicide prevention behaviors performed by participants over the previous three months. It includes five core actions: (1) asking someone about suicidal thoughts or emotional distress, (2) listening empathetically to a person in distress, (3) providing relevant information, (4) referring someone to an appropriate support resource, and (5) identifying suicide warning signs. Participants rate the frequency of each behavior. Higher scores indicate greater implementation of gatekeeper behaviors. The Spanish version of the instrument, translated and back-translated by the research team, will be validated as part of this study.

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3).

Secondary Outcomes (7)

• Change in Suicide Literacy Score Using LOSS-SF from Baseline to 2-Month Follow-Up

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3).

• Change in Stigma Toward Suicide Score Using SOSS-SF from Baseline to 2-Month Follow-Up

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3)

• Change in Depressive Symptoms Using PHQ-9 from Baseline to 2-Month Follow-Up

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3)

• Self-Reported Emotional Burden After Completing Gatekeeper Training

  From baseline (T0) to T1 (2 weeks after T0), with a 2-3month follow-up at T2 (approximately 2.5 months after T0) and a follow-up at 9-12 months from T1 (T3)

• Participant Satisfaction and Perceived Preparedness After Gatekeeper Training

  Immediately after the training (T1): two weeks after T0.

Study Arms (2)

Gatekeeper Immediate Training Group (GTK-IG)

EXPERIMENTAL

Participants in this arm are university students who will receive the Gatekeeper Immediate Training (GTK-IG) during the main phase of the study, either face-to-face or online. The training includes two 3-hour sessions held one week apart, covering six structured modules: (1) Introduction to suicidal behavior (key concepts, myths, and statistics); (2) Warning signs and risk/protective factors based on the interpersonal theory of suicide; (3) Suicide crisis intervention and first aid techniques; (4) Safety planning and identification of local support resources; (5) Ethical considerations and self-care for gatekeepers; and (6) Practical skill application through simulations and discussion. Participants will complete pre- and post-intervention evaluations (T0, T1), as well as a follow-up assessment two-three months after T1 (T2), and 9-12 months after T1, followed by a booster session and a focus group to explore skill retention and real-world application.

Behavioral: Gatekeeper Training Program (GTK)

Delayed Gatekeeper Training (GTK-DG)

NO INTERVENTION

Participants in this arm will not receive any intervention during the main phase of the study. They will follow the same assessment schedule as the intervention group at three time points: before the program (T0), immediately after the intervention group completes training (T1), and two months later (T2). After completing the T2 evaluation, participants in this group will be offered the Delayeed Gatekeeper Training (GTK-DG) under the same conditions as the intervention group (face-to-face or online). This waitlist design ensures ethical access to the program while allowing for comparisons between trained and untrained participants during the primary analysis period.

Interventions

Gatekeeper Training Program (GTK) BEHAVIORAL

Behavioral: Gatekeeper Training Program (GTK-UNI) The GTK program is a suicide prevention intervention for university students. It includes two sessions of 3 hours each (total: 6 hours), delivered over one week, either face-to-face or online. Content is organized into six modules: 1. Introduction to suicidal behavior. 2. Warning signs and risk/protective factors. 3. Crisis intervention and suicide first aid. 4. Safety planning and community resources. 5. Ethics and gatekeeper self-care. 6. Practical simulations and skill application. The program includes interactive exercises, role-plays, take-home materials, and a booster session plus a focus group at the 2-month follow-up.

Gatekeeper Immediate Training Group (GTK-IG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older.
• Be currently enrolled as a university student in a Spanish university.
• Have access to the internet via personal computer, smartphone, or tablet (only applicable for participation in the online format).
• Acknowledge that the program offered is a suicide prevention training intervention.
• Provide informed consent to participate.

You may not qualify if:

• Inability to understand Spanish (the program will be delivered exclusively in Spanish).
• Inability or unwillingness to commit to attending both training sessions (regardless of whether the participant ultimately continues in the study).

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universidad de Valencia

Valencia, 46010, Spain

Location

Related Publications (7)

• Wolitzky-Taylor K, LeBeau RT, Perez M, Gong-Guy E, Fong T. Suicide prevention on college campuses: What works and what are the existing gaps? A systematic review and meta-analysis. J Am Coll Health. 2020 May-Jun;68(4):419-429. doi: 10.1080/07448481.2019.1577861. Epub 2019 Mar 25.

  PMID: 30908123 RESULT

• Litteken C, Sale E. Long-Term Effectiveness of the Question, Persuade, Refer (QPR) Suicide Prevention Gatekeeper Training Program: Lessons from Missouri. Community Ment Health J. 2018 Apr;54(3):282-292. doi: 10.1007/s10597-017-0158-z. Epub 2017 Aug 24.

  PMID: 28840363 RESULT

• Spafford SG, McWhirter Boisen MR, Tanner-Smith EE, Rodriguez G, Muruthi JR, Seeley JR. The Effects of Suicide Prevention Gatekeeper Training on Behavioral Intention and Intervention Behavior: A Systematic Review and Meta-Analysis. Prev Sci. 2024 Aug;25(6):978-988. doi: 10.1007/s11121-024-01710-w. Epub 2024 Jul 18.

  PMID: 39023720 RESULT

• Nozawa K, Ishii A, Asaoka H, Iwanaga M, Kumakura Y, Oyabu Y, Shinozaki T, Imamura K, Kawakami N, Miyamoto Y. Effectiveness of an Online Peer Gatekeeper Training Program for Postsecondary Students on Suicide Prevention in Japan: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 26;11(4):e34832. doi: 10.2196/34832.

  PMID: 35471412 RESULT

• Pierantonelli M, Mira A, Zamora A, Desdentado L, Diego-Pedro R, Gonzalez-Hernandez E, Breton-Lopez J, Garcia-Palacios A, Banos RM. Levels and Predictors of Suicide Literacy and Suicide Stigma in Spanish-Speaking Individuals. Brain Behav. 2024 Nov;14(11):e70125. doi: 10.1002/brb3.70125.

  PMID: 39501547 RESULT

• Aldrich RS, Cerel J. The Willingness to Intervene Against Suicide Enhanced Questionnaire. Health Commun. 2024 Jul;39(8):1606-1615. doi: 10.1080/10410236.2023.2227435. Epub 2023 Jun 22.

  PMID: 37349882 RESULT

• Gould MS, Cross W, Pisani AR, Munfakh JL, Kleinman M. Impact of Applied Suicide Intervention Skills Training on the National Suicide Prevention Lifeline. Suicide Life Threat Behav. 2013 Dec;43(6):676-91. doi: 10.1111/sltb.12049. Epub 2013 Jul 25.

  PMID: 23889494 RESULT

MeSH Terms

Conditions

Suicide Prevention; Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Control Trial, efficacy Study

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available immediately following publication
• Access Criteria: The data will be available to anyone who wishes to access them.

Locations

ES (1)