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Enrolling by invitation NCT07052240

Implementation of a Suicide Prevention Gatekeeper Program in the University Setting

No phase Interventional Suicide Prevention Suicide Awareness Suicide Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gatekeeper Training Program (GTK).
Who it may be relevant to
Registry conditions: Suicide Prevention, Suicide Awareness, Suicide Behavior. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

GTK-UNI: Effectiveness of a Suicide Prevention Gatekeeper Program in the University Setting

Overview

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.

Detailed description

Title: Effectiveness of a Multicenter Suicide Prevention Gatekeeper Program for Students at Spanish Universities (GTK-UNI)

Background and Rationale:

Suicide is a leading cause of death among young adults worldwide, and university students represent a particularly vulnerable population due to psychosocial, academic, and transitional stressors. Despite the growing recognition of the importance of suicide prevention, few evidence-based interventions have been adapted for university environments in Spain. Gatekeeper Training (GKT) programs are short interventions designed to equip non-specialists with the ability to recognize warning signs, intervene appropriately, and refer at-risk individuals to professional support. This project, titled GTK-UNI, aims to develop, implement, and rigorously evaluate the effectiveness of a Gatekeeper Training program adapted to Spanish university settings.

Study Objectives:

The main objective of this multicenter randomized controlled trial (RCT) is to evaluate the effectiveness of a suicide prevention Gatekeeper program delivered to university students. The program will be tested both in online and face-to-face formats to determine its utility, scalability, and long-term impact. Specific aims include:

Designing a structured and culturally relevant GKT program for university students in Spain.

Validating two measurement tools in Spanish: the Willingness to Intervene Against Suicide Enhanced Questionnaire (WISE) and the ACT as Gatekeeper questionnaire.

Implementing the program in both in-person and online formats to ensure accessibility.

Measuring the impact of the training on knowledge, attitudes, perceived control, and actual gatekeeper behaviors, with gender-stratified analyses.

Evaluating participants' adherence to and satisfaction with the program, identifying gender-related barriers and facilitators to participation.

Collecting qualitative data through focus groups to explore how gender norms influence program engagement and effectiveness.

Disseminating results to support gender-sensitive suicide prevention strategies in educational and mental health policy.

Contributing to translational research by developing a validated guide for university-level suicide prevention planning.

Methods:

This is a multicenter, two-arm, randomized controlled trial with a waitlist control group. Participants are university students (age ≥18) from multiple Spanish universities, recruited via university mailing lists, social media, student associations, and institutional partnerships. Recruitment materials clarify that the training is a suicide prevention initiative and outline the voluntary nature of participation.

Randomization and Conditions:

After providing informed consent, participants are randomly assigned to one of two groups:

Intervention group (GTK-IG): Receives the Gatekeeper Training immediately, either in online or face-to-face format, depending on their preference.

Delayed Intervention Group (GTK-DG): which will be a waitlist control during the first phase of the study and will receive the interventions after T2 (2-3 months later).

Training Format and Content:

The GTK-UNI program consists of 6 modules delivered in two 3-hour sessions over two weeks. Modules include:

Introduction to suicidal behavior and epidemiology

Recognition of warning signs and risk/protective factors

Crisis intervention and suicide first aid strategies

Safety planning and community resources

Ethics and self-care for gatekeepers

Practical evaluation and case simulation

Evaluation Timeline:

T0 (Baseline): Online survey before intervention

T1 (Post-intervention): Immediately after last session (two weeks after T0)

T2 (Follow-up): To be conducted 2 months after T1, with a booster session and focus group for GTK-GE participants scheduled approximately 2.5 months after T0.

T3 (Follow up 2): 9-12-month after T1.

After each session: Assessments will be also administered to monitor progressive skill acquisition.

Control group receives the training after T2 (approximately 2.5-3 months after T0)

Instruments:

Primary outcome measures include:

WISE Questionnaire (Aldrich \& Cerel, 2024): Measures attitudes, norms, perceived control, and intention to intervene.

ACT as Gatekeeper (Nozawa et al., 2020): Evaluates actual gatekeeper behaviors.

Secondary outcomes:

LOSS-SF (Calear et al., 2022): Assesses suicide literacy. SOSS-SF (Batterham et al., 2012): Measures stigma toward suicide. PHQ-9 (Kroenke et al., 2001): Assesses depressive symptoms. Additional variables include emotional burden, satisfaction, gender, and open-ended responses on program perception.

Interventions

  • Behavioral Gatekeeper Training Program (GTK)
    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. Pra

Primary outcome measures

  • Change in Willingness to Intervene Against Suicide (WISE) Score from Baseline to 2-Month Follow-Up [Time frame: 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 [Time frame: 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 outcome measures (7)
  • Change in Suicide Literacy Score Using LOSS-SF from Baseline to 2-Month Follow-Up [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Immediately after the training (T1): two weeks after T0.]
  • Suicidal behavior (self and others) [Time frame: 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)]
  • Intersession skill monitoring [Time frame: After each training session.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Universidad de Valencia — Valencia

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07052240 · 2024-PSILOG-3746002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗