Implementation of a Suicide Prevention Gatekeeper Program in the University Setting

Sponsor
University of Valencia
Study ID
NCT07052240
Status
Enrolling By Invitation

Conditions

  • Suicide Awareness
  • Suicide Behavior
  • Suicide Prevention

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jul 4, 2025
Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Gatekeeper Immediate Training Group (GTK-IG)
    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.
  • No Intervention: Delayed Gatekeeper Training (GTK-DG)
    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.

Primary Outcome Measure

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) ]

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