Suicide PreventionGTK-UNINCT07052240
Implementation of a Suicide Prevention Gatekeeper Program in the University Setting
A study testing Gatekeeper Training Program (GTK) in people with Suicide Prevention and Suicide Awareness, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention, Suicide Awareness, Suicide Behavior
- What is being tested?
- Gatekeeper Training Program (GTK)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: GTK-UNI: Effectiveness of a Suicide Prevention Gatekeeper Program in the University Setting
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.
Read more
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.
Read the 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.
Rosenbertg self steem (Rosenberg, 1965) Program satisfaction and perceived utility. Ad hoc questions. Suicidal behavior (self and others). Ad hoc questions. Intersession skill monitoring: ad hoc questions.
Ethical Considerations:
The study protocol was approved by the Human Research Ethics Committee of the University of Valencia (ID: UV-INV_ETICA-3746002). The project adheres to the Declaration of Helsinki, the Madrid Declaration of the World Psychiatric Association, and national ethical standards. All participants will provide informed consent and retain the right to withdraw at any time. Data will be anonymized and securely stored, with no sharing of personal information with third parties.
If participants report emotional distress or indicate prior suicidal behavior as a motivation for joining, LIme Survey platform triggers an emergency screen with contact information for psychological services and crisis helplines. Professional referral may be offered as needed.
Sample Size and Power Calculation:
Sample size calculations were based on previous studies evaluating GTK, assuming medium effect sizes for attitudinal and self-efficacy outcomes (Cohen's d = 0.50), a power of 0.80, and α = 0.05. Allowing for an estimated attrition rate of 20-25%, the target sample size was set to ensure sufficient statistical power for mixed-model and between-group analyses. The final recruitment goal was approximately 420 participants, distributed evenly between experimental conditions.
Data Collection and Analysis:
All assessments are administered through the secure Lime Survey-UV digital platform. Quantitative data will be analyzed using SPSS v29, following CONSORT guidelines. ANOVAs, χ² tests, and mixed-effects models will be used to analyze group-by-time interactions. Model fit indices for psychometric validation will be assessed using JASP. Qualitative data from focus groups will be analyzed thematically using NVivo or ATLAS.ti.
Collaborating Institutions:
University of Basque Country UPV/EUH
The principal investigators (Dr. Sandra Pérez and Dr. Monika Salgueiro) coordinate inter-university collaboration and oversight.
- Conditions
- Suicide Prevention, Suicide Awareness, Suicide Behavior
- Being tested
- Gatekeeper Training Program (GTK)
- Keywords
- Suicide Prevention, Gatekeeper Training, University Students, Mental Health Literacy, Suicide Awareness, Stigma Reduction, Help-Seeking Behavior
- Medical subject headings
- Suicide Prevention, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatekeeper Training Program (GTK)Behavioural
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:
- Introduction to suicidal behavior.
- Warning signs and risk/protective factors.
- Crisis intervention and suicide first aid.
- Safety planning and community resources.
- Ethics and gatekeeper self-care.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The Literacy of Suicide Scale - Short Form (LOSS-SF) is a 12-item measure that assesses participants' knowledge and understanding of suicide. It evaluates four content areas: (1) causes and nature of suicide, (2) risk and protective factors, (3) warning signs, and (4) treatment and prevention. Each item is scored as correct or incorrect. Higher total scores reflect greater literacy about suicide. The study will use a Spanish version previously validated by Collado et al. (2023) and Pierantonelli et al. (2024).
Measured: 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
The Stigma of Suicide Scale - Short Form (SOSS-SF) includes 16 items measuring public attitudes toward individuals who die by suicide. Each item is a descriptor rated by the respondent and contributes to one of three subscales: (1) stigmatizing attitudes, (2) attribution of suicide to isolation or depression, and (3) normalization or glorification of suicide. Higher scores on the stigma subscale indicate more negative attitudes. A validated Spanish version will be used for this study.
Measured: 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
The PHQ-9 is a 9-item self-report questionnaire assessing depressive symptoms over the past two weeks, based on DSM-IV criteria. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. It has demonstrated good sensitivity (.87) and specificity (.88). The validated Spanish version (Diez-Quevedo et al., 2001) will be used.
Measured: 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
A single-item question assessing participants' emotional response to the training:
"To what extent did participating in the program cause you emotional distress or stress?" Responses are rated on a 5-point Likert scale from 1 (Not at all) to 5 (Very much). This item provides insight into the psychological acceptability of the intervention.
Measured: 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
A short set of self-report questions assessing participants' satisfaction and perceived utility of the training. Items include:
Global satisfaction with the training (1-10 scale). Willingness to recommend the program. Perceived preparedness to act as a gatekeeper (1-5 scale). One open-ended question on most useful aspects and suggestions for improvement.
Measured: Immediately after the training (T1): two weeks after T0.
Suicidal behavior (self and others)
Assessed through items examining personal history of suicidal ideation or attempts and exposure to suicidal behavior in close others (e.g., "Have you ever experienced suicidal thoughts?", "Has someone close to you attempted or died by suicide?"). These items were included to explore contextual and psychosocial correlates of preventive behavior, in line with the project protocol.
Measured: 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
Captured through a 12-item self-report scale assessing progressive improvement in knowledge, attitudes, self-efficacy, behavioral intention, and detection-related actions after each training session (e.g., "After today's session, I feel more capable of recognizing warning signs", "I feel more confident in initiating a conversation with someone at risk").
Measured: After each training session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start15 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial, efficacy Study
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Sandra Pérez Rodríguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052240
- Sponsor's protocol ID
- 2024-PSILOG-3746002
- Acronym
- GTK-UNI
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available after deidentification
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.
PubMed 30908123Litteken 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.
PubMed 28840363Spafford 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.
PubMed 39023720Nozawa 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.
PubMed 35471412Pierantonelli 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.
PubMed 39501547Aldrich 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.
PubMed 37349882Gould 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.
PubMed 23889494
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GTK-UNI: Effectiveness of a Suicide Prevention Gatekeeper Program in the University Setting
- ClinicalTrials.gov ID
- NCT07052240
- Acronym / sponsor ID
- GTK-UNI / 2024-PSILOG-3746002
- Conditions
- Suicide Prevention, Suicide Awareness, Suicide Behavior
- Keywords
- Suicide Prevention, Gatekeeper Training, University Students, Mental Health Literacy, Suicide Awareness, Stigma Reduction, Help-Seeking Behavior
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Rosenbertg self steem (Rosenberg, 1965) Program satisfaction and perceived utility. Ad hoc questions. Suicidal behavior (self and others). Ad hoc questions. Intersession skill monitoring: ad hoc questions.
Ethical Considerations:
The study protocol was approved by the Human Research Ethics Committee of the University of Valencia (ID: UV-INV_ETICA-3746002). The project adheres to the Declaration of Helsinki, the Madrid Declaration of the World Psychiatric Association, and national ethical standards. All participants will provide informed consent and retain the right to withdraw at any time. Data will be anonymized and securely stored, with no sharing of personal information with third parties.
If participants report emotional distress or indicate prior suicidal behavior as a motivation for joining, LIme Survey platform triggers an emergency screen with contact information for psychological services and crisis helplines. Professional referral may be offered as needed.
Sample Size and Power Calculation:
Sample size calculations were based on previous studies evaluating GTK, assuming medium effect sizes for attitudinal and self-efficacy outcomes (Cohen's d = 0.50), a power of 0.80, and α = 0.05. Allowing for an estimated attrition rate of 20-25%, the target sample size was set to ensure sufficient statistical power for mixed-model and between-group analyses. The final recruitment goal was approximately 420 participants, distributed evenly between experimental conditions.
Data Collection and Analysis:
All assessments are administered through the secure Lime Survey-UV digital platform. Quantitative data will be analyzed using SPSS v29, following CONSORT guidelines. ANOVAs, χ² tests, and mixed-effects models will be used to analyze group-by-time interactions. Model fit indices for psychometric validation will be assessed using JASP. Qualitative data from focus groups will be analyzed thematically using NVivo or ATLAS.ti.
Collaborating Institutions:
University of Basque Country UPV/EUH
The principal investigators (Dr. Sandra Pérez and Dr. Monika Salgueiro) coordinate inter-university collaboration and oversight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial, efficacy Study
| Arm | Type | Receives |
|---|---|---|
| Gatekeeper Immediate Training Group (GTK-IG) | Experimental | Behavioral: Gatekeeper Training Program (GTK)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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 |
|---|---|---|
| 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. 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. | Behavioural | Gatekeeper Immediate Training Group (GTK-IG) |
Primary outcome
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)
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.
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).
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 30908123Wolitzky-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.
- Results publication: PubMed 28840363Litteken 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.
- Results publication: PubMed 39023720Spafford 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.
- Results publication: PubMed 35471412Nozawa 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.
- Results publication: PubMed 39501547Pierantonelli 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.
- Results publication: PubMed 37349882Aldrich 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.
- Results publication: PubMed 23889494Gould 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be available after deidentification
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gatekeeper Training Program (GTK) in people with Suicide Prevention and Suicide Awareness, run by University of Valencia at 1 site in Spain.
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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 15 Jan 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
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)). The study lists 2 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 NCT07052240, which also lists 7 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 15 Jan 2026.