Suicide PreventionNCT06629220
Co-creation of Tools for Men With Suicidal Thoughts and/or Behavior
A study testing Tools in people with Suicide Prevention and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
Trial summary
The primary objective of this project is to co-create suicide prevention tools for men with suicidal thoughts ensuring these tools are supported by their future users. The researchers will organize up to 10 online or live co-creation meetings of maximum 2 hours each in which men (18 years or older) with a history of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviour
- What is being tested?
- Tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men (≥ 18y/o)
- Experienced suicidal thoughts in the past three year
Who cannot join
- Limited comprehension
- Acute suicidality (as evaluated by a clinical psychologist of the research team)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Flemish Centre of Expertise in Suicide Prevention, Ghent University
Ghent, 9000
About this study
The primary objective of this project is to co-create suicide prevention tools for men with suicidal thoughts ensuring these tools are supported by their future users. The researchers will organize up to 10 online or live co-creation meetings of maximum 2 hours each in which men (18 years or older) with a history of suicidal thoughts and/or behavior will help develop tools by providing their needs and feedback. Up to 30 men can participate.
Read the detailed description
Approximately three out of four people who die by suicide are men. Suicide is a complex phenomenon, which cannot be explained by a single factor, but rather is a result of a variety of neuro-biological, psychological and social risk factors.
Considering the difference in suicide risk between men and women, researchers have tried to identify risk factors specific to men, which might contribute to the increased suicide risk. Differences in help-seeking behavior and received help have repeatedly been put forward as being one of these factors as men are less likely to seek help and have a higher drop-out rate once having started interventions.
A currently ongoing study (BUN: B6702024000090) focuses on mapping out these needs and barriers among adult men with suicidal thoughts and their healthcare providers.
The next step is to develop tools that meet the indicated needs and facilitate help-seeking and (continuous) help-receiving among men with suicidal thoughts and behavior. To develop these tools a co-creation process will be used, where men with a history of suicidal thoughts will be involved. Using the input of future users of tools is crucial. The investigators want to ensure that the developed tools are user-friendly for future users so that the barriers of using them remain as low as possible. The investigators want to do this by adapting the used language and layout to the preferences of our future users. In addition, the investigators want to ensure that the content in the tools is relevant and understandable for everyone. The investigators also aim to develop tools that appeal to a diverse group of users.
It is therefore crucial that the people who will use the tools are involved in their creation and design to suit their needs and use valuable experiential knowledge (Boyle, 2007; Hanlon et al., 2022; Watling et al., 2020). This is also called participatory co-creation. It means that men with a history of suicidal thoughts are at the center of the decision about how the tools should look. Additionally, experts on healthcare and masculinity, as well as international research literature will be consulted.
The primary objective of this project is to co-create suicide prevention tools for men with suicidal thoughts ensuring these tools are supported by their future users.
This will be done by maximum 10 live or online co-creation meetings with men (18 years or older) who experienced suicidal thoughts and/or behaviors in the past 3 years. The co-creation meetings will take place in groups with a maximum of 10 participants. Participants can participate in a minimum of 1 and a maximum of 10 co-creation meetings. The meetings will last a maximum of 2 hours. The co-creation meetings will be supervised and carried out by the Flemish Center of Expertise in Suicide prevention researchers.
If participants feel that participating in group is too much of a barrier, the investigators offer the possibility to have a one-on-one interview with the same content/questions. This exception allows us to gain information from all interested participants without excluding individuals due to their unwillingness or inability to participate in group. At the meeting, two researchers will be present and possibly people specialized in developing tools. The tools are developed in consultation with the developer, Flemish Center of Expertise in Suicide Prevention researchers, experts in the field and men with a history of suicidal thoughts.
After expressing interest to participate, participants will be contacted by telephone by one of the researchers to provide more information about the co-creation meetings and to answer any questions. During this phone call, a researcher (clinical psychologist) will evaluate the exclusion criteria. If the participant is interested in participating in the co-creation meetings and is eligible for participation, they will be asked to provide informed consent online. After providing consent, they will be asked to complete a short online background questionnaire on demographic characteristics because the researchers would like to ensure diversity and cultural and social aspects are considered in the tool development. The participants in the co-creation meetings must therefore be a representative group of the intended population. The participant will then receive the invitation to the meetings by email or text message.
- Conditions
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviour
- Being tested
- Tools
- Keywords
- co-creation, participatory research, men, suicide prevention, suicidal ideation, male health
- Medical subject headings
- Suicide Prevention, Suicidal Ideation, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToolsOther
In the co-creation meetings, developed tools will be presented. Participants will be asked to provide feedback and input to tailor these tools to the needs and preferences of men with suicidal thoughts/behavior.
| Study group | Role | What they receive |
|---|---|---|
| Co-creation meetings | Other | All participants will be invited to participate in the co-creation meetings. Receives: Other: Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-creation questions
During the meetings, participants will be asked to provide feedback on developed tools and drafts (open questions). Here are some topics and questions the researchers will consider during the meetings:
- Current healthcare/tools usage
- Preferences and needs (this will be mainly based on the results of our previous study, BUN B6702024000090)
- Accessibility and usability of the tool
- Privacy and confidentiality
- Social support and sensitivity
- Help and professional support
- Continuity and long-term implementation
- Feedback on prototypes of the tool
- Feedback on final version of the tool
Measured: From enrolment to end of co-creation sessions (10 sessions of 2 hours max over the course of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start10 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629220
- Sponsor's protocol ID
- ONZ-2024-0366
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boyle, E. (2007),
Hanlon CA, McIlroy D, Poole H, Chopra J, Saini P. Evaluating the role and effectiveness of co-produced community-based mental health interventions that aim to reduce suicide among adults: A systematic review. Health Expect. 2023 Feb;26(1):64-86. doi: 10.1111/hex.13661. Epub 2022 Nov 14.
PubMed 36377305Watling D, Preece M, Hawgood J, Bloomfield S, Kolves K. Developing an Intervention for Suicide Prevention: A Rapid Review of Lived Experience Involvement. Arch Suicide Res. 2022 Apr-Jun;26(2):465-480. doi: 10.1080/13811118.2020.1833799. Epub 2020 Oct 18.
PubMed 33073734
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-creation of Tools for Men With Suicidal Thoughts and/or Behavior
- ClinicalTrials.gov ID
- NCT06629220
- Acronym / sponsor ID
- ONZ-2024-0366
- Conditions
- Suicide Prevention, Suicidal Ideation, Suicidal Behaviour
- Keywords
- co-creation, participatory research, men, suicide prevention, suicidal ideation, male health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Oct 2024 (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 primary objective of this project is to co-create suicide prevention tools for men with suicidal thoughts ensuring these tools are supported by their future users. The researchers will organize up to 10 online or live co-creation meetings of maximum 2 hours each in which men (18 years or older) with a history of suicidal thoughts and/or behavior will help develop tools by providing their needs and feedback. Up to 30 men can participate.
Detailed description
Approximately three out of four people who die by suicide are men. Suicide is a complex phenomenon, which cannot be explained by a single factor, but rather is a result of a variety of neuro-biological, psychological and social risk factors.
Considering the difference in suicide risk between men and women, researchers have tried to identify risk factors specific to men, which might contribute to the increased suicide risk. Differences in help-seeking behavior and received help have repeatedly been put forward as being one of these factors as men are less likely to seek help and have a higher drop-out rate once having started interventions.
A currently ongoing study (BUN: B6702024000090) focuses on mapping out these needs and barriers among adult men with suicidal thoughts and their healthcare providers.
The next step is to develop tools that meet the indicated needs and facilitate help-seeking and (continuous) help-receiving among men with suicidal thoughts and behavior. To develop these tools a co-creation process will be used, where men with a history of suicidal thoughts will be involved. Using the input of future users of tools is crucial. The investigators want to ensure that the developed tools are user-friendly for future users so that the barriers of using them remain as low as possible. The investigators want to do this by adapting the used language and layout to the preferences of our future users. In addition, the investigators want to ensure that the content in the tools is relevant and understandable for everyone. The investigators also aim to develop tools that appeal to a diverse group of users.
It is therefore crucial that the people who will use the tools are involved in their creation and design to suit their needs and use valuable experiential knowledge (Boyle, 2007; Hanlon et al., 2022; Watling et al., 2020). This is also called participatory co-creation. It means that men with a history of suicidal thoughts are at the center of the decision about how the tools should look. Additionally, experts on healthcare and masculinity, as well as international research literature will be consulted.
The primary objective of this project is to co-create suicide prevention tools for men with suicidal thoughts ensuring these tools are supported by their future users.
This will be done by maximum 10 live or online co-creation meetings with men (18 years or older) who experienced suicidal thoughts and/or behaviors in the past 3 years. The co-creation meetings will take place in groups with a maximum of 10 participants. Participants can participate in a minimum of 1 and a maximum of 10 co-creation meetings. The meetings will last a maximum of 2 hours. The co-creation meetings will be supervised and carried out by the Flemish Center of Expertise in Suicide prevention researchers.
If participants feel that participating in group is too much of a barrier, the investigators offer the possibility to have a one-on-one interview with the same content/questions. This exception allows us to gain information from all interested participants without excluding individuals due to their unwillingness or inability to participate in group. At the meeting, two researchers will be present and possibly people specialized in developing tools. The tools are developed in consultation with the developer, Flemish Center of Expertise in Suicide Prevention researchers, experts in the field and men with a history of suicidal thoughts.
After expressing interest to participate, participants will be contacted by telephone by one of the researchers to provide more information about the co-creation meetings and to answer any questions. During this phone call, a researcher (clinical psychologist) will evaluate the exclusion criteria. If the participant is interested in participating in the co-creation meetings and is eligible for participation, they will be asked to provide informed consent online. After providing consent, they will be asked to complete a short online background questionnaire on demographic characteristics because the researchers would like to ensure diversity and cultural and social aspects are considered in the tool development. The participants in the co-creation meetings must therefore be a representative group of the intended population. The participant will then receive the invitation to the meetings by email or text message.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co-creation meetings | Other | Other: ToolsAll participants will be invited to participate in the co-creation meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men (≥ 18y/o)
- Experienced suicidal thoughts in the past three year
Key exclusion criteria (2 listed)
- Limited comprehension
- Acute suicidality (as evaluated by a clinical psychologist of the research team)
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 |
|---|---|---|
| ToolsIn the co-creation meetings, developed tools will be presented. Participants will be asked to provide feedback and input to tailor these tools to the needs and preferences of men with suicidal thoughts/behavior. | Other | Co-creation meetings |
Primary outcome
Co-creation questions
Time frame: From enrolment to end of co-creation sessions (10 sessions of 2 hours max over the course of the study)
During the meetings, participants will be asked to provide feedback on developed tools and drafts (open questions). Here are some topics and questions the researchers will consider during the meetings: 1. Current healthcare/tools usage 2. Preferences and needs (this will be mainly based on the results of our previous study, BUN B6702024000090) 3. Accessibility and usability of the tool 4. Privacy and confidentiality 5. Social support and sensitivity 6. Help and professional support 7. Continuity and long-term implementation 8. Feedback on prototypes of the tool 9. Feedback on final version of the tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- BackgroundBoyle, E. (2007),
- Background: PubMed 36377305Hanlon CA, McIlroy D, Poole H, Chopra J, Saini P. Evaluating the role and effectiveness of co-produced community-based mental health interventions that aim to reduce suicide among adults: A systematic review. Health Expect. 2023 Feb;26(1):64-86. doi: 10.1111/hex.13661. Epub 2022 Nov 14.
- Background: PubMed 33073734Watling D, Preece M, Hawgood J, Bloomfield S, Kolves K. Developing an Intervention for Suicide Prevention: A Rapid Review of Lived Experience Involvement. Arch Suicide Res. 2022 Apr-Jun;26(2):465-480. doi: 10.1080/13811118.2020.1833799. Epub 2020 Oct 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gwendolyn Portzky, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tools in people with Suicide Prevention and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 14 Apr 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Co-creation questions (time frame: From enrolment to end of co-creation sessions (10 sessions of 2 hours max over the course of the study)). 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 NCT06629220, which also lists 3 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 14 Apr 2026.