Viewing Study NCT06629220



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06629220
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-04

Brief Title: Co-creation of Tools for Men with Suicidal Thoughts Andor Behavior
Sponsor: None
Organization: None

Study Overview

Official Title: Co-creation of Tools for Men with Suicidal Thoughts Andor Behavior
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 suicidal thoughts andor 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 andor 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 contentquestions 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None