Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 5:24 AM
Study NCT ID:
NCT06629220
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2024-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-creation of Tools for Men With Suicidal Thoughts and/or Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Socio-demographic characteristics: gender', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'gender \\[male, female, non-binary, other\\]'}, {'measure': 'Socio-demographic characteristics: age', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'age \\[open\\]'}, {'measure': 'Socio-demographic characteristics: history of suicidal ideation', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'previous suicidal thoughts \\[never; more than 3 years ago, 1-3 years ago, in the past year\\]'}, {'measure': 'Socio-demographic characteristics: education level', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'education \\[no degree, primary education, secondary education, higher education non-university, higher education university\\]'}, {'measure': 'Socio-demographic characteristics: employment status', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'employment status \\[student, mainly employed, mainly self-employed, mainly houseman; looking for work, incapacitated, retired\\]'}, {'measure': 'Socio-demographic characteristics: sexual orientation', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'sexual orientation \\[heterosexual, homosexual, bisexual, asexual, other, prefer not to say, dont know\\]'}, {'measure': 'Socio-demographic characteristics: relationship status', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'relationship status \\[single, in relationship, married/cohabitant, separated, divorced, widowed\\]'}, {'measure': 'Socio-demographic characteristics: living situation', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'living situation \\[alone, with partner, with children, with parents, with others, other - multiple options possible\\]'}, {'measure': 'Socio-demographic characteristics: cultural background', 'timeFrame': "Baseline. Completing the entire 'socio-demographic characteristics questionnaire' will take about 5 minutes", 'description': 'cultural background \\[Belgian background, Western migration background, non-Western migration background, other\\]'}], 'primaryOutcomes': [{'measure': 'Co-creation questions', 'timeFrame': 'From enrolment to end of co-creation sessions (10 sessions of 2 hours max over the course of the study)', 'description': '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:\n\n1. Current healthcare/tools usage\n2. Preferences and needs (this will be mainly based on the results of our previous study, BUN B6702024000090)\n3. Accessibility and usability of the tool\n4. Privacy and confidentiality\n5. Social support and sensitivity\n6. Help and professional support\n7. Continuity and long-term implementation\n8. Feedback on prototypes of the tool\n9. Feedback on final version of the tool'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['co-creation', 'participatory research', 'men', 'suicide prevention', 'suicidal ideation', 'male health'], 'conditions': ['Suicide Prevention', 'Suicidal Ideation', 'Suicidal Behaviour']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Boyle, E. (2007),'}, {'pmid': '36377305', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33073734', 'type': 'BACKGROUND', 'citation': 'Watling 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nConsidering 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.\n\nA currently ongoing study (BUN: B6702024000090) focuses on mapping out these needs and barriers among adult men with suicidal thoughts and their healthcare providers.\n\nThe 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.\n\nIt 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.\n\nThe 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.\n\nThis 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.\n\nIf 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified male participants can participate (based on gender and not sex)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men (≥ 18y/o)\n* Experienced suicidal thoughts in the past three year\n\nExclusion Criteria:\n\n* Limited comprehension\n* Acute suicidality (as evaluated by a clinical psychologist of the research team)'}, 'identificationModule': {'nctId': 'NCT06629220', 'briefTitle': 'Co-creation of Tools for Men With Suicidal Thoughts and/or Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Co-creation of Tools for Men With Suicidal Thoughts and/or Behavior', 'orgStudyIdInfo': {'id': 'ONZ-2024-0366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Co-creation meetings', 'description': 'All participants will be invited to participate in the co-creation meetings.', 'interventionNames': ['Other: Tools']}], 'interventions': [{'name': 'Tools', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Co-creation meetings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pauline Stas, MSc', 'role': 'CONTACT', 'email': 'pauline.stas@ugent.be', 'phone': '+3293320775'}], 'facility': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Pauline Stas, MSc', 'role': 'CONTACT', 'email': 'pauline.stas@ugent.be', 'phone': '+32 (0)9 332.07.75'}, {'name': 'Eva De Jaegere, PhD', 'role': 'CONTACT', 'email': 'eva.dejaegere@ugent.be', 'phone': '+32 (0)9 332.07.75'}], 'overallOfficials': [{'name': 'Gwendolyn Portzky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}