Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT06611956
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2024-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Needs Assessment Among Carers of Someone With Suicidal Thoughts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Background information: information on the participant', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Personal information (self-developed questionnaire): age, gender identity, education, cultural background, work status, recruitment type'}, {'measure': 'Background information: information on the suicidal person', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Information on the suicidal person (self-developed questionnaire): relationship with the person, age, gender identity, suicidality, degree of contact'}, {'measure': 'Experienced burden: suicidality', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'based on national health survey (Sciensano, 2018)'}, {'measure': 'Experienced burden when supporting the individual with suicdial thoughts', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'self-developed questionnaire on the role of the carer and current degree of care'}, {'measure': 'Experienced burden when supporting the individual with suicdial thoughts', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Zarit Caregiver Burden 4-item questionnaire (Zarit et al., 1985; Higginson et al., 2010)'}, {'measure': 'Experienced burden: psychological stress', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Kessler Psychological Distress Scale , 6-item (Kessler et al., 2002, 2003)'}, {'measure': 'Experienced needs', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Self-developed questionnaire examining the need for information, need for support and needs with regards to health care'}, {'measure': 'Experience with existing initiatives and tools', 'timeFrame': 'Baseline. Completing the questionnaire will take about 15-20 minutes', 'description': 'Self-developed questionnaire about the experience of participants with existing initiatives and tools'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['needs assessment', 'informal caregivers', 'suicide'], 'conditions': ['Suicide Prevention', 'Informal Caregivers']}, 'descriptionModule': {'briefSummary': 'With this study the investigators would like to gain insight into the experienced needs carers of individuals with suicidal thoughts, who attempted suicide or who died by suicide. By carers the investigators mean everyone who knows/knew someone close to them who is thinking about suicide, attempted suicide or died by suicide. By mapping out these needs, the investigators hope to better support carers and develop/improve initiatives and tools.\n\nThe investigators examine this by means of an online one-time questionnaire. In this questionnaire the investigators ask the participants questions about what it is like to be a carer and what are some of the experienced needs, as well as experiences with existing initiatives/tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are inidividuals (16 years or older) who know someone close to them with suicidal thoughts and/or behaviors in the past three years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 16 years or older\n* Someone close to them has experienced suicidal thoughts, attempted suicide or died by suicide in the past three years\n* Access to internet\n* Understand sufficient Dutch (to complete the questionnaire)\n\nExclusion Criteria:\n\n* /'}, 'identificationModule': {'nctId': 'NCT06611956', 'briefTitle': 'Needs Assessment Among Carers of Someone With Suicidal Thoughts', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Needs Assessment Among Carers of Someone With Suicidal Thoughts', 'orgStudyIdInfo': {'id': 'ONZ-2024-0404'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'No intervention (observational study)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Flemish Centre of Expertise in Suicide Prevention, Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Gwendolyn Portzky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Flemish Centre of Expertise in Suicide Prevention (Ghent University)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}