Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 7:26 AM
Study NCT ID:
NCT06307366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Themes around the topics (related to perceptions and experiences) explored.', 'timeFrame': '1 hour', 'description': 'We developed an interview guide around the main themes (i) risk and resilience; (ii) information needs for care and counselling; and (iii) (biological) research to ensure key aspects relating to perceptions, experiences, and needs of participants around the chance risk for mental illness in (future) children will be covered during the interviews. It additionally allows the interviewer to ask follow-up questions on interesting perspectives put forth by participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental illness', 'risk', 'resilience', 'offspring', 'qualitative research', 'mood-psychosis spectrum'], 'conditions': ['Mental Illness']}, 'descriptionModule': {'briefSummary': 'Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old.\n\nIf including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression\n* At least 18 years old\n\nExclusion Criteria:\n\n* Insufficient proficiency of the Dutch language\n* No demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from Appelbaum \\& Grisso, 1988).\n* Unable to give consent to all aspects of the study.'}, 'identificationModule': {'nctId': 'NCT06307366', 'acronym': 'PANDAcc', 'briefTitle': 'Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Perceptions and Experiences of (Future) Parents With Mental Illness and Family Members of People With Mental Illness About Risk for Mental Illness in (Future) Children, Potential Resilience Factors, and Needs for Care and Research', 'orgStudyIdInfo': {'id': 'ErasmusMC10365'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(Future) parents with (a partner with) mental illness in the mood-psychosis spectrum', 'description': 'The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old.\n\nIf including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents.', 'interventionNames': ['Other: No intervention will be used']}], 'interventions': [{'name': 'No intervention will be used', 'type': 'OTHER', 'description': 'This is a qualitative study, no intervention will be used', 'armGroupLabels': ['(Future) parents with (a partner with) mental illness in the mood-psychosis spectrum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000CB', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'contacts': [{'name': 'Lisanne AE van Houtum, PhD', 'role': 'CONTACT', 'email': 'l.vanhoutum@erasmusmc.nl', 'phone': '+31107037005'}, {'name': 'Hilmar H Bijma, MD, PhD', 'role': 'CONTACT', 'email': 'h.bijma@erasmusmc.nl', 'phone': '+31107036109'}, {'name': 'Hilmar H Bijma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Neeltje EM van Haren, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisanne AE van Houtum, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eline MP Poels, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Lisanne AE van Houtum, PhD', 'role': 'CONTACT', 'email': 'l.vanhoutum@erasmusmc.nl', 'phone': '+31107037005'}, {'name': 'Hilmar H Bijma, MD, PhD', 'role': 'CONTACT', 'email': 'h.bijma@erasmusmc.nl', 'phone': '+31107036109'}], 'overallOfficials': [{'name': 'Hilmar H. Bijma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only processed, group-level data (i.e., themes, subthemes) can be shared, given that interviews can be traced back to individual participants. The PI will verify the authenticity of the requesting researcher and will check whether their intentions are in line with the informed consent and whether the intended methodology is suitable and will approve the request before providing access to the data.\n\nA Data Transfer Agreement will be signed, and the Technology Transfer Office will be involved to ensure the appropriate agreements are made.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral researcher designated by Prinicipal Investigator', 'investigatorFullName': 'Lisanne van Houtum', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}