Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 1:24 PM
Study NCT ID:
NCT04771195
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-14
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'September 2021 - May 2024', 'description': 'Score on self-reported depression measure: Center for Epidemiological Studies Scale - 10 item version. Range = 0 to 30. Higher scores indicate more depressive symptoms'}, {'measure': 'Anxiety', 'timeFrame': 'September 2021 - May 2024', 'description': 'Score on self-reported anxiety measure: State-Trait Anxiety Inventory - 20 item version. Range = 20 to 80. Higher scores indicate more symptoms of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Loneliness', 'timeFrame': 'September 2021 - May 2024', 'description': 'Score on self-reported loneliness measure: University of California Loneliness Scale - 8 item version. Range = 1 to 5. Higher score indicate greater feeling of loneliness.'}, {'measure': 'Stress', 'timeFrame': 'September 2021 - May 2024', 'description': 'Score on self-reported stress measure: Perceived Stress Scale. Range = 1 to 3. Higher scores indicate greater feeling of stress.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression', 'Loneliness', 'Stress']}, 'descriptionModule': {'briefSummary': 'The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.', 'detailedDescription': 'The proposed work will consist of four key components. The investigators will collect data from the class of 2023 in each of their remaining years at college, producing (i) longitudinal data that will allow them to probe the long-term mental health effects of connections made during the transition to college, as well as mental health issues and resilience in the wake of the COVID-19 pandemic as a function of social connectedness. The investigators will leverage this rich dataset to build (ii) prospective quantitative models to predict mental health outcomes later in college based on a range of social factors measured early in college. They will further collect (iii) a longitudinal replication cohort, the class of 2024, allowing to establish the robustness of their initial findings across samples. Finally, the investigators will add (iv) a neuroimaging component to this dataset in a subset of the class of 2024. This will allow them to examine brain "markers" of connectedness, and add them to a prospective model, providing a novel integration across brain, behavior, and community levels of analysis, and a synthetic assessment of social factors in long-term mental health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Stanford undergraduate students in the classes of 2023 and 2024, as well as all students who reside in their dorms.\n\n\\-\n\nExclusion Criteria: People under the age of 18\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04771195', 'briefTitle': 'Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis', 'orgStudyIdInfo': {'id': '24593'}, 'secondaryIdInfos': [{'id': 'R01MH125974', 'link': 'https://reporter.nih.gov/quickSearch/R01MH125974', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Class of 2023 and 2024', 'description': 'Stanford undergraduate students who are expected to graduate in Spring of 2023 or 2024', 'interventionNames': ["Behavioral: Examination of students' naturally occurring social ties"]}], 'interventions': [{'name': "Examination of students' naturally occurring social ties", 'type': 'BEHAVIORAL', 'description': "In this observational study, features of students' social lives, such as the number of quality of relationships they form, and their subjective loneliness, will be used to predict their mental health and well being at later time points.", 'armGroupLabels': ['Class of 2023 and 2024']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Jamil Zaki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': "Unidentifiable data will be shared with other researchers. To that end, alphanumeric identifiers will be assigned to each individual in the sample's population. Direct nomination lists will not be shared because the potential traceability for participants who may gain access to the data after it is published."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jamil Zaki', 'investigatorAffiliation': 'Stanford University'}}}}