Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT05225103
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2022-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brief Suicide Intervention for Youth in Juvenile Detention Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.goldston@duke.edu', 'phone': '919-681-1100', 'title': 'David Goldston', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'As an intervention development study, this study is not powered to test hypotheses. Rather, the purpose of this study is to demonstrate feasibility and acceptability of the intervention and procedures, and to demonstrate viability of the proof of concept.\n\nFull implementation at all but one of the facilities was challenging because of overcrowding and understaffing.'}}, 'adverseEventsModule': {'timeFrame': 'up to 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Suicide attempt (unverified)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Determined by a response of "yes" to question #6 on the C-SSRS: "Have you done anything, started to do anything, or prepared to do anything to end your life?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on one participant.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Non-Suicidal Self Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on one participant.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Were Linked to Mental Health Services After Release', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on four participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Urgency to Act on Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2-month follow-up assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021). Number of participants who report they strongly agree that they have hope for the future and reasons for living after leaving the facility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Report Acceptance of Their Current Situation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2-month follow-up assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Self-Efficacy in Keeping Safe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Adapted from items used by Czyz (2016, 2019). The number of participants reporting that they very much agreed that they felt confident in keeping themselves safe is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Juvenile Detention Sites', 'recruitmentDetails': 'Eligible youth were asked to assent to the study after being admitted to the facility, and parents and caregivers were then approached for consent.', 'preAssignmentDetails': 'Data were only collected from the 8 youth who were identified as being acutely suicidal and who then received the new intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites\n\nSAFETY-Acute intervention: The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2024-12-04', 'size': 434203, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-19T17:21', 'hasProtocol': True}, {'date': '2024-05-01', 'size': 234393, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-03T12:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Trial is Single Group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2022-01-25', 'resultsFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-31', 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Determined by a response of "yes" to question #6 on the C-SSRS: "Have you done anything, started to do anything, or prepared to do anything to end your life?"'}, {'measure': 'Number of Participants Who Reported Non-Suicidal Self Injury', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.'}, {'measure': 'Number of Participants Who Were Linked to Mental Health Services After Release', 'timeFrame': 'Up to 2 month follow-up assessment', 'description': 'Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Urgency to Act on Suicidal Thoughts', 'timeFrame': 'Up to 2-month follow-up assessment'}, {'measure': 'Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021). Number of participants who report they strongly agree that they have hope for the future and reasons for living after leaving the facility.'}, {'measure': 'Number of Participants Who Report Acceptance of Their Current Situation', 'timeFrame': 'Up to 2-month follow-up assessment'}, {'measure': 'Number of Participants Reporting Self-Efficacy in Keeping Safe', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Adapted from items used by Czyz (2016, 2019). The number of participants reporting that they very much agreed that they felt confident in keeping themselves safe is reported.'}, {'measure': 'Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)', 'timeFrame': 'Up to 2-month follow-up assessment', 'description': 'Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Juvenile detention', 'suicidal thoughts'], 'conditions': ['Suicide Prevention']}, 'descriptionModule': {'briefSummary': 'This is an intervention development study and therefore is not designed or powered to test hypotheses. Following initial development and refinement of intervention and protocol, an open trial will be conducted at one juvenile detention facility (n=20). Following further refinement, six juvenile detention sites will be randomized to first or second wave of intervention implementation. All youth at an implementation site in suicidal crises will receive the intervention. Data will only be collected from youth with prior assent/consent. Youth will be assessed at the time of the suicidal/self-harm crisis, and at 2 and 4 weeks after initial intervention, and at a two-month follow-up assessment. We will preliminarily examine feasibility of the intervention and associated patterns of suicidal thoughts and behavior and non-suicidal self-injury, linkage to care following release, and presumed mechanisms of change such as hopelessness, self-efficacy to remain safe, urgency to act on suicidal thoughts, and acceptance.', 'detailedDescription': 'The primary objective of this phase of the study is to develop and refine procedures for the new multi-faceted intervention for trauma-informed suicide prevention (brief cognitive-behavioral and trauma-informed strategies and safety planning for youth who are suicidal and/or self-harming, as well as training of staff in trauma-informed crisis management and de-escalation strategies) for youth in juvenile detention settings. An associated objective is to develop procedures for training staff working with youth in short-term juvenile detention settings to conduct the new intervention for reducing suicidal thoughts and behavior. A third objective is to examine the feasibility of this trauma-informed suicide prevention intervention in terms of initial participant recruitment, fidelity to the treatment model, treatment acceptability, and monitoring of adverse events in an open trial (n=20). This intervention will be iteratively refined during this open trial based on feedback from youth and staff, and experiences using the intervention in juvenile detention. We will also gather information regarding the presumed mechanisms of action and targeted outcomes for this intervention (although the small open trial will not be able to statistically examine effects).\n\nAs an intervention development study, this study is not powered to test hypotheses. Rather, the purpose of this study is to demonstrate feasibility and acceptability of the intervention and procedures, and to demonstrate viability of the proof of concept.\n\nThe study is a collaboration between Duke and Wake Forest investigators, and Juvenile Justice in the NC Department of Public Safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* At least 13 years of age or older and 18 years old or younger\n* Without evidence from school or other records of intellectual disability\n* Without evidence of active psychosis\n* Not wards of the state\n* Risk for suicidal behavior or non-suicidal self-harm behavior\n\nExclusion Criteria:\n\n* Not English-speaking or caregivers are not English-speaking\n* Wards of the state\n* Younger than 13 years old or older than 18 years of age\n* Evidence from school or other records or suspected intellectual disability\n* Active psychosis'}, 'identificationModule': {'nctId': 'NCT05225103', 'briefTitle': 'Brief Suicide Intervention for Youth in Juvenile Detention Settings', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Brief Suicide Intervention for Youth in Juvenile Detention Settings', 'orgStudyIdInfo': {'id': 'Pro00106321'}, 'secondaryIdInfos': [{'id': 'R34MH124986', 'link': 'https://reporter.nih.gov/quickSearch/R34MH124986', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAFETY-A Implementation Sites', 'description': 'New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites', 'interventionNames': ['Behavioral: SAFETY-Acute intervention']}], 'interventions': [{'name': 'SAFETY-Acute intervention', 'type': 'BEHAVIORAL', 'description': 'The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts). Delivered in addition to usual care in facilities.', 'armGroupLabels': ['SAFETY-A Implementation Sites']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David Goldston, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}