Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 5:37 AM
Study NCT ID:
NCT05087966
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012725', 'term': 'Sexual Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajblashill@sdsu.edu', 'phone': '619-594-2245', 'title': 'Dr. Aaron Blashill', 'organization': 'San Diego State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was conducted to assess the feasibility and acceptability of a newly developed suicide prevention intervention. By design, the quantitative outcome measurement was not sufficiently powered to evaluate preliminary efficacy and/or mechanistic target engagement.'}}, 'adverseEventsModule': {'timeFrame': 'Six months', 'description': "An adverse event is defined as any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign, symptom, or disease, temporally associated with participant's study participation, whether or not considered related to participant's study participation; it encompasses both physical and psychological harm. This study also included non-medical events that may be behavioral (i.e., self-harm) or social (e.g., child protective services involvement with the family).", 'eventGroups': [{'id': 'EG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Concerns Following Interview Questions', 'notes': 'After signing informed consent, subject was deemed ineligible and referred to higher levels of care. They expressed concerns about clinical interview questions putting them at risk for suicide. Case was deemed anticipated, related but not serious.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Interrupted Suicide Attempt', 'notes': 'Subject engaged in an interrupted suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Hospitalization for Sciatica', 'notes': 'Subject was hospitalized for sciatica.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Emergency Room Visit', 'notes': 'Subject went to emergency room for panic-like symptoms and suicidal ideation without plan.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}], 'seriousEvents': [{'term': 'Hospitalization Following Method Research', 'notes': 'A school system detected that the subject searched for attempt method on school-owned computer. Subject was hospitalized for nine days and enrolled in an intensive outpatient program.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Suicide Attempt', 'notes': 'Subject engaged in a suicide attempt by walking into traffic.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Hospitalization Following Symptom Worsening', 'notes': 'Subject was hospitalized for two days for reasons of severe depression and eating disorder symptoms.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}, {'term': 'Suicide Attempt', 'notes': 'Subject engaged in a suicide attempt by attempting to strangle themselves.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'US DHHS OHRP'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.83', 'spread': '9.31', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.13', 'spread': '10.32', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.36', 'spread': '9.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline thwarted belongingness scores at 3 and 6 months', 'description': 'Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.'}, {'type': 'PRIMARY', 'title': 'Suicide-Related Coping Scale (SRCS) - Internal Coping Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.26', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.83', 'spread': '2.96', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.20', 'spread': '2.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline suicide-related internal coping scores at 3 and 6 months', 'description': 'Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better internal coping)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.'}, {'type': 'PRIMARY', 'title': 'Suicide-Related Coping Scale (SRCS) - External Coping Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.35', 'spread': '3.56', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.79', 'spread': '3.39', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.48', 'spread': '2.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline suicide-related external coping scores at 3 and 6 months', 'description': 'Assess suicide-related external coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '31 participants completed their baseline assessment. 24 participants completed their three-month follow-up assessment. 25 participants completed their six-month follow-up assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'November 2021 through May 2022; San Diego County.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Planning Intervention With Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).\n\nSafety Planning Intervention with Navigation Services: A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Identity', 'categories': [{'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Trans Man', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Trans Woman', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Non-Binary', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Genderqueer', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Gender Non-Conforming', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Gender Fluid', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Agender', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Other Gender Identity', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sexual Orientation', 'classes': [{'categories': [{'title': 'Gay/Lesbian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Bisexual', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Straight/Heterosexual', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Pansexual', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asexual', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Queer', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Other Sexual Orientation', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-30', 'size': 771815, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-29T19:17', 'hasProtocol': True}, {'date': '2022-05-06', 'size': 180775, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-29T19:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A broad recruitment strategy will be used to recruit participants within the greater San Diego. Potential participants will be requested to contact study personnel via email or telephone. A trained member of the study team will contact each potential participant to explain the study, obtain verbal consent for pre-enrollment screening, and conduct the screening process. For those who meet screening criteria, a trained member of the study team will provide more information about the study and engage in an informed consent process at an in-person appointment. Following informed consent, participants will complete self-report questionnaires and clinician-based interviews in person. At baseline, 3-month, and 6-month follow-ups, participants will be asked to complete measures of suicidal coping and thwarted belongingness. At the 3- and 6-month follow-up, satisfaction with mental health services and satisfaction with interpersonal relationship with patient navigator will be assessed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2021-10-08', 'resultsFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-20', 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Interpersonal Needs Questionnaire-15 (INQ-15) - Thwarted Belongingness', 'timeFrame': 'Change from baseline thwarted belongingness scores at 3 and 6 months', 'description': 'Assess thwarted belongingness (9 items on 7-point scales; scores range from 9 to 63 with higher scores indicating greater thwarted belongingness)'}, {'measure': 'Suicide-Related Coping Scale (SRCS) - Internal Coping Skills', 'timeFrame': 'Change from baseline suicide-related internal coping scores at 3 and 6 months', 'description': 'Assess suicide-related internal coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better internal coping)'}, {'measure': 'Suicide-Related Coping Scale (SRCS) - External Coping Skills', 'timeFrame': 'Change from baseline suicide-related external coping scores at 3 and 6 months', 'description': 'Assess suicide-related external coping skills (7 items on 5-point scales; scores range from 0 to 28 with higher scores indicating better external coping)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual and gender minority youth', 'Prevention', 'Patient Navigation', 'Safety Planning Intervention'], 'conditions': ['Suicide']}, 'referencesModule': {'references': [{'pmid': '28903161', 'type': 'BACKGROUND', 'citation': 'Olfson M, Blanco C, Wall M, Liu SM, Saha TD, Pickering RP, Grant BF. National Trends in Suicide Attempts Among Adults in the United States. JAMA Psychiatry. 2017 Nov 1;74(11):1095-1103. doi: 10.1001/jamapsychiatry.2017.2582.'}, {'pmid': '28981481', 'type': 'BACKGROUND', 'citation': 'Ivey-Stephenson AZ, Crosby AE, Jack SPD, Haileyesus T, Kresnow-Sedacca MJ. Suicide Trends Among and Within Urbanization Levels by Sex, Race/Ethnicity, Age Group, and Mechanism of Death - United States, 2001-2015. MMWR Surveill Summ. 2017 Oct 6;66(18):1-16. doi: 10.15585/mmwr.ss6618a1.'}, {'pmid': '26511788', 'type': 'BACKGROUND', 'citation': 'Shepard DS, Gurewich D, Lwin AK, Reed GA Jr, Silverman MM. Suicide and Suicidal Attempts in the United States: Costs and Policy Implications. Suicide Life Threat Behav. 2016 Jun;46(3):352-62. doi: 10.1111/sltb.12225. Epub 2015 Oct 29.'}, {'pmid': '22013611', 'type': 'BACKGROUND', 'citation': 'Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK64806/'}, {'pmid': '29902162', 'type': 'BACKGROUND', 'citation': 'Kann L, McManus T, Harris WA, Shanklin SL, Flint KH, Queen B, Lowry R, Chyen D, Whittle L, Thornton J, Lim C, Bradford D, Yamakawa Y, Leon M, Brener N, Ethier KA. Youth Risk Behavior Surveillance - United States, 2017. MMWR Surveill Summ. 2018 Jun 15;67(8):1-114. doi: 10.15585/mmwr.ss6708a1.'}, {'pmid': '28254960', 'type': 'BACKGROUND', 'citation': 'Miranda-Mendizabal A, Castellvi P, Pares-Badell O, Almenara J, Alonso I, Blasco MJ, Cebria A, Gabilondo A, Gili M, Lagares C, Piqueras JA, Roca M, Rodriguez-Marin J, Rodriguez-Jimenez T, Soto-Sanz V, Vilagut G, Alonso J. Sexual orientation and suicidal behaviour in adolescents and young adults: systematic review and meta-analysis. Br J Psychiatry. 2017 Aug;211(2):77-87. doi: 10.1192/bjp.bp.116.196345. Epub 2017 Mar 2.'}, {'pmid': '29998307', 'type': 'BACKGROUND', 'citation': 'Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.'}, {'pmid': '31112330', 'type': 'BACKGROUND', 'citation': 'Labouliere CD, Stanley B, Lake AM, Gould MS. Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. Suicide Life Threat Behav. 2020 Feb;50(1):29-41. doi: 10.1111/sltb.12554. Epub 2019 May 21.'}, {'pmid': '29062296', 'type': 'BACKGROUND', 'citation': 'Cramer RJ, Kapusta ND. A Social-Ecological Framework of Theory, Assessment, and Prevention of Suicide. Front Psychol. 2017 Oct 9;8:1756. doi: 10.3389/fpsyg.2017.01756. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'https://www.cdc.gov/nchs/products/databriefs/db293.htm', 'label': '10 Leading Causes of Death, United States: 2016, All Races, Both Sexes'}, {'url': 'https://doi.org/10.1016/j.cbpra.2011.01.001', 'label': 'Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk'}]}, 'descriptionModule': {'briefSummary': 'The overarching goal of this study is to develop a suicide prevention program for sexual-and-gender-minority youth and emerging adults. After development of the intervention program, an open phase trial will be conducted to test its feasibility, acceptability, and preliminary impact on three intervention targets.', 'detailedDescription': 'Suicide is the 10th leading cause of death among all U.S. citizens, and is the 2nd leading cause of death among youth and emerging adults between the ages of 15 and 34. Moreover, U.S. representative data indicate increasing trends in suicide attempts and death by suicide. In addition to the immense psychological burden experienced by the family and friends of individuals who attempt and complete suicide, the costs of death by suicide and suicide attempts in 2013 were estimated at $93.5 billion.\n\nOne group that is particularly vulnerable to suicide is sexual and gender minorities (SGMs). SGM is an umbrella term used to describe individuals who identify as non-exclusively heterosexual (e.g., gay, lesbian, bisexual) and/or as transgender/non-binary (e.g., identify as a gender different from their birth sex). Extant research consistently notes substantial mental health disparities among SGMs in comparison to their heterosexual and cis-gender counterparts. In 2017, in the U.S., 23% of sexual minority youth reported one or more suicide attempts (in the past 12 months) vs. 5.4% of heterosexual youth. This disparity has also been noted in a meta-analysis of population-based longitudinal studies, with sexual minority adolescents and emerging adults reporting 2.26 increased odds of suicide attempts compared to their heterosexual counterparts. Prevalence of lifetime suicide attempts among gender minorities is also substantially elevated compared to the general population, with 45% of 18-24-year-old transgender individuals reporting history of one or more suicide attempts.\n\nDespite these substantial health disparities in suicide among SGM youth/emerging adults, no known suicide prevention programs exist for this highly vulnerable population. Given this crucial gap in the literature, the proposed study will adapt and test a patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community). This study will accomplish the following specific aims:\n\nSpecific Aim 1: To adapt and test an integrated PN+SPI designed to reduce suicide attempts among SGM youth and emerging adults. In this open-phase trial (N = 30), within-person changes in thwarted belongingness and suicide-related coping skills will be tested. It is hypothesized that PN+SPI participants will display decreases in thwarted belongingness and increases in suicide-related coping skills. Feasibility and acceptability of the PN+ SPI intervention will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Identify as gay, lesbian, bisexual, transgender, genderqueer, asexual, pansexual, non-binary, or another non-exclusively heterosexual identity, and/or reports same-gender romantic attraction, and/or reports same-gender sexual behavior in the past 12 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) age 15 to 29 years; 2) identifies as gay, lesbian, bisexual, transgender, genderqueer, asexual, pansexual, non-binary, or another non-exclusively heterosexual identity, and/or reports same-gender romantic attraction, and/or reports same-gender sexual behavior in the past 12 months; 3) resides in San Diego County, California; 4) speaks English; 5) is willing and able to provide informed consent; 6) reports suicidal ideation over the past two weeks, as indicated by the clinician-administered Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline version; and 7) reports a lifetime history of one or more suicide attempts.\n\nExclusion Criteria:\n\n* Individuals with immediate intention to attempt suicide will be excluded.'}, 'identificationModule': {'nctId': 'NCT05087966', 'briefTitle': 'Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)', 'orgStudyIdInfo': {'id': 'HS-2020-0076 (2)'}, 'secondaryIdInfos': [{'id': '1R61MH120236-01', 'link': 'https://reporter.nih.gov/quickSearch/1R61MH120236-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Planning Intervention with Navigation Services', 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).', 'interventionNames': ['Behavioral: Safety Planning Intervention with Navigation Services']}], 'interventions': [{'name': 'Safety Planning Intervention with Navigation Services', 'type': 'BEHAVIORAL', 'otherNames': ['PN+SPI'], 'description': 'A patient navigation (PN) intervention for SGM youth/emerging adults designed to target mechanisms (i.e., decreasing thwarted belongingness and increasing suicide-related coping skills) that theoretically underlie suicide. The proposed intervention will integrate a single-session, empirically supported, suicide prevention intervention (Safety Planning Intervention; SPI) with PN services (PN+SPI). The patient navigator will deliver the SPI and continue frequent contact for the purpose of providing motivational enhancement, problem-solving, reinforcing coping strategies, and connecting participants to social support and mental health resources (e.g., SGM-specific support groups within the community).', 'armGroupLabels': ['Safety Planning Intervention with Navigation Services']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Aaron Blashill, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}, {'name': 'Kristen J Wells, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Aaron Blashill', 'investigatorAffiliation': 'San Diego State University'}}}}