Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT05244733
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Culture and Well-Being for Latinos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cultural-Social Engagement (A)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Average number of cultural-social interactions (measured via EMA), with greater number indicating greater cultural-social engagement (i.e., better outcome).'}, {'measure': 'Change in Cultural-Social Engagement (B)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Time spent in positive Spanish-language conversations (measured via passive monitoring of conversations), with more time indicating greater cultural-social engagement (i.e., better outcome).'}, {'measure': 'Change in Cultural-Social Engagement (C)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Number of visits to cultural-social settings outside the home (measured via GPS), with greater number indicating greater cultural-social engagement (i.e., better outcome).'}, {'measure': 'Change in Cultural-Social Engagement (D)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Self-reported feelings of belonging to Hispanic cultural groups (measured via EMA with the Interpersonal Needs Questionnaire), with greater scores indicating greater cultural-social engagement (i.e., better outcome).'}], 'secondaryOutcomes': [{'measure': 'Change in Suicide Risk (A)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Reasons for living total score, measured by the Reasons for Living Inventory, with 48 items rated from 1 to 6, with greater scores indicating greater importance for reasons for living (i.e., better outcome).'}, {'measure': 'Change in Suicide Risk (B)', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Suicide ideation total score, measured by the Beck Scale for Suicide Ideation, with scores ranging from 0 to 38, with greater scores indicating greater suicide ideation (i.e., worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Isolation', 'Loneliness', 'Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Hispanic/Latino adult (age 18+);\n* Primary Spanish-Speaker;\n* Patient in the UR health system;\n* Low cultural-social engagement (i.e., score ≤ 2 on the adapted Berkman-Syme Social Network Index);\n* Elevated suicide risk (i.e., presence of passive or active suicide ideation in the past month on the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]).\n\nExclusion Criteria:\n\n* Medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).'}, 'identificationModule': {'nctId': 'NCT05244733', 'briefTitle': 'Culture and Well-Being for Latinos', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Culture and Well-Being for Latinos: Study Protocol for Cultural-Social Engagement and Suicide Among Hispanics (K23MH125078)', 'orgStudyIdInfo': {'id': 'STUDY00006325'}, 'secondaryIdInfos': [{'id': 'K23MH125078', 'link': 'https://reporter.nih.gov/quickSearch/K23MH125078', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Engage (S-ENGAGE)', 'description': 'S-ENGAGE is a skills-based psychotherapy that focuses on helping patients engage in meaningful rewarding social activities. Subjects will receive 10 one-hour individual sessions of S-ENGAGE over 10 weeks.', 'interventionNames': ['Behavioral: Social Engage (S-ENGAGE)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The Healthy Lifestyles Education Program', 'description': 'The healthy lifestyles education program consists of a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources. Study staff meet with participants once, individually, for 1 hour to review each section and answer questions participants might have.', 'interventionNames': ['Behavioral: The Healthy Lifestyles Education Program']}], 'interventions': [{'name': 'Social Engage (S-ENGAGE)', 'type': 'BEHAVIORAL', 'description': 'S-ENGAGE uses the process of action planning to foster sustained behavior change. Action planning involves: 1) select a goal; 2) develop ideas to meet this goal; 3) choose one or more of these ideas; 4) identify concrete steps to implement the goal (i.e., form an action plan); 5) identify and address barriers if needed.', 'armGroupLabels': ['Social Engage (S-ENGAGE)']}, {'name': 'The Healthy Lifestyles Education Program', 'type': 'BEHAVIORAL', 'description': 'The healthy lifestyles education program is a self-guided psychoeducational program, including a notebook containing evidence-based educational material on mental health, physical activity, and information on community resources.', 'armGroupLabels': ['The Healthy Lifestyles Education Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caroline Silva, PhD', 'role': 'CONTACT', 'email': 'caroline_silva@urmc.rochester.edu', 'phone': '585-275-2392'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Caroline Silva, PhD', 'role': 'CONTACT', 'email': 'caroline_silva@urmc.rochester.edu', 'phone': '585-275-2392'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Caroline Silva', 'investigatorAffiliation': 'University of Rochester'}}}}