Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT01175603
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Postpartum Depression in African American Home Visiting Clients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000064', 'term': 'Acclimatization'}], 'ancestors': [{'id': 'D000222', 'term': 'Adaptation, Physiological'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000220', 'term': 'Adaptation, Biological'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Baseline'}, {'measure': 'Depressive symptoms', 'timeFrame': '1 week post intervention'}, {'measure': 'Depressive Symptoms', 'timeFrame': '3 months post-intervention'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 months post-intervention'}], 'secondaryOutcomes': [{'measure': 'Depressive episodes', 'timeFrame': '3 months post-intervention'}, {'measure': 'Depressive Episodes', 'timeFrame': '6 Months Post-Intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression, African American, home visiting, prevention'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.', 'detailedDescription': 'This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child \\< 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant or has child \\< 6 months of age\n* enrolled in home visiting program\n* exhibiting elevated depressive symptoms and/or personal history of clinical depression\n\nExclusion Criteria:\n\n* no current clinical depression at time of enrollment'}, 'identificationModule': {'nctId': 'NCT01175603', 'briefTitle': 'Preventing Postpartum Depression in African American Home Visiting Clients', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'orgStudyIdInfo': {'id': 'JHMI ICTR 2009'}, 'secondaryIdInfos': [{'id': 'ICTR 2009', 'type': 'OTHER', 'domain': 'Johns Hopkins University ICTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral intervention', 'description': 'Women in the intervention condition will receive 6 two-hour intervention sessions delivered weekly in a group format by the Study Clinician. Each session contains didactic instruction on core content, as well as activities and group discussion. One of the strengths of embedding the MB Course within home visiting is our ability to have home visitors reinforce the material presented by the Study Clinician. The 6-week curriculum is divided into three modules: (a) pleasant activities, (b) thoughts, and (c) relationships with others. Each module has two sessions. These sessions map onto core cognitive-behavioral concepts.', 'interventionNames': ['Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual home visiting', 'description': 'Women in the control group will receive usual home visiting services and information on postpartum depression.'}], 'interventions': [{'name': 'Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)', 'type': 'BEHAVIORAL', 'description': '6 weekly 2-hour cognitive-behavioral intervention sessions held in group format', 'armGroupLabels': ['Cognitive behavioral intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20001', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "People's Community Health Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'DRUM Healthy Families', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maternal and Infant Nursing Program', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital Perinatal Depression Outreach Program', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Shiv D Tandon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abell Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}