Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT01298804
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2011-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Maternal Depression In Head Start
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-17', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Major Depressive Episode', 'timeFrame': '12 months', 'description': 'SCID Interview'}, {'measure': 'Post Traumatic Stress Disorder', 'timeFrame': '12 months', 'description': 'SCID Interview'}, {'measure': 'Anxiety', 'timeFrame': '12 months', 'description': 'SCID Interview'}], 'primaryOutcomes': [{'measure': 'Depression Symptoms', 'timeFrame': '2 months', 'description': 'QIDS'}, {'measure': 'Depression Symptoms', 'timeFrame': '4 months', 'description': 'QIDS'}, {'measure': 'Depression Symptoms', 'timeFrame': '6 months', 'description': 'QIDS'}, {'measure': 'Depression Symptoms', 'timeFrame': '8 months', 'description': 'QIDS'}, {'measure': 'Depression Symptoms', 'timeFrame': '10 months', 'description': 'QIDS'}, {'measure': 'Depression Symptoms', 'timeFrame': '12 months', 'description': 'QIDS'}, {'measure': 'Problem Solving Skills', 'timeFrame': '6 months', 'description': 'Social Problem Solving Inventory'}, {'measure': 'Problem Solving Skills', 'timeFrame': '12 months', 'description': 'Social Problem Solving Inventory'}], 'secondaryOutcomes': [{'measure': 'Social functioning', 'timeFrame': '6 months', 'description': 'Social Adjustment Scale- Self-report'}, {'measure': 'Parent functioning/stress', 'timeFrame': '6 months', 'description': 'Parenting Stress Index; Perceived Stress Index'}, {'measure': 'Head Start attendance', 'timeFrame': '12 months', 'description': 'Head Start records, analyzed as monthly absence rates'}, {'measure': 'Receipt of Mental Health Services', 'timeFrame': '12 months'}, {'measure': 'Social functioning', 'timeFrame': '12 months', 'description': 'Social Adjustment Scale- Self-report'}, {'measure': 'Parent functioning/stress', 'timeFrame': '12 months', 'description': 'Parenting Stress Index, Perceived Stress Index'}, {'measure': 'Child Behavior', 'timeFrame': '6 months', 'description': 'Teacher Version of Social Skills Rating System'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '30646083', 'type': 'DERIVED', 'citation': 'Silverstein M, Cabral H, Hegel M, Diaz-Linhart Y, Beardslee W, Kistin CJ, Feinberg E. Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial. JAMA Netw Open. 2018 Jun 1;1(2):e180334. doi: 10.1001/jamanetworkopen.2018.0334.'}, {'pmid': '30256184', 'type': 'DERIVED', 'citation': 'Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Broder-Fingert S, Kistin CJ, Patts G, Feinberg E. Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start. Psychiatr Serv. 2018 Nov 1;69(11):1175-1180. doi: 10.1176/appi.ps.201800173. Epub 2018 Sep 26.'}, {'pmid': '28614554', 'type': 'DERIVED', 'citation': 'Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Hegel M, Haile W, Sander J, Patts G, Feinberg E. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Aug 1;74(8):781-789. doi: 10.1001/jamapsychiatry.2017.1001.'}]}, 'descriptionModule': {'briefSummary': 'Maternal depression disproportionately affects low-income and minority women, and has profound negative impacts on their children. The investigators are conducting a randomized trial of a systems approach to identify mothers at risk for depression in Head Start - a federally funded early learning program for children of low-income families - and to provide an on-site intervention to prevent or alleviate depressive symptoms; improve functioning; and, where appropriate, proactively link mothers to more definitive mental health services.', 'detailedDescription': "This study is one component of a series of studies that aims to develop a comprehensive system of maternal depression prevention and management within Head Start. In our March 2014 review of the CT.gov protocol, we synchronized it with our institution's IRB protocol, which had been modified based on how the individual studies within this series relate to one another. Specifically, the original IRB protocol combined two studies into one: a 'main' depression prevention trial (n=230, R01MH091871), and a small adjunct pilot aimed at referring those with symptoms of major depression to further care (n=60). Thus, the original CT.gov protocol included subjects both at risk for depression and with symptoms consistent with major depression. When the latter pilot study subsequently received external funding, we separated the two studies into two IRB protocols, and thus have adjusted our CT.gov protocol to the appropriate sample size of 230, and indicated symptoms of major depression as an exclusion criterion for the prevention trial. Because Major Depressive Episode was inadvertently listed as a primary outcome measure for the prevention trial (and PTSD and Anxiety as secondary outcome measures), we have removed them as such and listed it under 'other' outcomes, thereby aligning the CT.gov protocol with the statistical analysis plan of the original grant application and IRB protocol. Lastly, we corrected administrative errors in the study's projected end date and masking design."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Family enrolled in Head Start, and child expected to attend Head Start activities for at least 6 months of the 12-month follow-up period.\n* Family without imminent plans to relocate\n* Mother is comfortable in English or Spanish.\n* Parent/guardian who has a child that attends Head Start\n* Child attending Head Start and is between the ages 0-5\n* Screen positive to 2-question depression screener (PHQ2), or have a past history of depression\n* Ability to provide informed consent.\n* Not suicidal\n\nExclusion Criteria:\n\n* High suicidal ideation\n* Cognitive limitation\n* Psychosis\n* No known risks for depression\n* Symptoms reflecting major depressive episode'}, 'identificationModule': {'nctId': 'NCT01298804', 'briefTitle': 'Preventing Maternal Depression In Head Start', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Preventing Maternal Depression In Head Start', 'orgStudyIdInfo': {'id': 'R01MH091871', 'link': 'https://reporter.nih.gov/quickSearch/R01MH091871', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Problem Solving Education', 'interventionNames': ['Behavioral: Problem Solving Education and Activated Referral to Care']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Problem Solving Education and Activated Referral to Care', 'type': 'BEHAVIORAL', 'description': 'The intervention represents an integrated identification and intervention system based on the evidence-based construct of screening, brief intervention, and referral to treatment (SBIRT). Within the comprehensive case management services of Head Start, eligible women will be randomized to receive either usual care or the Head Start-based intervention. In our intervention, mothers at risk for depression will receive a problem-solving intervention; depression symptom monitoring; and an "Activated" referral to more definitive services for those who have worsening symptoms over time.', 'armGroupLabels': ['Problem Solving Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'ABCD Head Start', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael Silverstein, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Michael Silverstein', 'investigatorAffiliation': 'Boston Medical Center'}}}}