Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-31 @ 3:25 PM
Study NCT ID:
NCT01303458
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C072598', 'term': '6-bromo-2-naphthyl sulfate'}, {'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'unmet basic needs', 'timeFrame': 'at enrollment', 'description': "Questions from Children's HealthWatch survey used to measure 6 needs: food insecurity (18-item US food security scale), housing instability, education i.e., not completed high school, childcare, heat, employment."}], 'primaryOutcomes': [{'measure': 'Enrollment in new community-based resources and services', 'timeFrame': 'when index child is 1 yr of age'}], 'secondaryOutcomes': [{'measure': 'Food insecurity', 'timeFrame': 'when index child is one yr of age'}, {'measure': 'Maternal depression', 'timeFrame': 'when index child is one yr of age'}, {'measure': 'preventative care adherence, child health, child maltreatment', 'timeFrame': 'when index child is one yr of age'}, {'measure': 'referrals received by mother at index well-child care visit', 'timeFrame': '1st well-child care visit', 'description': 'referrals received for any of the 6 following unmet needs (food, housing, employment, education, childcare, heat)'}, {'measure': 'contact of community resource', 'timeFrame': 'child is 9 months of age', 'description': 'self-report of contact of a community resource for one of the 6 unmet needs (food, housing, employment, childcare, education, heat)'}, {'measure': 'unmet basic needs', 'timeFrame': '12 month follow-up', 'description': 'food, housing, employment, education, childcare, heat'}, {'measure': 'parenting stress, maternal life satisfaction', 'timeFrame': '12 month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['community resource', 'well-child care visit', 'low-income'], 'conditions': ['Low Income Families Basic Social Needs']}, 'referencesModule': {'references': [{'pmid': '25560448', 'type': 'DERIVED', 'citation': 'Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.'}]}, 'descriptionModule': {'briefSummary': "This research project is aimed to address low-income families' basic social needs (housing, food, employment, education, childcare, utilities) within the context of pediatric primary care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive impact of a similar intervention on pediatric residents' screening and referral to community agencies. This study will specifically test whether a further strengthened intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal enrollment in community resources and receipt of eligible benefits. In addition, we will measure the intervention's impact on maternal well-being, and compliance with well-child care (WCC) visits.\n\nThe project will take place at eight community health centers in the Greater Boston Area. The centers will be randomized to either an intervention or control site. Mothers who bring their infant in for a WCC visit from birth to 6 months will be eligible. They will be followed until their child is one year of age. Study subjects will complete two self-administered surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9 months old). Pediatric providers will also be subjects; and will fill out a demographic questionnaire at the time of enrollment.\n\nThe BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers.\n\nFamilies attending the control health centers will receive standard of care. Enrolled mothers will be offered the intervention at the end of the 12-month follow-up interview. When follow-up data collection is complete, the PI will offer the control sites the opportunity to implement the BNS protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mothers (18 yrs or older) who bring their infant between the ages of birth and 6 months for a well-child care visit\n* Medical providers who provide care to pediatric patients at the participating community health centers\n\nExclusion Criteria:\n\n* Foster parent\n* Mothers who anticipate changing their infant's site for care\n* Mothers who are non-English or non-Spanish speaking\n* Infants with hx of prematurity (born before 32 weeks)\n* Infants with chronic cardiac or respiratory diseases\n* Previously enrolled mother"}, 'identificationModule': {'nctId': 'NCT01303458', 'briefTitle': "Addressing Low-Income Families' Basic Social Needs at Pediatric Visits", 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': "Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project", 'orgStudyIdInfo': {'id': '4R00HD056160-02', 'link': 'https://reporter.nih.gov/quickSearch/4R00HD056160-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '4R00HD056160-02', 'link': 'https://reporter.nih.gov/quickSearch/4R00HD056160-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Study subjects will receive the Basic Needs Surveillance (BNS) intervention.', 'interventionNames': ['Behavioral: Basic Needs Surveillance (BNS) protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Study subjects in the control arm will receive the standard of care.'}], 'interventions': [{'name': 'Basic Needs Surveillance (BNS) protocol', 'type': 'BEHAVIORAL', 'description': "The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers", 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Arvin Garg', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02121', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Street Neighborhood Health Center', 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02122', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dorchester House Multi-Service Center', 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02122', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neponset Health Center', 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02124', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Codman Square Health Center', 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02125', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Upham's Corner Health Center", 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02131', 'city': 'Roslindale', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Greater Roslindale Medical and Dental Center', 'geoPoint': {'lat': 42.29121, 'lon': -71.1245}}, {'zip': '02119', 'city': 'Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'The Dimock Center', 'geoPoint': {'lat': 42.3251, 'lon': -71.09533}}, {'zip': '02127', 'city': 'South Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'South Boston Community Health Center', 'geoPoint': {'lat': 42.33343, 'lon': -71.04949}}], 'overallOfficials': [{'name': 'Arvin Garg, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Arvin Garg', 'investigatorAffiliation': 'Boston Medical Center'}}}}