Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 2:48 PM
Study NCT ID:
NCT04135469
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2019-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tax Preparation Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086522', 'term': 'Financial Stress'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Financial well being', 'timeFrame': '12 months', 'description': 'The consumer financial protection bureau (cfpb) financial -well-being questionnaire will be used to assess financial stability. It has 5 items with scores from from 0 to 4 where 4 is the response associated with the best financial well being. Total scores can range from 0 to 16. They are interpreted with a table stratifying the participants age as 19-61 and 62+ and higher scores are more favorable.'}, {'measure': 'Tax refund', 'timeFrame': '12 months', 'description': 'A copy of the IRS tax return form will be reviewed to extract the total tax refund amount'}, {'measure': 'Tax credits', 'timeFrame': '12 months', 'description': 'A copy of the IRS tax return form will be reviewed to extract the Earned Income Tax Credit and Child Tax Credit amounts'}], 'secondaryOutcomes': [{'measure': 'Maternal mental health', 'timeFrame': '12 months', 'description': 'The Beck depression inventory is a 21 item instrument with options of responses from 0 to 3. Total scores can range from 0 to 63 and are interpreted with this rubric: 1-10, these ups and downs are considered normal; 11-16, mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression'}, {'measure': 'Maternal well being', 'timeFrame': '12 months', 'description': 'The Flourishing Scale is a 12-item summary measure of well being. Each of the items is self-rated on a a scale of 0 to 10 where 10 is the best possible response related to well being. Total scores can range from 0 to 120. HIgher scores are associated with higher levels of well being.'}, {'measure': 'Parenting skills', 'timeFrame': '12 months', 'description': "The 'Me as a Parent' questionnaire will be used to assess parenting skills. It is a 16 item scale where a parent is asked to rate how strongly they agree or disagree with the statements. Responses range from 1 to 5 with 1- strongly disagree and 5= strongly agree. Total scores range from 16 to 80 and higher scores are associated with stronger parenting skills."}, {'measure': 'Maternal healthcare utilization', 'timeFrame': '12 months', 'description': 'The electronic medical record for the mother/guardian will be reviewed and the total number and types of health care utilized (eg outpatient visits and hospitalizations) will be abstracted.'}, {'measure': 'Child healthcare utilization', 'timeFrame': '12 months', 'description': 'The electronic medical record for the child will be reviewed and the total number and types of health care utilized (eg outpatient visits and hospitalizations) will be abstracted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tax preparation service', 'Tax filing', 'Earned Income Tax Credit (EITC)', 'Child tax credit'], 'conditions': ['Financial Stress', 'Maternal Distress']}, 'descriptionModule': {'briefSummary': "The goal of this study to understand what percentage of families in the pediatric clinic at Boston Medical Center (BMC) currently file taxes and use free tax preparation and would accept and use referral to a free tax preparation service. The investigators specifically want to understand which of two methods of connecting to free tax preparation (referral versus navigated connection) is more effective. Also studied will be the feasibility of using surveys on financial wellness and other health indicators to track participants' health.\n\nThese pilot findings will be used to design a larger study that aims to assess whether integrating free tax preparation services into a pediatric clinic can increase tax filing rates and, as a result, the amount of money families receive in tax refunds. Additionally, the investigators hope to understand whether receiving this service impacts parental stress as well as how parents and babies are using the healthcare system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Guardian of a child 0-5 years\n* English, Spanish, or Haitian-Creole -speaking\n* Child is a Boston Medical Center pediatric primary care patient\n\nExclusion Criteria:\n\n* Guardian not present at time of clinic visit\n* Have no taxable income for the calendar year\n* Not using BMC for pediatric primary care\n* Have already filed their taxes for 2020'}, 'identificationModule': {'nctId': 'NCT04135469', 'briefTitle': 'Tax Preparation Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Integration of Tax Preparation Into Pediatric Clinics: A Pilot Study', 'orgStudyIdInfo': {'id': 'H-38575'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Referral for tax preparation', 'description': 'Participants will be given contact information on financial services, including all the free tax preparation services in the city, including Boston Medical Center.', 'interventionNames': ['Other: Referral for tax preparation services']}, {'type': 'EXPERIMENTAL', 'label': 'BMC tax preparation', 'description': 'A navigator will help the participants with using free tax preparation services located at Boston Medical Center or a service located elsewhere in the city.', 'interventionNames': ['Other: Referral for tax preparation services', 'Other: Navigator assisted tax preparation services at BMC']}], 'interventions': [{'name': 'Referral for tax preparation services', 'type': 'OTHER', 'description': 'Printed materials will be provided with contact information for tax preparation services at BMC and other sites in the city.', 'armGroupLabels': ['BMC tax preparation', 'Referral for tax preparation']}, {'name': 'Navigator assisted tax preparation services at BMC', 'type': 'OTHER', 'description': 'A study navigator will assist the participant in accessing the BMC located tax preparation services.', 'armGroupLabels': ['BMC tax preparation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lucy Marcil, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}