Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-25 @ 1:38 AM
Study NCT ID:
NCT04901403
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2021-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Earned Income Tax Credit Access Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D006792', 'term': 'House Calls'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-14', 'size': 141155, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-27T11:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Earned Income Tax Credit receipt', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': 'Self-report'}], 'secondaryOutcomes': [{'measure': 'Child maltreatment behaviors', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': 'Self-report on the Brief Child Abuse Potential Inventory. 34 Yes/No questions. E.g. "A child needs very strict rules."'}, {'measure': 'Intimate partner violence', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': "Self-report from Women's Experiences of Battering Scale. 10 items relating to how they would describe their life with their partner. Scale ranges from Strongly agree to strongly disagree. E.g. 1. He makes me feel unsafe even in my own home."}, {'measure': 'Depression', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': 'Self-report from the Center for Epidemiologic Studies Depression Scale (CES-D). 20 questions on a scale from "rarely" to "most or all of the time" relating to things experienced within the past week. E.g. "I was bothered by things that usually don\'t bother me."'}, {'measure': 'Anxiety', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': 'Self-report from the General Anxiety Disorder (GAD-7). 7 questions relating to feelings experienced over the past 2 weeks, with response options ranging from "not at all" to "nearly every day." E.g. "Not being able to stop or control worrying."'}, {'measure': 'Economic hardship', 'timeFrame': 'Within 2 years of receiving the intervention', 'description': 'Self-report on 11 yes or no items indicating whether individual hardships were experienced in the past year. E.g. "Was there anyone in your household who needed to see a doctor or go to the hospital but could not go because of the cost?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Study is Intended to Increase Take-up of EITC']}, 'descriptionModule': {'briefSummary': 'The EITC Access Study an intervention study provided to families in 7 counties in Michigan.The intervention involves appending a concentrated benefits advocacy intervention onto an existing home visiting program. There are 5 treatment counties and 2 control counties that will survey families in the home visiting program to compare the relative benefits of the added benefits advocacy intervention on the outcomes of parent mental health, intimate partner violence, economic hardship, earned income tax credit take-up, and child maltreatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age, has a child in their home\n\nExclusion Criteria:\n\n* Does not speak or read English, Spanish, Burmese, or Arabic'}, 'identificationModule': {'nctId': 'NCT04901403', 'briefTitle': 'Earned Income Tax Credit Access Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Earned Income Tax Credit Access Study', 'orgStudyIdInfo': {'id': 'HUM00190754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Education intervention', 'description': 'Parents in the treatment group will receive information about Earned Income Tax Credit, including how to sign up for free. They will also receive help with budgeting and finances from their home visitor.', 'interventionNames': ['Other: Education', 'Other: Home visiting']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Control group families will receive home visiting services as usual.', 'interventionNames': ['Other: Home visiting']}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'description': 'Parents will be provided with information about Earned Income Tax Credits and budgeting', 'armGroupLabels': ['Education intervention']}, {'name': 'Home visiting', 'type': 'OTHER', 'description': 'Parents as Teachers home visiting program', 'armGroupLabels': ['Control group', 'Education intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49017', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Calhoun Intermediate School District', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '48197', 'city': 'Belleville', 'state': 'Michigan', 'country': 'United States', 'facility': 'SOS Community Services', 'geoPoint': {'lat': 42.20476, 'lon': -83.48521}}, {'zip': '48422', 'city': 'Croswell', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sanilac Intermediate School District', 'geoPoint': {'lat': 43.27558, 'lon': -82.62104}}, {'zip': '49931', 'city': 'Houghton', 'state': 'Michigan', 'country': 'United States', 'facility': 'Keweenaw Family Resource Center', 'geoPoint': {'lat': 47.12187, 'lon': -88.56901}}, {'zip': '49048', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Catholic Charities Diocese of Kalamazoo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48040', 'city': 'Marysville', 'state': 'Michigan', 'country': 'United States', 'facility': 'St Clair RESA', 'geoPoint': {'lat': 42.91253, 'lon': -82.48686}}, {'zip': '49002', 'city': 'Portage', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kalamazoo KRESA', 'geoPoint': {'lat': 42.20115, 'lon': -85.58}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only aggregate information will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Katie Maguire-Jack', 'investigatorAffiliation': 'University of Michigan'}}}}