Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01264718
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2010-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Glenn.Flores@medica.com', 'phone': '952-992-3367', 'title': 'Dr. Glenn Flores, Distinguished Chair of Health Policy Research', 'organization': 'Medica Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This project involved a behavioral intervention (not a drug- or device-based intervention), so no participants were at risk of adverse events and no adverse event assessment process was instituted.', 'description': 'This project involved a behavioral intervention (not a drug- or device-based intervention), so no participants were at risk of adverse events and no adverse event assessment process was instituted.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Children With Health Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'OG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}], 'classes': [{'categories': [{'title': 'Child obtained health insurance', 'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Child did not obtain health insurance', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year after enrollment', 'description': 'A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)'}, {'type': 'SECONDARY', 'title': 'Number of Days From Study Enrollment to Obtaining Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'OG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '112'}, {'value': '140', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '236'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One year after enrollment', 'description': 'Zero time (the point at which the maneuver is imposed) is the data and time of study enrollment. Occurrence of the main outcome event is the date and time of official notification that the child is insured.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)'}, {'type': 'SECONDARY', 'title': 'Parental Satisfaction With the Process of Obtaining Coverage for Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'OG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}], 'classes': [{'categories': [{'title': '1- Parent very unsatisfied with process', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '2- Parent unsatisfied with process', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '3- Parent uncertain about process', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': '4- Parent satisfied with process', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': '5- Parent very satisfied with process', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year after enrollment', 'description': 'Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '121 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, 9 withdrew prior to one-year follow-up, 2 did not answer); and 113 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, 15 withdrew prior to one-year follow-up, and 1 did not answer).'}, {'type': 'SECONDARY', 'title': 'Intervention Cost-Effectiveness Ratio (ICER)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'OG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}], 'classes': [{'title': 'PM stipends- total cost', 'categories': [{'measurements': [{'value': '53,838', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PM travel and supplies- total cost', 'categories': [{'measurements': [{'value': '5,195', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PM training sessions and meetings- total cost', 'categories': [{'measurements': [{'value': '1411.61', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Program coordinator salary- total cost', 'categories': [{'measurements': [{'value': '25,350', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ED visits- total cost', 'categories': [{'measurements': [{'value': '60,885', 'groupId': 'OG000'}, {'value': '62,730', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalizations- total cost', 'categories': [{'measurements': [{'value': '58,431', 'groupId': 'OG000'}, {'value': '81,537', 'groupId': 'OG001'}]}]}, {'title': 'ICU stays- total cost', 'categories': [{'measurements': [{'value': '74,742', 'groupId': 'OG000'}, {'value': '277,094', 'groupId': 'OG001'}]}]}, {'title': 'Wage loss/other costs of caring for sick child', 'categories': [{'measurements': [{'value': '12,985', 'groupId': 'OG000'}, {'value': '33,589', 'groupId': 'OG001'}]}]}, {'title': 'Total for all costs', 'categories': [{'measurements': [{'value': '291,426', 'groupId': 'OG000'}, {'value': '454,647', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'ICER', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6,045.22', 'estimateComment': 'The estimated value is the savings per child per year insured.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.'}, {'groupIds': ['OG000'], 'paramType': 'ICER', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4,185.15', 'estimateComment': 'The estimated value is the savings for each percent increase in children obtaining insurance per year.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.'}], 'paramType': 'NUMBER', 'timeFrame': 'One year after enrollment', 'description': 'The difference in total costs between the intervention group and controls', 'unitOfMeasure': 'Dollars', 'reportingStatus': 'POSTED', 'populationDescription': '237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'FG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Loss of Medicaid/CHIP eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention: Parent Mentors', 'description': 'Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training.'}, {'id': 'BG001', 'title': 'Control: No Intervention', 'description': 'Families received traditional Medicaid/CHIP outreach'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Latino', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': 'African-American/Black', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of months child had been uninsured', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '8', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '24'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'participants', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': '237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2010-12-20', 'resultsFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-18', 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Children With Health Insurance', 'timeFrame': 'One year after enrollment', 'description': 'A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center.'}], 'secondaryOutcomes': [{'measure': 'Number of Days From Study Enrollment to Obtaining Coverage', 'timeFrame': 'One year after enrollment', 'description': 'Zero time (the point at which the maneuver is imposed) is the data and time of study enrollment. Occurrence of the main outcome event is the date and time of official notification that the child is insured.'}, {'measure': 'Parental Satisfaction With the Process of Obtaining Coverage for Child', 'timeFrame': 'One year after enrollment', 'description': 'Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions'}, {'measure': 'Intervention Cost-Effectiveness Ratio (ICER)', 'timeFrame': 'One year after enrollment', 'description': 'The difference in total costs between the intervention group and controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['minority health', 'child', 'Medicaid'], 'conditions': ['Uninsured Children Eligible for Medicaid or CHIP']}, 'referencesModule': {'references': [{'pmid': '25476583', 'type': 'BACKGROUND', 'citation': "Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children. Contemp Clin Trials. 2015 Jan;40:124-37. doi: 10.1016/j.cct.2014.11.015. Epub 2014 Dec 2."}, {'pmid': '25447369', 'type': 'BACKGROUND', 'citation': 'Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured children. Acad Pediatr. 2015 May-Jun;15(3):275-81. doi: 10.1016/j.acap.2014.09.011. Epub 2014 Dec 1.'}, {'pmid': '27244706', 'type': 'BACKGROUND', 'citation': 'Flores G, Lin H, Walker C, Lee M, Currie JM, Allgeyer R, Fierro M, Henry M, Portillo A, Massey K. Parent Mentors and Insuring Uninsured Children: A Randomized Controlled Trial. Pediatrics. 2016 Apr;137(4):e20153519. doi: 10.1542/peds.2015-3519. Epub 2016 Mar 17.'}, {'pmid': '27000795', 'type': 'BACKGROUND', 'citation': 'Flores G, Lin H, Walker C, Lee M, Portillo A, Henry M, Fierro M, Massey K. A cross-sectional study of parental awareness of and reasons for lack of health insurance among minority children, and the impact on health, access to care, and unmet needs. Int J Equity Health. 2016 Mar 22;15:44. doi: 10.1186/s12939-016-0331-y.'}, {'pmid': '28378019', 'type': 'BACKGROUND', 'citation': 'Flores G, Portillo A, Lin H, Walker C, Fierro M, Henry M, Massey K. A successful approach to minimizing attrition in racial/ethnic minority, low-income populations. Contemp Clin Trials Commun. 2017 Mar;5:168-174. doi: 10.1016/j.conctc.2017.01.009. Epub 2017 Feb 14.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4314321/', 'label': "Manuscript: Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children"}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=A+successful+program+for+training+parent+mentors+to+provide+assistance+with+obtaining+health+insurance+for+uninsured+children', 'label': 'Manuscript: A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured children'}, {'url': 'http://equityhealthj.biomedcentral.com/articles/10.1186/s12939-016-0331-y', 'label': 'Manuscript: A cross-sectional study of parental awareness of and reasons for lack of health insurance among minority children, and the impact on health, access to care, and unmet needs'}]}, 'descriptionModule': {'briefSummary': "The Kids' HELP trial rigorously documented that a Parent Mentor intervention results in multiple benefits: more children are insured faster, children's access to healthcare and parental satisfaction improve, quality of well-child care is enhanced, thousands of dollars are saved per child, jobs are created, disparities are eliminated, and the intervention potentially could save our nation billions of dollars.", 'detailedDescription': "Background: Six million US children are uninsured, despite two-thirds being eligible for Medicaid/Children's Health Insurance Program (CHIP), and minority children are at especially high risk. The most effective way to insure uninsured children, however, is unclear.\n\nMethods: We conducted a randomized trial of the effects of parent mentors (PMs) on insuring uninsured minority children. PMs were experienced parents with \\>=1 Medicaid/CHIP-covered child who received 2 days of training, then assisted families for 1 year with insurance applications, retaining coverage, medical homes, and social needs; controls received traditional Medicaid/CHIP outreach. The primary outcome was obtaining insurance 1 year post-enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance\n2. The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both\n3. The uninsured child is eligible for either Medicaid or CHIP\n4. The parent/guardian is willing to be contacted monthly by telephone, or in the form of a home visit (if no functioning telephone is present in the household).'}, 'identificationModule': {'nctId': 'NCT01264718', 'briefTitle': 'A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children', 'orgStudyIdInfo': {'id': '082010-138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "After randomization to the control group, minority low-income parents of uninsured, Medicaid/CHIP-eligible children received only traditional Medicaid/Children's Health Insurance Program (CHIP) outreach and enrollment."}, {'type': 'EXPERIMENTAL', 'label': 'Parent Mentors', 'description': 'After randomization to the Parent Mentor group, minority low-income parents of uninsured Medicaid/CHIP-eligible children received face-to-face instruction and guidance from Parent Mentors on obtaining and keeping Medicaid/CHIP for their child; getting a doctor, dentist, and pharmacist; and addressing social determinants of health.', 'interventionNames': ['Behavioral: Parent Mentors']}], 'interventions': [{'name': 'Parent Mentors', 'type': 'BEHAVIORAL', 'otherNames': ["Kids' HELP"], 'description': 'After random assignment to the Parent Mentor group, minority low-income parents of Medicaid/CHIP eligible children met with Parent Mentors to receive instruction and help on completing, submitting applications for, and maintaining Medicaid/CHIP coverage for their child.', 'armGroupLabels': ['Parent Mentors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Glenn Flores, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Connecticut Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief Research Officer, and Associate Chair of Research', 'investigatorFullName': 'Glenn Flores, MD', 'investigatorAffiliation': "Connecticut Children's Medical Center"}}}}