Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05194020
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matt.shepherd@midwestevaluation.com', 'phone': '833-643-9377', 'title': 'Dr. Matthew Shepherd', 'organization': 'Midwest Evaluation and Research'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'High levels of attrition due to items not being applicable to some participants'}}, 'adverseEventsModule': {'timeFrame': '1 year through study completion', 'description': 'The definitions of adverse events do not differ from the clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.', 'otherNumAtRisk': 720, 'deathsNumAtRisk': 720, 'otherNumAffected': 0, 'seriousNumAtRisk': 720, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Healthy Parenting Behavior Measurement #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'classes': [{'title': 'Mean at baseline', 'categories': [{'measurements': [{'value': '3.96', 'spread': '.87', 'groupId': 'OG000'}]}]}, {'title': 'Mean at follow-up', 'categories': [{'measurements': [{'value': '4.12', 'spread': '.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in mean from baseline in behavior in parenting behavior (interaction with children) to mean at 12 months from enrollment.', 'description': '1A) Will participants report significantly healthier parenting behavior after completing primary educational services and employment support services?\n\n7 items engage w/child measured on the Healthy Parenting Behavior Scale #1.\n\nThe scale was 1-5 and as follows:\n\n1=Never, 2=1 to 2 days per month, 3=3 or 4 days per month, 4=2 or 3 days per week, 5=Every day or almost every day\n\n1 item- frequency reach out to children (categories, 4-point scale); Measured on the Healthy Parenting Behavior Scale #2\n\n1=Every day or almost every day, 2=One to three times a week, 3=One to three times in the past month, 4=Never in the past month\n\nThe 8 items are measured as a construct. All items are added together and divided by 8 to create the construct score. The higher the score, the better the outcome.\n\nmaximum score of 4.5, minimum score of 1.0', 'unitOfMeasure': 'total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '248 participants responded to at least 80% of the items in this measure.'}, {'type': 'PRIMARY', 'title': 'Healthy Co-parenting Behavior Measurement #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'classes': [{'title': 'Mean at Baseline', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Mean at Follow-Up', 'categories': [{'measurements': [{'value': '3.39', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline in co-parenting behavior at 12 months from enrollment.', 'description': '2\\) Will participants report significantly healthier co-parenting behavior after completing primary educational services and employment support services?\n\nCo-parenting behavior:\n\n11 items: frequency of agreement with key co-parenting behaviors (interval, 5-point scale)\n\nMeasured on the Healthy Co-Parenting Behavior Scale #1 as:\n\n1. Strongly Disagree\n2. Disagree\n3. Neutral\n4. Agree\n5. Strongly Agree\n\nIndividually, for five items, the higher the score the better. Six items are reverse scored, the lower the rating, the better the score.\n\nThe construct is created by adding all scores together and dividing by 11. The higher the score on a scale of 1-5, the better the outcome. The lower the score, the worse the outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '468 participants responded to at least 80% of the items in this measure.'}, {'type': 'PRIMARY', 'title': 'Healthy Financial Behavior Measurement #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'classes': [{'title': 'Number of participants with checking account at baseline', 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with checking account at 12-month follow-up', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with savings account at baseline', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with savings account at 12-month follow-up', 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from baseline in father financial behavior at 12 months from enrollment.', 'description': '3\\) Will participants report significantly healthier financial behavior after completing primary educational services and employment support services?\n\nFather financial behavior:\n\n2 items: yes or no questions for have resume, checking/savings accounts (dichotomous)\n\nNumbers reported in the results are counts of yes (participant has a checking account and participant has a savings account).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '507 participants responded to at least 80% of the items in this measure.'}, {'type': 'SECONDARY', 'title': 'Healthy Parenting Attitudes Measurement #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'classes': [{'title': 'Mean at Baseline', 'categories': [{'measurements': [{'value': '4.56', 'spread': '.44', 'groupId': 'OG000'}]}]}, {'title': 'Mean at Post-Program Survey', 'categories': [{'measurements': [{'value': '4.59', 'spread': '.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in parenting attitudes (towards children) from enrollment to completion of the program (post-survey).', 'description': '4\\) Will participants report significantly healthier parenting attitudes after completing primary educational services and employment support services?\n\nParenting attitudes (toward children) 7 items: frequency of key attitudes (categories, 5-point scale)\n\nMeasured on the Healthy Parenting Attitudes Scale #1 as:\n\n1. Always\n2. Often\n3. Sometimes\n4. Rarely\n5. Never\n\nA construct is created by adding the score of the 7 items together and dividing by 7.\n\nMaximum score=5 (7\\*5/7), minimum score=1.0 (1\\*7/7)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '331 participants responded to at least 80% of the items in this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This is the number of participants who enrolled into the program.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '720'}]}, {'type': 'Baseline Survey Completion', 'comment': 'This is the number of participants enrolled into the study who completed the baseline survey.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '697'}]}, {'type': 'Post Program Survey Completion', 'comment': 'This is the number of participants who completed the post-program survey. It was not required to take the baseline survey to complete the post-program survey.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}]}, {'type': '12-Month Follow-Up Survey Completion', 'comment': 'We still collected a follow-up survey from participants who did not complete the program if we were able to reach them. Participants were not required to have completed the post-program survey to take the follow-up, but needed to have taken the baseline survey.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '532'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '720'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '720', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.\n\nPrimary Services: Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '718', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.30', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '720', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '662', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '524', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '720', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline is number of participants who consented to be in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-17', 'size': 485536, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-22T17:39', 'hasProtocol': True}, {'date': '2024-10-17', 'size': 200537, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-22T17:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 731}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2021-11-22', 'resultsFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-24', 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthy Parenting Behavior Measurement #1', 'timeFrame': 'Change in mean from baseline in behavior in parenting behavior (interaction with children) to mean at 12 months from enrollment.', 'description': '1A) Will participants report significantly healthier parenting behavior after completing primary educational services and employment support services?\n\n7 items engage w/child measured on the Healthy Parenting Behavior Scale #1.\n\nThe scale was 1-5 and as follows:\n\n1=Never, 2=1 to 2 days per month, 3=3 or 4 days per month, 4=2 or 3 days per week, 5=Every day or almost every day\n\n1 item- frequency reach out to children (categories, 4-point scale); Measured on the Healthy Parenting Behavior Scale #2\n\n1=Every day or almost every day, 2=One to three times a week, 3=One to three times in the past month, 4=Never in the past month\n\nThe 8 items are measured as a construct. All items are added together and divided by 8 to create the construct score. The higher the score, the better the outcome.\n\nmaximum score of 4.5, minimum score of 1.0'}, {'measure': 'Healthy Co-parenting Behavior Measurement #1', 'timeFrame': 'Change from baseline in co-parenting behavior at 12 months from enrollment.', 'description': '2\\) Will participants report significantly healthier co-parenting behavior after completing primary educational services and employment support services?\n\nCo-parenting behavior:\n\n11 items: frequency of agreement with key co-parenting behaviors (interval, 5-point scale)\n\nMeasured on the Healthy Co-Parenting Behavior Scale #1 as:\n\n1. Strongly Disagree\n2. Disagree\n3. Neutral\n4. Agree\n5. Strongly Agree\n\nIndividually, for five items, the higher the score the better. Six items are reverse scored, the lower the rating, the better the score.\n\nThe construct is created by adding all scores together and dividing by 11. The higher the score on a scale of 1-5, the better the outcome. The lower the score, the worse the outcome.'}, {'measure': 'Healthy Financial Behavior Measurement #1', 'timeFrame': 'Change from baseline in father financial behavior at 12 months from enrollment.', 'description': '3\\) Will participants report significantly healthier financial behavior after completing primary educational services and employment support services?\n\nFather financial behavior:\n\n2 items: yes or no questions for have resume, checking/savings accounts (dichotomous)\n\nNumbers reported in the results are counts of yes (participant has a checking account and participant has a savings account).'}], 'secondaryOutcomes': [{'measure': 'Healthy Parenting Attitudes Measurement #1', 'timeFrame': 'Change in parenting attitudes (towards children) from enrollment to completion of the program (post-survey).', 'description': '4\\) Will participants report significantly healthier parenting attitudes after completing primary educational services and employment support services?\n\nParenting attitudes (toward children) 7 items: frequency of key attitudes (categories, 5-point scale)\n\nMeasured on the Healthy Parenting Attitudes Scale #1 as:\n\n1. Always\n2. Often\n3. Sometimes\n4. Rarely\n5. Never\n\nA construct is created by adding the score of the 7 items together and dividing by 7.\n\nMaximum score=5 (7\\*5/7), minimum score=1.0 (1\\*7/7)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fathers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help fathers establish and strengthen their relationship with their children and the mothers of their children; to reduce domestic violence in vulnerable families; to improve economic stability of fathers through comprehensive, job-driven career services; to employ intensive case management barrier removal, individual job coaching, and comprehensive family development to improve short and long-term outcomes.', 'detailedDescription': 'After being informed about the study and giving consent, participants will enroll in a five-week All in Dads! program that collects data at enrollment, at the end of the program, and 12 months following the program. Research questions in this study are framed by a Descriptive Evaluation Design to assess whether outcomes improve for low-income fathers who participate in the All in Dads! (AID!) Project. Primary and secondary outcomes are assessed before and after participants complete core curricula-Father Factor, The New Playbook, and Money Smart-and Job Readiness Coaching and Career Development as employment support services (pre to post). Primary outcome measures will indicate whether behavior improved for healthy family relationships (parent, co-parent, and partner) and economic stability (financial, employment). Secondary outcome measures will indicate whether behavior improved for the attitudes and expectations that facilitate and reflect behavior for healthy family relationships and economic stability.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age 18 and older)\n* Father/father figure\n* Reside in Franklin County, Ohio\n\nExclusion Criteria:\n\n* Minor (under the age of 18)\n* Not a father/father figure\n* Reside outside of Franklin County, Ohio'}, 'identificationModule': {'nctId': 'NCT05194020', 'briefTitle': 'All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Midwest Evaluation & Research'}, 'officialTitle': 'All in Dads! Program Evaluation', 'orgStudyIdInfo': {'id': '2002/03/30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary Services', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.', 'interventionNames': ['Other: Primary Services']}], 'interventions': [{'name': 'Primary Services', 'type': 'OTHER', 'description': 'Participants receive 16 hours of Father Factor curricula, 4 hours of The New Playbook curricula, 4 hours of Money Smart curricula over the course of five weeks. Participants also receive on-going job readiness support and post-employment support.', 'armGroupLabels': ['Primary Services']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Action for Children', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Matt D Shepherd, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwest Evaluation & Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participant data will be confidential and aggregated. No individual participant data will be released unless requested by the courts. The study looks at data as a whole.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Evaluation & Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Action for Children', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matt Shepherd', 'investigatorAffiliation': 'Midwest Evaluation & Research'}}}}