Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-27 @ 3:46 AM
Study NCT ID:
NCT05311592
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2022-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting Responsible Fatherhood Program (Fatherhood FIRE)
Sponsor:
Organization:
Raw JSON
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Participants will be randomized either to the virtual condition, or to the in person condition.\n\nUpdate: Effective 1/1/2025 randomization ceased and from that date onward data participants were able to choose which arm they partook in.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1475}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Father Involvement (IFI) (Father Involvement)', 'timeFrame': 'Baseline', 'description': 'The IFI49, is a 26-item self-report instrument that assesses indirect and direct involvement using a 7- point Likert scale ranging from 0 (very poor) to 6 (excellent). This measure addresses the 3 main domains of father involvement: engagement, accessibility, and responsibility. Overall scores can therefore range from 0 to 156. Higher scores represent increased levels of engagement. Reliability of subscales in the initial study ranged from α = .69 to α = .90.'}], 'secondaryOutcomes': [{'measure': 'Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics', 'timeFrame': 'Baseline', 'description': 'This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study, that gathers demographic information regarding participants.'}, {'measure': 'Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey', 'timeFrame': 'At start of intervention (Week 1 of 4)', 'description': 'This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.'}, {'measure': 'Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey', 'timeFrame': 'Immediately post intervention (Week 4 of 4 weeks)', 'description': 'This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.'}, {'measure': 'Child-Parent Relationship Scale Short Form (CPRS-SF) (Parent-Child Relationship Quality)', 'timeFrame': 'Baseline', 'description': "CPRS-SF48 is a self-report measure about the child and parent's interactions with child related to closeness and conflict. 15-items are rated on 5-point Likert scales. The ratings can be summed into groups of items corresponding to conflict and closeness subscales. The 8-item conflict subscale measures the degree to which a parent feels that his or her relationship with a child is characterized by negativity. Scores for conflict scale range from 8-40. Higher score on the conflict questions suggest parents feel their relationship with their child is characterized by negativity and a lower score is desirable. The 7-item closeness scale assesses the extent to which a parent feels that the relationship is characterized by warmth, affection, and open communication. Scores for closeness subscale range between 7-35. A higher score on the closeness questions suggest the parent/child relationship is characterized by warmth, affection and open communication and a higher score is desirable"}, {'measure': 'Skills/Knowledge Assessment (Skills/Knowledge Acquisition)', 'timeFrame': 'Change from Baseline Skills at immediately post intervention and at 6 months', 'description': 'The Skills/Knowledge Assessment is an outcome measure that will be developed by program staff together with the local evaluator. The measure will be a multiple-choice assessment using scenarios describing parent-child and co-parenting interactions to determine whether fathers have learned skills and techniques taught at workshops. This measure will be calculated by obtaining the percentage of correctly-scored items. Higher scores indicate great skill acquisition. Two versions of this assessment will be created to prevent practice effects. Given that this is a homegrown measure, to validate this measure, the investigators will correlate the skill assessment scores with the well validated Assessing Emotions Scale and assess whether relationship skill scores differ by key demographic and social economic factors.'}, {'measure': 'Assessing Emotions Scale (Emotional Intelligence)', 'timeFrame': 'Baseline', 'description': 'The Assessing Emotions Scale47 is a 33-item measure of emotional intelligence that uses a Likert scale of measurement (value 1 - 5, ranging from strongly disagree to strongly agree), calculated by summing the responses across all items. Higher scores indicate higher levels of emotional intelligence. This measure has demonstrated good internal consistency, test-retest reliability, and convergent validity.'}, {'measure': 'Childhood Trauma Questionnaire Short Form (CTQ-SF) (Childhood Trauma)', 'timeFrame': 'Baseline', 'description': 'The CTQ-SF45 is a 28-item measure of childhood trauma that uses a Likert scale of measurement ranging from 1 (never true) to 5 (very often true). Items are divided into 5 sub-categories: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. This measure is calculated by summing most responses and reverse scoring select items and has demonstrated good test-retest reliability, criterion-related validity, and internal consistency.'}, {'measure': 'Parenting Alliance Inventory (PAI) (Quality of Co-Parenting Relationship)', 'timeFrame': 'Baseline', 'description': "The PAI46 is a self-report instrument that assesses the degree to which parents believe that they have a sound working relationship with their child's other parent using a 5- point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). All items are averaged to create a global parenting alliance score (α = .97). Higher scores indicate a stronger parenting alliance. This measure demonstrated excellent internal consistency and good construct and concurrent validity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parenting', 'Family Relations', 'Father-Child Relations']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Hawkins, A. (2019) Are federally-supported relationship education programs for lower-income individuals and couples working? A review of evaluation research. American Enterprise Institute.'}, {'type': 'BACKGROUND', 'citation': 'Haskins, R. & Sawhill, I. (2003) Work and marriage: The way to end poverty and welfare. The Brookings Institution Policy Brief: Welfare Reform and Beyond #28, 1-8.'}, {'type': 'BACKGROUND', 'citation': 'Acs, G. & Nelson, S. (2004) What do \'I do\'s do? Potential benefits of marriage for cohabiting couples with children." Assessing the New Federalism Policy Brief B-59. Washington, DC: The Urban Institute.'}, {'pmid': '11439708', 'type': 'BACKGROUND', 'citation': 'Kiecolt-Glaser JK, Newton TL. Marriage and health: his and hers. Psychol Bull. 2001 Jul;127(4):472-503. doi: 10.1037/0033-2909.127.4.472.'}, {'pmid': '12183886', 'type': 'BACKGROUND', 'citation': 'Bramlett MD, Mosher WD. Cohabitation, marriage, divorce, and remarriage in the United States. Vital Health Stat 23. 2002 Jul;(22):1-93.'}, {'type': 'BACKGROUND', 'citation': 'McLanahan, S., Garfinkel, I., Reichman, N. et al. (2003) The Fragile Families and Child Wellbeing Study: Baseline National Report. Princeton, NJ: Center for Research on Child Wellbeing, Princeton University.'}, {'pmid': '18613490', 'type': 'BACKGROUND', 'citation': "Carlson MJ, McLanahan SS, Brooks-Gunn J. Coparenting and nonresident fathers' involvement with young children after a nonmarital birth. Demography. 2008 May;45(2):461-88. doi: 10.1353/dem.0.0007."}, {'pmid': '29681652', 'type': 'BACKGROUND', 'citation': "Carlson MJ, VanOrman AG, Turner KJ. Fathers' Investments of Money and Time Across Residential Contexts. J Marriage Fam. 2017 Feb;79(1):10-23. doi: 10.1111/jomf.12324. Epub 2016 Jun 27."}, {'type': 'BACKGROUND', 'citation': 'Amato, P. R. (2000). Consequences of divorce for adults and children. Journal of Marriage and Family, 58, 356 365.'}, {'pmid': '11584788', 'type': 'BACKGROUND', 'citation': 'Amato PR. Children of divorce in the 1990s: an update of the Amato and Keith (1991) meta-analysis. J Fam Psychol. 2001 Sep;15(3):355-70. doi: 10.1037//0893-3200.15.3.355.'}, {'pmid': '11642350', 'type': 'BACKGROUND', 'citation': "Amato PR, Booth A. The legacy of parents' marital discord: consequences for children's marital quality. J Pers Soc Psychol. 2001 Oct;81(4):627-38."}, {'type': 'BACKGROUND', 'citation': 'Whisman, M. A., & Uebelacker, L. A. (2003). Comorbidity of relationship distress and mental and physical health problems. In D. K. Snyder & M. A. Whisman (Eds.), Treating difficult couples (pp. 3-26). New York, NY: Guilford.'}, {'type': 'BACKGROUND', 'citation': 'Institute for American Values (2002). Why marriage matters: Twenty-one conclusions from the social sciences.'}, {'type': 'BACKGROUND', 'citation': 'Yoder, J., Brisson, D. & Lopez, A. (2016) Moving beyond fatherhood involvement: The association between father-child relationship quality and youth delinquency trajectories. Family Relations, 65: 462-476.'}, {'type': 'BACKGROUND', 'citation': 'Cabrera, N. & Tamis-LeMonda, C. (Eds.) (2013) Handbook of Father Involvement: Multidisciplinary Perspectives (2nd Ed). New York, NY: Routledge'}, {'type': 'BACKGROUND', 'citation': 'Hawkins, A. J., & Fackrell, T. A. (2010). Does couple education for lower-income couples work? A meta-analytic study of emerging research. Journal of Couple & Relationship Therapy: Innovations in Clinical and Educational Interventions, 9(2), 181-191.'}, {'type': 'BACKGROUND', 'citation': 'Cummings, E. & Merrilees, C. (2010) Identifying the dynamic processes underlying links between marital conflict and child adjustment. In M. Schulz, M. Pruett, P. Kerig & R. Parke (Eds.) Strengthening couple relationships for optimal child development: Lessons from research and intervention (pp. 27-40). Washington, D.C.: American Psychological Association.'}, {'type': 'BACKGROUND', 'citation': 'Gottman,J.M., Coan, J. A., Carrere, S., & Swanson, C. (1998). Predicting marital happiness and stability from newlywed interactions. Journal of Marriage and Family, 60, 5-22.'}, {'type': 'BACKGROUND', 'citation': 'Markman, H. J., & Hahlweg, K. (1993). The prediction & prevention of marital distress: An international perspective. Clinical Psychology Review, 13, 29-43.'}, {'type': 'BACKGROUND', 'citation': 'Gottman, J. M. (1994). What predicts divorce? The relationship between marital processes and marital outcomes. Hillsdale, NJ: Erlbaum.'}, {'type': 'BACKGROUND', 'citation': 'Wetzler, S. Government-funded relationship education can work, The Atlantic, March 14, 2014.'}, {'type': 'BACKGROUND', 'citation': 'Hsueh, J., Alderson, D. P., Lundquist, E., Michalopoulos, C., Gubits, D., Fein, D., & Knox, V. (2012). The Supporting Healthy Marriage evaluation: Early impacts on low-income families (OPRE Report No. 2012-11). Washington, DC: U.S. Department of Health and Human Services, Administration for Children and Families, Office of Planning, Research and Evaluation.'}, {'type': 'BACKGROUND', 'citation': 'Lundquist, E., Hsueh, J., Lowenstein, A., Faucetta, K., Gubits, D., Michalopoulos, C., & Knox, V. (2014). A family strengthening program for low-income families: Final impacts from the Supporting Healthy Marriage evaluation. OPRE Report 2013-49A. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U. S. Department of Health and Human Services.'}, {'type': 'BACKGROUND', 'citation': 'Cowan, P. & Cowan, C. (2014). Controversies in couple relationship education: Overlooked evidence and implications for research and policy. Psychology, Public Policy, and Law, 20, 361-383.'}, {'pmid': '18837590', 'type': 'BACKGROUND', 'citation': 'Hawkins AJ, Blanchard VL, Baldwin SA, Fawcett EB. Does marriage and relationship education work? A meta-analytic study. J Consult Clin Psychol. 2008 Oct;76(5):723-34. doi: 10.1037/a0012584.'}, {'pmid': '22304880', 'type': 'BACKGROUND', 'citation': 'Hawkins AJ, Stanley SM, Blanchard VL, Albright M. Exploring programmatic moderators of the effectiveness of marriage and relationship education programs: a meta-analytic study. Behav Ther. 2012 Mar;43(1):77-87. doi: 10.1016/j.beth.2010.12.006. Epub 2011 Jun 1.'}, {'type': 'BACKGROUND', 'citation': 'Pinquart, M., & Teubert, D. (2010). A meta-analytic study of couple interventions during the transition to parenthood. Family Relations, 59, 221-231.'}, {'type': 'BACKGROUND', 'citation': "Wood, R., McConnell, S., Quinn, M., Clarkwest, A., & Hsueh, J. (2010). Strengthening Unmarried parents' relationships: The early impacts of building strong families. Washington DC: Mathematic Policy Research."}, {'type': 'BACKGROUND', 'citation': 'Schutte, N. S., Malouff, J. M., Hall, L. E., Haggerty, D. J., Cooper, J. T., Golden, C. J., & Dornheim, L. (1998). Development and validation of a measure of emotional intelligence. Personality and Individual Differences, 25(2), 167-177.'}, {'type': 'BACKGROUND', 'citation': 'Abidin, R. R., & Brunner, J. F. (1995). Development of a parenting alliance inventory. Journal of Clinical Child Psychology, 24(1), 31-40.'}, {'pmid': '12615092', 'type': 'BACKGROUND', 'citation': 'Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.'}, {'type': 'BACKGROUND', 'citation': "Driscoll, K., & Pianta, R. C. (2011). Mothers' and fathers' perceptions of conflict and closeness in parent-child relationships during early childhood. Journal of Early Childhood & Infant Psychology, (7)."}, {'type': 'BACKGROUND', 'citation': "Hawkins, A. J., Bradford, K. P., Palkovitz, R., Christiansen, S. L., Day, R. D., & Call, V. R. (2002). The inventory of father involvement: A pilot study of a new measure of father involvement. The Journal of Men's Studies, 10(2), 183-196."}, {'type': 'BACKGROUND', 'citation': 'Lamb, M. E., Pleck, J. H., Charnov, E. L., & Levine, J. A. (1987). A biosocial perspective on paternal behavior and involvement. In J. B. Lancaster, J. Altmann, A. S. Rossi, & L. R. Sherrod (Eds.), Parenting across the lifespan: Biosocial perspectives (pp. 111-142). Hawthorne, NY: Aldine.'}], 'seeAlsoLinks': [{'url': 'http://www.mdrc.org/publications/393/workpaper.html', 'label': 'Married and poor: Basic characteristics of economically disadvantaged married couples in the US. Working Paper SHM-01, Supporting Healthy Marriage Project, New York: MDRC'}, {'url': 'https://www.mdrc.org/sites/default/files/innovative_parenting_b3_findings_dec_2019_0.pdf', 'label': 'Implementing an innovative parenting program for fathers: Findings from the B3 study OPRE Report 2019-111.'}]}, 'descriptionModule': {'briefSummary': 'Montefiore Medical Center (in partnership with BronxWorks) is implementing a large-scope program to promote responsible fatherhood in the Bronx among low-income adult (18 years or older) fathers with non-custodial children (under the age of 24). The program, called HERO Dads (Healthy, Empowered, Resilient, Open Dads), will promote responsible fatherhood by enhancing relationship and anger-management skills and providing marriage education; providing skills-based parenting education, disseminating information about good parenting practices, and encouraging child support payments (in partnership with our local OCSE); and fostering economic stability by providing employment-related supports inclusive of job search, vocational skills training, job referrals, and job retention.', 'detailedDescription': 'The program model is based on the premise that relationship and parenting skills can be taught, and will lead to improvements in relationships (knowledge about relationships, communication skills, stress management, reduction in destructive conflict), parenting (knowledge about child development, engagement with non-custodial children, effective parenting, co-parent communication, child well-being), and economic status (vocational skills, new employment or career advancement, financial literacy, child support). The investigator will provide core relationship and relationship education workshops using an empirically supported curriculum (24/7 Dad) plus employment workshops, numerous supplemental activities to promote responsible fatherhood, individualized vocational case management, and job-driven employment services. In total, the investigator expects to enroll 1,475 non-custodial fathers in the program and provide an average of 34 hours of total programming per participant (including 24 hours of core workshops), which the investigator believes is a sufficient dosage to detect impacts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be over 18 years of age\n* Must have a child under the age of 24\n* Must be a non-custodial parent or have shared custody\n* Income below 200% poverty line\n\nExclusion Criteria:\n\n* Active intimate partner violence and increased risk of intimate partner violence.'}, 'identificationModule': {'nctId': 'NCT05311592', 'acronym': 'FIRE', 'briefTitle': 'Supporting Responsible Fatherhood Program (Fatherhood FIRE)', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Montefiore Medical Center Supporting Responsible Fatherhood Program', 'orgStudyIdInfo': {'id': '2021-12757'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In Person', 'description': 'Participants will receive all services in person, including participating in the initial intake process, and attending all workshops.', 'interventionNames': ['Behavioral: HERO Dads Program']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual (Zoom)', 'description': 'Participants will complete their intake process in person, but will complete all workshops virtually through Zoom.', 'interventionNames': ['Behavioral: HERO Dads Program']}], 'interventions': [{'name': 'HERO Dads Program', 'type': 'BEHAVIORAL', 'description': 'The HERO Dads Program is a 4-week series of workshops for non-custodial fathers that focuses on improving parenting, offering job support, and financial counseling.', 'armGroupLabels': ['In Person', 'Virtual (Zoom)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Scott Wetzler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Bureau - Administration for Children and Families", 'class': 'OTHER'}, {'name': 'BronxWorks', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}