Father Inclusive Prenatal Care Study

NCT05652387 | Completed

• 1 other identifier: 20062803-IRB01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Young families need additional institutional support to help them meet the challenges of parenthood. Prenatal clinics are well situated to address some of their needs by expanding services to include fathers. The Father Inclusive Prenatal Care (FIPC) model is designed to prepare young men for the challenges of parenting by supporting the development of their relationship skills as part of routine prenatal healthcare. This approach involves assessing expectant fathers and mothers with a "parent prep-check" (PPC) to identify their needs and then offer services to address those needs and prepare them for parenthood. Services include: (1) parent education about how to understand and care for infants, and how to build secure parent-child bonds; (2) an evidence-based co-parenting program to strengthen and stabilize their family; and (3) educational and employment support designed to help young parents find and keep living wage jobs. The project will be implemented through several community based healthcare sites that are well positioned to engage young fathers through their prenatal clinics. To extend the reach and accessibility of the model, trainings and most services will be available online. As a result of participating in this project it is expected that young couples will have better co-parenting relationships and be better prepared to take care of their infants.

Conditions

Antenatal Care; Pregnancy Related; Parent-Child Relations; Parenting; Education; Counseling

Keywords

fatherhood; prenatal care; coparenting; parenting education

Outcome Measures

Primary Outcomes (7)

• Change in conflict in Adolescent Dating Relationship Inventory- Short Form

  Used to measure couple relationships and potential conflict.

  Change from Baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth

• Parenting Stress Index - Short Form

  Evaluates parents' perception of parenting-related stress

  At 6 months and 18 months post birth

• Perceived Maternal Parenting Self-Efficacy Tool

  Evaluates how confident parents feel taking care of their infant

  Time 2 - six months post birth

• Self-efficacy for Parenting Task Index - Toddler-Short

  Evaluates how capable parents feel of addressing their child's needs.

  Time 3 - eighteen months post birth

• Julion Index of Paternal Involvement

  Measures how often fathers are involved with their children in a variety of activities

  At 6 months and 18 months post birth

• Brief Infant Toddler Social & Emotional Assessment (BITSEA)

  This form is used to measure infant social-emotional development

  Time 3- eighteen months post birth

• Quality of Relationship Inventory

  Examines the quality of the relationship between co-parenting couples

  At 6 months and 18 months post birth

Secondary Outcomes (3)

• Maternal Health Outcome Assessment

  Six months post birth

• Trait Emotional Intelligence Questionnaire

  At 6 months and 18 months post birth

• Parent Health Questionnaire (PHQ9)

  At 6 months and 18 months post birth

Other Outcomes (4)

• Changes in Administration for Children & Families Survey

  Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth.

• Post-traumatic Stress Symptoms Questionnaire

  At 6 months and 18 months post birth

• The CRAFFT Screener for Drug and Alcohol Abuse Questionnaire

  At 6 months and 18 months post birth

Study Arms (1)

Father Inclusive Prenatal Care

OTHER

Co parenting, parenting education, employment and educational readiness training and support.

Behavioral: Father Inclusive Prenatal Care

Interventions

Father Inclusive Prenatal Care BEHAVIORAL

Pregnant and parenting couples participate in co-parenting and parenting education, and job skills and education readiness

Father Inclusive Prenatal Care

Eligibility Criteria

• Age: 17 Years - 29 Years
• Gender Eligibility Details: Pregnant women age 17-25 Expectant biological fathers age 18-29
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women: pregnant woman
• Men \& women have to be willing to participate at baseline interview together

You may not qualify if:

• Men \& Women: Language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Children's Bureau - Administration for Children and Families: collaborator
• University of Wisconsin, Milwaukee: collaborator
• Skills for Chicagoland's Future-Chicago: collaborator
• Parent Child Center (PCC) Community Wellness Center: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (6)

• Florsheim P, Burrow-Sanchez JJ, Minami T, McArthur L, Heavin S, Hudak C. Young parenthood program: supporting positive paternal engagement through coparenting counseling. Am J Public Health. 2012 Oct;102(10):1886-92. doi: 10.2105/AJPH.2012.300902. Epub 2012 Aug 16.

  PMID: 22897540 BACKGROUND

• Florsheim, P., McArthur, L., Hudak, C., Heavin, S., & Burrow-Sanchez, J. (2011). The Young Parenthood Program: Preventing intimate partner violence between adolescent mothers and young fathers. Journal of Couple & Relationship Therapy, 10(2), 117-134.

  BACKGROUND

• Paul, H. A. (2015). The Young Parenthood Program: A Guide to Helping Young Mothers and Fathers Become Effective Co-Parents, by P. Florsheim: New York, NY: Oxford University Press, vii+ 222 pp., $45.00 (paperback).

  BACKGROUND

• Julion WA, Breitenstein SM, Waddell D. Fatherhood intervention development in collaboration with African American non-resident fathers. Res Nurs Health. 2012 Oct;35(5):490-506. doi: 10.1002/nur.21492. Epub 2012 Jun 8.

  PMID: 22685066 BACKGROUND

• Julion WA, Sumo J, Bounds DT, Breitenstein SM, Schoeny M, Gross D, Fogg L. Study protocol for a randomized clinical trial of a fatherhood intervention for African American non-resident fathers: Can we improve father and child outcomes? Contemp Clin Trials. 2016 Jul;49:29-39. doi: 10.1016/j.cct.2016.05.005. Epub 2016 May 28.

  PMID: 27241687 BACKGROUND

• Julion, W. A., Sumo, J. N., Schoeny, M. E., Breitenstein, S. M., & Bounds, D. T. (2021). Predictors of Maternal Participation in Fatherhood Intervention Research With African American Nonresident Fathers. Research on Social Work Practice, 10497315211005538.

  BACKGROUND

Study Officials

• Wrenetha A Julion, PhD, MPH, RN

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Paul w Florsheim, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Descriptive/Evaluative

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 15, 2022
• Study Start: June 9, 2021
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the completion of the study following all analyses by the primary research team.
• Access Criteria: All data will be deidentified; information will be provided about the type of data available; the research proposal of the requestor will be reviewed by an independent review panel; data will be available for use but not downloadable; registration and the use of data use agreements are required;

Locations

US (1)