Father Inclusive Prenatal Care Study

Pregnancy Related Clinical Trial

— FIPC  

Official title:

Preparing for Parenthood: A Father Inclusive Model of Prenatal Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652387
• Other study ID #: 20062803-IRB01
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: September 29, 2025

Study information

• Verified date: February 2024
• Source: Rush University Medical Center
• Contact: Wrenetha A Julion, PhD, MPH, RN
• Phone: (312) 942-6272
• Email: Wrenetha_A_Julion[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Recruitment: This project will recruit/engage young expectant fathers using a multi-stage process. First, primary care providers (PCP) will ask their patients (17-25-year-old pregnant women) about the degree to which the father of her child will be participating in parenting and supporting their baby. If the mother anticipates the fathers' involvement, the provider will tell her about the Parent Prep-Checks (PPC), give her a brochure about describing that process (including incentives), and ask about connecting her with members of the research team in order to receive additional information. The research team members will establish father eligibility based upon age (18-29 years) and schedule time to meet with both parents. The intake process - the Parent Prep Check - is a strategy for engaging young fathers and mothers in research and intervention activities. In addition to collecting useful baseline data, the PPC is designed to build a strong alliance between project staff and participants. For example, FIPC intake staff are trained to administer a semi-structured interview designed to help participants articulate their feelings about becoming parents, which most find to be an interesting and rewarding experience. Then to facilitate recruitment into the intervention, a motivational interviewing approach is used that (a) gives feedback to participants based on their self-reported data and (b) engages them in thinking about what services will help them get ready for parenthood. When fathers are given the chance to say what concerns them, they are more likely to be receptive to participating in programs that can address those concerns. Intake staff will then introduce expectant parents to a FIPC provider, who discusses the goals and benefits of the FIPC program. Emphasizing how FIPC programs address a parent's self-identified goals has been an effective way to engage and retain participants. The most critical element in this process is the quality of communication between FIPC staff and the expectant mother and father. If done well, both parents will feel appreciated, supported, and respected. Another key factor is flexibility. FIPC staff are trained to be as accommodating as possible about scheduling appointments. Related to this, almost all FIPC services and research activities are available online to increase participant reach and accessibly. Finally, fathers and mothers are told they will be reimbursed for their time. Incentivizing patients is not sustainable over the long run; however, it is deemed necessary to get a representative sample for this project. In years 4 and 5, incentives for services will be reduced as part of the sustainability plan. In past projects, this strategy has been effective in recruiting between 60 and 75% of eligible expectant fathers. Staff at partner clinics and Rush program coordinators who will be trained on the FIPC program and research/evaluation data protocol will be responsible for recruiting the sample. The clinic staff will be asking eligible mothers if they think their partner (father of the baby) would be interested in participating. The FIPC program coordinators will be responsible for contacting fathers and recruiting them to participate after mothers share their contact information. Barrier reduction strategies will be used to support participant engagement. Due to the length of the Parent Prep check (3 hours), expectant parents will be offered a snack during the interview.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 29, 2025
• Est. primary completion date: September 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Father Inclusive Prenatal Care
Pregnant and parenting couples participate in co-parenting and parenting education, and job skills and education readiness

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (6)

Lead Sponsor	Collaborator
Rush University Medical Center	Advocate Health Care, Children's Bureau - Administration for Children and Families, Parent Child Center (PCC) Community Wellness Center, Skills for Chicagoland's Future-Chicago, University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Administration for Children & Families Survey	Detailed demographic information required by funder	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth.
Other	Change in Participant Additional Demographics (e.g. Clinic-based Social Determinants of Health screening)	Demographic Information not required by funding agency	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Other	Change in Screen for Post-traumatic Stress Symptoms Questionnaire	screens for post traumatic stress	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Other	Change in The Car; Relax; Alone; Forget; Friends; Trouble (CRAFFT) Screener for Drug & Alcohol Abuse Questionnaire	Screens for substance abuse	Change baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Other	Parent Readiness Questionnaire	Examines fathers readiness to be a parent	Baseline (2nd trimester of pregnancy)
Other	Motivators & Attitudes Towards Changing Health (MATCH)	Examines participant's motivation for self management	Baseline (2nd trimester of pregnancy)
Primary	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
Primary	Change in Coparenting Relationship Questionnaire	Used to examine father-mother relationship status	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Primary	Change in Parenting Stress Index - Short Form	Evaluates parents' perception of parenting-related stress	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Primary	Perceived Maternal Parenting Self-Efficacy Tool	Evaluates how confident parents feel taking care of their infant	Time 2 - six months post birth
Primary	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
Primary	Change in Julion Index of Paternal Involvement	Measures how often fathers are involved with their children in a variety of activities	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Primary	Brief Infant Toddler Social & Emotional Assessment (BITSEA)	This form is used to measure infant social-emotional development	Time 3- eighteen months post birth
Primary	Change in Quality of Relationship Inventory	Examines the quality of the relationship between co-parenting couples	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Secondary	Maternal Health Outcome Assessment	Instrument used to report infant birth and mother delivery data.	Six months post birth
Secondary	Change in Trait Emotional Intelligence Questionnaire	Measure of emotional intelligence	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
Secondary	Change in Parent Health Questionnaire (PHQ9)	Screening for symptoms of depression	Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth