Clinical trial NCT05652387: Father Inclusive Prenatal Care Study
Official title: Preparing for Parenthood: A Father Inclusive Model of Prenatal Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antenatal Care
Pregnancy Related
Parent-Child Relations
Parenting
Education
Counseling
Keywords: fatherhood
prenatal care
coparenting
parenting education
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Bureau - Administration for Children and Families
name: University of Wisconsin, Milwaukee
name: Skills for Chicagoland's Future-Chicago
name: Parent Child Center (PCC) Community Wellness Center
name: Wake Forest University Health Sciences
First posted: 2022-12-15
Enrollment: 250
Sex: ALL
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Descriptive/Evaluative
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women: 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.

Primary outcomes:
measure: Change in conflict in Adolescent Dating Relationship Inventory- Short Form
timeFrame: Change from Baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
measure: Parenting Stress Index - Short Form
timeFrame: At 6 months and 18 months post birth
measure: Perceived Maternal Parenting Self-Efficacy Tool
timeFrame: Time 2 - six months post birth
measure: Self-efficacy for Parenting Task Index - Toddler-Short
timeFrame: Time 3 - eighteen months post birth
measure: Julion Index of Paternal Involvement
timeFrame: At 6 months and 18 months post birth
measure: Brief Infant Toddler Social & Emotional Assessment (BITSEA)
timeFrame: Time 3- eighteen months post birth
measure: Quality of Relationship Inventory
timeFrame: At 6 months and 18 months post birth
Secondary outcomes:
measure: Maternal Health Outcome Assessment
timeFrame: Six months post birth
measure: Trait Emotional Intelligence Questionnaire
timeFrame: At 6 months and 18 months post birth
measure: Parent Health Questionnaire (PHQ9)
timeFrame: At 6 months and 18 months post birth
Other outcomes:
measure: Changes in Administration for Children & Families Survey
timeFrame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth.
measure: Post-traumatic Stress Symptoms Questionnaire
timeFrame: At 6 months and 18 months post birth
measure: The CRAFFT Screener for Drug and Alcohol Abuse Questionnaire
timeFrame: At 6 months and 18 months post birth
measure: Parent Readiness Questionnaire
timeFrame: Baseline (2nd trimester of pregnancy)
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Wrenetha A Julion, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Milwaukee
name: Paul w Florsheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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).
citation: 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.
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.
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.