Skip to main content
OpenTrials
Completed

NCT Number: NCT05652387

Father Inclusive Prenatal Care Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Father Inclusive Prenatal Care

Behavioral

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

Primary outcomes

  1. Change in conflict in Adolescent Dating Relationship Inventory- Short Form

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

    Used to measure couple relationships and potential conflict.

  2. Parenting Stress Index - Short Form

    Time frame: At 6 months and 18 months post birth

    Evaluates parents' perception of parenting-related stress

  3. Perceived Maternal Parenting Self-Efficacy Tool

    Time frame: Time 2 - six months post birth

    Evaluates how confident parents feel taking care of their infant

  4. Self-efficacy for Parenting Task Index - Toddler-Short

    Time frame: Time 3 - eighteen months post birth

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

  5. Julion Index of Paternal Involvement

    Time frame: At 6 months and 18 months post birth

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

  6. Brief Infant Toddler Social & Emotional Assessment (BITSEA)

    Time frame: Time 3- eighteen months post birth

    This form is used to measure infant social-emotional development

  7. Quality of Relationship Inventory

    Time frame: At 6 months and 18 months post birth

    Examines the quality of the relationship between co-parenting couples

Secondary outcomes

  1. Maternal Health Outcome Assessment

    Time frame: Six months post birth

    Instrument used to report infant birth and mother delivery data.

  2. Trait Emotional Intelligence Questionnaire

    Time frame: At 6 months and 18 months post birth

    Measure of emotional intelligence

  3. Parent Health Questionnaire (PHQ9)

    Time frame: At 6 months and 18 months post birth

    Screening for symptoms of depression

Other outcomes

  1. Changes in Administration for Children & Families Survey

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

    Detailed demographic information required by funder

  2. Post-traumatic Stress Symptoms Questionnaire

    Time frame: At 6 months and 18 months post birth

    screens for post traumatic stress

  3. The CRAFFT Screener for Drug and Alcohol Abuse Questionnaire

    Time frame: At 6 months and 18 months post birth

    Screens for substance abuse

  4. Parent Readiness Questionnaire

    Time frame: Baseline (2nd trimester of pregnancy)

    Examines fathers readiness to be a parent

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • 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
  • Wake Forest University Health Sciences

Registry information

Official study title

Preparing for Parenthood: A Father Inclusive Model of Prenatal Care

Acronym: FIPC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2022
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.