Antenatal CareFIPCNCT05652387
Father Inclusive Prenatal Care Study
A study testing Father Inclusive Prenatal Care in people with Antenatal Care and Pregnancy Related, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Antenatal Care, Pregnancy Related, Parent-Child Relations
- What is being tested?
- Father Inclusive Prenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women: pregnant woman
- Men \& women have to be willing to participate at baseline interview together
Who cannot join
- Men \& Women: Language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Preparing for Parenthood: A Father Inclusive Model of Prenatal Care
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.
Read the 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.
- Conditions
- Antenatal Care, Pregnancy Related, Parent-Child Relations, Parenting, Education, Counseling
- Being tested
- Father Inclusive Prenatal Care
- Keywords
- fatherhood, prenatal care, coparenting, parenting education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Father Inclusive Prenatal CareBehavioural
Pregnant and parenting couples participate in co-parenting and parenting education, and job skills and education readiness
| Study group | Role | What they receive |
|---|---|---|
| Father Inclusive Prenatal Care | Other | Co parenting, parenting education, employment and educational readiness training and support. Receives: Behavioral: Father Inclusive Prenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in conflict in Adolescent Dating Relationship Inventory- Short Form
Used to measure couple relationships and potential conflict.
Measured: 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
Measured: At 6 months and 18 months post birth
Perceived Maternal Parenting Self-Efficacy Tool
Evaluates how confident parents feel taking care of their infant
Measured: 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.
Measured: 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
Measured: 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
Measured: Time 3- eighteen months post birth
Quality of Relationship Inventory
Examines the quality of the relationship between co-parenting couples
Measured: At 6 months and 18 months post birth
Secondary outcomes (3)
Maternal Health Outcome Assessment
Instrument used to report infant birth and mother delivery data.
Measured: Six months post birth
Trait Emotional Intelligence Questionnaire
Measure of emotional intelligence
Measured: At 6 months and 18 months post birth
Parent Health Questionnaire (PHQ9)
Screening for symptoms of depression
Measured: At 6 months and 18 months post birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Jun 2021
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Antenatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive/Evaluative
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, University of Wisconsin, Milwaukee, Skills for Chicagoland's Future-Chicago, Parent Child Center (PCC) Community Wellness Center, Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Wrenetha A Julion, PhD, MPH, RN, Principal investigator, Rush University Medical CenterPaul w Florsheim, PhD, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652387
- Sponsor's protocol ID
- 20062803-IRB01
- Acronym
- FIPC
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2022
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based upon guidance by the funding agency de-identified descriptive and quantitative data will be housed at a designated site and made available to eligible researchers.
Publications
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.
PubMed 22897540Florsheim, 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.
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).
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.
PubMed 22685066Julion 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.
PubMed 27241687Julion, 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for Parenthood: A Father Inclusive Model of Prenatal Care
- ClinicalTrials.gov ID
- NCT05652387
- Acronym / sponsor ID
- FIPC / 20062803-IRB01
- Conditions
- Antenatal Care, Pregnancy Related, Parent-Child Relations, Parenting, Education, Counseling
- Keywords
- fatherhood, prenatal care, coparenting, parenting education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, University of Wisconsin, Milwaukee, Skills for Chicagoland's Future-Chicago, Parent Child Center (PCC) Community Wellness Center, Wake Forest University Health Sciences
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive/Evaluative
| Arm | Type | Receives |
|---|---|---|
| Father Inclusive Prenatal Care | Other | Behavioral: Father Inclusive Prenatal CareCo parenting, parenting education, employment and educational readiness training and support. |
Who may qualify
- Ages
- 17 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women: pregnant woman
- Men \& women have to be willing to participate at baseline interview together
Key exclusion criteria (1 listed)
- Men \& Women: Language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Father Inclusive Prenatal CarePregnant and parenting couples participate in co-parenting and parenting education, and job skills and education readiness | Behavioural | Father Inclusive Prenatal Care |
Primary outcome
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.
Parenting Stress Index - Short Form
Time frame: At 6 months and 18 months post birth
Evaluates parents' perception of parenting-related stress
Perceived Maternal Parenting Self-Efficacy Tool
Time frame: Time 2 - six months post birth
Evaluates how confident parents feel taking care of their infant
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.
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
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
Quality of Relationship Inventory
Time frame: At 6 months and 18 months post birth
Examines the quality of the relationship between co-parenting couples
3 secondary outcomes
Maternal Health Outcome Assessment
Time frame: Six months post birth
Trait Emotional Intelligence Questionnaire
Time frame: At 6 months and 18 months post birth
Parent Health Questionnaire (PHQ9)
Time frame: At 6 months and 18 months post birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Background: PubMed 22897540Florsheim 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.
- BackgroundFlorsheim, 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.
- BackgroundPaul, 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: PubMed 22685066Julion 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.
- Background: PubMed 27241687Julion 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.
- BackgroundJulion, 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.
- Individual participant dataSharing planned: Yes. Based upon guidance by the funding agency de-identified descriptive and quantitative data will be housed at a designated site and made available to eligible researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wrenetha A Julion, PhD, MPH, RN principal investigator
Rush University Medical Center
Paul w Florsheim, PhD principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Father Inclusive Prenatal Care in people with Antenatal Care and Pregnancy Related, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652387, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.