- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652387
Father Inclusive Prenatal Care Study (FIPC)
Preparing for Parenthood: A Father Inclusive Model of Prenatal Care
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wrenetha A Julion, PhD, MPH, RN
- Phone Number: (312) 942-6272
- Email: Wrenetha_A_Julion@rush.edu
Study Contact Backup
- Name: Paul W Florsheim, PhD
- Phone Number: 414-227-4490
- Email: paulf@uwm.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- Rush University Medical Center
-
Contact:
- Paul W Florsheim, PhD
- Phone Number: 414-227-4490
- Email: paulf@uwm.edu
-
Contact:
- Wrenetha A Julion, PhD, MPH, RN, CNL, FAAN
- Phone Number: (312) 942-6272
- Email: Wrenetha_A_Julion@rush.edu
-
Principal Investigator:
- Wrenetha A Julion, PhD, MPH, RN, CNL, FAAN
-
Sub-Investigator:
- Paul W Florsheim, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Father Inclusive Prenatal Care
Co parenting, parenting education, employment and educational readiness training and support.
|
Pregnant and parenting couples participate in co-parenting and parenting education, and job skills and education readiness
|
No Intervention: Standard Care
Participants will receive usual prenatal care services and information about community resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Change in Coparenting Relationship Questionnaire
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Used to examine father-mother relationship status
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Change in Parenting Stress Index - Short Form
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Evaluates parents' perception of parenting-related stress
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Perceived Maternal Parenting Self-Efficacy Tool
Time Frame: Time 2 - six months post birth
|
Evaluates how confident parents feel taking care of their infant
|
Time 2 - six months post birth
|
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.
|
Time 3 - eighteen months post birth
|
Change in Julion Index of Paternal Involvement
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
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
|
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
|
Time 3- eighteen months post birth
|
Change in Quality of Relationship Inventory
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Health Outcome Assessment
Time Frame: Six months post birth
|
Instrument used to report infant birth and mother delivery data.
|
Six months post birth
|
Change in Trait Emotional Intelligence Questionnaire
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Measure of emotional intelligence
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Change in Parent Health Questionnaire (PHQ9)
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Screening for symptoms of depression
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change 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
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth.
|
Change in Participant Additional Demographics (e.g. Clinic-based Social Determinants of Health screening)
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Demographic Information not required by funding agency
|
Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Change in Screen for Post-traumatic Stress Symptoms Questionnaire
Time Frame: Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
screens for post traumatic stress
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Change from baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Change in The Car; Relax; Alone; Forget; Friends; Trouble (CRAFFT) Screener for Drug & Alcohol Abuse Questionnaire
Time Frame: Change baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Screens for substance abuse
|
Change baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth
|
Parent Readiness Questionnaire
Time Frame: Baseline (2nd trimester of pregnancy)
|
Examines fathers readiness to be a parent
|
Baseline (2nd trimester of pregnancy)
|
Motivators & Attitudes Towards Changing Health (MATCH)
Time Frame: Baseline (2nd trimester of pregnancy)
|
Examines participant's motivation for self management
|
Baseline (2nd trimester of pregnancy)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wrenetha A Julion, PhD, MPH, RN, Rush University Medical Center
- Principal Investigator: Paul w Florsheim, PhD, University of Wisconsin, Milwaukee
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20062803-IRB01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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