Father Inclusive Prenatal Care Study

Not Applicable

Recruiting

• Conditions: Antenatal Care; Parent-Child Relations; Education; Counseling; Pregnancy Related; Parenting
• Interventions: Behavioral: Father Inclusive Prenatal Care

• Registration Number: NCT05652387
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2021-06-09
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Father Inclusive Prenatal Care	Father Inclusive Prenatal Care	Co parenting, parenting education, employment and educational readiness training and support.

Primary Outcome Measures

Name	Time	Method
Parenting Stress Index - Short Form	At 6 months and 18 months post birth	Evaluates parents' perception of parenting-related stress
Self-efficacy for Parenting Task Index - Toddler-Short	Time 3 - eighteen months post birth	Evaluates how capable parents feel of addressing their child's needs.
Julion Index of Paternal Involvement	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 3- eighteen months post birth	This form is used to measure infant social-emotional development
Perceived Maternal Parenting Self-Efficacy Tool	Time 2 - six months post birth	Evaluates how confident parents feel taking care of their infant
Change in conflict in Adolescent Dating Relationship Inventory- Short Form	Change from Baseline (2nd trimester of pregnancy) at 6 months and 18 months post birth	Used to measure couple relationships and potential conflict.
Quality of Relationship Inventory	At 6 months and 18 months post birth	Examines the quality of the relationship between co-parenting couples

Secondary Outcome Measures

Name	Time	Method
Parent Health Questionnaire (PHQ9)	At 6 months and 18 months post birth	Screening for symptoms of depression
Maternal Health Outcome Assessment	Six months post birth	Instrument used to report infant birth and mother delivery data.
Trait Emotional Intelligence Questionnaire	At 6 months and 18 months post birth	Measure of emotional intelligence

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States