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Fathers and Babies (FAB) Research Study

Examining the Effectiveness of the Fathers and Babies Intervention During the Perinatal Period

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Fathers and Babies (FAB) program improves fathers’ mental health and helps them support their female partners’ mental health. It also tests FAB together with Mothers and Babies (MB), a program to help prevent depression around pregnancy and birth. The study is for fathers, mothers, and home visiting staff linked to programs in Illinois or Texas.

The purpose of this study is to examine the effectiveness of the Fathers and Babies intervention (FAB). FAB aims to improve the mental health of fathers and provide strategies that help fathers support the mental health of their female partner. FAB was adapted from Mothers and Babies (MB), an evidence-based perinatal depression prevention intervention. FAB can be delivered as a standalone intervention or can be delivered alongside MB as a dyadic intervention to both fathers and mothers. In this longitudinal randomized controlled trial (RCT), the investigators will examine the effectiveness and implementation of the FAB intervention. To do this, the investigators will partner with Home Visiting (HV) programs in the state of Illinois (IL) and Texas (TX). Home visitors will be randomized to receive (intervention) or not to receive (controls) the FAB training. Home visitors that are randomized to receive FAB training will be trained and implement FAB or FAB with MB. The specific aims include: 1. To evaluate the effectiveness of FAB, delivered as a stand-alone intervention, in improving paternal mental health outcomes compared to a control group that does not receive the FAB intervention; 2. To evaluate the effectiveness of FAB, when delivered in conjunction with MB, in improving paternal and maternal mental health outcomes compared to a control group that does not receive the FAB or MB intervention. 3. To evaluate FAB implementation to inform future intervention delivery and scalability; the investigators will assess key implementation outcomes guided by the RE-AIM framework (feasibility, acceptability, barriers, facilitators, reach, adoption, implementation, and maintenance).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Fathers: Help raise the child with the mother and/or have a pregnant partner. You do not need to be the child’s birth father or live with your partner.
  • Fathers: You must be in a home visiting program, or your child’s mother must be in one in Illinois or Texas.
  • Fathers and mothers: Must speak English or Spanish.
  • Fathers and mothers: Must be older than 18.
  • Mothers: Must have a child and/or be pregnant.
  • Mothers: You must be in a home visiting program, or your child’s father must be in one in Illinois or Texas.
  • Home visiting staff: Must work for a home visiting program in Illinois or Texas.
  • Home visiting staff: Must currently serve families through home visits. Roles may include home visitors, case workers, family support staff, doulas, or parent educators.

Who can't join

  • Mothers: Completed the Mothers and Babies (MB) program within the past 12 months.
  • Mothers: The child’s father is not taking part in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria for fathers are: 1. Must be in a fathering role with the mother of the index child (irrespective of whether he is biological father or co-residing with partner) and/or have a pregnant partner (mother of the child). 2. Be enrolled in a HV program OR have a partner (mother of the child) enrolled in an IL or TX HV program 3. Ability to speak English or Spanish 4. \>18 years old Inclusion criteria for mothers are: 1. Be enrolled in a HV program OR have a partner (father of the child) enrolled in an IL or TX HV program 2. Ability to speak English or Spanish 3. \>18 years old 4. Must be a mother and/or are currently pregnant Exclusion criteria for mothers are: 1. Previously completed MB within the last 12 months 2. Father does not participate in the research study Inclusion criteria for home visitors are: 1. Employed at a HV program in Illinois or Texas 2. Have an active caseload in which they deliver HV services can include roles such as home visitors, case workers, family support specialists, Doulas, parent educators or any other role that fits within the home visiting models and roles.

Study sites (1)

IL