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Fathers and Babies (FAB) Research Study

Northwestern University · NCT07893210

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
624
US sites recruiting
1
Study start
January 8, 2026
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

  • 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;
  • 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.
  • 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).

Being studied: Fathers and Babies Program; Mothers and Babies Program

Conditions: Perinatal Mental Health; Fathers; Stress Management

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria for fathers are

  • 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).
  • Be enrolled in a HV program OR have a partner (mother of the child) enrolled in an IL or TX HV program
  • Ability to speak English or Spanish
  • >18 years old

Inclusion criteria for mothers are

  • Be enrolled in a HV program OR have a partner (father of the child) enrolled in an IL or TX HV program
  • Ability to speak English or Spanish
  • >18 years old
  • Must be a mother and/or are currently pregnant

Exclusion criteria for mothers are

  • Previously completed MB within the last 12 months
  • Father does not participate in the research study

Inclusion criteria for home visitors are

  • Employed at a HV program in Illinois or Texas
  • 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.

Recruiting US locations

  • Northwestern University

    Chicago, IL 60611

    Site contact: Jocelyne Chavez, Master of Public Health · 312-503-5050 · jocelyne.chavez@northwestern.edu

Study contacts (from the official record)

  • Jocelyne Chavez, Master of Public Health · 773-503-5050 · jocelyne.chavez@northwestern.edu
All mental health studies in Illinois →
Fathers and Babies (FAB) Research Study (NCT07893210) | Bored Studies