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Fathers and Babies (FAB) Research Study
Sponsor: Northwestern University
Summary
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).
Official title: Examining the Effectiveness of the Fathers and Babies Intervention During the Perinatal Period
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
624
Start Date
2026-01-08
Completion Date
2027-12-31
Last Updated
2026-10-23
Healthy Volunteers
Yes
Interventions
Fathers and Babies Program
FAB is a 9-session intervention divided into four modules: Introduction, Pleasant Activities, Thoughts, and Contact with Others. Fathers will be provided with a participant workbook that contains skill-based worksheets relevant to each session. Fathers will be able to choose how they would like to receive FAB: 1-on-1 delivered by a home visitor, text-based, or a combination of both. Home visitors will deliver FAB or FAB with MB based on participants' preference. FAB or FAB with MB must be delivered within 18 weeks. In the 1-on-1 modality, fathers will receive FAB through 9 in-person or virtual sessions with their home visitor. Each session lasts 20-25 minutes. The 9 sessions may occur on a weekly or bi-weekly basis. FAB content can also be delivered in a text-based format, with an initial in-person or virtual session with a home visitor to deliver session 1. The HealthySMS online platform will be used to deploy the text messages and track FAB completion by session for each father.
Mothers and Babies Program
Mothers offered MB as part of their study participation will receive the intervention in conjunction with FAB. In the 1-on-1 MB modality, mothers will receive MB through 9 in-person or virtual sessions with their home visitor. Each session will last 20-25 minutes. The nine sessions must be delivered within 18 weeks. The MB content is divided into four modules: Introduction, Pleasant Activities, Thoughts and Contact with Others. Mothers will be provided with a participant workbook that contains skill-based worksheets relevant to each session.
Locations (1)
Northwestern University
Chicago, Illinois, United States