Recruiting

Fathers and Babies (FAB) Research Study

ClinicalTrials.gov IDNCT07893210

PhaseNA

Enrollment624

SponsorNorthwestern University

Age18 Years and older

SexALL

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Conditions studied

Perinatal Mental Health, Fathers, Stress Management

About this study

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).

Interventions

Behavioral: 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.
Behavioral: 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.

Primary outcomes

Mental Health Outcomes: Stress (All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants).)
Mental Health Outcome: Depression (All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants).)
Mental Health Outcome: Anxiety (All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants).)

Eligibility information

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 locations

Northwestern University, Chicago, Illinois 60611 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.