Recruiting

Fathers and BabiesFathers and Babies (FAB) Research Study

Sponsor:

Northwestern University

Code:

NCT07893210

Conditions

Perinatal Mental Health

Fathers

Stress Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Fathers and Babies Program

Mothers and Babies Program

Study Details

Brief 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).

Conditions

Perinatal Mental Health

Fathers

Stress Management

Study ID

NCT07893210

Start date

Jan 8, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

624 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Fathers (Intervention)

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 the two. Home visitors will deliver FAB or FAB in conjunction with MB based on participants' preference. FAB or FAB in conjunction 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 nine 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 remaining 8 sessions are delivered through text messages.

no intervention: Fathers (Control)

Control father participants will not receive the FAB intervention and will continue receiving normal home visiting services.

experimental: Mothers (Intervention)

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.

no intervention: Mothers (Control)

Control mother participants will not receive the FAB with MB intervention and will continue receiving normal home visiting services.

experimental: Home Visitor (Intervention)

Home visitors randomized to the intervention arm will receive the FAB training. After training, intervention home visitors will recruit and refer study participants (fathers and mothers) who will receive either FAB or FAB with MB. If FAB is delivered with MB, the father and mother dyad would receive the FAB and MB intervention concurrently. MB can be delivered in person, virtually, or via phone. FAB can be delivered in person or via text messages. Home visitors will deploy the FAB text-messages on the HealthySMS online platform, in which they will also track their FAB implementation completion by session for each father participant.

no intervention: Home Visitor (Control)

Home visitors randomized to the control arm will not receive FAB training or implement FAB/FAB with MB. Although they will not deliver the FAB or MB intervention initially as part of this study, these home visitors will still be responsible for identifying and referring eligible study participants to the research team who will be recruited as control participants. Control group home visitors will continue to deliver standard HV services. After all study activities are completed, control group home visitors will receive FAB training and will be able to deliver FAB.

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

Primary outcome measure

Mental Health Outcomes: Stress [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Jocelyne Chavez, Master of Public Health

773-503-5050 jocelyne.chavez@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jocelyne Chavez, Master of Public Health

312-503-5050 jocelyne.chavez@northwestern.edu

Principal Investigator:

Darius Tandon

More Information

Sponsor

Northwestern University

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

fathers
perinatal mental health
paternal depression
home visiting
parenting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.