Fathers and Babies (FAB) Research Study

NCT07893210 | Recruiting

• 1 other identifier: STU00224192
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Keywords

fathers; perinatal mental health; paternal depression; home visiting; parenting

Outcome Measures

Primary Outcomes (3)

• Mental Health Outcomes: Stress

  The Perceived Stress Scale will be used to assess perceived stress in father and mother participants. assigning values from 0 to 4 to each of its 10 questions ("Never" = 0, "Almost never" = 1, "Sometimes" = 2, "Fairly often" = 3, "Very often" = 4). Reverse scoring is applied to the four positive items (items 4, 5, 7, and 8) where 0=4, 1=3, 2=2, 3=1, and 4=0. All scores are then summed. Scores between 14-26 indicate moderate stress. Scores between 27-40 indicate high perceived 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

  The Edinburgh Postpartum Depression Scale will be used to assess depression symptoms. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire scored from 0 to 30. Questions 1, 2, and 4 score 0 to 3 sequentially, while questions 3 and 5-10 are reverse-scored (3 to 0). A total score of 13 flags a possible depressive risk requiring clinical evaluation, and any positive response to question 10 regarding self-harm requires immediate safety assessment.

  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

  The Generalized Anxiety Disorder Scale will be used to assess anxiety symptoms. The GAD-7 (Generalized Anxiety Disorder-7) is a seven-question tool used to measure anxiety severity. Each question is scored from 0 to 3 based on how often symptoms occurred over the past two weeks. A score of 10 or higher suggests probable clinical 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).

Secondary Outcomes (5)

• Mental Health Outcome: Mood Regulation

  All father 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 Outcomes: Behavioral Activation Depression Scale

  All father participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants).

• Parenting Outcome: The Fatherhood Research and Practice Network (FRPN) Father Engagement Scale

  All father participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants).

• Relationship Satisfaction: Revised Dyadic Adjustment Scale

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

• Social Support: Social Support Effectiveness Survey

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

Other Outcomes (8)

• HVs trained in FAB that delivered FAB (RE-AIM Framework; REACH)

  12 months post-training

• Fathers' Enrollment (RE-AIM Framework; REACH)

  Up to 2 years

• FAB Intervention Dosage (RE-AIM Framework; ADOPTION)

  up to 18 weeks

Study Arms (6)

Fathers (Intervention)

EXPERIMENTAL

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.

Behavioral: Fathers and Babies Program

Fathers (Control)

NO INTERVENTION

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

Mothers (Intervention)

EXPERIMENTAL

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.

Behavioral: Mothers and Babies Program

Mothers (Control)

NO INTERVENTION

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

Home Visitor (Intervention)

EXPERIMENTAL

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.

Behavioral: Fathers and Babies Program; Behavioral: Mothers and Babies Program

Home Visitor (Control)

NO INTERVENTION

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 BEHAVIORAL

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.

Fathers (Intervention); Home Visitor (Intervention)

Mothers and Babies Program BEHAVIORAL

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.

Home Visitor (Intervention); Mothers (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (6)

• Tandon SD, Hamil J, Gier EE, Garfield CF. Examining the Effectiveness of the Fathers and Babies Intervention: A Pilot Study. Front Psychol. 2021 Jul 15;12:668284. doi: 10.3389/fpsyg.2021.668284. eCollection 2021.

  PMID: 34335380 BACKGROUND

• Muñoz R. F., Le H., Ippen C., Diaz M., Urizar G., Soto J., et al. (2007). Prevention of postpartum depression in low-income women: development of the Mamás y Bebés/mothers and babies course. Cogn. Behav. Pract. 14 70-83. 10.1016/j.cbpra.2006.04.021

  BACKGROUND

• Figueroa CA, Hernandez-Ramos R, Boone CE, Gomez-Pathak L, Yip V, Luo T, Sierra V, Xu J, Chakraborty B, Darrow S, Aguilera A. A Text Messaging Intervention for Coping With Social Distancing During COVID-19 (StayWell at Home): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 14;10(1):e23592. doi: 10.2196/23592.

  PMID: 33370721 BACKGROUND

• Aguilera A, Bruehlman-Senecal E, Demasi O, Avila P. Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial. J Med Internet Res. 2017 May 8;19(5):e148. doi: 10.2196/jmir.6914.

  PMID: 28483742 BACKGROUND

• Lovett E, Smith A. Mental Health, Declining Physical Activity and Social Connection during Transitions into Fatherhood in the UK. Int J Environ Res Public Health. 2024 Jul 9;21(7):890. doi: 10.3390/ijerph21070890.

  PMID: 39063466 BACKGROUND

• Panter-Brick C, Burgess A, Eggerman M, McAllister F, Pruett K, Leckman JF. Practitioner review: Engaging fathers--recommendations for a game change in parenting interventions based on a systematic review of the global evidence. J Child Psychol Psychiatry. 2014 Nov;55(11):1187-212. doi: 10.1111/jcpp.12280. Epub 2014 Jul 1.

  PMID: 24980187 BACKGROUND

Study Officials

• Darius Tandon, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne Chavez, Master of Public Health

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: October 23, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)