Fathers and Babies (FAB) Research Study
Public ClinicalTrials.gov record NCT07893210. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Examining the Effectiveness of the Fathers and Babies Intervention During the Perinatal Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07893210
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 624 participants
Conditions and interventions
Conditions
Interventions
- Fathers and Babies Program Behavioral
- Mothers and Babies Program Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 8, 2026 (Actual)
- Primary completion
- Dec 31, 2027 (Estimated)
- Completion
- Dec 31, 2027 (Estimated)
- Last update posted
- Oct 23, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07893210, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07893210 live on ClinicalTrials.gov.