An interventional study of Fathers and Babies Program and Mothers and Babies Program in Perinatal Mental Health, Fathers and Stress Management, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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:
FAB was adapted from Mothers and Babies (MB), an evidence-based perinatal depression prevention intervention. Like MB, FAB was designed using principles from cognitive behavioral therapy (CBT) to help parents manage negative moods and emotions through pleasant activities, helpful ways of thinking and contact with others. MB and FAB can be delivered concurrently or as stand-alone interventions. MB and FAB are both delivered in nine sessions, with each session lasting 20-25 minutes. FAB can be implemented in-person, virtually, or via text message. MB has been found effective to prevent the onset of postpartum depression and reduce depressive symptoms through multiple randomized controlled trials (RCT). Home Visiting (HV) services target expectant parents and parents of young children to provide support in the home using evidence-based models that focus on children's development.
Though HV programs tend to focus on mothers, there have been increasing efforts to engage fathers in HV services. Evidence-based models vary in their approach to reaching fathers, though most models place an emphasis on the promotion of responsible fatherhood. Efforts to include fathers in these programs stem from the increasing knowledge that father involvement is associated with positive child development outcomes, like peer relationships, increased self-esteem, and fewer externalizing and internalizing behaviors. Furthermore, fathers involved in HV services with their partners show increased knowledge of child development and more responsive parenting practices.
More attention has been recently directed toward fathers' perinatal mental health, with epidemiological evidence indicating an unmet need for the treatment of paternal depression and anxiety. Paternal depression in the United States has a reported prevalence of 8.4% during pregnancy and the postpartum period, though the prevalence between three and six months postpartum can be as high as 13%. Postpartum depression disproportionately affects low-income men across racial and ethnic groups. However, men across racial and ethnic groups are less likely to seek mental health services compared to women. Fathers with worse mental health outcomes during the perinatal period are less likely to have nurturing relationships with their children, which can negatively affect child outcomes from infancy through adolescence. Despite the prevalence of paternal depression, few interventions have targeted fathers during the perinatal period to address their mental health. To address this gap, FAB was developed to address the mental health of fathers during the perinatal period.
FAB was developed in collaboration with infant mental health consultants, academics, home visitors, fatherhood experts, and fathers. In the pilot study, FAB was concurrently delivered with MB, and tested among 30 mother-father dyads. Data from the pilot study showed that FAB led to reductions in anxiety and depressive symptoms, and perceived stress among fathers receiving the intervention. Additionally, 88% of fathers indicated that FAB gave them skills to help manage their mood and stress and 82% indicated that FAB helped them and their partner talk about stress and parenting. All pilot participants indicated that they would recommend FAB to other fathers.
In this longitudinal RCT, the investigators will examine the effectiveness and implementation of the FAB intervention. To do this, the investigators will partner with 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 the FAB or FAB with MB. Home visitors randomized to serve as controls will continue to deliver their normal home visiting services during the study and refer fathers or fathers and their partners (mother of the child).
Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for fathers are:
Inclusion criteria for mothers are:
Exclusion criteria for mothers are:
Inclusion criteria for home visitors are:
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
Control father participants will not receive the FAB intervention and will continue receiving normal home visiting services.
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
Control mother participants will not receive the FAB with MB intervention and will continue receiving normal home visiting services.
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 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.
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 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.
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.
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
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.
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
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.
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: Mood Regulation
The Negative Mood Regulation Scale will be used to asses mood regulation. The Negative Mood Regulation (NMR) Scale is a 30-item questionnaire measuring a person's belief that their actions or thoughts will help change a negative mood. Total scores range from 30 to 150, calculated by summing all item responses on a 5-point Likert scale. Higher scores mean stronger confidence in managing negative moods.
Time frame: 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
The Behavioral Activation for Depression Scale (BADS) is a 25-item self-report instrument scored on a 7-point Likert scale from 0 ("not at all") to 6 ("completely"). It uses four subscales (Activation, Avoidance/Rumination, Work/School Impairment, Social Impairment) where subscale items are summed directly, and a total score is computed by reverse-scoring the avoidance and impairment subscales. Higher total scores reflect healthier behavioral activation and less overall depressive disengagement.
Time frame: 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
The Fatherhood Research and Practice Network (FRPN) Father Engagement Scale is a free, validated research tool designed to assess the frequency of a father's involvement and engagement with his children. The scale is divided into four distinct age-based versions. This study will use version 1 and 2 (version 1: children 1 month to 1 year old; version 2: children 1 year, 1 month to 6 years old).
Time frame: 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
The Revised Dyadic Adjustment Scale (RDAS) is a 14-item questionnaire scored by summing all item values to yield a total score from 0 to 69. Higher scores mean better relationship adjustment, while a total score of 48 or less indicates relationship distress.
Time frame: 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
The Social Support Effectiveness Questionnaire (SSE-Q), yields full-scale scores ranging from 0 to 80, with each subscale ranging from 0 to 20. Higher scores reflect more effective and adaptive social support.
Time frame: 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).
HVs trained in FAB that delivered FAB (RE-AIM Framework; REACH)
Percentage of home visitors trained in FAB who begin implementing the intervention
Time frame: 12 months post-training
Fathers' Enrollment (RE-AIM Framework; REACH)
The percentage of clients meeting FAB eligibility criteria that enroll in the study.
Time frame: Up to 2 years
FAB Intervention Dosage (RE-AIM Framework; ADOPTION)
To assess "adoption" descriptive statistics will be used to determine the dosage of the FAB intervention received by participants.
Time frame: up to 18 weeks
Acceptability of Intervention Measure (RE-AIM Framework; IMPLEMENTATION)
To assess different aspects of intervention implementation, we will administer the Acceptability of Intervention Measure (AIM). The AIM is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. It is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores reflecting greater perceived acceptability.
Time frame: 20 weeks after 1st intervention session and up to 2 years
Feasibility of Intervention Measure (RE-AIM Framework; IMPLEMENTATION)
To assess different aspects of intervention implementation, we will administer the Feasibility of Intervention Measure (FIM). The FIM is a 4-item survey tool used in implementation science to evaluate how easily an intervention can be carried out within an organization. Each item is rated on a 5-point Likert scale ranging from completely disagree (1) to completely agree (5). Scores range from 4 to 20, with higher scores reflecting greater perceived feasibility.
Time frame: 20 weeks after 1st intervention session and up to 2 years
Intervention Appropriateness Measure (RE-AIM Framework; IMPLEMENTATION)
To assess different aspects of intervention implementation, we will administer the Intervention Appropriateness Measure (IAM). The IAM is a 4-item psychometric questionnaire used in implementation science to evaluate the perceived fit, relevance, or compatibility of an intervention within an organization. Responses are averaged to produce a composite score from 1 to 5, with higher scores reflecting greater perceived appropriateness.
Time frame: 20 weeks after 1st intervention session and up to 2 years
Modification and Adaptation Checklist (RE-AIM Framework; IMPLEMENTATION)
The Modification and Adaptation Checklist (MAC) measure will be used to assess home visitors' reported fidelity-consistent and fidelity-inconsistent adaptations of FAB. The MAC does not generate a single numerical score. Instead, it functions as a descriptive and categorical tracking tool (checking yes/no)
Time frame: Up to 2 years
Normalization Measure Development Questionnaire (RE-AIM Framework; MAINTENANCE)
To assess "maintenance," (the extent to which a program becomes institutionalized or part of the routine organizational practices) the Normalization Measure Development Questionnaire (NoMAD) will be used. The NoMAD is a 23-item survey tool used in implementation science to measure and monitor how a new intervention becomes embedded into routine workflows within an organization. Analysis of the NoMAD will generate an overall score averaged across respondents.
Time frame: Up to 2 years
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
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