Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners
Phase: NA
Conditions: Perinatal Depression, Postpartum Depression, Depression
Sponsor: Northwestern University

PROTOCOL TITLE: The Mothers and Babies Text Project
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PROTOCOL TITLE:
Integrating Text Messages into the Mothers and Babies Course to Address Depression in Low-
Income Women and their Partners
PRINCIPAL INVESTIGATOR:
Darius Tandon, PhD
Associate Professor, Medical Social Sciences
Northwestern University Feinberg School of Medicine
312-503-3398
dtandon@northwestern.edu
NCT03420755 (Phase 1) 
NCT03427528 (Phase 2) 
VERSION DATE:
8/1/2020
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1.0 Purpose of the Study: 
Despite the well-established negative effects of postpartum depression on mother and child, most 
efforts have been directed at treating women already exhibiting depressive episodes rather than 
prevention. Emphasis on treatment neglects the large number of women with mild to moderate 
depressive symptoms, in high psychosocial risk contexts, who are at risk for developing postpartum 
depression. Interventions exist that are efficacious in preventing the onset and worsening of 
depression among perinatal women. In particular, the PI and colleagues have demonstrated that the 
Mothers and Babies Course (MB) prevents the worsening of depressive symptoms and onset of new 
major depressive episodes. 
Enhancements to MB are warranted in two main areas. First, prior MB trials suggest the intervention 
is less successful for women who exhibit smaller changes in hypothesized intervention mechanisms 
and less fully engage in homework completion between sessions—a core component of cognitive-
behavioral therapy (CBT) interventions like MB. Second, previous postpartum depression preventive 
interventions—including MB—have neglected to intervene with partners of pregnant women, despite 
the growing recognition that paternal depression also exerts influence on children’s social-emotional 
development6 and occurs in a similar timeframe.7 Thus, in an otherwise successful intervention, these 
limitations—mixed success in improving hypothesized intervention mechanisms and limited 
engagement of fathers—may mitigate intervention efficacy.  We hypothesize that core MB modules 
will prevent onset of major depressive episodes and worsening of depressive symptoms. We also 
conceptualize that relationships between MB modules and maternal mental health outcomes will be 
mediated by mechanisms that are the direct focus of MB content. Paternal depression is also 
hypothesized to mediate the relationship between MB modules and maternal mental health outcomes. 
This study addresses these limitations. We will collaborate with 10-12 home visiting (HV) programs 
serving primarily low-income women. HV is an ideal setting for this study given the large numbers of 
perinatal women they serve and will build on the PI’s existing relationships with HV programs in 
Illinois. In Phase 1, we will recruit 108 pregnant women for a RCT in which half the participants will 
receive MB and half will receive MB with a text message enhancement (MB-TXT). MB-TXT will 
provide reinforcement of key MB skills that are linked to hypothesized mechanisms of change, 
promote completion of MB personal projects (homework), and facilitate self-monitoring of one’s mood. 
In Phase 2, we will recruit 36 mother-father dyads for an uncontrolled pilot in which mothers will 
receive MB-TXT and fathers will receive a Fathers and Babies (FAB) (previously referred to as MB 
DAD) pilot curriculum developed using existing materials and data collected via qualitative research 
with HV clients, their partners, and HV staff.    
Aim 1. To determine the feasibility and acceptability of conducting the MB-TXT intervention 
protocol across three HV programs in preparation for a larger fully powered RCT. Using MB text 
messages already developed by Co-I Barrera, we will collect data on home visitor adherence to 
delivering text messages at specified intervals, percentage of clients responding to text messages, 
and client comprehension of text messages as well as perceptions of text messages’ utility. 
Aim 2. To calculate a preliminary effect size that could be used, along with other relevant data, 
to calculate sample size for a future fully powered RCT. 
H1. Women receiving MB-TXT will exhibit greater reductions in depressive symptoms, compared to 
women receiving MB.
H2. Women receiving MB-TXT will experience greater changes in hypothesized intervention 
mechanisms compared to women receiving MB—specifically, fewer negative cognitions and 
increased behavioral activation, use of social support networks, and mood regulation.
H3. Women who participate in MB-TXT will report greater completion of personal projects. 
Aim 3. To develop and determine the feasibility and acceptability of a) conducting the FAB 
intervention protocol and b) assessing paternal and dyadic outcomes across two HV 
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programs. Focus groups with RCT participants, their male partners, and HV staff will generate 
information on a) intervention content, b) frequency of contact, and c) relationship to MB materials 
received by their partner. These data will be used, in conjunction with materials already developed by 
Co-I Garfield, to create the FAB curriculum and protocol. 
2.0  Background / Literature Review / Rationale for the study:
Postpartum depression is a serious mental illness that poses significant health and mental health risks 
for families.8-15 Prevalence of postpartum depression is estimated at 10-22%, disproportionately 
affecting low-income women with 30-45% prevalence of depressive symptoms. 16-21 The strongest risk 
factors include a prior history of depression and depression during pregnancy, with a 25-50% risk of 
recurrence.18,,22-27 Postpartum depression is associated with suicide risk,28-32 and is a risk factor for 
poor parenting practices. 33-35  Children of depressed mothers are more likely to have poor attachment 
with caregivers, emotional and behavioral dysregulation, attention and memory problems, and are at 
greater risk for childhood psychiatric disorders. Depression occurs in 5-7% of new fathers with similar 
negative outcomes for children of depressed fathers.36-39 
Despite calls for increased detection of postpartum depression, with the U.S. Preventive Services 
Task Force recommending universal prenatal and postpartum screening,40 perinatal women are less 
likely to receive mental health services than women in the general population41,42,46-51 due to factors 
such as stigma, lack of knowledge about treatment options, limited access to mental health providers, 
and childcare and family responsibilities.42-44 Interventions specifically targeting women with elevated 
depressive symptoms are crucial to prevent the worsening of depressive symptoms and onset of 
major depression during the perinatal period.      
Fathers are a missing yet important component of perinatal interventions. Depressed fathers (5-10% 
prevalence) 37,65 exhibit poorer parenting behaviors and greater likelihood of child neglect than non-
depressed fathers,39,66 and their children are at-risk for later psychiatric disorders,37 poorer language 
and reading development67 and increased behavior problems.36,38 These findings suggest that 
interventions in the perinatal period focused exclusively on maternal mental health may be limited in 
their effectiveness. Nevertheless, according to recent Cochrane Reviews on perinatal depression 
prevention and treatment interventions, 51,68 no interventions explicitly address fathers’ psychosocial 
wellbeing.69  
Home Visiting (HV) programs offer services in every state 70 and typically enroll women prenatally with 
services continuing until a child reaches 2-4 years. Many HV models exist, with 14 evidence-based 
models showing favorable impacts on multiple maternal and child health outcomes.71 Addressing 
maternal depression has been identified by federal agencies,72,73 HV model developers,74 and HV 
researchers75 as a critically needed and highly impactful HV enhancement given high rates of women 
experiencing depressive symptoms in HV programs.76-78 
Text messaging via a mobile device is low cost and accessible to the majority of people regardless of 
race, ethnicity, and socioeconomic status, 56,57 making texting an ideal tool to deliver health 
information and interventions, especially to communities where barriers to mental health care exist. A 
systematic review of studies using texts to deliver health information showed increased use of health 
services, dissemination of educational information, and utilization of disease management skills.58,59 
Although text messaging interventions are increasing in popularity, few have focused on perinatal 
depression. Several studies have examined feasibility and acceptability of implementing text message 
interventions among perinatal women without examining health outcomes.60-63 A 2015 review 64 found 
48 studies evaluated effects on knowledge, attitudes, or behaviors among pregnant women, women 
of reproductive age, or women with young children: of these, none focused on postpartum depression. 
RCTs have demonstrated the association of the Mothers and Babies curriculum with prevention of 
new cases of major depression and reduction of depressive symptoms among perinatal women 
receiving MB.13,14,16,17,55  Enhancements to MB are warranted in two main areas. First, prior MB trials 
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suggest the intervention is less successful for women who exhibit smaller changes in hypothesized 
intervention mechanisms and less fully engage in homework completion between sessions—a core 
component of CBT interventions like MB. Second, previous postpartum depression preventive 
interventions—including MB—have neglected to intervene with partners of pregnant women, despite 
the growing recognition that paternal depression also exerts influence on children’s social-emotional 
development18 and occurs in a similar timeframe.19 Thus, in an otherwise successful intervention, these 
limitations—mixed success in improving hypothesized intervention mechanisms and limited 
engagement of fathers—may mitigate intervention efficacy.  
3.0  Inclusion and exclusion criteria:
The study population will consist 212 study participants. During phase 1,108 participants will be HV 
clients and 16 will be Home Visiting supervisors/managers and home visitors. We will enroll 108 HV 
clients at 10-12 HV programs: 54 women will receive Mothers and Babies 1-on-1 without text 
message enhancements and 54 women will receive Mothers and Babies 1-on-1 with text message 
enhancements. Of the 108 women, 16 will be recruited for focus group participation in phase 2 of the 
study.  The 16 HV supervisors/managers and home visitors will participate in two groups of 8 focus 
group participants. All focus groups will only be held in English. 
During phase 2 of the study we will conduct focus groups with the identified 16 women from phase 1 
of the study. We will also include their male partners (n=16) in two focus groups of 8 participants. All 
focus groups will only be held in English. Additionally we will recruit 36 women and their male partners 
(36 dyads from 10-12 HV programs) to participate in an uncontrolled pilot of the FAB intervention at 
two HV programs not participating in the Phase 1 RCT. We will conduct additional, qualitative data 
from 22 male partners after receiving FAB. Our informed consent from includes an option to be 
contacted for future research studies, we will only contact participants who indicate “yes” to this option 
for qualitative data collection activities (focus groups and key informant Interviews) after completing 
FAB.  
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Study Participants 
 Phase 1 (MB-TXT RCT)
We will recruit 108 study participants from 10-12 Home Visiting programs. English or Spanish-
speaking women >16 years old enrolled in HV programs who are in their 1st or 2nd trimester (< 26 
weeks) will be eligible for enrollment; across the 10-12 HV programs ~80% of women meet these 
criteria. 
Phase 2 (FAB Development and Pilot)
(A) Focus Groups for FAB Development
We will recruit a total of 48 focus group participants, consisting of 16 female clients who participated in
MB-TXT in Phase 1, 16 male partners of the female focus group participants, and 16 Home Visiting
supervisors/managers and home visitors from the HV programs. The focus groups with the Home
Visiting supervisors/managers and home visitors will be conducted during Phase 1 and 2 of the study.
The focus groups will consist of 16 Home Visiting supervisors/managers and home visitors from the
HV programs. The focus groups in phase 2 will consist of 16 female clients who participated in MB-
TXT in Phase 1 and 16 male partners of the female focus group participants. All focus groups will only
be held in English.
(B) FAB Pilot Study
We will recruit 36 women and their male partners (36 dyads from 8-10 HV programs).Eligible women
(n=36) may be English speaking, >18 years old and enrolled in HV programs who are pregnant or
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have a young child or children. Eligible men (n=36) may be English speaking, >18 years old, partners 
of female participants. We will recruit a total of 22 male partners who have received FAB (post-
intervention) for focus group and key informant interviews. 
Home Visiting Programs
The 10-12 HV programs that use either the Healthy Families America (HFA) or Parents as Teachers 
(PAT) model. HFA and PAT are evidence-based71 paraprofessional HV models that enroll women 
prenatally and continue services until a child’s second birthday (HFA) or entry into kindergarten (PAT). 
Both HFA and PAT recruit women at high risk for poor pregnancy and/or parenting outcomes via 
referrals from prenatal care clinics, community outreach, and current program participants. Both the 
HFA and PAT models call for weekly or bi-weekly home visits during pregnancy and the first six 
months postpartum. English or Spanish-speaking women >16 years old enrolled in HV programs who 
are pregnant will be eligible for enrollment in Phase 1 of the study. English speaking dyads; women 
>18 years old enrolled in HV programs and their male partners >18 years will be eligible for 
enrollment in Phase 2 of the study. Across the HV programs ~80% of women meet these criteria. 
Vulnerable Populations
We will enroll pregnant women in both studies given that the Mothers and Babies Course can 
delivered prenatally as a postpartum depression prevention intervention.  In Phase 1, we will offer 
participation to pregnant women, ages 16 and older, knowing that the client population of HV 
programs is younger, on average, than the general population. In Phase 2, we will offer participation 
to pregnant women or have a young child or children who are enrolled in HV, ages 18 and older. 
Mothers and Babies has been used in similar HV settings in the state of Illinois and nationally, with 
high ratings of acceptability and usefulness and no ill effects of participation detected.  
4.0  Procedures Involved:
Phase 1 (MB-TXT RCT)
Study Activities Include: 

Recruitment of participants for MB / MB + Text RCT

Focus Groups with Home Visiting supervisors/managers and home visitors (2 Groups of 8, 
n=16) 
Program Implementation (MB-TXT RCT)
We will conduct a cluster RCT to determine the feasibility and acceptability of the MB-TXT 
intervention and calculate a preliminary effect size to determine a sample size for a future RCT. This 
RCT will also allow us to examine MB-TXT effects on proposed mechanisms underlying intervention 
efficacy. Cluster allocation by HV program minimizes contamination between study groups. We will 
work with 10-12 HV programs that have been trained on MB 1-on-1 and have working relationships 
with the PI. These programs provide a geographically, racially, and ethnically diverse set of 
recruitment sites. These programs are part of a network of Illinois HV programs overseen by the 
Illinois Governor’s Office of Early Childhood Development which has supported scaling MB throughout 
Illinois and is enthusiastic about using text messaging to enhance intervention effectiveness. We will 
use a stepped wedge design—a form of RCT that involves sequential, but random, rollout of the 
intervention over multiple time periods. We have created two HV program clusters. Both clusters will 
initially implement MB 1-on-1 and will recruit MB participants for one quarter (i.e., three months) 
before crossing over to recruit MB-TXT participants for one quarter. MB-TXT’s core curriculum is 
identical to MB 1-on-1 and adds a series of text messages throughout the curriculum.  
Study Conditions:
MB 1-on-1. Half of our study participants (n=54) will receive MB 1-on-1. MB 1-on-1 is a manualized 
12-session intervention divided into five modules. An introductory 2-session module establishes key 
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concepts related to stress, monitoring of one’s mood, and ways in which one’s mood influences one’s 
internal thoughts and external environment; three 3-session modules correspond with key cognitive-
behavioral elements: pleasant activities, thoughts, and social support/contact with others; a 1-session 
summary reviews content and identifies areas for future use of MB skills. Throughout MB, mood 
management skills are integrated using psycho-educational activities that encourage participants to 
understand connections between their mood and their activities, thoughts, and contacts with others. 
Content is tailored to specific needs and issues of pregnancy and the postpartum periods. Each MB 
session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit. 
MB-TXT. Half of our study participants (n=54) will receive MB 1-on-1 along with text enhancements. 
Co-Investigator Barrera has developed text messages to complement MB content, both in English and 
Spanish. These texts focus on: a) skill reinforcement (e.g., Some thoughts just come to us, but we can 
make a conscious effort to think of positive thoughts.); b) homework reminders (e.g., What pleasant 
activity will you try today?), and c) self-monitoring (e.g., On a scale of 1-9, how would you rate your 
mood?).We will append the MB 1-on-1 Instructor Manual with instructions on how and when to 
integrate these 36 texts into the existing curriculum. These texts will be linked with the 12 MB 
sessions. Specifically, after completing each in-person session, 3 texts will be sent by a home visitor 
to her client; one text will focus on skill reinforcement, one will be a homework reminder, and one will 
focus on self-monitoring. We anticipate that texts will be sent within one week of the completion of a 
session to ensure standardization and minimize the likelihood that home visitors will forget to send 
messages. All texts will be sent through the HealthySMS platform used in Co-I Barrera’s pilot study. 
To increase participant engagement (i.e., reading texts), messages will be sent at different times of 
the day, per the study participant’s preference.64 The Instructor Manual will specify the order in which 
the texts should be sent. Some messages will ask for a response from the client. This will allow 
investigators to determine whether a message is read and obtain data related to usefulness of a text 
message and/or client behavior. For example, in response to a text asking the client to rate her mood 
(i.e., self-monitoring), the client can enter 1 (worst mood ever) through 9 (best mood ever); these data 
will be sent to the HealthySMS platform which can be accessed by the home visitor. Additional open-
ended responses can also be provided by clients. Each text and related response are linked and 
stored in HealthySMS for immediate access and review or future download and analysis. Home 
visitors will be trained by Co-I Barrera and PI Tandon  on MB-TXT implementation. We have budgeted 
for participants to receive a monthly stipend to cover the costs text messaging until the 12 MB 
sessions are completed or up to six months post baseline. In phase 1 (MB-TEXT) this is available to 
only participants receiving texts. If participants do not cell phones with unlimited texting to ensure 
access to necessary technology. 
Phase 1 Focus Groups 
We will also recruit and conduct two focus groups with 16 HV supervisors/managers and home 
visitors beginning in phase one and into phase 2 of the study. 
Training and Supervision of HV programs. The majority of participating All HV programs have been 
trained on MB 1-on-1 and are currently implementing the curriculum. Programs new to the MB Course 
will receive in-person training from the PI and/or study team. All programs will receive a half-day 
refresher training on MB along with guidelines on implementing MB-TXT conducted by Co-I Barrera 
and PI Tandon. All  programs will receive supervision from PI Tandon after the first implementation of 
the intervention begins at the HV programs
Participant Screening: Participants will initially be screened for eligibility criteria by their home 
visiting program sites. Upon permission from the potential study participant, program sites will fill out a 
referral form, which will include the potential study participants name and contact information, and 
send it to the research team. The HV will explain the study and provide a brochure with study details 
during the referral process. Once the program sites refer potential study participants, a member of the 
study team will call the participant using the “Phone Script for Referrals” to screen the potential study 
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participant for eligibility criteria and move forward with the consent process either via telephone or a 
REDCap survey link.
Participant Outcomes Surveys: 
Clients MB TEXT: Participant outcomes will be collected at three time points—baseline and 6 months 
post-intervention. Participants will receive $20 remuneration at the baseline and 6-months, 
assessments. $20 remuneration will be in the form of a Northwestern PNC stored-value card (Visa 
Gift-Card). 
Home Visitors: Home visitors will be asked to respond to a REDCap survey items after completing 
each MB session to assess if clients came to the session having completed their personal project, 
implemented session, and next scheduled session date. Home visitors will measure clients’ perceived 
utility and comprehension of text messages by asking clients to rate the extent to which each of the 3 
text messages received between sessions was a) useful and b) easy to understand. Questions will be 
on a 4-point Likert Scale and will be asked of clients at the end of each MB session. These data will 
be inputted into the HealthySMS system.
Focus Groups: There will be six focus groups during the study. Two focus groups with HV 
supervisors, managers, and home visitors will take place during phase 1 and 2. Four focus groups 
with clients and their partners will take phase during phase 2. All focus group participants will receive 
$30 remuneration in the form of a Northwestern PNC stored-value card (Visa Gift-Card).
Related to Aim 1, MB-TXT feasibility and acceptability data will be collected from clients and home 
visitors. Similar to previous SMS studies, we will use percentage of text responses as an indicator of 
“read” messages. We will assess home visitor adherence to the MB-TXT protocol by using archived 
data from HealthySMS to calculate percentage of texts sent at appropriate intervals, as stated in the 
MB Instructor Manual. Home visitors will complete a brief web-based REDCap survey after 
completing each MB session to assess if clients came to the session having completed their personal 
project. Using a 4-point Likert Scale, home visitors will also ask clients to rate the extent to which each 
of the 3 intersession texts was a) useful and b) easy to understand; these data will be entered into 
REDCap. Related to Aim 2, participant outcomes will be collected via survey at baseline and 6 
months. Data will be collected and managed using REDCap electronic data capture tools hosted at 
Northwestern. Participants will receive $20 remuneration for each assessment. At each assessment, 
a link to REDCap will be sent to study participants who can complete the assessment on any web 
platform (smartphone, tablet, and computer). The Project Manager or Research Assistant will 
complete assessments by phone for participants who prefer not to use REDCap. Depressive 
symptoms, as measured by the the Beck Depression Inventory-II (BDI)100 a 21-item self-report 
measure is our primary outcome. Secondary outcomes, which map onto the hypothesized 
mechanisms for influence on depressive symptoms are: cognitive structuring (Experiences 
Questionnaire),85 behavioral activation (Behavioral Activation Depression Scale),86-88 social support 
(MOS Social Support Survey),89 and mood regulation (Negative Mood Regulation Scale).90,91 We 
estimate 15% attrition at 6months, resulting in 46 participants per arm; previous MB trials conducted 
by PI Tandon had 12 month attrition rates <10% and we will use similar procedures for minimizing 
attrition.
Analysis for Aim 2 is limited to the fact that this is a pilot study. As such, we will compare MB and MB-
TXT groups at the individual level (not adjusting for potential clustering effect of either home visitor or 
HV program). The data will also provide key insights for future studies on how correlated the BDI 
scores will be over time, as longitudinal data during this postpartum period is not readily available. To 
address hypothesis 2, the first step in mediation is to determine the mediator’s association with the 
criterion (group), as well as the outcome. The sample provides 80% power to detect effect sizes of 
0.59 using two sided Mann Whitney tests at a type I error rate of 5% (for the between group 
comparison of potential mediators: negative cognitions, behavioral activation, use of support systems, 
mood regulation), as well as 80% power to detect correlations as small as 0.287 (comparing BDI to 
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the potential mediators). Pilot data will allow us to examine potential ranges of Intraclass Correlation 
Coefficients (ICC), which we need to account for in a larger RCT. These data will allow us to explore 
whether randomization should be done at HV program level, or the home visitor level. This sample 
provides 80% power to detect ICCs of 0.179 (13-14 observations at 10-12 HV programs), or of 0.261 
(3 observations in 36 home visitors).  
Phase 2 (FAB Development and Pilot)
Study Activities Include: 

Focus Groups with HV Clients (n=16) and their male partners (n=16) 

Development of FAB 

Pilot FAB

Note: The research team submitted a modification to add/update details about the focus 
groups for phase 2 of the study. Focus group guide for these groups was submitted a 
modification for versions 7 of the protocol. 

Note: The research team submitted a modification to add/update details for the FAB 
intervention pilot in phase 2 of the study including recruitment materials.  Modifications are 
included in version 8 of the protocol. 

FAB Post Intervention Focus Groups and Key Informant Interviews 

Note: The research team will submit a modification to add/update details about the FAB post 
intervention focus groups and key informant interviews. The modification will include focus and 
key informant consents, the focus group guide and the key informant interview guide. 

Overview of Phase 2 (FAB Development and Pilot). For Phase 2, we will conduct an uncontrolled pilot 
of FAB—an intervention for fathers that aims to a) support fathers’ mental health and b) support their 
partners’ mental health, as they become parents. This pilot will determine the feasibility and 
acceptability of conducting the FAB intervention with women enrolled in HV, and their male partners. It 
will also provide guidance on the appropriateness of measures to assess fathers’ mental health and 
dyadic relationships and generate preliminary data from those measures that can guide a subsequent 
RCT.  
Program Implementation (FAB Development and Pilot)
To develop the FAB curriculum and protocol we will conduct a series of focus groups with key 
stakeholders along with using materials already developed by Co-I Garfield (see C2). We will conduct 
a total of six focus groups, each comprised of 8 individuals per focus group (total 54 focus group 
participants). Two focus groups will be conducted with female clients who participated in MB-TXT in 
Phase 1; one focus group will be with predominately low-income African American women from a 
Chicago-area HV program while the other will be with predominately low-income white women from 
suburban Chicago. Two focus groups will be held with the male partners of the female focus group 
participants and two focus groups will be conducted with HV supervisors/managers and home visitors 
from the HV programs. The focus groups with the HV supervisors/managers and home visitors will 
begin in Phase I. At each HV program, 18 women will take part in MB-TXT, thereby making 8 women 
with their male partners a reasonable enrollment target. 
Focus group questions will emphasize four domains: 1) content appropriate for fathers to support their 
own mental health, 2) content appropriate for fathers to support their female partner’s mental health, 
3) recommendations for frequency and duration of FAB text intervention, and 4) relationship/ synergy 
of MB-TXT and FAB content and delivery. Focus groups will be moderated by Co-I Garfield and the 
Project Manager. Notes will be recorded by the Project Manager. All focus groups will be audio 
recorded and transcribed verbatim. PI Tandon and Co-I Garfield have expertise with qualitative 
analysis79,91-95 and will independently code the focus groups along with the Project Manager to identify 
key concepts and themes related to each of the four domains. These data will be used to develop a 
series of texts for the FAB intervention and the protocol for delivering those texts. This process will be 
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led by PI Tandon and Co-Garfield as well as three focus group participants—one female HV client, 
one male partner, and one home visitor—who will meet with the investigators in person (as needed) 
and by phone. Both PI Tandon and Co-I Garfield have experience developing and adapting 
intervention curricula while engaging stakeholders in the development process.79,96 Once the series of 
texts and protocol is drafted, two additional focus groups will be conducted to refine the FAB protocol 
and content. These focus groups will be mixed-gender—i.e., women and their male partners can 
attend—and will consist of individuals who participated in the initial set of focus groups.  
We will conduct an uncontrolled pilot of the FAB intervention at 10-12 HV programs. Programs from 
the TEXT phase will be included in the pilot and additional programs will be recruited. The additional 
programs will have been previously been trained in MB and are currently implementing the 1-on-1 
modality. . HV programs will serve predominately low-income African American women and 
predominately low-income white women. We will recruit 36 women and their male partners. Eligibility 
criteria will be different from Phase 1 RCT. English speaking dyads; women >18 years old enrolled in 
HV programs who are pregnant or have a young child or children and their male partners >18 years 
will be eligible. Recruitment processes will be identical to the Phase 1 RCT. Male partners will also 
provide informed consent. Female clients will receive the MB-TXT curriculum (i.e., MB 1-on-1 plus 
MB-TXT) and their male partners will receive the FAB text based curriculum. Home visitors will be 
responsible for sending texts to both their female clients and the clients’ male partners. Participant 
outcomes will be assessed at baseline and post-intervention at 3, and 6 months. All measures used in 
Phase 2 (see Table 2) will be administered to both female and male participants; these measures all 
have been widely used with both genders in prior research. Additional measures will be administered 
to both female and male clients on their relationship status,97 father involvement with child,98 and 
perceived social support from partner99. 
We will recruit a total of 22 male partners who have received FAB (post-intervention) for focus group 
and key informant interviews, to inform which aspects of FAB content and delivery are working well 
and which require modification. We will develop focus group guides and semi-structured interviews 
that prompt discussion about the following topics: (1) satisfaction with the existing FAB Course, 
identifying the most and least enjoyable, understandable, and useful content; (2) effectiveness of 
content delivery (e.g., web-based links to content, text-messages); (3) additional topics that should be 
included to meet the needs of new fathers and families; and, (4) methods to best engage fathers in 
the FAB intervention.  Focus groups and key informant interviews will be audio-recorded, transcribed, 
and then analyzed to identify common themes to guide FAB Course revisions. In keeping with a 
collaborative approach that our research team has undertaken throughout our MB and FAB work, 
during our focus group and key informant interviews we will identify 2-3 fathers from different cultural 
backgrounds to serve as consultants, who will remain engaged in an iterative process of review and 
feedback about FAB revisions.
Study Conditions:
MB 1-on-1 plus MB-TXT. The female study participants (n=36) will receive MB 1-on-1 along with text 
enhancements. Co-Investigator Barrera has developed text messages to complement MB content. 
These texts focus on: a) skill reinforcement (e.g., Some thoughts just come to us, but we can make a 
conscious effort to think of positive thoughts.); b) homework reminders (e.g., What pleasant activity 
will you try today?), and c) self-monitoring (e.g., On a scale of 1-9, how would you rate your mood?). 
These texts will be linked with the 12 MB sessions. Specifically, after completing each in-person 
session, 3 texts will be sent by a home visitor to her client; one text will focus on skill reinforcement, 
one will be a homework reminder, and one will focus on self-monitoring. 
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FAB.  The male study participants (n=36) will receive FAB a text based intervention/curriculum. PI 
Tandon, Co-Investigator Garfield, and the Research Project Manager have developed a curriculum 
that aligns and is complimentary to MB 1-on-1 plus MB-TXT. The first FAB session can be delivered 
in person with the dyad (female and male client) during a home visit, or separately. If the male client 
cannot be  present for the first session, the Home Visitor or Project Manager will deliver the session 
over the phone. After the first session is initiated with the dyad, the female client will receive MB 1-on-
1 and MB-TXT and the male client will receive FAB texts (9-15 per module). The HV will have 
flexibility to deliver additional sessions in to the male client but is not required. Text messages to 
complement MB content (English Only). These texts focus on: a) skill reinforcement b) practice 
reminders (c) self-monitoring. These texts will be linked with the 12 MB sessions that the female client 
is receiving but the male partner will receive additional texts to deliver the content in a text-based 
sessions. He will receive 3-6 text messages per session while his partner will receive 3 messages 
after each session. Specifically, after completing each in-person session, texts will be sent by a home 
visitor to both her female client (Total # of Txts = 36) and her partner (Total # of Txts = 51). 
We anticipate that texts will be sent within one week of the completion of a session to ensure 
standardization and minimize the likelihood that home visitors will forget to send messages. All texts 
will be sent through the HealthySMS platform used in Co-I Barrera’s pilot study. To increase 
participant engagement (i.e., reading texts), messages will be sent at different times of the day, per 
the study participant’s preference.64 Each text and related response are linked and stored in 
HealthySMS for immediate access and review or future download and analysis. 
We have budgeted for each dyad to receive a monthly stipend to cover the costs of text messaging 
until the 12 MB sessions are completed or up to six months post baseline. In phase 1 (MB-TEXT) this 
is available to only participants receiving texts. If participants do not cell phones with unlimited texting 
to ensure access to necessary technology. 
Training and Supervision of HV programs. All the participating HV programs have been trained on MB 
1-on-1 and are currently implementing the curriculum. All programs will receive a two-hour training on 
implementing FAB and MB-TXT conducted by  the Research Project Manager. All programs will 
receive supervision after the first implementation of the intervention begins at the HV programs. 
Participant Screening: Participants will initially be screened for eligibility criteria by their home 
visiting program sites. Upon permission from the potential study participant, program sites will fill out a 
referral form, which will include the potential study participants name and contact information, and 
send it to the research team (e-mail or fax). The HV will explain the study and provide brochures for 
both the female client and male partner with study details during the referral process. Once the 
program sites refer potential study participants, a member of the study team will call the participants 
using the “Phone Script for Referrals” to screen the potential study participants for eligibility criteria 
and move forward with the consent process either via telephone or a REDCap survey link. The female 
client and male partner will be contacted and consented separately. The female and male client will 
both have to agree to participate in the study to be eligible to participate. If there is discordance, 
(female client or male partner does not agree) to participate the dyad will be ineligible. Our informed 
consent from includes an option to be contacted for future research studies, we will only contact 
participants who indicate “yes” to this option for qualitative data collection activities (focus groups and 
key informant Interviews) after completing FAB.  
Participant Outcomes Surveys: 
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Clients FAB: Participant outcomes will be collected at three time points—baseline and 3 and 6 months 
post- intervention. Participants will receive $20 remuneration and will be in the form of a Northwestern 
PNC stored-value card (Visa Gift-Card). 
We will measure male clients’ perceived utility and comprehension of text messages by asking clients 
to rate the extent to which the text messages were a) useful, b) enjoyable, and c) easy to understand. 
Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each MB module 
(Introduction, Pleasant Activities, Thoughts, Contact with Others and Review/Conclusion). We will 
measure male and female clients’ perceived feasibility and acceptability post intervention.  These data 
will be  collected via REDCap. 
Home Visitors: Home visitors will be asked to respond to a REDCap survey items after completing 
each MB session to assess if  female clients came to the session having completed their personal 
project, implemented session, and next scheduled session date. Home visitors will measure female 
clients’ perceived utility and comprehension of text messages by asking clients to rate the extent to 
which each of the 3 text messages received between sessions was a) useful and b) easy to 
understand. Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each 
MB session. These data will be inputted into the HealthySMS system. We will assess home visitors’ 
perceived feasibility and acceptability post intervention after all 12 session of MB-TXT and FAB are 
completed.. These data will be collected via  REDCap.
Focus Groups: There will be three focus groups and 4 key informant interviews during the study and 
will take place during phase 2 after participants have completed FAB. All focus group and key 
informant participants will receive $35 remuneration in the form of a Northwestern PNC stored-value 
card (Visa Gift-Card).
Table 1: Detailed Description of Study Measures for Phase1 
Text messages read by HV clients will be measured by calculating the percentage of text 
messages responded to by clients. 
Home Visitor Adherence to MB-TXT protocol will be measured by using the archived data from 
HealthySMS to calculate the percentage of texts sent at the appropriate intervals, as stated in the 
MB Instructor Manual 
Client completion of personal projects will be measured by asking home visitors to respond to a 
REDCap survey item after completing each MB session to assess if clients came to the session 
having completed their personal project. 
Client perceived utility and comprehension of text messages will be measured by asking home 
visitors to rate the extent to which each of the 3 text messages received between sessions was a) 
useful and b) easy to understand. Questions will be on a 4-point Likert Scale and will be asked of 
clients at the end of each MB session. These data will be inputted into REDCap. 
Depressive Symptoms will be assessed using the Beck Depression Inventory-II (BDI),100 a 21-item 
self-report measure of depressive symptoms to assess severity of depressive symptoms consistent 
with DSM-IV symptom criteria. The BDI has excellent internal reliability for outpatient samples and its 
construct validity has been established. 
Cognitive Structuring will be measures using the Experiences Questionnaire85 a 20-item self-report 
scale measuring decentering and rumination, which has demonstrated strong internal consistency in 
studies examining effects of interventions that incorporate cognitive restructuring. 
Behavioral Activation will be measured using the Behavioral Activation Depression Scale,86 a 25-
item, four subscale self-report with strong psychometric properties.86,87 The four subscales assess 
activation, avoidance/rumination, work/school impairment, and social impairment. We will also use a 
brief checklist adapted from the Pleasant Events Schedule, a psychometrically strong 
questionnaire.88 This 25 item self-report contains a list of pleasant events relevant to low-income 
pregnant women and assesses the extent to which subject’s engaged in, and experienced pleasure 
from, these activities. 
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Social Support using the 19-item Medical Outcomes Study Social Support Survey.89 This self-
administered survey includes an overall functional social support index, as well as four functional 
support subscales: affectionate, emotional/informational, tangible, and positive social interaction. 
Mood regulation will be measured using the Negative Mood Regulation Scale (NMRS).90 The 
NMRS assesses an individual’s expectancy that some behavior or cognition will alleviate a negative 
mood state. For each question, respondents use a five-point scale from “very much disagree” to 
“very much agree” to indicate what they believe they can do when they are disappointed or 
experiencing a negative mood. The scale has demonstrated excellent internal consistency, good 
test-retest reliability, and correlational evidence of both convergent and discriminant validity with 
constructs such as depressive symptoms and locus of control, respectively.91 
Mothers and Babies Skill Utilization will be assessed using items developed the study 
investigators. 
Client demographics will be assessed using items developed by the study investigators. 
Baseline Demographics –17 items
3 & 6 month Follow-up Demographics – 8 items 
Prenatal Behavior and Service Utilization. - will be assessed using items developed by the study 
investigators.
Table 2: Detailed Description of Study Measures for Phase 2
Text messages read by HV clients will be measured by calculating the percentage of text 
messages responded to by female and male study participants. 
Home Visitor Adherence to MB-TXT protocol will be measured by using the archived data from 
HealthySMS to calculate the percentage of texts sent at the appropriate intervals, as stated in the 
MB Instructor Manual. 
HV Post Intervention Survey will be assessed using questions developed by the study 
investigators.  Questions will be on a 4-point Likert Scale and will be asked of home visitors at the 
end of the 12 MB sessions.
Female Client perceived utility and comprehension of text messages will be measured by 
asking home visitors to rate the extent to which each of the 3 text messages received between 
sessions was a) useful and b) easy to understand. Questions will be on a 4-point Likert Scale and 
will be asked of clients at the end of each MB session. These data will be inputted into HealthySMS. 
Female Client Post Intervention Survey will be assessed using questions developed by the study 
investigators.  Questions will be on a 4-point Likert Scale and will be asked of the female clients at 
the end of the 12 MB sessions.
Male Partner perceived utility and comprehension of text messages will be measured by a 
survey to rate the extent to which the text messages received were a) useful and b) easy to 
understand. Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each 
MB module. 
Male Partner Post Intervention Survey will be assessed using questions developed by the study 
investigators.  Questions will be on a 4-point Likert Scale and will be asked of male partners at the 
end of the 12 MB sessions.
Depressive Symptoms will be assessed using the Beck Depression Inventory-II (BDI),100 a 21-item 
self-report measure of depressive symptoms to assess severity of depressive symptoms consistent 
with DSM-IV symptom criteria. The BDI has excellent internal reliability for outpatient samples and its 
construct validity has been established. 
Anxiety symptoms will be assessed using the GAD-7- To assess anxiety, we will administer the 
Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006), which is a widely used self-
report measure of anxiety symptoms. 
Perceived stress will be assessed using the Perceived Stress Scale 10-item version. 
We will use the 10-item Perceived Stress Scale (PSS-10; Cohen & Williamson, 1988; Remor et al., 
2006) to assess the level to which an individual considers their life stressful and how controllable a 
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person appraises her life. 
Social Support will be assessed using the NIH Toolbox Instrumental Support and Emotional 
Support measures. Each measure asks 8 questions and asks respondents to indicate the extent to 
which they have received support for each area in the last month.  
Mothers and Babies Skill Utilization will be assessed using items developed the study 
investigators. 
Client demographics will be assessed using items developed by the study investigators. 
Female Client Baseline Demographics- 18 items 
Female Client 3 & 6 Follow-Up Demographics- 10 items 
Male Partner Baseline Demographics – 14 items
Male Partner 3 & 6 Follow-Up Demographics- 8 items 
Prenatal Behavior and Service Utilization. - will be assessed using items developed by the study 
investigators.
Relationship with partner will be measured using the Revised Dyadic Adjustment Scale (RDAS) 
cohesion subscale. The RDAS cohesion subscale is most relevant to this study and measures items 
such as engaging in activities together.  The cohesion subscale consists of 4 items, each of which 
asks respondents to rate certain aspects of his/her relationship on a 5- or 6- point scale. Higher 
scores indicate greater relationship satisfaction. The RDAS has demonstrated excellent internal 
consistency.97 
Fathers’ involvement with child will be measured using the 10-item Father Engagement Scale 
(Dyer et al., 2015) which measures the number of times per month fathers engage in different types 
of activities with their child. 
Perceived social support from partner will be measured using the Social Support Effectiveness-
Questionnaire (SSE-Q) a 25-item version (Rini et al., 2011, J Consult Clin Psychol). 
Participant Outreach and Contact: Study participants will be contacted at the following time points 
throughout the study:
1.
Upon referral into the study. This contact will be from a member of the research team in order 
to conduct eligibility screening and review the study and next steps for consent and 
assessments
2.
To schedule and/or conduct assessments by phone or REDCap survey link at baseline, post 
intervention, 3 and 6 months. 
3.
Text Messages after each session (MB +Text Only and FAB) 
4.
To check in with the study participants to make sure the study team has up to date contact 
information for the participant, as well as to stay engaged and build a rapport with the 
participant. 
5.
If the study participant is selected to participate in a focus group, research staff will call and 
coordinate focus group logistics. 
6.
Congratulation cards will be sent to each study participant after the birth of their baby
7.
An information sheet will be mailed to notify participants who were previously consented and 
currently enrolled about the study being included in ClinicalTrials.gov and the change to the 
follow-up time points. We will only be following up at 6 months post-intervention and not at 9 
month post-intervention. 
5.0 Multiple sites:  Alinne Barrera is a CO-I on this grant. CO-I Barrera is the developer of the text 
messages and HealthySMS platform. Since she will be overseeing the implementation of the text 
message platform she will have access to participant information. She will not be involved in the 
consent or follow-up procedures and will not be directly interacting with participants. Alinne Barrera’s 
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Institution is Palo Alto University. Palo Alto's IRB is ceding IRB review to Northwestern and signed an 
IRB Authorization Agreement (IAA). 
6.0  Incomplete Disclosure or Deception: N/A
7.0  Recruitment:
Study Participants: During phase 1, we will recruit 108 study participants from each of the 
participating HV programs. We will enroll 108 HV clients at 10-12 HV programs, 54 women will 
receive Mothers and Babies 1-on-1 without text message enhancements and 54 women will receive 
Mothers and Babies 1-on-1 with text message enhancements. Of the 108 women, 16 will be recruited 
for focus groups phase 2 of the study.  
During phase 2 of the study we will conduct focus groups with the identified 16 women from the 108 
group that participated in phase 1 of the study. We will also include their male partners (n=16) in two 
focus groups of 8 participants. Additionally we will recruit 36 women and their male partners  to 
participate in the FAB Pilot Study. 
Home Visitors: We will recruit approximately 36 home visitors from 10-12 participating HV programs 
throughout the state of Illinois. All HV programs recruit women at high risk for poor pregnancy and/or 
parenting outcomes via referrals from prenatal care clinics, community outreach, and current program 
participation. All of the home-visitors who are being recruited through the participating home-visiting 
sites have been previous trained and are currently implementing Mothers and Babies 1-on-1. Home 
visitors that have not been trained will receive an in-person training (see training section for more 
detail). Each home-visitor will identify 1-4 client that will participate in study activities, of these clients 
1-2 will receive MB without Text and 1-2 will receive MB with Text.  All home-visitors will implement 
MB without text and MB with text. Programs will initially implement MB 1-on-1 and will recruit MB 
participants for six months before crossing over to recruit MB-TXT participants for 6 months. To pilot 
FAB 1-3 home-visitors from each program will identify 1-4 client dyads that will participate in FAB pilot 
study activities; Home-visitors who will implement FAB will recruit dyads. 
We anticipate 16 home-visitors will participate in focus groups during phase 1 and 2 of the study.  10-
12 HV programs will be recruited to implement the FAB pilot. 
Recruitment Procedures/Attrition: Recruitment procedures will be identical to those used in a 
previous RCT of MB in HV programs conducted by Dr. Tandon. A postcard and/or flyer will be 
provided to the participating HV sites and the potential eligible study participants prior to NU research 
staff calling the study participants. The postcard/flyer will explain the purpose and overview of the 
study. Prior to beginning program implementation, potential study participants contact information will 
be obtained by the participating trained HV sites. The HV programs will fill out the referral form for 
eligible and interested participates, the form will be faxed or e-mailed to the Project Manager. The 
Project Manager and Research Assistant will share responsibility for calling each woman receiving HV 
services to tell them more about the recruitment and consenting process. A recruitment letter will be 
sent to the participants by the RA asking them to participate in the research study if the research team 
is unable to reach them by phone or email. The NU research team will also email the survey link to 
the study participants using email addresses provided by the HV sites, the link on NU REDCap 
database to be able to consent to participate in the program and complete a baseline assessment. 
The surveys will be available in both English and Spanish.
We will obtain names, phone numbers, and addresses of women and their partners. Individuals who 
meet our criteria for study eligibility but who are not interested in participating in our research activities 
will still be able to participate in the MB intervention. Based on previous research, we expect that 
fewer than 5% of eligible participants will opt out of research activities.
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Phase 1 (MB-TXT RCT)
Each program will send contact information for an eligible participant to the Project Manager. The 
Research Assistant or Project Manager will contact these women to introduce women to the study, 
answer questions about participation, and ascertain interest in study participation. For women 
expressing interest, the Research Assistant will send an email link to the REDCap data collection 
portal to conduct the baseline assessment. Before completing the assessment, participants will 
provide informed consent via the REDCap system. Informed consent and surveys will be conducted 
by telephone with participants who do not have consistent internet access. These recruitment 
procedures have been used successfully in Dr. Tandon’s current HV research in Illinois.
Phase 2 (FAB Development and Pilot)
 Focus Groups
Informed consent forms will indicate that women participating in the MB-TXT intervention may be 
approached to participate in a focus group upon completion of the intervention. We anticipate 
recruiting women from the HV programs participating in MB-TXT. Should we have difficulty recruiting 
study participants from these programs, we will recruit from programs that have been previously 
trained in MB 1-on-1. . 
To recruit male partners for the focus groups, we will use recruitment procedures used by Co-I 
Garfield in his previous research. We will first check with the female client that she agrees that her 
male partner should be invited to participate; this is an important consideration given the multitude of 
reasons female partners may not want their partner to engage in this project (e.g., domestic violence). 
If the female client agrees and provides contact information for their partners, we will directly contact 
fathers to inform them about the focus groups and gage their interest in participating. This may either 
occur through attempts at in-person or phone exchanges between the Project Manager/Research 
Assistant and fathers. 
HV programs participating in this project understand that one goal is to develop intervention materials 
for fathers of HV clients, and are aware that home visitors from programs implementing MB-TXT will 
be recruited for focus group participation. Recruitment of home visitors for focus groups will be done 
by the Project Manager. We anticipate that home visitor focus groups will be conducted during a 
regularly scheduled supervision meeting among HV staff—a recruitment method that has proven 
effective in previous studies conducted by Dr. Tandon.
FAB Pilot
We anticipate recruiting women from the HV programs participating in MB-TXT and 2-3 new 
programs. We will take a three-pronged approach to recruitment and engagement of fathers in the 
pilot of FAB intervention. First, rather than take a maternal-gatekeeping approach to recruitment, we 
will take a father-centric approach where we directly contact fathers to inform them about this study. 
The home visitor will explain the pilot to her client and her partner during a regularly scheduled visit. 
The home visitor will leave brochures for both the mothers and fathers. Father-specific recruitment 
materials left for fathers who are not present at the time of recruitment by the HV staff. Second, all 
study materials will include father-specific language, images, and content supporting their role and 
importance to the family and the study. If the dyad is interested the HV will fill out the referral form and 
fax or e-mail it to the Project Manager.  The Research Assistant or Project Manager will contact the 
female client and her partner separately and explain the study. For the uncontrolled pilot, recruitment 
procedures for females will be similar to those described earlier for Phase 1 (MB TEXT RCT).  
Recruitment procedures for male partners will use the same strategies as listed above. Male partners 
will also be sent an email link to the REDCap data collection portal to conduct baseline assessments 
and will be asked to provide informed consent via REDCap prior to completing this assessment. 
Informed consent and surveys will be conducted by telephone with participants who do not have 
consistent internet access. These recruitment procedures have been used successfully in 
Dr.Tandon’s current HV research in Illinois.
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Informed consent forms will indicate that male partners participating in the FAB intervention may be 
approached to participate in a focus group or key informant upon completion of the intervention.
8.0  Consent Process 
All recruitment and consent procedures will be performed in accordance with guidelines of the
Northwestern University Institutional Review Board. Women enrolling in home visiting programs 
during recruitment periods will complete the screening administered by phone by the Project Manager 
or Research Assistant. We request a waiver of written documentation of consent in order to 
administer this study online, or over the telephone if client participants do not have easy access to 
web-based resources. Online study implementation will decrease the time required to complete study 
assessments, and is more feasible to implement given that home visiting programs and clients across 
the State of Illinois and adjacent states will be participating, and our resources are limited.
Regardless of whether or not the study participant consents to the study online or over the phone, NU
Research staff will offer the participant a copy of the consent form. If the study participant would like a 
copy of the consent, Research staff will either email or mail a copy of the consent form to the 
participant per their preferred method of contact.
Informed consent from home visiting participants and male partners will be collected primarily via a 
web-based survey using REDCap. For study participants who do not complete informed consent via 
REDCap, informed consent will be obtained by phone. Because in-person written consent will not take 
place, we will seek a waiver of documentation of consent from Northwestern University’s Institutional 
Review Board. This protocol has been used successfully in prior HV studies conducted by Dr. 
Tandon. 
If the enrollee meets eligibility criteria and is interested in participating in the study, the Project 
Manager or RA will indicate that a web-link with instruction on completing the baseline assessment via 
REDCap will be emailed or texted to them within the next two weeks. Consent will be conducted using 
online administration at the time of the first web-based survey. A brief questionnaire will follow the 
consent form in order to ensure the participant understands that (1) their participation is voluntary, and 
(2) they may withdraw or refuse participation at any time without consequence to their home visiting 
services. Both the online consent form and the study surveys for home visiting clients will be available 
in English and Spanish. Each time a study participant fills out a survey, the survey will include a 
prompt to the participant asking if they wish to continue their participation by completing the next 
survey.
For phase 1, we are requesting a waiver of parent permission in order to wave the signature of 
parents of children who are participants (Pregnant women >16years old; < 18 years old). This 
research involves minimal risk to the participants by only requiring the administration of online surveys 
and/or telephone interviews in order to collect data. Guidance from the U.S. Department of Health and 
Human Services Office of Research Protections (OHRP) indicates that individuals < 18 years of age 
can consent to study participation without parental consent if the study procedures for which they are 
consenting are such that they could provide consent outside of the research context. The waiver of 
parent permission will not adversely affect the rights and welfare of the minor subjects. This is a low-
risk study. We will assess the Minor’s ability to consent to participate by asking them a series of 
questions at the end of the informed consent process to ensure they understand 1) the main points of 
the study, including the research requirements, 2) the main risks of the study (in our case, feeling 
uncomfortable about some of the mental health questions, and 3) understanding that they can refuse 
to answer any questions on assessments and/or opt out of the study at any time w/o adversely 
affecting their relationship with their HV program. This research could not practically be carried out 
without the waiver of parent permission. Home- Visiting Program protocol is that parent/guardian 
consent is not required for a client under 18 to be able to enroll in a home-visiting program. The 
minors who we anticipate enrolling into the study may have fractured relationships with their parents 
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given the predominance of unplanned pregnancies may often cause family discord and even 
relocation of pregnant teens. 
The study RA is bilingual and, therefore, will be able to communicate with both
English- and Spanish-speaking participants. All of the surveys and assessments provided to the
participants will be in either English or Spanish and administered either orally or written in the
language in which the participants are most comfortable speaking.
 
The Co-PI (Garfield), Research Project Manager will conduct the focus groups. All focus group 
participants will be asked to provide informed consent prior to participating in the focus groups. 
Consent forms will clearly indicate that some study participants will be asked to participate in this 
additional data collection activity. 
For Phase 1, we will enroll only pregnant women, given that our Mothers and Babies Course is 
delivered prenatally as a postpartum depression prevention intervention. We will offer participation to 
pregnant women, ages 16 and older. Each HV program will send contact information for an eligible 
participant to the Program Manager. The Manager or Research Assistant will contact these women to 
introduce women to the study, answer questions about participation, and ascertain interest in study 
participation. For women expressing interest, the Manager or Research Assistant will send an link to 
the REDCap data collection portal via email or text message, or Facebook message to conduct the 
baseline assessment. Participants that do not have access to online resources will be consented 
verbally and the baseline assessment will be conducted over the phone. Second, we will enroll HV 
supervisors/managers to participate in two focus groups. Consent will also be conducted in person by 
the Program Manager on the day the focus groups take place (prior to the focus groups). 
For Phase 2, we will enroll two sets of study participants.  First, we will enroll HV clients and their 
male partners of women participating in MB-TXT during Phase 1 to participate in four focus groups. 
Two focus groups will consist of 8-6 HV clients. Two separate focus groups will consist of 6-8 of their 
male partners. The Program Manager will administer the focus group consent in person on the day 
the focus groups take place (prior to the focus groups). We will enroll who are pregnant or have a 
young child or children and their male partners enrolled in HV and their male partners 18 years and 
older for our uncontrolled pilot of the FAB intervention.  We will use processes similar to the ones 
described above to consent these individuals via REDCap prior to their baseline assessments.  Again, 
for those individuals who choose not to consent via REDCap, phone consent will be conducted by the 
Program Manager or Research Assistant.  
9.0  Process to Document Consent: 
We request a waiver of written documentation of consent in order to administer this study online, or
over the telephone. Online consenting will take place in Northwestern University’s secure REDCap
Database. There will be a continuous prompt to participants when filling out surveys regarding their
current willingness to continue participation. Instructions to the REDCap assessments will provide 
rationale for the use of certain survey questions. Research team members administering assessments 
via phone or in person will be instructed to make sure this rationale is provided to study participants 
who do not see this rationale on the web-based REDCap system. Participants will be informed via 
informed consent and during all assessments that they may choose to not answer any question at any 
time for any reason and that not answering questions will not affect their relationship with their HV 
programs or ability to keep receiving the MB intervention (for those enrolled in the two intervention 
arms). Research assistants will consult with the Research Manager and PI, Dr. Tandon, if necessary, 
to resolve any questions they are unsure how to handle.
Because the majority of consents will be conducted online, we are asking for a waiver of written 
documentation of consent. For study participants who consent via REDCap, consent will be 
conducted prior to completion of the first web-based survey. The full consent form is provided in 
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REDCap and participants will be asked to indicate whether they agree to participate via a signature 
line for them to type in their name, which is their electronic signature.  Participants who provide online 
informed consent to participate will be able to print the screen to retain the consent form for their 
records. If consent is being obtained over the phone, verbal consent will be used. The person 
obtaining consent will sign and the date the verbal consent form. A copy of the consent form will be 
mailed to the participant with their compensation. For study participants who consent prior to focus 
groups, a hard copy of the consent form will be signed at the time of consent. Regardless of how 
consent is obtained, all respondents will be asked 2-3 questions to ascertain understanding of the 
informed consent process—in particular, that their participation is voluntary, and they may withdraw or 
refuse participation at any time without consequence to their relationship to their home visiting 
program. All client consent forms are available in both English and Spanish. 
10.0  Risks to Participants:
Potential Risks
There are no major risks to study participation.  A participant in the study may experience some 
psychological discomfort while answering questions that may be considered of a sensitive nature 
about oneself or one’s family.  The Project Manager and Research Assistant are trained in a protocol 
for responding to participants’ questions on the rationale for, and use of, certain survey questions. The 
Project Manager and Research Assistant will consult with the PI, Dr. Tandon, if necessary; to resolve 
any questions they are unsure how to handle. Study participants may also experience some 
discomfort discussing stressful life events during the MB intervention.  Home visitors delivering MB 
materials will be specifically trained on protocols to handle such situations. Should a female 
participant wish to withdraw from the study for any reason, at any time, there will be no consequences 
to her access to home visiting and her relationship with her home visitor. Similarly, if a male 
participant chooses to withdraw from the study, this will not have an adverse effect on his partner’s 
receipt of HV services. Given that all female study participants, to be eligible, will have some mild to 
moderate depression symptoms at study entry, it is within reason to expect there may be participants 
who experience and endorse some level of suicidality during the study. We have a safety protocol in 
place (please refer to Protection Against Risks) for such occasions and will ensure the Project 
Manager and home visitors are trained and prepared to implement any safety measures. 
Protection against risks
Only the research team will have access to individually identifiable private information about human 
subjects, for the purpose of tracking recruitment and retention, as well as participation payments. All 
data will be deidentified in study databases. To safeguard confidentiality and anonymity, all data 
collection instruments will identify participants only by study ID number.  Logs linking information to 
study numbers will be kept locked in a file cabinet in the Project Manager’s office.  Data analysis staff 
will not have access to identifying information.  We will inform participants of the areas to be covered 
in the surveys and focus groups prior to their administration. Study participants will be told that if they 
experience any discomfort while participating in the data collection procedures they can ask to be 
removed from the study. Also, participants will be told that they do not have to respond to any 
questions that make them feel uncomfortable.  Individuals will be told that their refusal to answer any 
question will not jeopardize their relationship with their HV program (female clients), their partner’s 
relationship with their HV program (male clients), or their HV colleagues (home visiting supervisors 
and staff).   
Consent forms for female HV clients and their male partners will include a statement that the privacy 
of family members will be respected and information not shared with anyone else, with the exception 
of concerns about risk of harm (e.g., suspected child abuse or suicidality).  All staff will be certified in 
online State of Illinois mandated reporter training provided by the Illinois Department of Child and 
Family Services.  Families will be explicitly informed during the consent process that they will be 
informed if confidentiality must be broken due to mandatory reporting guidelines designed to keep 
children and families safe.  Participants will be invited to be present should the mandated reporting 
occur. 
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Mental health referrals and mandated reporting. There are several types of concerns that may 
arise that will require review and possible referral: (1) imminent risk of harm and/or potential abuse; 
(2) observed or reported extreme distress by the parent and/or by the parent in relation to the child; 
and (3) non-reportable concerns about practices during pregnancy that could be harmful to the fetus.  
All potential concerns will be overseen by the PI, Dr. Tandon. We will use procedures developed by 
the PI to respond to concerns about imminent harm and/or potential abuse. It is possible that some 
study participants will discuss suicidal ideation or having a suicide plan while discussing MB content. 
In these cases, home visitors will be directed to call their program supervisor for consultation, or, in 
extreme cases, 911. Home visitors will remain with participants until an action plan is implemented. 
While it is unlikely, some study participants may text home visitors with thoughts of harming oneself or 
another individual. In these cases, home visitors will similarly contact their program supervisor or 911. 
Home visitors will also be instructed to remain in electronic contact with the study participant. We 
believe the most likely imminent risk will be study participants who endorse suicidal ideation on 
research assessments. In these cases, the protocol will be to refer the study participant to a licensed 
clinical social worker at each HV program (typically the program manager), who will make a 
determination regarding whether the study participant is in danger of harming herself and will 
determine necessary steps to ensure the safety of the study participant.  In addition, the study team 
will provide the participant with contact information (telephone and text) for 24-hour suicide and 
mental health crisis hotlines. Non-imminent concerns will be flagged and discussed in weekly team 
meetings and shared with providers as necessary. Since survey instruments will be asking about 
sensitive subjects such as family relationships, life stress, and mental health, it is possible that 
participants may become distressed.  We will train all research staff how to identify distress during 
assessment procedures, identify flagged items indicating imminent risk (e.g., suicidality), as well as 
safety protocols to follow in different scenarios. 
Phase 1 and 2 of this study will be registered as separate studies on ClinicalTrials.gov. 
11.0  Potential Benefits to Participants: 
Potential Benefits of the Proposed Research to the Subjects and Others
There may be no direct and immediate benefits for individuals participating in the research component 
of this study. We believe that women receiving the MB Course (Phase 1) will exhibit greater 
reductions in depression symptoms and improvements in hypothesized intervention mechanisms 
(e.g., behavioral activation).  We also believe that partners of HV clients receiving the FAB 
intervention (Phase 2) will receiving useful information on how to improve their own mental health and 
be supportive of their partners’ mental health. Findings from this study will be made available to 
researchers and the general public as soon as possible. 
12.0  Financial Compensation:
Participant remuneration will be paid at the completion of each research activity. We will be using the 
STORED VALUE (VISA) CARD PROGRAM pre-paid PNC Stored-Value Cards (Visa Gift Cards). 
There are no fees associated with these cards. All gift cards come with full use instructions and will 
have a sticker on the front of the gift card with the following information: 

Can withdraw at any other ATM but fees may apply. No fees at PNC bank.

Do not use at a Pump at a Gas station

Use within 6 months to avoid fees
Participant remuneration is as follows: 
Study Phase 1 (MB-TXT)

$20 per assessment (n=108) x 3 surveys (baseline, and 6-months) 

$30 per focus group participant (n=16) 
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
$10 monthly stipend to cover monthly text messaging costs while receiving the MB text 
message up to six months (per participant) 
Study Phase 2 (FAB)

$20 per assessment (n = 72; 36 females, 36 males) x 2 surveys 

$30 per focus group participant (n=32) 

$10 monthly stipend to cover monthly text messaging costs while receiving the MB text 
message up to six months (per dyad) 

$35 per focus group or key informant participant (Post FAB Intervention) (n=22; 18 focus 
group participants and 4 key informants)
There is no cost to participate in any of the research activities. To ensure all participants in MB-TXT 
and FAB have access to the required technology for study participation, we have budgeted to 
purchase and provide no-contract cell phones with 6 months of service and text messaging capability 
for 25% of the study sample. Prior work with home visiting programs shows that between 70-75% of 
clients use cell phones as their primary contact with home visitors. We have budgeted to provide cell 
phones for the 54 participants who will participate in the text message intervention. We will rely on the 
discretion of the HV to indicate if the HV client will need assistance with minutes. During the referral 
process we will ask the HV clients if they have a cell phone to be able to participate in the study. 
There could be a cost to participating if participants have to pay for text messages. However, most 
people have unlimited text messaging plans included in their mobile phone service. If they incur 
additional costs, participants may choose not to participate. Participants can opt out at any time by 
sending the word “STOP.”
13.0  Provisions to Protect the Privacy Interests of Participants:
All data records will be identified using an ID number and e-mail only and will not contain other 
personally identifying information. All data will be collected electronically using (REDCap). The PI and 
project staff will have minimal contact with clients since all recruitment is being done through the 
service providers and data collection is being done electronically through a web-based survey. Only 
authorized persons will be granted access to study data.  Passwords and system ID’s for the REDCap 
system will not be shared with other team members. Identifying information (e.g. personal and/or 
contact information) will be kept separate from the other data. All subject information collected will be 
kept in secure, password protected files on Northwestern University servers with access restricted to 
authorized personnel only. Redcap data will be periodically exported to a SPSS database (Statistical 
Package for Social Sciences) that will only be accessible to study personnel on a password-protected 
shared project drive. 
14.0  Confidentiality and Data Management:
We will use several procedures to secure data to maintain its confidentiality.  Only authorized study 
personnel will be granted access to study data.  Only authorized persons will be allowed to enter and 
view study data.  Passwords and system ID’s for the REDCap system will not be shared with other 
team members.  Additionally, the physical security of the workstations and files where REDCap data 
are stored will be maintained by study personnel.  All data collected will be de-identified using a study 
ID. The only document with identifying information is the consent form. We believe that the use of the 
Redcap data collection system will allow us to collect high quality data from all study participants and 
will not require the need for additional procedures to monitor data quality.
Related to Aim 1, MB-TXT feasibility and acceptability data will be collected from clients and home 
visitors. Similar to previous SMS studies, we will use percentage of text responses as an indicator of 
“read” messages. We will assess home visitor adherence to the MB-TXT protocol by using archived 
data from HealthySMS to calculate percentage of texts sent at appropriate intervals, as stated in the 
MB Instructor Manual. Home visitors will complete a brief web-based REDCap survey after 
completing each MB session to assess if clients came to the session having completed their personal 
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project. Using a 4-point Likert Scale, home visitors will also ask clients to rate the extent to which each 
of the 3 intersession texts was a) useful and b) easy to understand; these data will be entered into 
REDCap. Related to Aim 2, participant outcomes will be collected via survey at baseline, 6 months, 
and 9 months. Data will be collected and managed using REDCap electronic data capture tools 
hosted at Northwestern. Participants will receive $20 remuneration for each assessment. At each 
assessment, a link to REDCap will be sent to study participants who can complete the assessment on 
any web platform (smartphone, tablet, computer). The Project Manager will complete assessments by 
phone for participants who prefer not to use REDCap. Depressive symptoms, as measured by the the 
Beck Depression Inventory-II (BDI)100 a 21-item self-report measure is our primary outcome. 
Secondary outcomes, which map onto the hypothesized mechanisms for influence on depressive 
symptoms are: cognitive structuring (Experiences Questionnaire),85 behavioral activation (Behavioral 
Activation Depression Scale),86-88 social support (MOS Social Support Survey),89 mood regulation 
(Negative Mood Regulation Scale), and skills utilization.90,91 We estimate 15% attrition at 6 months, 
resulting in 46 participants per arm; previous MB trials conducted by PI Tandon had 12 month attrition 
rates <10% and we will use similar procedures for minimizing attrition.
Analysis for Aim 2 is limited to the fact that this is a pilot study. As such, we will compare MB and MB-
TXT groups at the individual level (not adjusting for potential clustering effect of either home visitor or 
HV program). As such, the analytic sample size of 46 per arm provides > 80% power to detect effect 
sizes of 0.59 or 0.52 using two or one-sided (respectively) t-tests at a type I error rate of 5% for the 
primary outcome, the BDI. 
15.0  Data Monitoring Plan to Ensure the Safety of Participants:
Data and Safety Monitoring Plan and Board.  In the collection of information about depressive 
symptoms, the research team has the ethical responsibility to appropriately respond to clinical 
information obtained in this study. Oversight of the data and safety monitoring plan will be the 
responsibility of the PI, Dr. Darius Tandon, with support from Co-Investigator Dr. Mary Kwasny for 
data monitoring. Dr. Tandon has conducted multiple trials of the MB Course with perinatal women in a 
variety of community settings. Dr. Kwasny has extensive experience as lead biostatistician in 
numerous behavioral health research projects over the past decade, including those focusing on 
depression and perinatal populations. 
Online Survey: 
Any study participant who endorses thoughts of self-harm will be referred to the supervisor at the 
home visiting program, by the Project Manager. The supervisor, who is trained in responding to and 
addressing suicidal ideation, will use their agency’s protocol to make a determination regarding 
whether the study participant is in danger of harming herself or others and will determine necessary 
steps to ensure the safety of the study participant. The Principal Investigator will be notified 
immediately of any such referrals made by study staff. In addition, should administration of depression 
scale indicate the participant is experiencing severe depressive symptoms, the supervisor at the 
home visiting program will be notified in order to provide appropriate referrals for their client’s mental 
health treatment linkage.
During any of the research assessments, if the participant endorses current thoughts of harming 
herself or others, the following protocol should be followed, and documented on an Incident Report.
Beck Depression Inventory-II (BDI) Question 9 
→ In the past few days, subject selects answer #1, 2, or 3 (I have thoughts of killing myself, but I 
would not carry them out, I would like to kill myself, or I would kill myself if I had the chance).
When assessments are completed over the phone or online during regular business hours the 
following protocol will be completed within 24 hours.
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Within 24 hours of the study participant’s completion of their assessments a member of the Research 
team will call the study participant and will let the participant know that he/she will be contacting their 
home visiting program to let them know about the difficulties they are having with thoughts about
death/suicide/hurting yourself/others, so they can reach out and offer support. The research team 
member will ask the study participant the following questions:

“Are you thinking about killing yourself?”

“Have you ever tried to hurt yourself before?”

“Have you thought of ways that you might hurt yourself?”

“Do you have pills/weapons in the house?”

“Do you think you might try to hurt yourself today?”
o
If her response is Yes, then call 911 and stay on the phone with her until help arrives
All individuals that complete the above surveys will receive the following resources immediately upon
answering the above answer choices on the noted assessments

Home Visiting Program Office phone number

National Suicide Prevention Hotline (24/7)
o
1-800-273-8255 (1-800-273-TALK)
o
 http://www.suicidepreventionlifeline.org/ (online chat available 24/7: “Lifeline Chat”)

 Postpartum Support International (outside of Illinois)
o
1-800-944-4773

NorthShore Perinatal Support, 24-hour Crisis Hotline (in Illinois)
o
1-866-364-MOMS (866-364-6667)
All of these resources (except the home visiting program office number) will also be shared with all 
study participants, regardless of answers to assessment questions, at the end of each assessment.
The research team member will stay on the phone with those individuals who endorse the possibility 
of imminent self-harm. After the research team member ends the call with the study participant, they 
will call the Program Manager with relevant details, reporting what the client said and endorsed, as 
well as the information they gathered during the assessment and call with the participant. The 
research team member will then follow up with an email to the home visitor, supervisor, Project 
Manager, as well as the PI with relevant details.
If the survey is completed outside of regular business hours (i.e. weekends/holidays) the research 
team will follow-up with the participant within 24 hours. As noted above, the risk would be 
acknowledged in real time as the participant would still receive resources immediately following their 
answer selection to the above survey questions.
Text Message Reponses: 
There are none to minimal physical, social, or legal risks to the participants associated with the text 
messages. Some messages may cause some discomfort among participants because they deal with 
issues of mood and depression, however, the goal of these text messages is to provide coping 
strategies. Participants who indicate that that they currently are experiencing increased thoughts of 
death or pose a risk to themselves or someone else will be given automated information for a suicide 
hotline. More specifically, participants will be referred to 1-800-944-4PPD which is a hotline that 
provides resources for perinatal mood and anxiety disorders and community resources. The hotline is 
sponsored by Postpartum Support International and includes a Spanish-language option. The 
researchers will be notified if a keyword is sent (to the system phone number) such as “die,” “kill” and 
we will respond accordingly. However, participants will be clearly notified that the system is automated 
and that it does not constitute direct communication with a provider or therapist. The Research 
Manager’s phone number is also listed at the bottom of the recruitment flyer.
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All of our text messages are sent by an automated system. That means that there is not a live person 
sending, receiving, or monitoring the content of messages. Although we will review the content of the 
messages received by participants, we cannot respond to individual messages.
If participant responds to the sent text with the potential following responses: 

Or types a keyword (to the system phone number) such as “die,” “kill”
A text message will be automatically sent to the participant with the following messages: 

Based on your responses to a recent text, we would like to remind you that to talk to someone 
or find resources in your community for support, call 1-800-944-4PPD (4773). 

If at any point you feel that you are in danger of harming yourself, please visit the nearest 
hospital or call your doctor. You can contact 1-800-273-TALK (8255) if you need someone to 
talk to for support at this time.
REDCap will be programmed to notify the Research Manager  if a participant indicates self-harm on a 
survey response.  In addition, the Research Manager will review all text message responses no later 
than 24 hours from the time the text message response is sent.  If a participant indicates self-harm on 
a survey response or a response to a text message, they will automatically receive resource 
messages listed above. In addition, the Research Manager will contact the participant’s Program 
Manager to notify them of their client’s response within this 24 hour period. HV programs have their 
own safety protocols they will follow. HV Program Managers are typically licensed clinical social 
workers who have the necessary skills to assess the extent to which clients need further response to 
their mental health needs. Moreover, they have established relationships with their clients. If a text 
message is received outside of regular business hours (i.e. weekends/holidays) the research team will 
follow-up with the participant’s Program Manager within 24 hours. As noted above, the risk would be 
acknowledged in real time as the participant would still receive resources immediately following their 
answer selection to the above survey questions.
We believe this to be a reasonable expectation in regards to protecting human subjects and the role 
of the research team. Previous Mothers and Babies studies conducted by the PI, as well as other 
nationally representative studies of perinatal women have shown that less than 1% of study 
participants will endorse the most “severe” response choice on survey items related to suicidality. As 
such, we anticipate that the number of study participants who endorse the most severe response 
related to suicidality outside of regular business hours over the course of this study will likely be < 1 
individuals. As such, we believe our approach to handling this potential risk to study participants—i.e., 
immediate provision of 24/7 resources and follow-up by the study team no later than 24 hours —is 
reasonable given its likelihood of occurrence. Moreover, women receiving the Mothers and Babies 
intervention (100% of the sample) will be receiving information on modifying harmful thought patterns 
that may contribute to decreased thoughts about self-harm.
16.0  Data and if applicable, Specimen Banking: 
All data collection will be conducted through web-based survey links via REDCap. Participants will 
click on a survey link in a direct email from the Mothers and Babies Research Team. Web-based 
survey data completed by participants are directly linked to our REDCap project.  The Project 
Manager is responsible for regularly exporting REDCap data into SPSS databases, which are stored 
on our FSM/IPHAM/Mothers and Babies Project Folder on the shared drive, which is accessible only 
to authorized research team members via Net ID login. 
17.0  Qualifications to Conduct Research and Resources Available:
Darius Tandon, PhD (Principal Investigator). Through my professional training as a community 
psychologist and prevention scientist and my subsequent career, I have developed skills and 
expertise that will be crucial for this application. My research has been devoted to the study of 
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psychological outcomes among low-income perinatal women, and I have participated in many studies 
focused on the prevalence of depression in community samples, postpartum depression screening, 
and programmatic response to maternal depression. In addition, as PI or co-Investigator on several 
extramurally funded projects, I have participated in the development and implementation of maternal 
stress and depression preventive interventions among perinatal populations. In particular, I was PI of 
an RCT of the Mothers and Babies intervention that is the focus of this application, conducted in home 
visiting (HV) programs in Baltimore which demonstrated the efficacy of the intervention in preventing 
the worsening of depressive symptoms and onset of major depression. I also served as co-
investigator of a recently completed RCT of Mothers and Babies in HV programs in Hawaii that found 
similar effects on depressive symptoms.  We are currently conducting an efficacy study of the 1-on-1 
version of Mothers and Babies with a network of HV programs in Illinois, with preliminary findings 
indicating support for the intervention’s efficacy in reducing depressive symptoms. Eight of these HV 
programs are the sites for this application—an indication of these programs’ interest in the 
intervention and strength of the relationships between HV programs and my Northwestern research 
team. As such, this application is a natural progression of my research examining the efficacy and 
effectiveness of Mothers and Babies. I am currently the lead faculty for a Maternal and Child Health 
Bureau Collaborative Improvement and Innovation project aimed at helping HV programs across the 
United States better address maternal depression among their clients and have been invited to 
participate in numerous local and national panels, webinars, and conference presentations on 
intervention strategies to address perinatal depression among HV families. I also have considerable 
expertise in the science and practice of community engaged research, characterized by the 
meaningful collaboration between researchers and community stakeholders.  My own mental health 
research has used a community engaged framework which explicitly includes patients and community 
stakeholders as research collaborators. I was previously Director of the community engagement core 
of the Clinical and Translational Science Award (CTSA) at Johns Hopkins University, where I was the 
architect of several activities and programs to promote the practice of community-university 
partnerships. I am currently the Associate Director of the Center for Community Health at 
Northwestern University, which helps facilitate the engagement of patients and stakeholders into the 
research process.  I am also a member of the Patient Centered Outcomes Research Institute’s 
(PCORI) inaugural Patient Engagement Advisory Panel, and was selected co-chair of this Panel by 
my fellow members.
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We will recruit a total of 22 male partners who have received FAB (post-intervention) for focus group 
and key informant interviews. to inform which aspects of FAB content and delivery are working well 
and which require modification. We will develop focus group guides and semi-structured interviews 
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that prompt discussion about the following topics: (1) satisfaction with the existing FAB Course, 
identifying the most and least enjoyable, understandable, and useful content; (2) effectiveness of 
content delivery (e.g., web-based links to content, text-messages); (3) additional topics that should be 
included to meet the needs of new fathers and families; and, (4) methods to best engage fathers in 
the FAB intervention.  Focus groups and key informant interviews will be audio-recorded, transcribed, 
and then analyzed to identify common themes to guide FAB Course revisions. In keeping with a 
collaborative approach that our research team has undertaken throughout our MB and FAB work, 
during our focus group and key informant interviews we will identify 2-3 fathers from different cultural 
backgrounds to serve as consultants, who will remain engaged in an iterative process of review and 
feedback about FAB revisions.
IRB #: STU00203918-MOD0022 Approved by NU IRB for use on or after 8/1/2020