Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Phase: NA
Conditions: Perinatal Depression, PostPartum Depression
Sponsor: Northwestern University

Page 1 of 18
PROTOCOL TITLE:
“Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal 
Depression.”
PRINCIPAL INVESTIGATOR:
S. Darius Tandon, PhD
Department of Medical Social Sciences 
312-503-3398
dtandon@northwestern.edu
VERSION NUMBER:
Version 13
VERSION DATE:
July 3, 2018
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 2 of 18
1.0 Purpose of the Study:
There is considerable evidence that most perinatal women at risk for postpartum depression do not 
engage in mental health services, even when referred by home visiting (HV) programs, primary care 
physicians, obstetricians, or gynecologists (Zittel-Palamara et al., 2008). Thus, interventions that can 
be delivered via alternative settings—e.g., HV programs—are essential to prevent the onset of major 
depression and worsening of depressive symptoms among perinatal women. This PCORI funded 
project aims to evaluate whether the Mothers and Babies (MB) intervention, when led by 
paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB 
enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior 
to MB delivered by mental health professionals. The results of this study will inform decision-making 
by HV programs regarding provision of MB to perinatal women at risk for developing major 
depression.
Study Aims:
Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional 
home visitors versus usual care (i.e., home visiting without MB) on patient-reported outcomes, 
including depressive symptoms, quality of life, parenting practices, engagement in pleasant activities, 
and relationship with one’s partner.
Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered by (a) 
mental health clinicians versus (b) paraprofessional home visitors.
Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs. 
paraprofessional home visitor led) varies according to patient characteristics (e.g., race, ethnicity, first- 
time mother, and/or geographic type of home visiting (HV) program (i.e., urban vs. rural).
Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional home 
visitors and mental health clinicians.
2.0 Background / Literature Review / Rationale for the study:
Postpartum depression is a serious mental health disorder that poses significant health and mental 
health risks for mothers and their infants (Gaynes et al., 2005; National Research Council & Institute 
of Medicine, 2009). Research suggests that prevalence rates of postpartum depression are higher 
among low-income women than among middle-or high-income women (O’Hara & Swain, 1996; Rich- 
Edwards et al., 2006). There is also consistent evidence that low-income women are less likely to 
receive mental health services in the perinatal (i.e., pregnancy until child’s first birthday) period than 
their more affluent counterparts due to a variety of factors including stigma related to mental health 
service use and lack of access to community-based mental health providers (Abrams et al., 2009; Leis 
et al., 2011). Postpartum depression is a particularly serious problem for low-income women, as it has
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 3 of 18
the potential to create two generations of suffering, for both mother and child. It is estimated that over 
10% of low-income infants have a mother who has major depression and more than 50% have a 
mother with some depressive symptoms (Vericker et al., 2010). Postpartum depression has negative 
consequences for maternal parenting practices. Compared with women not suffering from postpartum 
depression, depressed women tend to be less positive, less spontaneous, and less responsive with their 
infants (e.g., VanDoesum, et al, 2007). Postpartum depression has been linked to developmental delays 
among infants of depressed mothers, including social interaction difficulties, attachment insecurity, 
and cognitive impairments (e.g., Grace, Evindar, & Stewart, 2003; Sohr-Preston & Scaramella, 2006).
Home visiting (HV) programs that provide services to perinatal women are one of the largest avenues 
through which perinatal women come to the attention of service providers, making HV a unique and 
viable setting for delivering mental health services. Although professional HV models exist (e.g., 
Nurse-Family Partnership), most HV programs in the United States use paraprofessionals. Previously, 
study investigators have established the efficacy of a group-based intervention —the Mothers and 
Babies (MB) Course—in preventing the onset of postpartum depression and reducing depressive 
symptoms when led by mental health professionals. However, to date there are no interventions led by 
non-health or non-mental health professionals that have demonstrated efficacy in preventing the onset 
and worsening of postpartum depression among low-income women. This project attempts to fill this 
notable gap.
We will conduct a cluster randomized trial in which HV clients receive either a) MB delivered by 
mental health professionals, b) MB delivered by paraprofessional home visitors, or c) usual home 
visiting services. This study design will allow us to conduct a superiority trial that compares the 
efficacy of MB delivered by paraprofessional home visitors versus usual care. A superiority trial will 
allow us to generate efficacy data on MB delivered by paraprofessional home visitors. Our study 
design will also allow us to conduct a non-inferiority trial that compares the effectiveness of MB 
delivered by mental health professionals versus paraprofessional home visitors. Should we find that 
paraprofessional home visitors are not inferior to mental health professionals in delivering the 
intervention, HV programs throughout the United States will be able to implement the MB Course with 
paraprofessional home visitors—an approach that is considerably more efficient and cost-effective 
than employing mental health professionals.
This study was born out of community stakeholders’ need and desire for a low-cost intervention that 
could prevent the onset and worsening of depression among low-income women enrolled in HV 
programs. Maternal depression is an enormous challenge facing HV programs. However, there is 
consistent evidence that low-income women exhibiting depressive symptoms—including women 
enrolled in HV programs—do not access mental health treatment in the community (Abrams et al., 
2009). Lack of available mental health professionals, stigma in seeking mental health services, and 
logistical challenges (e.g., childcare, transportation) are a few of the barriers faced by perinatal women 
seeking mental health services. For those clients who do access services, most perinatal women are 
likely to receive pharmacological treatments (Huybrechts et al., 2013), despite the fact that the vast 
majority of perinatal women prefer non-pharmacologic interventions (Leis et al., 2011).
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 4 of 18
HV programs are ideal settings for delivering mental health care to perinatal women because their 
mission is not stigmatizing and HV programs tend to be trusted entities in the communities they 
serve. However, there is not yet an evidence-based intervention that can be delivered by 
paraprofessionals (such as home visitors), thereby limiting HV programs’ capacity to meet the needs 
of their clients needing mental health services.
3.0 Inclusion and exclusion criteria:
The study population consists of 1722 individuals. Of this total, 1680 will be HV clients, 24 will be 
home visitors, and 18 will be mental health professionals. The HV client study population consists of 
1680 individuals recruited from 42 home visiting (HV) programs across Illinois and adjacent states. 
We will enroll these women as part of a randomized controlled trial, where 720 women will be 
enrolled at 18 HV programs randomized to Mothers and Babies group facilitation by 
paraprofessionals, 720 women will be enrolled at 18 HV programs randomized to Mothers and Babies 
group facilitation by mental health professionals, and 240 women from 6 HV programs will receive 
usual care home visiting services. The 42 HV programs participating in this project enroll clients via 
referrals from prenatal care clinics, Women, Infants, and Children (WIC) programs and other settings 
working with perinatal women; home visiting programs implementing the MB Course will implement 
five MB cohorts per site, over the course of the project. These women will be recruited ≤ 33 weeks 
gestation upon referral.
Vulnerable Populations
Among our 1680 HV clients we are enrolling, we will enroll only pregnant women in this study, 
given that our Mothers and Babies Course is delivered prenatally as a postpartum depression 
prevention intervention. We will offer participation to prenatal home visiting clients, ages 16 and 
older, knowing the client base for home visiting programs includes pregnant teens. In many states 
these young women are considered emancipated minors. The Mothers and Babies Course has been 
used in home visiting programs and other prenatal care settings, with high ratings of acceptability and 
no ill effects detected. Please refer to the protections against risk description for study procedures in 
which observations of concern arise.
Study participants: We will work with 42 home visiting throughout the state of Illinois and adjacent 
states on this project. The population to be studied is pregnant women enrolling in HV programs< 33 
weeks gestation upon referral, who are at-risk for major depression. Women > 16 years old enrolled 
in HV programs who are < 33 weeks gestation upon referral, will be eligible for enrollment; across 
the 42 HV programs ~80% of women receive a HV service < 33 weeks gestation, making them 
eligible for study participation.
Several met-analyses of risk factors for postpartum depression have been conducted (Beck 2001, 
O’Hara & Swain, 1996; Robertson et al., 2004).  The findings from these meta-analyses suggest that 
the following risk factors have the strongest association with developing postpartum depression: a) 
history of depression, b) elevated depressive symptoms during pregnancy, c) poor social support, d) 
stressful life events, e) poor marital relationship, and f) low socioeconomic status. Our previous 
research with HV programs suggest that nearly all HV clients exhibit one of these risk factors, with 
most clients exhibiting multiple risk factors. This is due to the fact that eligibility criteria for inclusion 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 5 of 18
in HV programs mirror these risk factors for postpartum depression—particularly, low SES, low 
social support, and stressful life events. As such, we will not limit our inclusion criteria for this study 
to onlyi ndividuals exhibiting elevated depressive symptoms, as this would potentially exclude women 
at risk for postpartum depression. Moreover, there is the potential for underreporting of depressive 
symptoms on screening instruments, which would lead to under enrollment of women at risk for 
developing major depression.
Women with high-risk medical and pregnancy conditions will be excluded since this may 
preclude women from regularly attending intervention sessions. We will not exclude women 
based on race/ethnicity or based on demographic characteristics other than the ability to speak 
English or Spanish.
Clinicians: 18 HV programs will receive the MB intervention delivered by clinicians. We will train 
approximately 18 clinicians to deliver MB. Although there will be variability in the expertise among 
clinicians, all clinicians will have a minimum of a Master’s Degree and at least five years’ experience 
working with children < 5 and their families. The clinicians will live and work in the three different 
regions of Illinois where this study will be conducted: Chicago, downstate Illinois, and western Illinois 
as well as adjacent states who are participating in the study
Paraprofessionals: 18 HV programs will receive the MB intervention delivered by paraprofessional 
home visitors. We will train ~72 home visitors from the 18 HV programs in this study arm, or ~4 
home visitors per program; HV programs participating in this study currently employ between 3-8 
home visitors, with most employing 4-5.All of the HVs will currently be a staff member of one of the 
participating study sites.
Home Visiting Supervisors/Managers/Directors:  We will also be consenting approximately 15 home 
visiting supervisors/managers/directors from HV programs outside of the state of IL, to participate in a 
5-10 minute survey about their experiences with the Mothers and Babies Program from their perspective 
as a home visiting program manager/director. The survey responses will help guide improvements and 
innovations as we continue to support the integration of Mothers and Babies into home visiting!
4.0 Procedures Involved:
Program Implementation: This project is a cluster randomized trial to be conducted in 42 HV 
programs across Illinois and adjacent states. Cluster allocation by HV program minimizes 
contamination between study groups that would likely occur if randomization were conducted at the 
home visitor level. Recruitment of women from throughout Illinois and adjacent states will allow us to 
increase study generalizability by enrolling a more geographically and demographically diverse sample 
than could be obtained by working in solely one part of the state. We will randomize 18 HV programs 
to implement MB with mental health professionals, 18 HV programs to implement MB with 
paraprofessional home visitors, and 6 HV programs to implement usual home visiting services.
Each HV program delivering MB (both the clinician- and home visitor-led arms), will implement five 
MB groups/cohorts. Each cohort will have approximately 8 women, which will allow us to reach our 
target of 40 study participants per program. This cohort size is consistent with previous MB trials. One 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 6 of 18
month prior to implementation, we will train home visitors and mental health professionals on MB. 
We will stagger implementation in two waves so that only half the sites are implementing at once. 
This will allow our Intervention Coordinator to focus her efforts on ensuring attendance at 
intervention groups and fidelity to intervention protocols. Study recruitment and implementation of all 
prenatal MB sessions will be completed by the 4th quarter of Year 2. This recruitment schedule will 
allow us to complete all postnatal MB sessions and follow-up data collection by the middle of Year 3, 
allowing study investigators to analyze data and prepare to disseminate study findings to both 
academic and community stakeholders.
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. 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 participant for eligibility criteria and move forward with the consent process either via 
telephone or REDCap survey link.
Participant Outcomes Surveys: Participant outcomes will be collected at four time points—
baseline, post-intervention, 12 weeks postpartum, and 24 weeks postpartum. Participants will receive 
$20 remuneration at the baseline, 12-week and 24-week assessments. The MMS and EPDS will be 
administered to all clients during their baseline surveys. This information will be used for data 
analytics but not as an exclusion criteria. Data will only be collected from study participants who 
have consented to participate in the study.
The post-intervention assessment consists of one depressive symptom measure, so no remuneration 
will be provided. Baseline and follow-up data will be collected and managed using REDCap 
(Research Electronic Data Capture), a secure web-based application designed to support data capture 
for research studies, hosted and supported by Northwestern’s Clinical and Translational Science 
Institute. Once research staff enters participant contact information, REDCap will generate emails or 
texts containing web-based survey links at scheduled time points. Baseline data will be collected 
within 2-3 weeks of establishing client eligibility and participation agreement. Women who do not 
complete the web-based baseline assessment in this timeframe will be contacted by phone by the 
Research Coordinator to complete the assessment either by phone or online, ensuring that baseline 
data are collected prior to the first MB group. Informed consent will be obtained prior to administering 
the baseline assessment. If a study participant decides that they do not want to consent to participate in 
this study, no data will be collected from this participant. For the post-intervention, 12-week 
postpartum, and 24-week postpartum assessments, study participants who do not complete web-based 
assessments within one week of the web link being sent to them will be contacted by the research 
team to complete the assessments by phone.
Table 4 describes this study’s outcome indicators, measures, and data collection timelines.
Outcome Indicator
Measure
Baseline
Post- 
Intervention
12 weeks 
postpartum
24 weeks 
postpartum
Depressive Symptoms
Edinburgh Postpartum 
Depression Scale
X
Current & Lifetime Major 
Depressive Episode
Maternal Mood Screener 
(MMS)
X
X
X
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 7 of 18
DEPRESSION
Depressive Symptoms*
Quick Inventory of Depressive
X
X
X
X
Symptomatology
PROXIMAL OUTCOMES
Behavioral Activation
Behavioral Activation
X
X
X
Pleasant Activities
Pleasant Activities Schedule
X
X
X
Mood Regulation
Negative Mood Regulation 
Scale
X
X
X
Social Support
MOS Social Support Survey
X
X
X
Decentering
Experiences Questionnaire
X
X
X
Relationship w/Partner
Dyadic Adjustment Scale
X
X
X
Responsive and Reactive 
Parenting
Parental Cognitions and 
Conduct toward the Infant 
Scale
X
X
Subjective Well-Being
Flourishing Scale
X
X
X
Perceived Stress
4-item Perceived Stress Scale
X
X
X
PRENATAL HEALTH 
BEHAVIORS
Developed by Investigators
X
X
X
DEMOGRAPHICS
Developed by Investigators
X
X
X
INTERVENTION SKILL USE
Developed by Investigators
X
X
INVOLVEMENT IN 
PRENATAL SERVICES
Developed by Investigators
X
X
X
Facilitator Assessments:
Outcome Indicator
Measure
Baseline
After Each Cohort
DEMOGRAPHICS
Developed by Investigators
X
MB GROUP FACILITATOR 
SURVEY
Developed by Investigators
X
The study surveys will be conducted using web-based surveys, created using REDCap, which is 
supported by Northwestern University IT.
Training: All home visitors from the 18 HV programs randomized to the home visitor-led MB Course 
and mental health professionals will attend a 1.5 day training on MB led by Dr. Tandon. These 1.5 day 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 8 of 18
trainings will be held in different parts of Illinois and adjacent states and we anticipate conducting
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 9 of 18
multiple trainings for home visitors and clinicians. Holding multiple trainings for home visitors allows 
for smaller numbers of home visitors per training; we anticipate no more than 30 home visitors will 
attend a MB training based on the number of home visitors employed by participating programs.
Home visiting supervisors from each of the HV programs and the mental health professional 
coordinator, Ms. Delimata, will also attend the 1.5-day training. Supervisors and Ms. Delimata will 
receive an additional half-day of training preparing them to provide supervision to home visitors 
delivering MB. Home visitors will receive supervision from Dr. Tandon the first time they deliver MB. 
However, to promote the sustainability of MB at HV sites, the clinical supervisors and Ms. Delimata 
will assume the supervisory role—with support from the research team—after home visitors have 
delivered the MB curriculum for the first time.
During the first six months of the project, home visitors and mental health professionals will also 
receive technical assistance from Co-Investigator Gollan and PI Tandon by web conference to ensure 
mastery and adherence to MB materials. Specifically, these technical assistance sessions will be 
designed to strengthen competency in the specific techniques using case illustrations and provide 
competency ratings to home visitors and mental health on how they are delivering core MB concepts 
professionals.
The plan for supervision was carefully developed to ensure a sufficient level of supervision while not 
placing undue time commitments on home visitors and clinicians implementing MB. Initially, 
supervision for home visitors and mental health professionals will be conducted via one hour weekly 
Skype sessions with Dr. Tandon. During these sessions, Dr. Tandon will first debrief the completed 
MB session and will then help the home visitors and mental health professionals plan for the 
subsequent group session. Accordingly, our Intervention Coordinator will schedule Skype sessions that 
consist of 2-3 individuals who are implementing on the same schedule. This will allow home visitors 
and clinicians to benefit from both Dr. Tandon’s supervision and the perspectives of colleagues 
implementing MB at the same time. Following the initial supervision, group facilitators will complete 
a brief survey after the completion of each cohort they facilitate, in order to reflect on the frequency 
and types of supervision utilized during a specific cohort.
Program Intervention: Study participants will be randomly selected to participate in one of three 
study arms; Groups led by paraprofessional home-visiting staff, groups led by Mental Health 
Consultants, or a control group. Women who participate in the group sessions will attend a two hour 
session, once a week, for six weeks at their home-visiting program site. The group facilitators will 
administer a short survey at the end of each group session, to obtain the study participant’s feedback on 
the group session. Each group facilitator will be trained on the Mothers and Babies curriculum prior to 
beginning group implementation.
The Mothers and Babies Group Curriculum has been used in home visiting (HV) programs and has 
demonstrated positive outcomes for women who receive MB. The curriculum is comprised of 6 
sessions. Mothers and Babies is divided into three overall sections, one on each of the following 
Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In
each of these sections, participants are first taught to understand how the component influences her 
mood. This teaching of the relationships between CBT components and mood is referred to as
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 10 of 
psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of 
the three sections (pleasant activities, thoughts, contact with others). These skills are intended to 
provide participants with a “toolkit” of approaches they can use to improve their mood.
We will randomly select 20% of the Mothers and Babies group sessions to be audio-recorded using a 
portable audio-recording device for purposes of examining intervention fidelity. While audiotapes will 
be used primarily to review fidelity of intervention implementation, we anticipate conducting 
exploratory analyses examining whether implementation fidelity affects clinical outcomes (e.g., 
depressive symptoms). The audio-recordings will be transferred back to the NU Research team by the 
group leader (i.e. Mental Health Clinician or Home Visitor) within 24 hours following the completion 
of each individual session. The group leader will email the file to the NU Research Team’s secured NU 
email address. Upon receipt, audio-recordings will be uploaded onto our research project shared drive, 
which is password protected and accessible only by our authorized study personnel. Should space 
become an issue, recordings will be burned onto DVDs, which will be stored in a locked file cabinet in 
our locked office location. Once the research team receives the audio-files, group facilitators will be 
instructed to immediately delete the recordings from the audio-device.
Participant Outreach and Contact: Recruitment procedures will emphasize the importance of 
participating in all MB sessions and remaining in the study through the 24-week assessment. We will 
obtain ample tracking information at baseline which would include the participants name, email, home 
and cell phone numbers, mailing address, home-visiting site, and secondary contact denoted by the 
participant. We will update the contact information at each follow-up, including contact information 
for two people who will always know how to reach a participant and each participant’s preferred mode 
of communication (e.g., phone, text, Facebook). We will allow participants to complete follow-up 
surveys by phone or in person for those who are unable (i.e., no internet access via computer, tablet, or 
smartphone) or less comfortable completing surveys electronically. We will conduct intensive follow- 
up with participants throughout the study via weekly communication from the Research/Intervention 
Coordinator using the participant’s preferred modes of contact; the Intervention Coordinator and RA 
are both bilingual and, therefore, able to communicate with both English- and Spanish-speaking 
participants. We will follow all study participants through the 24-week postpartum assessment 
regardless of their attendance at intervention sessions.
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 assessements by phone or REDCap survey link at baseline, post- 
intervention, 12 and 24 weeks postpartum
3. To remind study participants about attending their weekly group sessions
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
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 10 of 18
5. If the study participant is selected for a semi-structured interview, research staff will call and 
schedule the interview and conduct the interview via phone at a time mutually agreed upon by 
the parties
6. Congratulation cards will be sent to each study participant after the birth of their baby
Please note that communication with study participants will be based on participant preference and can 
be administered by phone, email, or text communication channels. We anticipate that it will take about 
10-15 minutes for item #1 above. For items 2-5, we anticipate that these outreach efforts will take less 
than five minutes per participant, with many of our study participants being contacted for item #4 via 
text message.
Completed intervention sessions: Will be collected by mental health professionals and home visitors 
delivering MB on an attendance form created for use in this study. Fidelity of intervention 
implementation will be assessed by reviewing a random sample of audiotaped sessions. Dr. Gollan, 
research staff, and the Project Coordinator will perform independent ratings using fidelity checklists 
developed and used in previous trials by the PI to assess fidelity to MB. Retraining will be triggered 
for adherence <90%.
Acceptability: We will collect data on MB acceptability via three data collection activities. First, we 
will conduct brief semi-structured interviews with 90 intervention participants—45 who received MB 
led by mental health professionals and 45 who received MB led by paraprofessional home visitors. To 
ensure representativeness of this sample, the 45 participants per group will be stratified across the three 
regions of Illinois—Chicago, downstate Illinois, and adjacent states. Second, we will conduct brief 
semi-structured interviews with 24 home visitors who delivered MB. Again, we will divide 
respondents equally across the three regions (n=8 home visitors from Chicago, downstate Illinois, 
adjacent states, respectively). We will also conduct semi-structured interviews with all ~18 mental 
health professionals delivering MB. Third, all participants will complete brief paper and pencil 
checklists immediately after receiving a MB session. Home visitors and mental health professionals 
will collect these checklists. We will ask each intervention participant to rate each session using three 
questions used in previous MB studies: “how much did you enjoy today’s group session?”, “how well 
did you understand what we talked about during today’s group session?”, and “how often do you think 
you will use the skills and information that you were given during today’s group session?”
5.0 Multiple sites:
N/A
6.0 Incomplete Disclosure or Deception:
N/A
7.0 Recruitment:
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 12 of 18
Home Visitors: We will recruit 72 home visitors from 42 participating HV programs throughout the 
state of Illinois and adjacent states. 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. We will be training all of the 72 home-visitors who are being recruited through 
the participating home-visiting sites. Out of those 72 home-visitors, we anticipate 24 of them to 
implement the intervention groups and in turn be our study participants being asked to complete a 
semi-structured interview after the completion of their cohorts.
Study Participants: We will recruit 40 study participants from each of the 42 participating HV 
programs. These 40 participants per program will be recruited in five cohorts. Each cohort will be 
recruited for approximately one month at a participating HV program; as such, each month we recruit 
at a participating HV program we will only need to enroll 8 study participants (40 participants/5 
cohorts).
Clinicians: We will also recruit and train ~18 clinicians to deliver MB; each clinician will deliver MB 
at one or more HV programs across the duration of the project. All of the clinicians who are 
implementing the intervention will be invited to participate in the semi-structured interviews after the 
completion of their cohorts. The 18 clinicians will live and work in the three different regions of Illinois 
where this study will be conducted: Chicago, downstate Illinois, and western Illinois, as well as adjacent 
states. A description of the study as well as the clinician role was sent out to the Illinois Association for 
Infant Mental Health (ILAIMH) listserv and the consultant email list at Illinois Children’s Mental 
Health Partnership (ICMHP). Linda Delimata, MS, the Consultation Coordinator at the Illinois 
Children’s Mental Health Partnership (ICMHP) and coordinator of the Infant Mental Health Consultant 
network in Illinois, has identified clinicians from the three regions of the Illinois where this study will 
be conducted. We have also sent a description of the study to the Home Visiting Research Network 
(HVRN) to recruit adjacent states participation for wave 2 of recruitment.
Home Visiting Supervisors/Managers/Directors:  We will also be consenting approximately 15 
home visiting supervisors/managers/directors from HV programs outside of the state of IL, currently 
participating in the parent study, to participate in a 5-10 minute survey about their experiences with the 
Mothers and Babies Program from their perspective as a home visiting program manager/director. 
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. The postcard/flyer will include a 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. The NU research team will also email the survey link to the study participants 
using email addresses provided by the HV sites.
Prior to beginning program implementation, potential study participants contact information will be 
obtained by the participating trained HV sites. The Research Coordinator, Intervention Coordinator, 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 13 of 18
and Research Assistant, will share responsibility for calling each woman receiving HV services ≤ 32 
weeks gestation 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.
We will obtain names, phone numbers, and addresses of women ≤ 33 weeks gestation upon referral. 
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.
The Research Coordinator, Intervention Coordinator, and RA will introduce women meeting eligibility 
criteria to the study, answer questions they have about participation, and ascertain their interest in 
participating in the research study. For women in HV programs that will implement MB, they will tell 
women expressing interest in MB the anticipated date and time for the first MB group session. The 
Research/Intervention Coordinator and/or RA will call to remind women of the date and time of their 
first MB group. We expect there will be no longer than four weeks’ time between the 
Research/Intervention Coordinators’ initial recruitment call and the first MB group, during which time 
the Research/Intervention Coordinator and/or RA will call participants at least once a week as well as 
daily in the two days prior to the first session.
We anticipate that 80% of eligible women will agree to participate (n = 1976; 80% of 2470 meeting 
eligibility criteria); in our previous RCTs in Baltimore and Hawaii, only 2% of eligible women 
declined. Thus, this is a very conservative estimate of the number of women who will decline study 
participation. We also conservatively estimate that 15% of women who agree to participate in the study 
will be lost to follow-up prior to the first MB session, resulting in 1680 study participants (85% of 
1976). The 15% lost to follow-up estimate is due to the transient nature of many HV participants.
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 the 42 home visiting 
programs during recruitment periods will complete the screening administered by phone by the 
Research or Intervention Coordinator. 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.
If the enrollee meets eligibility criteria and is interested in participating in the study, the Research or 
Intervention Coordinator 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 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 14 of 18
be conducted using online administration at the time of the first web-based survey. A preamble to 
the consent form will appear in REDCap on the screen prior to the participant reviewing the consent. 
This preamble will be an introduction to the consent form clearly explaining the participant’s role as 
a research participant in the study. The preamble will read: “The purpose of this study is to learn 
how well the Mothers and Babies program* works to help pregnant women and new mothers 
manage stress and reduce depression, when delivered by different types of facilitators. We are 
asking you to take part in this research study because you are receiving services from a home 
visiting program or an early childhood program and you are in your 2nd or 3rd trimester of 
pregnancy. Your participation in this study will last approximately 6-12 months after you complete 
your first survey.  You will be asked to complete surveys that ask about your mood, stress, social 
supports, and involvement in prenatal services. Surveys will take approximately 45 minutes to 
complete, and will be conducted at the beginning of the study, immediately following completion of 
the 6-week group sessions, 3-months after the birth of your child, and 6-months after the birth of 
your child. You can complete these surveys on the internet or by phone. You may also be asked to 
participate in a brief interview about your experience with the Mothers and Babies program. The 
interview will be conducted over the phone and will last approximately 30-60 minutes.”  
*The Mothers and Babies program intervention is described fully to the participant during the 
screening process prior to consenting into the research study. The preamble will be available in both 
English and Spanish. 
 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.
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 practicably 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 have 
fractured relationships with their parents given the predominately low-income populations we are 
working with. This will result in difficulties tracking down the parent/guardian for informed consent.
The Intervention Coordinator and RA are bilingual and, therefore, able to communicate with both 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 15 of 18
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 Research/Intervention Coordinators and the RA will conduct the semi-structured interviews. All 
home visitors and mental health professionals will be asked to provide informed consent prior to 
participating in their semi-structured interview. Consent forms will clearly indicate that some study 
participants will be asked to participate in this additional data collection activity.
For the home visiting supervisors/managers/directors who are interested in participating in the survey, 
the Research Coordinator will email the web-link with instruction on completing the survey via 
REDCap within one week of interest in completing the survey. Consent will be conducted using 
online administration at the time of the survey.
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 Coordinator and PI, Dr. Tandon, if necessary, to resolve any questions they are unsure how 
to handle.
10.0 Risks to Participants:
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 
herself, her child, or her family. Study participants randomized to the MB intervention group may also 
experience some discomfort discussing stressful life events. Facilitators leading MB intervention 
groups will be specifically trained on protocols to handle such situations. Should a participant wish to 
withdraw from the study for any reason, at any time, her access to home visiting program services will 
not be affected. It is within reason to expect there may be participants who experience and endorse 
some level of suicidality during the study. Any study participant who expresses suicidal thoughts on 
assessment instruments (including baseline screening) or during intervention activities will be referred 
to the supervisor at the home visiting program. 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. Other psychosocial concerns that may be raised 
among study participants during study intervention activities (i.e. substance abuse and domestic 
violence, will be closely monitored) per usual home visiting program protocols. Should home visitors 
become aware of these psychosocial risks, referrals will be made to an appropriate social service 
agency using protocols used by their home visiting program.
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 16 of 18
We do not anticipate any circumstances under which subjects will be withdrawn from the research 
without their consent. If a subject withdraws from the research, we will no longer collect survey data, 
but we will use data already collected unless the subject submits a written request to withdraw their 
data.
11.0 Potential Benefits to Participants:
There may be no direct and immediate benefits for individuals participating in the research component 
of this study. We believe that women randomized to the MB Course will exhibit greater reductions in 
depression symptoms, perceived stress and improved parenting.
12.0 Financial Compensation:
Participant outcomes will be collected at four time points—baseline, post-intervention, 12 weeks 
postpartum, and 24 weeks postpartum. Participants will receive $20 remuneration at the baseline, 12- 
week and 24-week assessments. They will also receive $20 if they are randomly selected for a 
qualitative interview post-intervention. The post-intervention assessment consists of one depressive 
symptom measure, so no remuneration will be provided.
Both the participants who complete the surveys online via the unique link sent to them by Research 
staff from the NU REDCap Database and those participants who decide to take the surveys verbally by 
phone, will receive their gift cards by mail once the survey has been completed.
There are no costs to participate in the study. We have budgeted for childcare and transportation for 
study participants requiring assistance in these areas. HV stakeholders involved in developing this 
project strongly supported the inclusion of transportation and childcare reimbursement.
13.0 Provisions to Protect the Privacy Interests of Participants:
We will use several procedures to secure data to maintain its confidentiality. Only authorized persons 
will be granted access to study data. Currently, this includes the PI (Dr. Tandon), Project Manager 
(Jessica Jensen) and Study Coordinators (Melissa Segovia and Alicia Diebold). 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.
14.0 Confidentiality and Data Management:
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 de-identified 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 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, 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 17 of 18
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 home visiting program and will not affect their receipt of home visiting 
services.
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.
Power Analysis: For our superiority analyses (Aim 1) comparing MB led by home visitors vs. usual 
care, we have assumed a standard deviation of ~6.0 points on the QIDS-16—our measure of 
depressive symptoms. We anticipate over 95% power to detect a five-point difference between study 
arms (HV- led MB vs. usual care) with ICC’s up to .01; thus, the planned sample size and anticipated 
dropout rate provide adequate power to detect meaningful differences across arms for our superiority 
analysis. We have also conducted power and sample size calculations that take into consideration the 
possible loss of clusters (i.e., HV programs) within each study arm. Even with a loss of two clusters 
implementing MB and one cluster providing usual care, we will have over 90% power to detect a five-
point difference between study arms on the QIDS-16. Previous published prevalence data and previous 
MB data illustrate a 15% reduction in incidence of depressive episodes, and again, we anticipate 
minimal ICC. We expect power >95% to detect an absolute risk reduction of 15% in the intervention 
arm for ICCs no larger than 0.01.
For our non-inferiority (NI) analyses (Aim 2) comparing MB led by home visitors vs. MB led by 
mental health clinicians, we used similar assumptions of a 6.0 SD on the QIDS-16. We will have 
>85% power to detect a difference in mean QIDS-16 scores of two points between the two arms with 
1224 analyzable participants’ data (i.e., 612 in each arm, or 18 clusters in each group with 34 
participants on average) with an ICC no larger than .01. We have taken into consideration the potential 
loss of up to two clusters in each study arm for our NI analyses. Even with a loss of two clusters, 
which would leave us with 1064 analyzable participants’ data (i.e., 532 in each arm), we will have 
>80% power to detect a difference in mean QIDS-16 scores of two points between study arms with an 
ICC no larger than .01. Since we recognize that power to claim NI will depend heavily on the 
magnitude of any ICC, we will perform several ICC calculations within each arm to assess power 
assumptions post hoc. We do not anticipate adequate power to claim NI regarding the incidence of 
new cases of major depression. If we assume 15% incidence in the professional arm versus 20% in the 
paraprofessional arm (i.e., a margin of NI of 5%), a sample size of 1224 participants would have 64% 
power and a sample size of 1064 would have >50% power at the 5% level of significance without 
accounting for any ICC. Thus, we will statistically compare the two arms with respect to MDD 
incidence, but do not anticipate the ability to claim NI.
15.0 Data Monitoring Plan to Ensure the Safety of Participants:
Any study participant who endorses thoughts of self-harm will be referred to the supervisor at the 
home visiting program, by the study coordinator. 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 
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 18 of 18
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.
We will administer the Maternal Mood Screener (MMS) (Le & Muñoz, 1998) to assess for history of 
MDD and current MDD. The MMS is a self-report checklist that assesses MDD using DSM-V criteria. 
Previous research supports the MMS as a valid instrument for MDD screening (Vasquez et al., 2008). 
Women meeting MDD criteria who are not currently in treatment will be referred to the supervisor at 
their HV agency.
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.
Maternal Mood Screener (MMS), Question 9d
→
In the past 2 weeks, subject endorses she has attempted suicide in the past two weeks
The Quick Inventory of Depressive Symptomatology (QIDS), Question 12
→
In the past week, subject selects answer #3 (I thought of suicide or death several times a day in 
some detail, or I made specific plans for suicide or actually tried to take my life)
The Edinburgh Postnatal Depression Scale (EPDS), Question 10
→
In the past week, subject endorses thoughts of harming herself quite often
When assessments are completed over the phone or online during regular business hours the following 
protocol will be completed within 24 hours.
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)
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.

Page 19 of 18
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 no later than the following business day. 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 < 10 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 the next business day—is reasonable given its likelihood of occurrence. Moreover, women receiving 
the Mothers and Babies intervention (~86% 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:
The study surveys will be conducted using web-based surveys, created using REDCap, which is 
supported by Northwestern University IT. We do not plan to share individual study results with 
subjects. However, aggregate data findings will be shared with home visiting programs.
17.0 Qualifications to Conduct Research and Resources Available:
Pregnant and postpartum women are the client base of home visiting programs, and are the intended 
recipients of our postpartum depression prevention intervention Dr. Darius Tandon, the Principal 
Investigator, is an associate professor and nationally recognized expert in the fields of maternal 
depression and home visiting. For example, Dr. Tandon is the lead faculty expert for a federally-funded 
Home Visiting Maternal Depression Collaborative Improvement and Innovation Network aimed at 
improving the ability of home visiting programs around the country to address maternal depression 
among their clients. This project builds on work he has conducted over the last 7 years integrating 
mental health services and interventions into home visiting. Alongside of Dr. Tandon, we also have 
three community stakeholders with strong relationships with the home visiting programs in the 
community, thereby enhancing the likelihood of this project's success.
IRB #: STU00203761 Approved by NU IRB for use on or after 8/2/2018 through 8/1/2019.