Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
Phase: NA
Conditions: Perinatal Depression, Perinatal Anxiety, Prenatal Stress
Sponsor: Children's National Research Institute

Advancing Perinatal Mental Health and Well-Being:
The DC Mother-Infant Behavioral Wellness Program
Study Protocol and Statistical Analysis Plan
Date:12/15/2020

CHILDREN'S NATIONAL HOSPITAL
Department of Diagnostic Imaging & Radiology
111 Michigan Ave., N.W.
Washington, DC 20010
(202) 476-5293
RESEARCH PROTOCOL
TITLE: Advancing Perinatal Mental Health and Wellbeing: The DC Mother-Infant Behavioral Wellness
Program
PRINCIPAL INVESTIGATOR: Catherine Limperopoulos, Ph.D.
Department: Diagnostic Imaging & Radiology
Telephone: (202) 476-5293
BACKGROUND
THE BURDEN OF STRESS, DEPRESSION AND ANXIETY IN PREGNANCY
Mental health (MH) disorders, including stress, depression, and anxiety (hereafter referred to as maternal
distress), are the most common complication of pregnancy, affecting up to 25% of women in the prenatal period
and/or first postpartum year.1 Stark disparities exist, with almost 40% of low-income women who are Black/of
African Descent suffering from maternal distress during pregnancy.2 These disparities extend to the stress,
anxiety and depression3triggered by giving birth amid a COVID-19 pandemic that has exacted a heavier toll4
among people of color5in the U.S. Pilot data from our Project RESCUE study indicate that high levels of anxiety,
depression and stress experienced by pregnant women in DC more than doubled from the pre- to the post
COVID-19 era. Repercussions of these pregnancy-related MH disorders are widespread and longstanding.6
Beyond their potentially devastating effects on the pregnant woman and her fetus (e.g., preterm labor, fetal
growth restriction, low birthweight – leading causes of infant mortality) and the associated postpartum (e.g.,
attachment dysregulation, low self-efficacy) and newborn complications (e.g., prematurity), the personal, familial
and societal impact is further magnified by known health repercussions across the child’s lifespan,7 and even
across generations. 8-23 Future pregnancies in the mother and her adult offspring may also be compromised,
perpetuating this enormous public health problem.6In a recent study of well-resourced pregnant women with
low-risk pregnancies, we investigated the impact of prenatal stress, depression, and anxiety on in vivo human
fetal brain growth using advanced non-invasive MRI tools. We reported for the first time that almost 30% of
these pregnant women reported high levels of stress that was associated with impaired fetal brain growth, both
global
and regional (hippocampus and cerebellar)24 and disturbances in fetal brain function.25 These alarming
findings highlight the need for effective screening and intervention programs to improve MH in pregnant women
and optimize infant outcomes, which we plan to address in the current proposal, building on our pilot data that
indicates early, effective interventions lessen toxic maternal stress, anxiety and depression.
There are major barriers to treatment for low-income women who are Black/of African Descent who develop
pregnancy-related MH complications.26 These include under-detection of mental illness, significant psychosocial
stressors, and lack of integrated health and mental health care. In an extensive recent report using a human
centered design (see below).27 The DC-Primary Care Association (DC-PCA) cited transportation, housing
insecurity, food insecurity, childcare, disrespectful care providers, and poor communication with providers as
potent barriers to care. These results corroborate those from our own pilot efforts in which psychosocial
stressors
emerge as potent and persistent barriers to care. These barriers highlight the need to develop,
implement and
evaluate evidence-based models of care that aim to: (1) increase screening for prenatal and
postpartum maternal
distress, (2) provide more immediate access to culturally-adapted, evidence-based
interventions (that include
both prevention and treatment) to decrease risk for maternal distress, and (3)
increase coordination of care
among various perinatal providers. Of note, one of the authors of the DC-PCA
report is a co-investigator on our
proposal, and the report’s key recommendations (novel technologies; care
coordination) are embedded in our research strategy.

Washington, DC, provides a useful model for evaluating strategies aimed at improving the detection of,
and intervention for, pregnancy-related mental health needs in low-income women who are Black/of
African Descent and their offspring for several reasons. First, the District of Columbia (DC) is a relatively
small and circumscribed area, with stark socioeconomic and healthcare disparities. Second, low-income
Black/of
African Descent communities are largely concentrated in the northeast and southeast of the district (Fig 1).
Maternal health care outcomes in the U.S. are among the worst in the developed world, and the DC maternal28
and infant29 mortality rates are among the highest in the nation. Recent reports
from the Centers for Disease Control (CDC)28,30 highlight the deep racial
disparities in maternal health care in DC. Maternal mortality in DC overall is
50% higher than the national average30, yet white women in DC have the lowest
maternal mortality in the nation.28,30 These disparities persist even when
controlling for education and income,31 reflecting a deeper set of issues related
to distrust, poor access, communication, and resource information. According
to the 2018 DC Perinatal Health and Infant Mortality Report, about 50% of
women who are Black/of African Descent enter prenatal care only in the 2nd or
3rd trimester, if at all. 29 Only 36% of Medicaid recipients in DC attend the
recommended number of prenatal visits,32 and < 50% have postpartum visits.32
Women of color, particularly those living in poverty, are less likely to proactively
seek help for stress, anxiety, and depression.33 These alarming statistics are
corroborated by a local survey of the delivery centers partnering in this
proposal. Recently, access to pregnancy-related care in DC was further compromised with the closure of two
maternity centers in predominantly low-income AA areas.
Aim 1: We will refine an individualized plan to integrate patient navigation and a culturally adapted cognitive
behavioral (CBT) intervention for low-income pregnant women who are Black/of African Descent, designed to
increase recruitment and retention within the healthcare community system.
Aim 2: Through a two-arm prospective randomized controlled design, women who are subthreshold and
threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) usual
care: existing prenatal intervention; or (b) patient navigation plus adapted CBT, and peer support group, per
patient preference.
PRELIMINARY STUDIES
Stress, depression, and anxiety are the most common complications of pregnancy, with enormous racial
disparities in prevalence and care. Prevalence of these disorders is almost two-fold higher among pregnant low
income Black/of African Descent women2,34 who, paradoxically, also face the greatest obstacles to mental health
care. These racial disparities are particularly striking in DC. Yet MH disorders remain seriously under-detected
in part due to poor implementation of recommended screening protocols. The CDC reports that about 60% of
women with depression go undiagnosed, and among those that are diagnosed about 50% go untreated
because of limited access to treatment, cost, medical mistrust, and stigma.35,36 As low-income women who are
Black/of
African Descent experience multiple psychosocial stressors, it is also imperative to screen for stress
alongside
depression and anxiety. In this proposal, we plan to partner with stakeholders within low-income
Black/of African
Descent communities37 to develop and implement strategies that reduce these obstacles to
screening, and to provide necessary follow-up resources, via navigation and evidence-based interventions, that
are tailored for  expectant low-income women who are Black/of African Descent.
After identifying women at risk, the next major knowledge gap lies in the optimal engagement and retention
within treatment programs: Which optimal navigation tools connect and retain women in the healthcare system?
As MH conditions during pregnancy may impact the behavioral and neurodevelopmental outcome of the
offspring, what is the best way to monitor these infants to detect early signs of these complications, and to
intervene early? Will the integration of maternal postpartum MH monitoring with the infant’s well-baby checks
provide benefit? A third gap in care is the absence of MH interventions for women at risk (subclinical) for

maternal
distress. Most clinical trials focus on women who meet “threshold,” based on DSM-5 criteria, for
clinical depression or anxiety then evaluate the effectiveness of a treatment for this group. However, mothers’
elevated depressive symptoms (i.e., “subthreshold” or subclinical depression that would not be diagnosed) can
also have negative consequences for infants’ and young children’s development.38 Therefore, it is necessary to
provide
more immediate access to evidence-based, preventive interventions for all women seeking prenatal
care to
decrease risk for future maternal distress, which are both acceptable and adapted to meet the
contextual realities of low-income women who are Black/of African Descent. CBT interventions are effective for
preventing and
treating perinatal depression;39,40 adapting these CBT interventions to address not only
depression but also stress and anxiety will further address the psychosocial needs of our target population. A
culturally tailored CBT
to manage pregnancy-related and psychosocial stress among these women may improve detection rates as
well
as implementation and adherence to interventions. Furthermore, studies have shown that when MH
services are co-located within the settings in which women are already receiving care, women are more likely
to use those
services.41 Our own pilot studies find that more women are likely to use services that are
co-located, and our AA
context experts advocated for this “one-stop shop” approach. Several overlapping
strategies for overcoming these obstacles and filling these critical knowledge gaps are proposed. We will test
whether Patient Navigation
optimizes case identification and retention, and reduces psychosocial barriers,
when delivered with a culturally adapted CBT intervention in an integrated obstetric-psychiatric-pediatric care
model (Fig 2). We will measure the outcomes in terms of case identification, engagement and retention, as well
as maternal, pregnancy, and
infant outcomes, including standardized measures of infant temperament,
behavior and development until age  one year.
Few PCORI-funded studies (Li NCT02371356,42 Silverstein NCT03221556,43
Tandon NCT02979444)44 have addressed pregnancy-related MH; each distinctly
differs from our current proposal. Most importantly, none focuses exclusively on low
income women who are Black/of African Descent. The first study (Li) compares the
efficacy
of
different
treatments
(and
no
treatment)
on
fetal
outcomes
(mortality/morbidity, prematurity and birthweight). The second study (Silverstein)
focuses on CBT as a first-line treatment, which enrolls 230 women both prenatal and
postpartum, with its primary outcome the effect on maternal depressive symptoms.
The third study (Tandon) evaluates whether having paraprofessional home visitors
lead the Mothers and Babies group prevention is more efficacious than providing usual care. Our proposal has
distinct and important differences from these ongoing studies. We focus on early
identification, both prevention and treatment, as well as engagement and retention of a large
intervention
group (N=700), and include both mothers and infants in our outcomes. While maternal
report of child outcomes is measured in the Silverstein study, there is no independent evaluation of the infant’s
attachment, temperament and development as is done in our study. In addition, all three studies focus only on
depression,
unlike ours which includes the more pervasive and co-occurring problems of prenatal maternal
stress and
anxiety. Lastly, our study also includes patient navigation, which addresses the multiple needs
reflecting  important social determinants among low-income Black/of African Descent perinatal women.
A major limitation of previous large community-based trials is the failure to sustain the benefits of the trial in
the community after completing the trial. A number of factors align to support the success and sustainability of
this proposal. First, is the team of investigators, experts drawn from all the disciplines relevant to the issues
targeted (discussed below). Second, is the integration of embedded patient and community stakeholders at the
center of this proposal (see below). Third, is the support from leadership at the hospitals and community centers
where the work will occur. In addition, our proposal harnesses momentum. The timing of this proposal coincides
with a surge of other local and national initiatives calling for prioritization of pregnancy-related health care. On a
national level, the importance of implementing and sustaining pregnancy-related MH screening has been
endorsed by a number of important agencies, including the American College of Obstetrics and Gynecology45,46
(ACOG, see letter) American Psychiatry Association (APA),47,48 and American Academy of Pediatrics (AAP, see
letter). On a local DC government level, insufficient MH screening and lack of referral resources49 are now
recognized as critical unmet perinatal health burdens, and maternal and infant health has been identified as a
priority. Our PCORI project closely aligns with the mission and milestones of a substantial investment from the

A. James & Alice B. Clark Foundation towards the Clark Parent & Child Network (Limperopoulos, co-director) to
bolster the quality and capacity of perinatal health for low-income families in Washington, DC, and includes
many of the same key stakeholders as this PCORI proposal. Since 2018, DC Mayor Muriel Bowser has hosted
annual Maternal and Infant Health Summits including politicians, health providers, community workers and DC
residents to explore strategies to improve perinatal health and address racial disparities in birth outcomes; the
2020
Summit highlights the transformational nature of our five-year, Clark-funded project.29 The DC City
Council recently passed legislation requiring the formation of a Maternal Mental Health Task Force to address
disparities
in perinatal health, health care access, and infant outcomes.29 Likewise, the Department of Health
Care Finance (DHCF) has convened a Perinatal Collaborative comprising managed care organization
representatives and
other relevant stakeholders charged with monitoring maternal and infant health care
efforts. This year (2020),
Deborah Perry, PhD is conducting the DC Perinatal Needs Assessment, funded by
the DC Department of Health,
to examine how racism adversely affects the decisions of women who are
Black/of African Descent to access prenatal care services. Dr. Perry and her team have already gathered data
from 22 multidisciplinary health providers who are knowledgeable about the services, systems, barriers to care
experienced by women who are
Black/of African Descent in Wards 5, 7, and 8, the most impoverished parts of DC. The team is currently
recruiting 40 women who are Black/of African Descent to further assess these structural issues. This report will
be ready by the end of 2020 and will enrich our understanding of the contextual barriers to care for women who
are
Black/of African Descent in DC (D. Perry, see letter). In recent years, the DHCF and DC Department of
Behavioral Health have focused on improving maternal MH, particularly homing in on integrating screening
efforts in pediatric primary care settings, an important aspect of this proposal (see below). Lee Beers, MD (co-I)
leads the Community Mental Health CORE (Collaboration, Outreach, Research and Equity), and created
screening toolkits and other resources to screen for perinatal mood and anxiety disorders in pediatric primary
care (Appendix A). Finally, Catherine Limperopoulos, PhD (co-PI) leads the DC Perinatal Mental Health
Consortium which has successfully formed a joint collaborative of local community partners from obstetrics,
psychiatry and pediatrics to develop perinatal screening and intervention strategies to improve behavioral health
in pregnant women and infants. The logical next step is to move this work into the obstetric setting, recognizing
that depression during pregnancy is the strongest predictor of postpartum depression.43, 44 Huynh-Nhu Le, PhD
(co-PI) and Aimee Danielson, PhD (co-I), led efforts in 2017-2019 to implement a screening process for
perinatal depression and anxiety in obstetrical settings. The DC-PCA conducted in-depth interviews of women
who are
Black/of African Descent in DC to better understand the barriers to pregnancy care, and to identify
opportunities for intervention. They recently published their findings and developed a roadmap for action.27 Two
of the women
who were in this report are part of the context experts team (n=6 in the DC-PCA’s Maternal
Health Equity Action Lab) and from April to July 2020 participated in 6 focus groups with our research team to
inform and co-create all aspects of the screening and intervention arms of this study. These women are all now
part of the Patient
Stakeholder group, known as Moms’ Collective WISDOM (see below). We have further
capitalized on this important initiative from the DC-PCA report by incorporating many of the recommendations
into our proposal, and by recruiting one of the two lead authors and director of Policy at the DC-PCA (Patricia
Quinn, Co-lead of our Stakeholder Engagement Core) and a patient stakeholder (Shanae Bond), a postpartum
doula and lactation
specialist, and one of the context experts in the Equity Action Lab, who has actively
participated in the focus  groups, into our research team.
RESEARCH DESIGN AND METHODS
Overall Research Design
Methods:
Specific Aim 1: Refinement of the intervention arm, integrating patient navigation with prevention and
treatment interventions already has begun with input from the context experts/focus groups from April to July
2020. This  process will continue through a systematic, multi-step process driven by the SEC during the first
year of the  study to further refine the individual roles of patient navigator and interventions. We remain wholly
committed to  continuing this stakeholder-driven and iterative process to define the specifics of the final
research questions  and the final intervention. The process will be completed by the first year of the study. They

represent a broad  array of local stakeholder expertise See Leadership Plan (Table 1). All members of the Core
will be reimbursed  for their service.
Specific Aim 1.a. Development and refinement of the patient navigator (MCS) role. The Patient
Navigation elements were developed in collaboration with our Stakeholder Engagement Core using the
feedback
and guidance from the patient stakeholders during our focus groups. The patient navigators,
“Maternity Care
Specialists,” are humans (rather than e-navigation) whose role should be to provide
“personalized care” -
support, resources, and referrals to address psychosocial issues that arise during the perinatal period.
Specific Aim.1. b. Refinement of the adapted CBT Interventions: The proposed content of the stress
management interventions (prevention, treatment) were co-created by the patient stakeholder group, will now
be reviewed with the providers for further refinement (Table 1, Appendix C). Also, five meetings of the entire
Stakeholder Engagement Core and four consultations with the National Advisory Board over the study’s first
year will provide additional opportunity for feedback and refinement. The process will follow a rapid cycle quality
improvement with refinement after focus group sessions to finalize the intervention components, including
patient  navigation, prevention, treatment and peer support group components.
Specific Aim 1.c. Refinement of the “Virtual Mommy Meet Ups”: Created and co-led by the context
experts,
these peer support group interventions will be reviewed in consultation with the National Advisory
Board for  further refinement and adaptation to the current study (Table 1, Appendix C).
Specific Aim 2: Through a two-arm prospective randomized controlled design, women who are subthreshold
and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a)
existing prenatal intervention/usual care/UC; n=350, Group 1); (b) patient navigator, n=350 (Group 2).
Randomization: We estimate an existing total
population of 4,000 women within the delivery center
network that would be eligible for participation. Due to
budgetary constraints, we assume a 25% working
population (n=1,000) available for screening of which,
based on our prior RCTs, 70% (n=714) will consent to
screen. Of these, we anticipate 2% of women (n=14)
will screen in the critical risk category (imminent risk
for harm to self or other and need immediate crisis
intervention at the site where they are receiving care)
and will be excluded. Therefore, we anticipate
consenting and randomizing 700 women (1:1) to one
of two arms: (Aim 2) (a) existing prenatal
intervention/usual care/UC; n=350, (Group 1); (b)
patient navigator, n=350 (Group 2). Following
randomization all women in either arm will participate
in a diagnostic interview based on DSM-V criteria to
‘self-select’ themselves into 1 of 2 groups (i.e., ‘threshold’ or ‘subthreshold’). Threshold includes women who
meet criteria for depression or anxiety based on DSM-V diagnostic criteria. Subthreshold includes all other
women who do not meet DSM criteria. We anticipate 70% (n=245) of women to present as ‘subthreshold’ risk
with the remaining 30% (n=105) to comprise the ‘threshold’ group. Women in the patient navigator arm (Group
2a) can choose to participate in group-based preventive interventions based on: (1) a culturally adapted CBT (in
person within prenatal care site or virtual given COVID); (2) peer support group (virtual); or (3) both. Women in
the threshold risk group (Group 2b) at baseline warrant treatment interventions and will be invited to participate
in: (1) culturally adapted CBT (individual, in person or virtual given COVID); (2) peer support (virtual); or (3)
both.
Women in this more severe risk group may be referred for psychiatric treatment if warranted.
Randomization lists will be generated by the study statistician using a permuted block design and uploaded to
a HIPAA compliant, password-protected website (REDCap) allowing for patient randomization at the time of
registration  in the data collection system.
Measurement Outcomes and their

psychometrics are detailed in Appendix
E. Although we consider stress, anxiety
and depression measures in our target
population as equally important, for this
project we will clarify that stress as
measured by the Perceived Stress
Scale50 (PSS) will be considered as the
primary outcome. Our recent studies
have shown that prenatal stress is
prevalent among expectant mothers
(27%) as measured by the PSS and is
associated with impaired fetal brain
development3 and an increased risk for
wide-ranging cognitive, and social
behavioral problems in the off-spring of these women at 12-18 month neurodevelopmental testing. Secondary
outcomes considered will be reductions in perinatal depression (EPDS) and anxiety (GAD-7), rate of program
adherence to pre-/postnatal mental health treatment, rate of pregnancy complications (e.g., bleeding, infection),
healthcare utilization (e.g., cost of care [U.S. dollars]), and infant outcomes (e.g., neurodevelopment, mother
baby dyad attachment, etc.). Our secondary outcomes are perinatal depression and perinatal anxiety. The
Edinburgh Postnatal Depression Scale51 (EPDS) is generally expressed as a rate with traditional clinical cut-off
points for minor or major depression set at 9/10 or 12/13, respectively. Thus, we assess clinical meaningfulness
as the change in pre- vs. post-intervention proportion above the selected threshold (depressed) to the post
proportion below. Participants scoring below the threshold are thought to have demonstrably improved.
Previous research has shown a 4-point drop using the Reliability Change Index to be adequate in assessing a
reduction in maternal depression. Thus, a pre-intervention null EPDS rate of depression (EPDS score of 14/15,
depressed), and a post-intervention depression rate of 15 suggests 413-450 subjects provide approximately
80% power, alpha=0.05, two-tailed, to detect a statistically significant reduction in maternal depression. Any
further decrease in EPDS score from a 4-point decrease to 5-point, etc. will increase our study power and
therefore require fewer subjects.
Recruitment and Eligibility Criteria:
Procedure at each recruitment site: After consulting with the clinical staff, a trained clinical research
coordinator (CRC) from Children’s National Hospital (CNH)
will approach patients during their visit (T1, Appendix E) to
determine their interest in the study and to confirm eligibility.
Following informed consent, the CRC will ask the patient to
complete the identified screening tools for stress, depression,
and anxiety, and for static risk factors for perinatal MH
disorders, including prior experience of trauma, personal,
familial MH history, and interpersonal violence, at multiple
time points (Table 2; Appendix E). The proposed screening
will include the following measures: the EPDS,51 the GAD-7,52
the PSS50 along with risk factors questions regarding MH
history, trauma, and interpersonal violence. Participants
determined to be at “critical risk” via “yes” responses to both
item 10 (suicidality) on the EPDS and screening question "Today I'm having difficulty with depression, anxiety,
anger, or frightening thoughts" warrant an immediate on-site risk assessment and psychiatric emergency
consultation, per standard of care available in each of the study sites and are ineligible for the study (Appendix
B). Participants will be randomized into UC or Intervention. At T2, a team psychologist will perform a structured
clinical interview to divide participants into two subgroups: (1) subthreshold: women who currently do not meet
criteria for major depression or anxiety, or threshold: women meeting criteria for depression and/or anxiety.
Follow-up visits will assess maternal depression, anxiety, and stress at T3-T9. Maternal risk and protective

factors will be assessed at T3 and T6 (PDRQ only).
Eligibility: Inclusion criteria include:
(a) Black/of African Descent;
(b) pregnant (gestational weeks ≤ 28 weeks),
(c) age 18‐45;
(d) English proficient;
(e) receiving services in one of the four study sites above;
(f) low‐income: i.e., receiving Medicaid
(g) subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety); and
(h) able to provide consent.
Exclusion criteria include: (a) age <18; (b) currently under the influence of a substance(s); (c) experiencing
psychosis; (d) critical (clinical) risk: actively suicidal or homicidal; e) not Black/of African Descent; and (f)
planning to deliver outside DC.
To honor the heterogeneity of Black participants, once participants who self-identify as Black/of African Descent
enroll in the study, we will also capture data about their country of birth and years in the U.S. if not born in the
U.S. We will use questions to further characterize their ethnic heritage, adapted from “My Family’s Cultural
Background,” part of the National Institute of Child Health and Human Development Study of Early Child Care
and Youth Development. These questions include:
1. Describe your African heritage (e.g., African American, African Caribbean, Kenyan, Nigerian, South
African, Ethiopian, Other (describe)_______________.
2. Of the groups checked, what is the primary group that describes your ethnic heritage other than
American? __________________________.
3. What national or cultural heritage do you most identify with?
❏ My American (U.S.) heritage
❏ My other heritage (named in Question #2)
❏ Both my American and my other heritage about equally
❏ Don’t know
Data Collection and Storage
Data will be maintained in a secure database system (REDCap), housed on the Children’s National  Research
Institute (CNRI) server, which will be used to track enrollment in the study, enter patient information, and
enter/store questionnaire data. The REDCap database system is a password
protected research database available to CTSA institutions. The REDCap data server is located behind the
CNRI firewall and is protected against intrusion. Access to these data is limited to only those designated by
the co‐PIs. All hard copy data will be stored in locked file cabinets in a secure suite within the Developing
Brain Institute at  Children’s National. Only study team members will have access to these files, and all will be
trained in the importa nce of keeping files secure and confidential.
Statistical Considerations
Analysis Plan: To evaluate the impact of expanded care (Aim 2) on maternal MH and maternal-infant outcomes,
we will compare outcomes across the two randomized treatment groups (1) Group 1 (UC) vs. (2) Group 2 (PN).
Analyses will be considered as intent to treat. Given the longitudinal design of the study, we anticipate missing
data during follow-up. Missing data rates per participant will be calculated per measure (e.g. GAD-7, PSS, etc.)
with > 10% missing data considered for multiple imputation. Rates of maternal outcomes (e.g. infection, severe
bleeding), pregnancy complications (e.g., pre-term delivery, gestational diabetes) will be compared using chi
square or unconditional logistic regression. Healthcare utilization will be compared using repeated measures
mixed models allowing for participant intra-correlation. The prevalence of depression, anxiety, etc. will be
compared using unconditional logistic regression. Three analysis strategies are planned to assess the effect of
treatment on depression (e.g. EPDS), anxiety (e.g. GAD-7) and stress (e.g. PSS). Analysis 1: compare the
overall impact of Group 1 vs. Group 2; Analysis 2: assess the impact of overall impact of treatment in addition to

assessing risk groups (e.g. subthreshold/2a, threshold/2b) nested within Group 2; and Analysis 3: utilize the
Analysis 2 framework (e.g. subthreshold/2a, threshold/2b nested within Group 2), but further assess the impact
of Group 2 choices of (1) peer support only, and/or (2) adapted CBT. Initial group comparisons will focus on
baseline characteristic using t-tests, chi-square, etc. to determine which characteristics may need inclusion
within
multivariate models (MV). Analyses 1-3 will utilize a latent growth model approach (LGM) to assess
trajectories
of rates of depression, anxiety, and stress until the end of the 12 postpartum-month study period.
Models will focus on the effect of treatment (Group 1 vs. Group 2), time (9 visits for mothers), time (group by
time interaction to assess whether trajectories differ between groups over time. Analyses 2 and 3 will include
nesting terms for risk subgroup (threshold vs. subthreshold) and group 2 choices (peer support, adapted CBT,
peer support +
adapted CBT). Statistically significant covariates from univariate group comparisons (e.g.
maternal age, GA, etc.) will be included as necessary. A two-sided p-value of 0.05 will be considered significant
for all analyses.
Adequacy of the Sample: Sample size estimates were conducted using PASS15 based on Aim 2 (Group 1 vs.
Group 2). All tests assume α= 0.05, β=.20, two-tailed. For the primary outcome of stress (PSS), a-priori results
suggest a mean PSS prior to intervention ranges from approximately 10-21 (SD= 4.5-6.5). For our MCID
(minimally clinically important difference), we chose a distributional approach of ½ the pre-intervention SD.
Published literature suggests a 2.15 to 2.75 decrease in PSS score represents the MCID. Thus, we estimate an
MCID equal to a 2-point decrease (15%) in total PSS score following intervention. This MCID of 2-points was
derived via a simulation using published estimates assuming an average pre-intervention mean total PSS score
of 14.50 (SD=4.72), a post-intervention total mean PSS score of 12.14 with risk subgroup nesting) using a
repeated measures latent growth modeling approach. For Aim 2, secondary outcome were reduction in
depression (EPDS) and anxiety (GAD7), a pre-intervention null rate of depression (EPDS score of 14/15,
depressed) or anxiety (GAD7 score of 15-19, moderate/severe), and a post-intervention depression rate of 15%
suggests 413-450 subjects (200-225 pe group) provides approximately 80% power, two-tailed, to detect a
statistically significant reduction in maternal depression or anxiety. Any further decrease in EPDS or GAD7 from
baseline (≥ 4-point decrease) will increase our study power and require fewer subjects.
STUDY POPULATION
We propose to prospectively screen 1,000 low-income pregnant women who are Black/of African Descent and
18-45 years of age using standardized screening tools for stress (Perceived Stress Scale [PSS]), anxiety
(Generalized Anxiety Disorder 7-item Scale [GAD-7]), and depression (Edinburgh Postnatal Depression Scale
[EDPS]) with the expectation of identifying 700 women eligible for enrollment into the intervention (Fig 5).
Screening and enrollment will occur at three large D.C.-based delivery centers: George Washington University
Hospital (GW), Howard University Hospital (HU) and Unity Health Care, a community outpatient health center.
Eligibility: Inclusion criteria include: (a) Black/of African Descent ; (b) pregnant (gestational weeks ≤28 weeks),
(c) age 18-45; (d) English proficient; (e) receiving services in 1 of 4 study sites above; (f) low-income: i.e.,
receiving Medicaid (g) subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety);
and (h) able to provide consent.
Exclusion criteria include: (a) age <18; (b) currently under the influence of a substance(s); (c) experiencing
psychosis; (d) critical (clinical) risk: actively suicidal or homicidal; e) not Black/of African Descent; and (f)
planning to deliver outside DC.
HUMAN SUBJECTS
Recruitment:
Recruitment will occur at three large D.C.-based delivery centers: George Washington University Hospital
(GW),
Howard University Hospital (HU) and Unity Health Care, a community outpatient health center.
Low-income pregnant women who are Black/of African Descent will be identified through the obstetric clinics at
these sites. Trained clinical research coordinators from CNH will review and sign consents with participants in
person at their
obstetric visit and enroll participants

once the
consenting process is complete. As these will be adult
participants with the ability to sign consent on their own
behalf, assent and parental permission do not apply.
Parental permission will apply at T10 (12 months
postpartum) at which time participants will provide
parental consent for their infants to complete a
standardized neurodevelopmental assessment.
Consent:
The informed consent process will be initiated at the second prenatal visit.
It will be conducted in a private clinic room. Informed consent will be obtained from participants prior to the initi
ation of any research study activities. The consent form will supplement, not replace, dialogue between particip
ants and research personnel.
Additional consent procedures that will be followed by the study team include:
●The informed consent document will be approved by each site’s IRB/IRB of record; the study participants must
sign a consent that has both a current IRB approval stamp and that reflects the most recent version of the
research protocol.
● Potential participants will be allowed ample time to review the document and encouraged to ask questions.
●Copies of the consent document will be given to participants for their records.
●A study investigator will be available to answer any questions that arise during the informed consent process.
● Potential participants will be given as much time as they desire to decide whether or not to participate.
RISKS AND SIDE EFFECTS
Breach of Confidentiality. The primary risk to participating in this study is breach of confidentiality. While there
are no known psychological risks to subjects when completing interviews or completing standardized
psychological questionnaires, the questions may make the subjects feel uncomfortable in that they ask about t
heir psychological health. Patients will be assured both verbally and in the written consent form that they can s
kip any questions that they do not wish to answer.
Severe stress, depression, anxiety and/or suicidality. We may identify patients who are severely depressed,
stressed, anxious and/or suicidal during recruitment, screening, and/or while participating in the study. The
research team will address the potential risk of increased suicidality in this study by following the
guidelines for risk management protocols delineated by NIMH.53 First, the CRCs who will have contact with
participants will receive extensive training in crisis intervention and suicide risk assessment by the Dr. Le (co
PI) and Dr. Danielson (co-investigator & lead of the Perinatal Mental Health Core). They will be trained to look
for behavioral signs of depression (e.g., participant looks sad, seems upset or disturbed by the material, has
blunted or flat affect, etc.). Second, participants will be told at the beginning of the study that confidentiality will
be broken if participants are currently suicidal. These participants will be referred to mental health resources
immediately following the study session to minimize embarrassing or humiliating the participant in question.
Should suicidality be identified at the first screening in the study (i.e. those who meet “critical risk” at
Time 1), we will implement a suicide prevention plan to assess immediate risk for harm and secure treatment. If
a
participant endorses anything other than “never” (0) on item #10 “The thought of harming myself has
occurred
to me” on the EPDS or endorsement on a screening question: "Today I'm having difficulty with
depression,
anxiety, anger, or frightening thoughts", the following questions will be asked: 1) Do you think
about killing yourself? If the answer is “Yes,” then a follow up question is asked: 2) When was the last time you
thought about
killing yourself? If the answer is within the last month, the CRC will follow the risk protocol
designated at each site for suicide screening, contacting the appropriate people on site for appropriate follow
up care. Additionally, if there is risk of the participant hurting others (expressing thoughts of harming another),
the CRC will follow the  same protocol as listed above. This participant would not be eligible for the study.
Should suicidality be identified during the course of the study (T2-T10), the CRC will immediately
contact the perinatal mental health (MH) specialist assigned to that study site, Dr. Danielson (co-investigator)

or Dr. Le (co-PI), and the Patient Navigator (PN) assigned to this participant. The Perinatal MH specialist, Drs.
Danielson
or Le, will conduct an assessment of the participant’s suicidality risk in person or by telephone.
These mental health professionals will work closely with the PN, research team, and study sites to develop a
safety plan, which  may involve referral back to the
Perinatal MH specialist (i.e., if the participant was already receiving CBT intervention), or Emergency
Department at a nearby hospital for evaluation for psychiatric hospitalization. All participants will be given the
number to the
National Suicide Prevention Hotline and additional resources in the D.C. area. Drs. Danielson
and Le are
licensed psychologists in Washington, D.C. Dr. Danielson, founder and director of the Women’s
Mental Health
Program at MedStar Georgetown University Hospital, specializes in women’s perinatal mental
health and
regularly sees clients in this program. Her clinical practice focuses on treating mood and anxiety
disorders in pregnancy and postpartum, as well as supporting women through the transition to motherhood. Dr.
Danielson
regularly assesses for suicidality in her clinical practice. Dr. Le has conducted several clinical
research studies
with mothers at high risk for depression and supervises clinical graduate students who see
many depressed
patients, requiring suicidality assessments. In addition, each of the four study sites has a
standard protocol for dealing with these situations, including making appropriate referrals as necessary, which
will be reviewed prior and quarterly throughout study implementation. The CRC also will inform the co-PIs and
on-site clinicians and patient navigators. A similar protocol for follow up would be instituted for patients at risk
for hurting others.
Child abuse. Participants will be told (verbally and in writing) during the informed consent process that we are
required to report any instances of child abuse or neglect. If participants report information that suggests the
possibility of child abuse or neglect, a clinician will be available by phone to evaluate the potential risk for the
presence of child abuse. If risk for child abuse is suspected, a clinician will discuss the situation with the
participant, and inform the participant of the advisability of making a report to the Child Protective Services
(CPS),  and tell them that the clinician is required to contact CPS. If, upon inquiry, there is no evidence of child
abuse,  the participant will be given a list of emergency numbers to be used if this should become necessary in
the future.
BENEFITS
This study has the potential for both direct (and indirect) benefit to low-income women who are Black/of African
Descent and of childbearing age who are suffering from stress, depression and anxiety. These data will
illustrate
if the interventions (PN, adapted CBT and/or peer support groups) are successful in increasing
engagement and retention in the healthcare system, reducing risk for maternal distress and improving maternal
and/or infant
health and behavior outcomes. In addition, study participants will benefit from extra monitoring
during their pregnancy and interventions that target their level of risk severity, providing appropriate follow-up
mental health
care. During postpartum care, mothers and babies may benefit from maternal interventions as
well as  neurodevelopmental assessments for the baby through 12 months of life.
Importance of Knowledge to be Gained
Stress, depression and anxiety during pregnancy are under-studied public health issues that have significant
consequences on population health outcomes. The ultimate long-term goal of this research is to elucidate the
risk factors for maternal stress, anxiety and depression during pregnancy and postpartum among low-income
African American women. If we demonstrate the effectiveness of these interventions (navigation and adapted
CBT – both prevention and treatment, peer support groups), there will be opportunities to expand such services
to manage perinatal mental health distress in other obstetrics and pediatric settings, where women are more
likely in their lifetimes to seek health care for themselves and for their children. The potential reach of the
findings  is great locally, nationally and internationally.
OUTSIDE CONSULTANTS/COLLABORATORS
None.
CONTRACTUAL AGREEMENTS
Huynh-Nhu Le, PhD – George Washington University (Subcontract)
Loral Patchen, PhD – MedStar Washington Hospital Center “MHRI” (Subcontract)

Jennifer Keller, MD – George Washington University/Medical Faculty Associates/OB: (Subcontract)
Kristin Atkins, MD – Howard University (Subcontract)
COSTS TO SUBJECTS
None.
CONFLICTS OF INTEREST
None.
CONFIDENTIALITY
All protected health information will be de-identified prior to analysis and reporting in compliance with HIPAA
regulations and CNMC institutional policies. All protected health information collected will be linked to a study ID
code. The study ID code will be assigned by the investigator. The linkage key and the PHI will be maintained
separately in locked file cabinets in a locked office accessible only by study staff. The database will be
password
protected and accessible only by study staff. No PHI will be stored on thumb drives. PHI will be
stored for three
years following the completion of the study also in locked file cabinets in a locked office
accessible only by study staff. Data will be disposed of according to CNMC institutional standards three years
after the completion of the  study.
SUBJECT COMPENSATION
Focus groups will be conducted before the RCT study. The purpose of these virtual focus groups is to elicit
additional feedback on the interventions (patient navigation, peer support group, and prevention and treatment)
from relevant stakeholders (women of Black/African descent) with lived experiences with maternal distress,
health and/or mental health experiences in the DC area. Each participant will be paid $50 for their time.
Participants will include the context experts team (n=6 in the DC-PCA’s Maternal Health Equity Action Lab) who
previously participated in 6 focus groups with our research team and other women in the DC area.

All participants will be compensated for their time in answering questionnaires, as listed above, from
T1 to T9. At T10,
Women in both the intervention arm (prevention and treatment) will be compensated for transportation
to attend their sessions at the OB site ($10/session; PN-Prevention at 8 sessions = $80;
PN-Treatment  at 12 sessions=$120).
To facilitate retention for participants in the study, incentives will be offered at three time points with
increasing amount over time. In total, participants who receive UC only will receive $275. Participants
randomized in to INT (Prevention) condition (n=245) will receive an additional $160 and to INT
(treatment) condition (n=105) will receive an additional $120.
FACILITIES AND EQUIPMENT
All study procedures will take place at CNH, GW, HU and Unity.
SAFETY ASSESSMENTS AND REPORTING
All suspected adverse reactions to study observations that are both serious AND unexpected will be reported
to the IRB.

ETHICAL CONSIDERATIONS
Ethical Standard
The study team will ensure that this study is conducted in full conformity with the Regulations for the Protection
of Human Subjects of Research codified in 45 Part 46 of the Code of Federal Regulations, Children’s National
Policies and Procedures and Good Clinical Practices.
Institutional Review Board (IRB)
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to
the Children’s National, HU andGW IRBs for review and approval. Approval of both the protocol and the
consent  form will be obtained before any participant is consented. Any change to the protocol, consent,
recruitment materials and participant information sheets or letters will require IRB approval before
implementation and use.  The IRBs will determine whether previously consented participants need to be
re-consented and whether  consent of more than one parent is required for minors.
The IRBs will be notified of study team updates via an amendment. Reports from regulatory oversight bodies
will be submitted at the time of the continuing review or with another applicable IRB transaction.
Other study events (e.g., protocol deviations, unanticipated problems) will be submitted per the Children’s
National, HU and GW IRB Reportable Events Module.
Maintaining Subject Privacy
Every effort to protect subject privacy and confidentiality will be maintained, including using a private area for
consenting, and immediately de-identifying data and the secure storage of all data.
Maintaining Study Data Confidentiality
Participant confidentiality is strictly held in trust by the participating investigators, their staff, the sponsor and
their
agents. Therefore, the study protocol, documentation, data, and all other information generated will be
held in strict confidence. No information concerning the study or the data will be released to any unauthorized
third party  without prior written approval of the sponsor.
The sponsor representatives and regulatory authorities (e.g., IRB, OHRP) may inspect all documents and
records required to be maintained by the investigator. The study team will permit access to such records.
The study participant’s contact information will be securely stored at each study site for internal use during the
study. At the end of the study, all research records will be stored in a secure location for the time period dictated
by the sponsor and institutional regulations.
The research data will not include the participant’s contact or identifying information. Rather, individual
participants and their research data will be identified by a unique study identification number. The study data
entry and study management systems used by research staff will be secured and password protected. At the
end of the study, all study databases will be archived at Children’s National.
Study Support and Conflicts of Interest
Salary support for this study is provided by Patient-Centered Outcomes Research Institute (PCORI) and
Children’s National Developing Brain Institute. REDCap® support is provided by The Clinical and Translational
Science Institute (CTSI) at Children’s National. All key study personnel will follow the Human Research
Protections Program Investigator, Study Staff, and Family Member Conflicts of Interest (COI) Policy.
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