Survivor Moms' Companion: A Perinatal PTSD Program
Phase: NA
Conditions: Posttraumatic Stress Symptom
Sponsor: State University of New York at Buffalo

 
 
 
 
 
 
 
 
 
 
Official Title: Survivor Moms’ Companion: A Perinatal Post-Traumatic Stress Disorder 
Program 
Unique Protocol ID: STUDY00007685 
Date: 8/28/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
BACKGROUND/RATIONALE  
Posttraumatic stress disorder (PTSD) related to maltreatment is a strong predictor of intergenerational cycles 
of abuse and vulnerability. These cycles intersect during the childbearing years when unresolved trauma often 
adversely affects a woman’s mental health. Women of color are especially at risk for developing PTSD as well 
experiencing disparities related to maternal and infant morbidity and mortality. Pregnancy is an opportune time 
to intervene to disrupt these cycles, however, screening and treating PTSD in the perinatal period is rarely 
undertaken. Therefore, readily available interventions for low-resourced and high-risk settings are warranted. 
Our agency, Buffalo Prenatal Perinatal Network (BPPN) provides home visiting and other supportive services 
to pregnant women and their families who bear considerable burden of poverty, adversity, and disparities. As 
such, we are well positioned to conduct research to address perinatal PTSD. Our previous research has 
established initial acceptability and feasibility for a novel front-line PTSD-specific perinatal intervention, the 
Survivor Moms’ Companion (SMC). In the proposed study, we will advance this trajectory of research and build 
our capacity for mental health service provision by conducting an initial randomized controlled pilot study. 
PTSD and the Childbearing Year 
In the U.S. and globally, approximately 20% of women experience sexual violence and other forms of 
maltreatment, including childhood physical, sexual, emotional abuse and neglect.1-3 Unresolved reactions to 
trauma can manifest as PTSD and its complex forms or comorbidities.4 Rates of childhood trauma exposure 
may be even higher in pregnancy, with 35% of pregnant women reporting at least one type of childhood abuse 
or neglect.5 As a result, PTSD incidence is higher during pregnancy (8%) than at any other time during the 
lifespan (5%),4 and increases risk for adverse outcomes including lower birth weight and shorter gestation,6-8 
less breastfeeding,9,10 postnatal PTSD and depression,11 impaired bonding,12,13 less sensitive parenting,14 a 
dysregulated infant,15,16 and more protective service involvement.17 This affirms the need to address PTSD with 
trauma-exposed mothers in order to help prevent negative intergenerational effects.18, 19 
Disparities in Risk 
African American families in particular are disproportionately affected by maternal and infant morbidity and 
mortality.20 However, pregnancy PTSD remains an understudied area of health disparity. African American 
women bear a four-fold greater rate of PTSD in pregnancy compared to all other groups (13.4% vs. 3.5%).4 
This is likely due to disproportionate exposure to racism, discrimination, and violence. In prior research by our 
team, this disparity was evidenced in multivariate models that took race/ethnicity and maltreatment-related 
PTSD into account, finding PTSD was a significantly stronger predictor of shorter gestational age than African 
American race and was a nearly equal predictor of decrements in birthweight.6 Therefore, addressing PTSD 
with pregnant African American women has the potential to reduce disparities in prematurity. 
Addressing Perinatal PTSD 
Addressing trauma and PTSD has been identified as a public mental health priority.21-23 However, currently in 
the U.S., maternity services focus on depression and do not address PTSD, despite there being a high rate of 
comorbidity between perinatal depression and PTSD (~50%)4. Although there are some existing programs for 
women with maltreatment histories,24-36 these have not been designed to address the specific needs of those 
with PTSD in the perinatal period and are not integrated in maternity care. Further, treatment of PTSD during 
pregnancy is hindered by several potential barriers including the lack of screening, lack of readily available 
behavioral health resources, stigma around seeking help, lack of cultural consideration, unacceptability due to 
navigating simultaneous demands of pregnancy, transportation, child care, and the high cost of mental health 
counseling.38-40 Our proposed research provides opportunity to evaluate the first intervention specifically 
designed to address PTSD in pregnant women, the Survivor Moms’ Companion. 
The SMC is designed for low-resourced settings and includes provision of information regarding the negative 
effects of PTSD during the perinatal period, incorporates skill building for managing traumatic reactions, and 
provides emotional support via client/interventionist discussion sessions. The SMC utilizes best practices for 
behavioral therapies development41 including that it: (a) was designed with input from target clients and 
clinicians, (b) is manualized per NIH workgroup best practices for behavioral interventions, and (c) has strong 
support for acceptability in preliminary studies.42-45 The SMC focuses on helping women manage PTSD 
symptoms in the presence of specific childbearing triggers, such as fear of labor pain, and promotes maternal 
development by anticipating parenting concerns, such as feelings elicited in response to infant crying. The 

SMC is also designed to target theorized mechanisms that maintain PTSD,46, 47 including intrusive re-
experiencing, hyperarousal, avoidance, and emotion dysregulation and interpersonal sensitivity.  
Our team conducted an initial pre- to post-test pilot of the SMC at BPPN from June 2018 to December 2019.45 
Ahead of implementation we engaged in community-based participatory research to optimize the SMC for our 
specific context. We recruited 56 women to the pilot; our sample included majority African American (57%), 
European American (18%), Latinx American (21%), Asian American (2%) women, and those identifying more 
than one race/ethnicity (9%).45 The entire sample struggled with poverty, and the vast majority reported having 
experienced 4 or more childhood adversities,45 which has been identified as placing individuals at high-risk for 
a variety of poor physical and mental health outcomes.48 All participants had clinically significant PTSD.45  
Intent-to-treat analyses (Table 1) showed improvements in 
PTSD symptom severity, interpersonal reactivity, and two 
indicators of affect dysregulation: anger expression and 
depression.45 The findings were also clinically important; 
for the per protocol sample at pretest, 25 individuals had 
symptom severity scores indicating they were in the clinical 
range for meeting PTSD diagnosis; at posttest, only 9 of 
those individuals remained in clinical range.45 Qualitative 
analysis found the SMC was highly acceptable, with the 
majority of clients indicating they would do it again if given 
a chance and would recommend it to others. They 
expressed appreciation in a variety of ways, including that 
“the SMC made me realize that not all has to be looked at 
in a negative way,” and that “without the support I got from 
BPPN and the SMC, I don’t know how I would have gotten 
through with this pregnancy.”  
Given the burden of PTSD among our clients, and these 
promising results,42-45 we propose a pilot randomized trial 
as the next logical step toward evaluating the SMC. We 
also wish to expand and improve our capacity to continue 
to conduct clinical research and to deliver and sustain the 
SMC through dedicating staff exclusively to the delivery and maintenance of the program.  
Relevance 
This proposed study is relevant for the following reasons: 1) it is designed to meet the needs of the 1 in 5 
pregnant women with a childhood maltreatment history; 2) it has the potential to reduce perinatal racial 
disparities related to PTSD symptomatology and poor outcomes; 3) it advances PTSD-specific care in the 
perinatal period; 4) it has strong theoretical underpinnings; 5) and it has the potential to play a significant role in 
preventing potential childhood adversity. Finally, this study will provide for the sustainability of the SMC at 
BPPN and help address the needs of our at-risk clients. Positive findings from this preliminary efficacy trial 
would advance the evidence base for the SMC and holds promise as a first step toward addressing 
intergenerational negative outcomes that result from maternal PTSD. 
Proposal Aims 
Our specific research aims are:  
Aim 1: Examine feasibility of the SMC by tracking participant engagement, accrual, and retention rates. 
Aim 2: Evaluate the preliminary efficacy of the SMC for reducing PTSD symptomatology as compared to the 
waitlist control group. Hypothesis: At posttest, intent to treat analyses will show that participants in the SMC 
intervention condition will have significantly lower levels of PTSD symptomatology as compared with 
participants in the waitlist control group. 
Aim 3: Assess acceptability of the SMC through post-intervention assessment feedback and evaluation of lost-
to-follow-up rates. 
Aim 4: This exploratory aim will examine how changes in the theorized targeted mechanisms (i.e., emotion 
regulation, and interpersonal sensitivity) mediate the relationship between the intervention and PTSD 
symptomatology. Hypothesis: At posttest, intent to treat analyses will show that participants in the SMC 
Table 1: Pre-posttest results of the Survivor Moms’ 
Companion initial pilot study at BPPN in Buffalo, NY 
Measure 
n 
M 
SE 
P 
PTSD symptom severity 
(PCL-5), range 0-80a 
56 
 
 
 
Pretest 
 
38.98 
2.54 
<.001 
Posttest 
 
23.69 
1.91 
Depression (EPDS), 
range 0-30b 
56 
 
 
 
Pretest 
 
14.20 
0.83 
<.001 
Posttest 
 
9.15 
0.64 
Anger (STAXI-AX), 
range 0-24c 
56 
 
 
 
Pretest 
 
18.02 
0.93 
.02 
Posttest 
 
16.12 
0.65 
Interpersonal Sensitivity 
(SCL-90), range 0-36d 
56 
 
 
 
Pretest 
 
17.73 
1.40 
<.001 
Posttest 
 
10.11 
0.90 
a PTSD Checklist for DSM-574 
b Edinburgh Postnatal Depression Scale75  
c State Trait Anger Expression Inventory73 
d Symptoms Checklist-90 Revised/Interpersonal 
Sensitivity Subscale76 

intervention condition will have lowered levels of emotion dysregulation and interpersonal sensitivity as 
compared with participants in the waitlist control group.  
RESEARCH ACTIVITIES  
Study Overview 
To achieve these aims, we will conduct a pilot randomized controlled trial. For Aim 1, we will assess feasibility 
of the SMC intervention through tracking and close monitoring of participant engagement, accrual, and 
retention rates. For Aim 2, we will conduct baseline assessments for all participants for trauma, PTSD 
diagnosis and symptoms, affect regulation including depression, anger expression, dissociation, and emotion 
regulation, as well as interpersonal sensitivity. We will then randomize participants to either the SMC 
intervention group or to the waitlist control group. Those in the SMC intervention (n = 30) will receive a 
minimum of 4 SMC modules and corresponding weekly sessions with an interventionist prior to completing the 
post-intervention assessment. Those in the waitlist control (n = 30) will complete a post-intervention 
assessment at 6 weeks following their baseline assessment and will then be offered the SMC intervention. We 
will use intent-to-treat analyses to evaluate the preliminary efficacy of the SMC for reducing PTSD. For Aim 3, 
we will examine post-intervention indices of client satisfaction and evaluation of drop-out rates. For Aim 4, we 
will examine how changes in the theorized targeted mechanisms mediate the relationship between the SMC 
intervention and PTSD. We will utilize knowledge gained to prepare applications for continued evaluation of the 
impact and implementation of SMC. Prior to beginning any study activities, we will apply for approval with the 
Institutional Review Board (IRB) at the University at Buffalo and will require human subjects training for all 
study team members through the Collaborative Institutional Training Initiative (CITI Program).49 
Participants 
Recruitment Site and Sample Size. We will recruit pregnant participants at BPPN, which provides 
services to over 800 families per year; services begin in pregnancy and include screening for risk factors and 
stressors and supportive home-based services. Consistent with the NIH-wide initiative to increase diversity in 
research, recruiting at BPPN ensures representation of women of color. Based on the previous SMC pilot 
studies,43, 45 we expect that 30% who initially consent to the study will not complete the full 4 intervention 
sessions. We plan to enroll and randomize 78 participants to retain 60 (30 SMC, 30 waitlist control). 
Eligibility Criteria. Inclusion criteria are: (1) English-speaking, (2) currently pregnant and after 12 weeks 
but before 30 weeks gestation to allow for study completion prior to expected delivery, (3) aged 18 and older, 
(4) a history of trauma and PTSD, (5) able to comprehend the study protocol, consent form and provide written 
consent, and (6) able to commit to a minimum of 4 weekly intervention sessions. Exclusion criteria are: (1) non-
English-speaking, (2) less than 18 years of age, (3) those with psychotic conditions or developmental 
disabilities requiring guardianship, (4) those with high-risk pregnancies necessitating extended bedrest or 
inpatient care, and (5) those unable to commit to completing the intervention sessions. 
Study Procedures  
For Aim 1, we will maintain a master tracking file that indicates mode of invitation (handouts or flyers, word 
of mouth), screening and determination of eligibility, random assignment to SMC or waitlist control, receipt of 
informed consent, mode of delivery (in-person or by telehealth), and completion of assessments and 
intervention sessions. We will also track SMC uptake for waitlist controls, who will be invited to begin the SMC 
6 weeks following baseline and immediately following the post-intervention assessment. We will enroll 3-4 
participants per week (divided between intervention and control groups) during the active recruitment period. 
For Aim 2, our procedures include baseline assessment for all participants, randomization to SMC or the 
waitlist control group, provision of a minimum of 4 SMC sessions for those in the SMC intervention arm, and 
post-intervention assessments (for both SMC and waitlist control groups).  
For Aim 3, we will assess the acceptability of the SMC through post-intervention assessment feedback and 
through evaluation of lost-to-follow-up rates.  
For Aim 4, we will examine how changes in the theorized targeted mechanisms mediate the relationship 
between the intervention and PTSD symptomatology, using the same assessment data utilized for Aim 2.  
Recruitment Strategy. We will disseminate study information to all BPPN clients through informational 
handouts and fliers. Those interested will be invited to contact the licensed master social worker (LMSW) for 
screening. Women who meet all inclusion criteria and no exclusion criteria will be provided with a detailed 
explanation of the study, and will be encouraged to ask questions prior to providing written consent. They will 
then be invited to complete the baseline assessment with the LMSW. Once baseline assessment is completed, 
participants will be: 1) randomized to the SMC or waitlist control arm in a 1:1 fashion using a block 
randomization scheme, 2) will be mailed the SMC materials and 3) be assigned to the community health 

worker (CHW) who will contact the participant and arrange the first session, either in-person or remotely 
according to the participant’s preference. Consent forms will outline remuneration for each aspect of the study 
($30 for the baseline and $40 for the post-intervention assessments).  
Structure of SMC. Weekly client modules with embedded worksheets will facilitate and guide practice of skills 
specific to addressing PTSD in the perinatal period. Weekly intervention sessions will center on reinforcement 
of information introduced in each SMC module, emotional support, and referrals to additional services or 
specialists as needed. A key activity of each session is to practice applying knowledge and skills using the 
module’s vignettes. Process guides prompt inquiry about in vivo management of PTSD reactions, and 
emotional and interpersonal reactions to events since the last session. Based on previous work, we anticipate 
each module will require 45 minutes of self-study prior to each session and 45 minutes of in-session time spent 
with the interventionist. This weekly commitment was highly acceptable in prior pilot efforts. 
 
Intervention Team. We will hire and train a half-time LMSW to facilitate consent processes, complete 
baseline and post-intervention assessments, bill for services and provide regular clinical supervision, and will 
hire a full-time CHW to deliver the SMC. Both the LMSW and CHW will have experience working in perinatal 
health and will undergo 40 hours of training with PI Sperlich on the SMC. Supervised training will include 
review of the module content, role-playing of sessions, and fidelity to the SMC manual.   
 
Intervention Integrity and 
Safety. A detailed treatment 
manual for the SMC will guide 
the content and flow of the 
sessions, and we will regularly 
assess for fidelity. At the end of 
each session, we will employ 
brief ‘mirror image’ fidelity 
checklists which will be 
completed separately by the 
CHW and participant. In 
preliminary studies these forms 
reached an inter-rater 
agreement of >94%. Co-PI 
Sperlich will review these 
weekly for inter-rater agreement 
and intervene if necessary. The 
sessions include monitoring of 
suicidality, substance use, and 
domestic violence. In instances 
where a participant expresses 
these concerns, the CHW 
and/or licensed social worker 
will notify the Co-PIs, who will 
initiate referral protocols to 
psychiatric, substance abuse, 
or domestic violence urgent 
care, as appropriate. The team 
will review each case in light of 
adverse event definitions and 
report any adverse events to 
the UB IRB.    
Measures 
We plan to use reliable and valid measures, these and their schedule of use are listed in Table 2. For 
eligibility screening we will use the 5 sentinel items from the Childhood Trauma Questionnaire (CTQ),50 and 
the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).51 For the baseline assessment we will assess 
trauma exposures, PTSD and its dissociative subtype, and measurements related to the theorized 
mechanisms of change, including for affect regulation and interpersonal sensitivity. All of these will be repeated 
at the post-intervention assessment. Also, at post-intervention, participants in the SMC arm will complete the 
Table 2: Study Measures 
Measure 
Eligibility 
Baseline 
During 
Intervention 
(5 weeks) 
Post-
Intervention 
Eligibility 
 
 
 
 
Demographics/Background 
Questionnaire 
X 
 
 
 
Childhood Trauma Questionnaire 
(CTQ)50 
X 
 
 
 
Primary Care PTSD Screen for DSM-
5 (PC-PTSD-5)51 
X 
 
 
 
Adversity/PTSD Outcomes 
 
 
 
 
Adverse Childhood Experiences 
Questionnaire (ACE)48 
 
X 
 
 
PTSD Checklist for DSM-5 (PCL-5)52 
 
X 
 
X 
Dissociative Subtype of PTSD Scale 
(DSPS)53 
 
X 
 
X 
Theorized Mechanisms of Change 
 
 
 
 
Patient Health Questionnaire-9 (PHQ-
9)54 
 
X 
 
X 
State Trait Anger Expression 
Inventory (STAXI-AX)55 
 
X 
 
X 
Symptoms Checklist-90 
Revised/Interpersonal Sensitivity 
Subscale (SCL-90/IPS)56 
 
X 
 
X 
Difficulties in Emotion Regulation 
Scale Short Form (DERS)57 
 
X 
 
X 
Treatment Attendance, Satisfaction, 
Distress 
 
 
 
 
Number of Completed 
Modules/Sessions 
 
 
X 
 
Client Satisfaction Questionnaire 
(CSQ-8)58 
 
 
 
X 
Fidelity Checklist 
 
 
X 
 
Subjective Units of Distress (SUD)59 
 
 
X 
 

Client Satisfaction Questionnaire (CSQ-8), 58  and invite feedback regarding perception and experience of in-
person vs telehealth sessions based on their choice of modality. For those in the SMC arm we will utilize two 
measures during each weekly intervention session: SMC fidelity checklists, as well as Subjective Units of 
Distress (SUD).59 The SUD will be assessed on a 0-10 scale by asking the participant to rate any distress 
experienced ahead of session, at mid-session, and at the close of the session. Those with SUD rating of 5 or 
above at the session’s end will be encouraged to participate in a brief relaxation exercise until their rating is 
reduced to 4 or lower. All who complete baselines and are randomized will be scheduled for the post-
assessment; those who fail to complete will be scheduled based on their anticipated completion date. 
Proposed Analysis                                                                                                                                    
     Data Quality Management. Biostatistician Wilding and PI Sperlich will oversee data collection, 
management, and storage using UB’s established IT infrastructure. A created Data Management Plan will track 
any critical milestones and data review activities. A full study build will be implemented with use of REDCap60 
and all necessary electronic case report forms (eCRFs) will be created in direct contact with relevant study 
personnel. Rigorous quality control procedures will be implemented so as to ensure data integrity. 
Effect Size and Power Calculations. Because data will be generated as part of a pilot case-control study, 
our hypotheses should be viewed as exploratory. Analyses will be conducted to not only test the predictions, 
but also to examine effect sizes. If effects are clinically meaningful, effect sizes will be used to inform power 
calculations for a larger, planned Stage II clinical trial.  
     Data Analyses. The amount and nature of missing data for study variables will be characterized and no 
method of imputation will be used for missing data for primary analyses. The robustness of primary results will 
be assessed using several statistical techniques including multiple imputation. Outcome variables will be 
summarized overall and by relevant demographic and baseline variables. Descriptive statistics will be 
computed for all categorical variables. Numeric variables will be summarized using mean, standard deviation 
and range. Statistical tests will be carried out using SAS version 9.4 (or higher) statistical software (Cary, NC).  
Aim 1 Analyses. Feasibility will be assessed via timely recruitment of participants, and through high study 
retention (70%). This will be carefully tracked and monitored closely by the Co-PIs. 
     Aim 2 Analyses. To describe the observed variability in the data and test for differences between groups, a 
linear mixed model will be fit to each considered outcome at each post-baseline measurement. Each outcome 
will be modeled as a function of randomized group assignment and the baseline value of the outcome variable, 
both treated as fixed effects. Once the model is fit, a linear contrast based on the estimated model parameters 
will be constructed and used to test for the overall effect of random assignment using an approximate F-test as 
implemented by SAS PROC MIXED. A point estimate and corresponding confidence interval to quantify group 
differences will be provided. Subject-level covariates predictive of outcome and their interactions with 
randomized assignment, such as modality (in-person vs telehealth) will be added to the models as a series of 
supportive analyses. To evaluate the robustness of initial analysis results, these models will be moreover used 
to evaluate the group effect within subgroups. Analyses will be conducted using intent-to-treat. All tests will be 
two-sided and tested at a 0.05 nominal significance level. Standard diagnostic plots will assess model fit and 
transformations of variables may be considered to meet statistical assumptions.  
     Aim 3 Analyses. We will examine acceptability of the SMC by evaluating the percentage of completion and 
drop-out rates as compared to similar PTSD treatments46 and through analysis of the CSQ scores58   
Aim 4 Analyses. We hypothesized that the effect of the intervention on PTSD symptomatology is 
mediated by emotion regulation and interpersonal sensitivity, that is, that there is a direct and indirect effect of 
the SMC on PTSD symptomatology. A generalized linear model-based approach will be utilized.  After 
establishing the total effect of the SMC on PTSD symptomatology in the context of the unmediated model of 
Aim 2, the effects of the intervention on the theorized targeted mechanisms will be estimated. This will be 
followed by the conduct of a multiple regression analysis with each of the factors (considered one at a time) 
and the SMC as independent variables in the prediction of PTSD symptomatology. This approach allows for 
estimation of the direct and indirect effects. The 95% confidence intervals for mediated effects will be based on 
bias-corrected bootstrap methods, which uses the cumulative distribution functions of the bootstrap parameter 
estimates to determine the upper and lower endpoints of the confidence intervals. The percentages mediated 
of total effect of the SMC on PTSD symptomatology will be calculated. Additional analyses with interaction 
terms between the SMC with emotion regulation and interpersonal sensitivity will be conducted and compared. 
OUTCOMES/IMPACT  
The SMC holds promise for addressing the needs of pregnant women with PTSD and bridges the gap between 
maternity health and mental health care. Our study aims to assess the feasibility, acceptability and initial 

efficacy of the intervention for reducing PTSD symptomatology among pregnant women. If successful, these 
findings could be used to inform testing of the intervention in a Stage II randomized clinical trial to determine 
efficacy. Our long-term goal is to develop a brief, evidence-based intervention that addresses perinatal PTSD, 
thus improving health outcomes for pregnant women with PTSD and their children. This has the potential to 
significantly advance treatment for perinatal PTSD and disrupt cycles of abuse and psychiatric vulnerability.  
Provision of the SMC at BPPN is closely aligned with our overall mission to improve maternal and infant health 
for women and families in our catchment area and is fully aligned with the IMPROVE program’s mission to 
reduce maternal health disparities. This project will help us expand and improve our capacity to continue to 
conduct clinical research at BPPN and to deliver and sustain the SMC with our at-risk clients, providing 
potential benefits to pregnant women and also to their infants.  
RISKS/BLOCKERS AND MITIGATION STRATEGIES  
A potential risk to the success of this research would be a lag in sample recruitment. However, as BPPN 
serves 800 families annually, we anticipate success in meeting our targeted goal of enrolling 78 to retain 60 
participants. However, it will be critical to maintain regular contact with all study participants to encourage their 
participation in all phases of the project (i.e., baseline assessment, intervention, and post-intervention 
assessments). If necessary, we can pivot our recruitment efforts to reach more broadly into the community 
using established partner networks through BPPN to identify additional study sites.  
Another potential risk/blocker would be any threats to intervention integrity. To mitigate this risk, Co-PI Sperlich 
will monitor the fidelity checklists for inter-rater agreement between client and interventionist versions; those 
with less than substantial agreement (Kappa < .80) will necessitate remedial interventionist training. PI Sperlich 
will focus on intervention adherence, competent delivery of the interventions in the weekly team meetings and 
will provide corrective feedback as needed. To promote intervention integrity, treatment sessions may be 
monitored through audiotaping (with written participant permission) allowing Sperlich to separately rate the 
session. There will be a shift to 100% monitoring of sessions and coaching if significant departures are noted. 
EXPERTISE AND RESOURCES  
PI LuAnne Brown, Chief Executive Officer at BPPN, oversees the two flagship programs at BPPN, including 
the national evidence-based Healthy Families Home Visiting Program, and the Maternal Infant Community 
Health Collaborative. Brown has extensive previous relevant experience, including serving as Vice President 
and Chief Nursing Officer at Women and Children’s Hospital of Buffalo, and as Director of their Maternal 
Neonatal services. BPPN’s overall mission is to promote equity and honor the dignity of all women, fathers, 
and families and to provide education, support, advocacy, and connection to community services in Western 
New York. It currently employs 53 staff to serve a predominately Black and Hispanic population residing in 21 
zip codes identified as high-risk due to poor infant mortality and morbidity rates and inadequacy of prenatal 
care. BPPN’s facilities include meeting rooms equipped with audio-visual equipment and phones for the 
duration of the study, as well as computers with internet access and Microsoft Office suite. 
Co-PI Sperlich, Assistant Professor at the UB School of Social Work, has been conducting research on trauma 
and its effects on childbearing processes for over 20 years. In addition to being a co-creator of the SMC, she 
has been involved with other cutting-edge research characterizing the prevalence and effects of perinatal 
PTSD. She has experience in the conduct of clinical research, data analysis, and ethical response to research 
with vulnerable human subjects. Together, Brown and Sperlich have successfully previously piloted the SMC 
at BPPN and have collaborated on other projects in the community, including a project with United Way of Erie 
County to provide training on trauma informed care to local obstetric providers.  
Co-I Wilding is a statistician with extensive expertise in the design of pilot randomized clinical trials, clinical 
trials, permutation tests, resampling techniques, goodness-of-fit tests, and distributional characterizations. He 
directs the Biostatistics, Epidemiology, and Research Design Core of the UB Clinical and Translational Science 
Institute where he oversees the statistical efforts as it pertains to associated interdisciplinary clinical and non-
clinical research projects. Co-PI Sperlich and Biostatistician Wilding will utilize resources at UB, including the 
Buffalo Center for Social Research (BCSR) and the UB Department of Biostatistics. The BCSR has 4,000 sq. 
ft. of office and interview space for project utilization, and provides infrastructure to assist investigators in their 
research studies, promotes and supports interdisciplinary collaboration, and disseminates research findings 
into the community and clinical practice. In addition, the BCSR coordinates effort with the UB Department of 

Biostatistics to facilitate secure capture and storage of sensitive data, utilizing such resources as REDCap, 
which is a secure web application for building and managing online surveys and databases.60