GPS (Giving Parents Support): Parent Navigation After NICU Discharge
Phase: NA
Conditions: Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity, Infant Newborn Disease
Sponsor: Children's National Research Institute

GPS (Giving Parents Support):  Parent Navigation After NICU Discharge 
NCT02743472 
Study Protocol 
Updated/approved by Children’s National IRB: 2/15/17 
PI: Karen Fratantoni, MD, MPH 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
GPS (Giving Parents Support): Parent Navigation After NICU Discharge 
Background: 
NICU parents experience high levels of stress, anxiety, and depression, and low levels of self-efficacy. 
Neonates comprise one of the largest groups of medically complex infants in the United States. Of the 4 
million live births in 2012, 11.5% (~460,000) were born preterm at < 37 weeks gestation1. The District of 
Columbia alone has a higher rate (12.8%) of preterm infants, which is 11% higher than the national 
average. The vast majority of infants born preterm and ~1% of full-term infants with significant illnesses 
at birth (e.g., congenital anomalies) will require care in a neonatal intensive care unit (NICU), and ~30% 
of infants being discharged from the NICU (“NICU graduates”) annually (110,000 babies) require 
supplementary short-term or on-going specialty care2 and have increased risk of long-term disability, 
including cerebral palsy, deafness, blindness, and neurodevelopmental impairment 3-6.  At discharge, this 
large cohort of neonates and their families face tremendous challenges as they transition from a highly 
structured medical environment to a less structured home environment7,8. Some challenges identified 
include feeling unprepared to care for their infant at home despite extensive teaching in the NICU 
setting, feeling socially isolated as the typical celebratory process of giving birth and going home with 
baby has been disrupted by a serious medical condition and prolonged hospital stay. Additionally, 
depression and anxiety among mothers of infants have been shown to be associated with infant feeding 
difficulties, suboptimal parenting practices, and altered health care utilization.  
NICU graduates can be classified as children with special health care needs (CSHCN), a group comprising 
15% of US children,9 who “have or are at increased risk for a chronic physical, developmental, 
behavioral, or emotional condition and who also require health and related services of a type or amount 
beyond that required by children generally.10”  CSHCN consume a majority of pediatric health care 
expenditures. The American Academy of Pediatrics posits that all children, including CSHCN, should 
receive accessible, continuous, comprehensive, family centered, coordinated, compassionate, and 
culturally effective care within a medical home.11 The inclusion of CSHCN in a medical home improves 
health related outcomes,12 but poses challenges on a practice level, as these patients need more 
sustained and intense interactions. 
Parent navigation is a unique patient-centered intervention in which parents with experience caring for 
their own CSHCN offer peer to peer support and mentoring to another parent of a child with a special 
health care need. In 2008, Children’s National instituted a Parent Navigation program, in which Parent 
Navigators (PNs), who are parents of children with special health care needs (CSHCN) are employed by 
CN to provide peer-peer support to other parents of CSCHN. They provide their own personal 
experience and expertise in navigating the often confusing and frustrating health care systems.  
Specifically, although the PN model is based on self-efficacy and social support models, there are no 
published studies on the impact of PN on parental self-efficacy, depression, stress, and infant health 
outcomes. We believe NICU graduates and their caregivers would benefit from peer-peer support 
provided by PNs after discharge. Currently, there are no data regarding the impact of PNs on patient and 
family outcomes of the NICU graduate. 

 
Preliminary Studies: 
As a first phase of this study, we conducted focus groups with parents of recently discharged NICU 
infants (4 focus groups, n=18 participants), parent navigators (1 focus group n=3), interviews with 
parents (n=2), NICU social workers, case managers, and nurses (1 focus group, n=23); NICU providers (1 
focus group, n=5) and community providers (n=2). (See Pro00004397 for details). Our intervention is 
informed by this data.  
Additionally, Dr. Tuchman (Co-PI) has recently completed a similar randomized controlled care 
coordination intervention focused on a population of youth with special health care needs transitioning 
their pediatric-focused care from Children's to community adult practices using similar methodology and 
outcomes measurement strategies. 
Specific Aims: 
Infants who are discharged from the NICU almost invariably have high levels of health care needs in the 
first year after discharge, requiring multiple sub specialist visits, medications, and/or medical technology 
needs. Parents of NICU infants are often overwhelmed by the needs of their infants after they are 
discharged home and frequently have few supports to help them cope. This study will investigate the 
impact of peer to peer support through a Parent Navigation program for NICU graduates and their 
parents. The study aims will be achieved through a randomized controlled trial of Parent Navigation 
using a care resource notebook as the control intervention.  
Our specific aims are to:  
1) Determine if Parent Navigation increases overall parental self-efficacy and decreases stress among 
parents caring for a child with a special health care need during the 12 months after NICU discharge.  
Hypothesis 1a: Parent Navigation will increase parental self-efficacy, when compared with the control 
group. 
Hypothesis 1b: Parent Navigation will decrease parenting stress, when compared with the control group. 
2) Determine if Parent Navigation improves overall levels of anxiety and depression in parents of 
children with special health care needs during the 12 months after NICU discharge. 
Hypothesis 2a: Parent Navigation will improve parent anxiety, compared with control group. 
Hypothesis 2b: Parent Navigation will lessen parent depression, compared with control group. 
3) Determine if Parent Navigation positively impacts on infant health outcomes during the 12 months 
after NICU discharge. 
Hypothesis 3a: Parent Navigation/Intervention group will have significantly fewer hospitalizations when 
compared with control group. 

Hypothesis 3b: Parent Navigation group will have significantly fewer emergency department (ED) visits, 
when compared with control group. 
Hypothesis 3c: Parent Navigation group will result in improved immunization status, when compared 
with control group.  
Hypothesis 3d: By supporting parents’ emotional function, infant developmental progress will be 
enhanced. 
Research Design and Methods 
The evaluation of the Parent Navigation NICU to home program will use a randomized trial design. We 
will do so by recruiting a population of parents who have an infant in the Children's National NICU, half 
of whom will receive enhanced usual care by provision of a NICU care notebook and half of whom will 
receive the same enhanced care- including care notebook- plus Parent Navigation (intervention). All will 
be patients in the NICU who are discharged from the CNMC NICU. Group assignment will be by 
randomization, stratified by birth weight (<=1500 grams or >1500 grams). The design incorporates 
extensive measurement of baseline attributes to assess the comparability of intervention and enhanced 
control groups at inception. 
We aim to enroll n=300 parents of infants receiving care in the Children's National NICU who are 
discharged from the CNMC NICU. CNMC has a Level IV NICU which receives a large number of complex 
cases. To allow for generalization of study findings to other NICUs and other centers, we will enroll all 
patients discharged from the CNMC NICU. 
Study personnel will identify eligible NICU patients by reviewing NICU census data or through the use of 
the PowerTrials Prescreening function.  PowerTrials is a HIPAA-compliant application that is integrated 
into the Children’s National Cerner electronic medical records system (PowerChart).  Study inclusion and 
exclusion criteria will be used to create a Prescreening Rule.  A screening engine in PowerChart will 
compare the criteria to patient data within the medical records system, and a list of potential study 
subjects will be generated.   
 
Research study staff will approach parents anticipating discharge within 1-2 weeks to invite their 
participation and, as appropriate, obtain informed consent. If parents of eligible patients are not 
available, we may contact a parent by phone to set up a time to discuss the study in person. We will 
obtain in person signatures of consent as appropriate before enrolling potential participants in the 
study. Recruitment will continue in this fashion until the required sample is enrolled.  
 
Inclusion criteria include: 
 NICU patients discharged from the CNMC NICU. One parent participant per NICU patient will be 
identified and enrolled as the participant. 
Exclusion criteria include: 

Exclusion criteria include if the infant is not being discharged with a custodial parent (e.g., in custody of 
Child Protection Services), neither parent can complete an interview in English, the parent who will be 
providing most of the care is younger than 18 years of age, or the parent/caregiver has plans to leave 
the DC metropolitan area permanently within the following year. 
We are limiting the sample to parents of NICU patients that are >18 years of age, because we are 
interested in adult behavior and concerns. There are no exclusions based on ethnicity or gender; 
however, all participants will need to be able to complete the interviews in English. We will selectively 
enroll the one parent/guardian of infants with the most proficient grasp of English. We do not anticipate 
that this will limit our inclusion of Hispanic families. Upon review of the past 6 months of NICU 
discharges, 11% report Hispanic ethnicity. Among those- 92% speak English and only 8% speak Spanish 
and no English. 
Study Design and Data Collection: 
Following consent and enrollment, the baseline interview will be conducted in person while the infant is 
still in the NICU.  To assure a consistent methodology for collecting subsequent data, all subsequent 
interviews will be conducted by telephone after NICU discharge. Participants will complete a short semi-
structured interview and a questionnaire of measures detailed below at each time point (see data 
collection sheets and phone script in documents section). Items and instruments were carefully selected 
to minimize participant burden.  All participants will be interviewed and complete instruments at 
enrollment and 1 week; 1 month; 3 months; 6 months; and 12 months post NICU discharge.  
The CESD is a measure to identify depression and is administered at baseline, 1 month, 3 months, 6 
months and 12 months.  The score is tabulated in redcap, and a report identifies scores of 10 or greater. 
If a participant has a score of 10 or greater on the CESD, the research team leadership (one of the PIs or 
co-investigators) will contact the participant by phone within 1 week to discuss the elevated 
score.  Please see telephone script for elevated CESD.  The team member will then send a letter and 
resources to the family.  Please see attached letters and information sheet detailing perinatal mental 
health resources.    If a participant cannot be reached by phone, a letter with resources will be sent.  If a 
participant has a subsequent score of 10 or greater on the CESD, a follow up letter and resources will be 
mailed within one week of the elevated score. 
 
Procedures for data collection will be the same for intervention and control group participants. We will 
have text telephone technology (TTY) available for phone interviews for participants with hearing 
impairment. RAs will be fully trained on interview procedures and will be supervised by Drs. Fratantoni 
and Tuchman. 
Assessment tools include (all are uploaded in Documents section): 
1) Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: 20 items. Mothers' perceptions of their 
ability to parent (maternal parenting self-efficacy) are a critical mechanism guiding their interactions 

with their preterm newborns. A robust measure is needed which can measure mothers' perceptions of 
their ability to understand and care for their hospitalized preterm neonates as well as being sensitive to 
the various levels and tasks in parenting. This will be administered at baseline, 1 week, 1 month, 3 
months, 6 months and 12 months post NICU discharge. 
2) State-Trait Anxiety Inventory (STAI).  This consists of 20-items total, and respondents indicate 
transitory anxiety on a 4-point Likert scale. The STAI has been used extensively in both medical and non-
medical populations, with excellent psychometric properties. The inventory contains the State Inventory 
(10 items, scale Y1), which will be administered at baseline and 1 week, 1 month, 3 months, 6 months 
and 12 months post NICU discharge.  The trait inventory (10 questions, Y2) will be administered only at 
baseline.  
3)  Depression/Anxiety Measure: Parent depressive symptoms will be assessed using the Center for 
Epidemiological Studies- Depression Scale (CES-D) short form. This 10-item self-report measures 
depressive affect, somatic symptoms, positive affect, and interpersonal relations. Items are rated on a 4-
point Likert scale. CES-D has adequate test-retest reliability and correlates well with clinical ratings of 
depression severity. This will be administered at baseline, 1 month, 3 months, 6 months, and 12 months. 
4) Social Support: Parental perceptions of social support will be measured with the Multidimensional 
Scale of Perceived Social Support (MSPSS). This 12-item self-report scale includes respondents’ support 
from family, friends, and significant other. The MSPSS has good internal and test-retest reliability and 
adequate construct validity. This will be assessed at baseline and 1 week, 3 months, 6 months, and 12 
months post NICU discharge. 
5) PSS: Parental Stressor Scale: The Parental Stress Scale is a self-report scale that contains 18 items 
representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal 
development) and negative components (demands on resources, opportunity costs and restrictions). 
This will be assessed at baseline and 1 week,1 month, 3 months, 6 months, and 12 months post NICU 
discharge. 
6) Parental NICU stress scale. PSS:NICU, a PROMIS measure. Will be administered at baseline only- 46 
items. 
7) Functional Status Scale is a measure of function in 6 areas: mental status, sensory, communication, 
motor function, feeding, and respiratory.  The FSS will be performed at baseline and at 12 months, along 
with the developmental evaluation. 
8) Perceived Stress Scale (Sheldon Cohen, 10 items) is a measure of the perception of stress.  It will be 
performed at baseline and at 1 week, 1 month, 3 months, 6 months and 12 months after discharge. 
Complete contact information will be collected at baseline and updated at each time point, including 
mobile numbers and contact information for someone who will know the whereabouts of the 
participant and be able to assist in locating them as needed. 

Participants will be reimbursed for their participation in data collection. Compensation will be $20 per 
each data collection time point and $50 for in person developmental assessment by Dr. Penny Glass (Co-
I) in Developmental Clinic at age 12-15 months. Our previous experience with longitudinal research in 
this population suggests that this amount provides adequate incentive without being coercive.  
Infant health outcomes: 
Infant health outcomes will include health care utilization (ED visits, hospitalizations, specialty visits, 
primary care visits) and immunization status. 
• Health care utilization: 
At each interview, parents will provide information about ED visits, hospitalizations, specialty visits, and 
primary care visits during the period since the prior interview. All parents/participants will be provided 
with a calendar to keep track of these encounters for easy recall. We will measure the total number of 
ED visits, hospitalizations, specialty visits, and primary care visits during the 12 month follow-up period 
post NICU discharge. 
• Immunization status is a frequent measure for use of preventive medical care services and is easily 
verifiable. We will use receipt of vaccines between NICU discharge and 12 months of age as the 
outcome measure. We will consider receipt of 3 diphtheria-tetanus acellular pertussis (DTaP) vaccines, 3 
Hemophilus influenzae b (HIB) vaccines, and 3 pneumococcal conjugate vaccines (PCV-13) as fully 
immunized. We will ask the primary caregiver to complete a release of medical information (for 
immunization records only) upon enrollment.  We will obtain immunization records by sending the 
release to the primary care pediatrician or, when applicable, from the DC or Maryland immunization 
registry, which is available to Children's National health care providers with a password.   
• Developmental testing between 12-15 months of age (or around 1 year corrected age if born 
prematurely). We will share the results with parents and pediatrician upon participant's request. Scores 
for five developmental domains (cognitive, language, motor, social-emotional and adaptive/behavioral) 
and the composite score for the Bayley Scales for Infant and Toddler Development TM, Third Edition 
(Bayley-III)(Pearson Educational) will be compared. Patients will be assessed in Developmental Clinic by 
Dr. Penny Glass and her team. At the end of the assessment parents will be provided with immediate 
feedback and suggestions for ways to help the baby at home.  A brief letter is sent to the pediatrician 
with copy to the family (and medical record). The full time for the assessment is about an hour.  The 
parent is present, and the baby sits on parent's lap.  Dr. Glass' staff will set up the appointment when 
they are enrolled in the study and then have the study coordinator help with reminders.  Parents can 
change the day/time to make it suit their own schedule. If needed, we will provide testing on Saturday 
to accommodate parents' schedules and to reduce burden.  
If a participant has already had the Bayley-III administered at CNMC within the participant’s designated 
study window, the data will be used, and family will qualify for a gift card. 

Additionally, infant’s medical records will be reviewed at baseline and at 12 months. See Data collection 
sheet in Documents section.  
Description of Intervention:  
Care notebook: All participants will be provided with a care notebook designed specifically for this study. 
It is an enhanced version of the resource notebook developed for use by the current parent navigators 
at CNMC, and is used to organize the care of medically complex children. The version of the care 
notebook in this study includes information important for NICU graduates, including available 
community resources, guidance on advocating for a child with special needs, healthcare providers and 
educational systems, and has sections where the parent or a healthcare provider can include 
information important for the child’s care (e.g., medications, appointment calendar, care plans, seizure 
logs, therapy goals, dietary schedules). 
Parent Navigation: Once parents/patients are enrolled, all participants will receive a NICU care notebook 
as described above. Within 24 hours, using a REDCap-based randomization schema built by Dr Carty (Co-
I) and blinded to the rest of the study team, participants will be randomized to either the control or 
intervention group.  Those randomized to the control group will not receive any Parent Navigation care 
but will receive the usual care offered in the NICU. Study personnel will notify control participants of 
their assignment to the control group. We do not want to add any additional stress for these families, 
and if left wondering and waiting their group assignment, we are concerned we may cause undue stress. 
Parents in the Intervention group will be introduced to a Parent Navigator while in the NICU, prior to 
discharge and following informed consent and enrollment. Parents can contact the Parent Navigator at 
any time after the initial meeting. If the Parent Navigator has not been contacted by the parent 
following enrollment or after discharge home from the NICU, the Parent Navigator will contact the 
parent within 2 business days after discharge to assess how the family is coping, answer questions, and 
provide necessary resources.  For those randomized to the intervention group, the study staff will obtain 
a signed release to send an information sheet to the identified primary care physician to notify the 
provider that his/her patient has been enrolled in the study and will receive parent navigation services.  
The letter will clearly state the roles/responsibilities of the parent navigator.   
The details of the intervention are as follows:   
Navigator training: An established Parent Navigator program has been led by Dr. Michelle Jiggetts 
(project coordinator), who is responsible for training and supervising Children's National Parent 
Navigator Program. Parent Navigators will be recruited specifically for serving families of NICU patients 
and will be the main source of the intervention in this study. Curriculum guide is attached in Documents 
Section. 
Control Group: To assist with the transition to home care, families in the control group will be provided 
with the same care resource notebook. 
End Points: 

Our endpoints are: 
1) Data collection: to enroll n=300 (n=150 in each group) and collect data for 12 months after NICU 
discharge. 
2) Data Analysis and writing/disseminating (Abstracts, Manuscripts, and other reports): completion of 
data analysis and papers accepted for publication in peer reviewed journal(s). 
 
Statistical Considerations: 
We will conduct intent-to-treat analyses to assess effects of the PN intervention such that randomized 
families will be analyzed according to their assigned intervention group, regardless of departures from 
the randomized intervention. While it is possible that families may seek some type of parental support 
independently of the intervention, these potential effects may be evaluated in sensitivity analyses. Our 
analysis strategy will first compare baseline characteristics between the PN and control groups to 
evaluate the balance produced by randomization. It is expected that randomization with stratification 
on one key confounder of birth weight (<=1500 grams or >1500 grams) will result in a balanced 
distribution of factors between the PN and care resource groups on most, if not all factors. However, 
even with randomization some imbalance may occur on a few factors and it is important to identify such 
factors, as these are the ones that need to be controlled during analysis.   
Aim 1a. and 1b. The outcome measures involved in this aim (e.g., parenting self-efficacy measured using 
the PMP S-E and perceived stress scale), are derived from multi-item scales and will be treated as 
continuous measurements.  For each scale, the mean score after baseline will be assessed at each of the 
visits (1 week, 1 month, 3 months, 6 months and 12 months).  The overall mean difference from baseline 
for each of the scales between the two intervention groups will be used to evaluate Aim 1.  We will 
assess the overall change in scores for the self-efficacy and depression scales, i.e. the population 
averaged effect of the intervention on changes in self-efficacy and depression, using a generalized 
estimating equation (GEE) model to account for the correlation between the repeated change 
measurements among primary care givers.  The GEE model is reasonably robust to missing data.  We will 
use an exchangeable correlation structure, but in sensitivity analyses, will also test unstructured 
correlation and compare parameter estimates.  The main independent variable in these analyses is 
intervention group, however we will also include (if necessary) a cross-product term of group-by-time 
which will enable us to estimate differences between the intervention groups over time. The group-by-
time term will be included only if it is statistically significant. The model will include covariates reflecting 
the randomization stratification variables, and other covariates only if imbalances are observed in the 
randomization groups at baseline. In addition, we will use the model to plot the change in parental self-
efficacy or parenting stress over time-by-group with 95% CI around each time point estimate. The 
degree of change at 3-months will allow us to assess the rapidity of any effect of intervention and a 
descriptive comparison of the differences between the groups at 6- and 12-months will allow us to 
assess the degree of persistence of any effect. We will consider the difference between groups to be 
statistically significant when the 95% confidence intervals around the difference do not include 0. 

Aim 2a. and 2.b. will compare measures of anxiety using the STAI, and depression using the CES-D in 
primary caregivers from the intervention and control groups. The independent variable will be the 
intervention group in both models. If necessary, the models will include covariates known to impact 
parental depression and anxiety (if different between the groups) and stratification variables. We will 
estimate and compare the covariate adjusted mean difference in the scores between the intervention 
groups using GEE models as described above (Aim 1). The difference will be considered to be statistically 
significant if the 95% CI around the difference fails to include 0. 
As in Aim 1, group-by time-interaction models will be used to evaluate differences between the groups 
over time. 
Aim 3. The NICU graduates may experience multiple ED visits or hospitalizations any time after baseline.  
The number of ED or hospitalization counts will be summed for each of the intervention groups.  To 
assess differences between the intervention groups for each of the outcomes (ED visits or 
hospitalizations), we will use the Wilcoxon–Mann–Whitney two-sample rank-sum test, which is 
appropriate for use with nonparametric data, such as the count data from this aim.  We will define the 
outcome, improved immunization status, as receipt of two diphtheria-tetanus-acellular pertussis (DTaP) 
vaccines, two Hemophilus influenzae b (HIB) vaccines, and two pneumococcal conjugate vaccines (PCV-
13) by the end of the observation period (12 months after baseline). This binary outcome will be 
contrasted using an unpaired t-test with unequal variances to measure the hypothesis that the 
intervention results in improved immunization status.   
Sensitivity Analyses. In sensitivity analyses, we will explore the effect of departures from assumptions 
made for the main analysis. A key assumption in our analyses is that missing data are missing at random, 
and groups who are and are not lost to follow-up are similar. We will compare characteristics of families 
who are, and are not, lost to follow-up. If significant differences between these two (p<0.05) are 
observed, we can test for intervention effects, but with the assumption that individuals with missing 
data have worse outcomes. We will then report these ‘worst case’ scenarios and report any changes in 
the clinical interpretation of the trial. 
Sample Size & Power. We calculated power to detect projected differences between the intervention 
groups for the 3 primary outcomes. All computations are based on a projected sample size of 300 
families of NICU infants (i.e. 300 primary care giver evaluations, and 300 NICU infant outcome 
evaluations) with randomization into 2 equal groups of 150, with data collected over multiple time 
points during the 12 months of follow-up post discharge. In Aims 1 and 2, we will have up to 5 repeated 
measures after baseline (1-week, 1-month, 3-months, 6-months, and 12-months), which increases our 
statistical power for those aims. We assumed a modest within-subject correlation of 0.50 between these 
repeated measures. Using Bonferroni correction, we adjusted alpha (0.05) for the number of primary 
outcomes, n=3. For Aim 1, we estimate that we will have excellent power (93%) to detect differences in 
parental self-efficacy scores as small as 0.33SD. This estimate is based on PMSPE score distributions as 
reported in the literature.  For the main infant outcome of number of hospitalizations during the 12-
month follow-up post discharge period, we estimate that we have excellent power (99%) to detect a 
difference of 1 in the median number of hospitalizations between the groups. Given our conservative 

assumptions, including modest correlation (r=0.5) between repeated measures and Bonferroni 
correction for the number of primary outcomes, we believe that our sample size ensures sufficient 
power to measure clinically relevant differences between the intervention groups. 
Consent and Recruitment: 
Recruitment will occur in the NICU. Research staff will use an information sheet to introduce the study 
to parents, approach parents in person (in the NICU, or contact them by phone to introduce the study 
and obtain contact information from those who are interested. Interested parents will be contacted by 
research staff, study details will be described, and parents who qualify and agree to participate will sign 
written informed consent. Parents wishing to discuss the study will also be given an option of discussion 
over the phone and then the option of: 1) sign, scan, and email the consent back, or 2) sign and fax the 
consent back, 3) mail the consent back in the self-addressed envelope provided or 4) sign and bring it 
with them the next time they are at the hospital. The parent will then complete baseline surveys (see 
Procedures) and given a care notebook. The participant will be randomized to the control or 
intervention group. For those randomized to the intervention group, a Parent Navigator will introduce 
themselves prior to discharge. Participants who are in the control group will be notified that they were 
randomized to the control group as to not create any additional sources of stress or uncertainty. 
Risks and Side Effects: 
There are no physical or biological risks to participation in the project. Potential risks include discussion 
of potentially embarrassing or uncomfortable material as well as both authorized and mandated 
disclosure of information that is potentially harmful or embarrassing. If a Parent Navigator is concerned 
about the mental health of a parent, he/she will offer the family mental health resources, accessed on 
the DC-MD-VA (DMV) Perinatal Mental Health Resource Guide publicly available on dchealthcheck.net. 
If a Parent Navigator is concerned about abuse or safety of a child participating in the study, he/she will 
consult with the Child and Adolescent Protection Center at CNMC AND notify PIs immediately by 
telephone. The PIs will be responsible for any further action or reporting. 
Measures taken to minimize risk: The study protocol and all related materials including educational 
materials, scripts, and survey questions will be approved by the institutional review board (IRB) at CN 
prior to the start of patient recruitment. All efforts will be made to protect the anonymity of 
participants. Using standard approaches, each participant will be reminded at the beginning of each 
interview that s/he has the right to refuse to answer any questions without further information or to 
terminate the interview and withdraw from the study at any time. No identifying information other than 
a unique study identifier will be used in the surveys. Information used to contact participants for follow-
up interviews will be recorded and stored separately from the surveys. Furthermore, to minimize breach 
of confidentiality, study records will be kept in a single secure location (locked cabinet in a locked room) 
at CNMC. Consent forms and master study documents that could link the unique identifier to 
participants will also be kept in locked files. To further ensure data security, all data entry, coding and 
analyses will be conducted centrally at CNMC. When analyses are actively being conducted, a copy of 
the data set will be kept on a password-protected machine behind our institution’s firewall; this 
machine will be kept in a locked office to physically limit access. Once analyses have been completed, 
the data will be removed from the hard drive(s) of any computer(s) used for analysis, and will be stored 

solely on CD-ROMs in a secure location. All members of the study team will maintain certification with 
their IRB of record of their qualification to be involved in human subjects research. 
Subject Privacy and Confidentiality: 
Study staff will explain the study and answer questions in a private setting in the hospital. A copy of the 
consent form, explaining the study and its procedures, will be given to the potential participant. Using 
standard procedures, participants can refuse to participate or terminate participation at any time. 
Decision to participate or not will not impact their care in any way. 
Data Security: To minimize breach of confidentiality, all study records, including consent forms and 
master study documents, will be kept in a single secure location (locked cabinet in a locked room) at 
Children’s National.  No identifying information other than a unique study identifier will be used in the 
surveys. The baseline and follow up assessment demographic forms will have the participant's basic 
demographic information and will be stored in a separate file from the surveys in the secure location 
(locked cabinet in a locked room). Information used to contact participants for follow-up interviews will 
be recorded and stored separately from the surveys. To further ensure data security, all data entry, 
coding and analyses will be conducted centrally at CN. All data will be stored on a password-protected 
hospital network drive or in a secure password-protected program behind our institution's firewall.  
Once study is finished and all data analysis in complete, the data will be move to long term storage, in 
accordance with CNMC and PCORI data storage policy.  All members of the study team will maintain 
certification with their IRB of record of their qualification to be involved in human subjects research. 
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