Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas
Phase: NA
Conditions: Postpartum Depression, Postpartum Anxiety
Sponsor: Johns Hopkins University

Virtual Group Psychoeducational Discussions With Spanish-Speaking 
Mothers of Infants in Pediatric Primary Care
NCT05423093
2/1/2023

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
JHMIRB eFormA  01 
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JHM IRB - eForm A – Protocol 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate 
material in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to 
the field at the top of JHM IRB eForm A. 
 
******************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
b. Postpartum depression (PPD)—depression in the first postnatal year—affects 10-
20% of women and is associated with diminished functioning, impaired 
interpersonal relationships, decreased parenting self-efficacy and less responsive 
parenting (1). Immigrant Latinas living in the United States are disproportionately 
affected by PPD, with rates estimated between 30-42% (2). According to the 2009 
US National Academies of Science review of maternal depression, “Few 
opportunities exist to identify the vulnerable population of children living in 
households with one or more parents experiencing depression or to offer prevention 
and treatment services that can improve the care of the depressed parent in a 
framework that also offers services for children” (3). The pediatric primary care 
setting provides a unique opportunity for the provision of such services, particularly 
in the current era, which promotes patient and family-centered care.    
c.  
d. Well-child care is often a missed opportunity to address psychosocial risk factors 
such as maternal depression (4). Capitalizing on this missed opportunity is critical, 
especially for low-income families generally and immigrant families with limited 
English proficiency (LEP) specifically. Latino immigrant children and families 
experience disparities in health care access and quality (5).     Serving the rapidly 
growing Latino immigrant community, the Children’s Medical Practice (CMP) of 
the Johns Hopkins Bayview Medical Center (JHBMC) is an ideal environment in 
which to develop and implement innovative primary care delivery models that meet 
identified health and psychosocial needs. We previously implemented a group model 
of well-child care at CMP for parents of infants ages 0-2 years, and noted that one 
benefit of group discussions amongst parents attending pediatric primary care was 
increased time to discuss psychosocial issues such as perinatal depression (6).  
However, the visits were also noted to require significant time commitment on the 
part of parents. In addition, with the onset of COVID-19, there were challenges 
converting the full visit model to a virtual format, including coordinating the 
scheduling of both virtual and in-person formats and provider billing (manuscript 
under review).  Therefore, we aimed to develop a more accessible, less time-
intensive virtual group discussion that could be delivered independent of primary 
care pediatricians and could used to augment the standard well-child care of 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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newborns and allow for enhanced education and discussion around topics such as 
perinatal depression in a group format.  We hypothesize that such an intervention 
may be a feasible and accessible way in which to provide psychoeducation around 
maternal depression and increase knowledge of clinic and community supports for 
Spanish-speaking families of infants. 
 
2. 
Objectives (include all primary and secondary objectives) 
The primary objective of this proposal is to evaluate the feasibility and acceptability of a 
virtual group augmentation of standard individual well-child care. The virtual group 
session is designed to provide (1) an introduction to ancillary clinic and community 
services, and (2) Provide an opportunity for psychoeducation and discussion about 
psychosocial factors impacting parents of infants, including postpartum depression.  The 
aims of the session are to (1) Increase participant knowledge about perinatal depression 
and the rationale for PPD screening in the general pediatric setting; (2) Decrease stigma 
about engaging in mental health treatment; and (3) Increase knowledge of available 
clinic and community resources related to addressing perinatal depression and social 
needs. 
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
This project builds upon other work that we have done with the Baltimore Latino 
community, and specifically with perinatal Latinas. This work includes (1) Formative 
research to inform a depression stigma campaign in Baltimore (IRB00211051, PI: Sarah 
Polk) which led to the development of a website that includes  (a) accessible, Spanish-
language information about depression; (b) video testimonials of community members 
who experienced depression (https://www.fortalecebaltimore.org/historias); and 
(c)Information about local resources. Our team also has experience successfully 
implementing virtual group discussions about psychosocial topics (IRB00186999, PI: 
Rheanna Platt). 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Design Overview: The current study is designed as an open/single-arm pilot of the intervention 
(no comparison arm for this initial/preliminary study, which is also being offered as a clinic 
service).  
 
Population and recruiting: There will be two categories of study participants: (1) Spanish-
speaking parents of infants (<6 months) attending Johns Hopkins Bayview Medical Center’s 
Children’s Medical Practice for pediatric primary care/infants of those parents and (2) 
Intervention facilitators.  We aim to recruit up to 60 parent participants (with 60 corresponding 
infant records reviewed) and up to 10 provider/stakeholder participants 
 
Recruitment procedures:   

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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For parent participants, there will be three primary means of recruitment. 
(1) We will post and distribute a flyer at CMP describing the visit session and providing the 
research team’s contact information for those interested in learning more about the program. 
 
(2) Newborn Visits: At CMP, social work typically meets with all families of newborn as part of 
one of the newborn checks within the first month after birth.  At this meeting, social work or 
pediatric providers/staff will let families know about the program (see recruitment flyer/script) 
and ask families whether they would be interested in being contacted by research staff for more 
information- and obtain permission to share family contact information from the research team 
so that the team may contact the family.  On days when research staff are on-site at CMP, they 
may ask clinic staff whether they are seeing a patient that day who may qualify for the study. In 
this case, clinic staff will follow the procedures above (staff obtains permission from family for 
research staff to discuss the study with the family at the visit and/or to contact the family at a 
later time). For in-person interactions, staff will follow clinic/staff COVID restrictions (e.g. 
recommendations on masking and social distancing) 
 
(3) Obstetric staff: Obstetric social work may identify families who have confirmed that the 
newborn will be receiving pediatric care at CMP and may share the recruitment flyer and ask 
families whether they would be interested in being contacted by research staff for more 
information- and obtain permission to share family contact information from the research team 
so that the team may contact the family.   
 
We will obtain oral consent. Baseline measures will be collected over the phone/zoom prior to 
session attendance.  Our team has experience obtaining oral consent and collecting measures 
over the phone, including those related to perinatal depression (IRB00186999, PI: Rheanna Platt) 
 
Intervention Sessions will be offered at regular intervals, on at least a monthly basis, via Zoom. 
Intervention sessions are being offered as part of care at CMP. Intervention sessions will be 
observed by research staff. 
   
The session, which will be observed by research staff with permission of participants, will 
consist of the following procedures: 
 
Outline of Information Session Content (total 60-75 minutes) 
- 
Introduction and discussion of purpose of the session (5 minutes) 
- 
Overview of services available at the clinic & procedures, reminder of MyChart (5 
minutes total) 
- 
Insurance, entitlement programs –  (10-15 minutes total) 
- 
Postpartum depression information, discussion of screening (30-40 minutes) 
o PPD information: show video and discussion afterwards 
▪ Video : (5 minutes) 
▪ Reflection/discussion about video 10 minutes  
▪ Additional core messages: 10 minutes 
• Prevalence and signs of of PPD 
• Discussion of PPD Screening procedures, rationale for screening 
at pediatric office 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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• Discussion of self care & social support 
▪ Community resources (5 minutes, link to clinic website also sent by text)  
•  Medical Care 
• Mental Health 
• Sources of information (clinic website) 
 
The video shown will be a testimonial developed by JHBMC’s Centro Sol for a local mental 
health stigma campaign (Formative research for the campaign conducted as part of 
IRB00211051), video to be shown is available at  https://www.fortalecebaltimore.org/historias   
 
After the session, ideally within 2 weeks post-session, the research team will collect post-session 
measures and semi-structured with parent participants and conduct post-intervention interviews 
with participants. The post session interviews may be conducted at the same time as the surveys, 
or at a separate time, depending on the preference of the participant. 
 
6 months after the session, the research team will administer questionnaires over the phone 
assessing feedback about the intervention, physical and mental health services utilization, and re-
administering measures of stigma, depression knowledge, intention to seek PPD treatment if 
needed, intention to seek primary health care, and self-efficacy to manage negative emotions.  A 
summary of measures used and timing is included in Table 1 below. 
 
 
For clinic staff/stakeholder participants:  
A research assistant will clinic staff (pediatrician, social work, community outreach specialist, 
medical assistant, and/or nursing) via email (see recruitment email) and will subsequently obtain 
oral consent and obtain baseline facilitator information via phone or redcap survey, depending on 
the preference of the participant.  After the first, 3rd and 6th session delivered by staff facilitators, 
brief measures of intervention feasibility and appropriateness will be obtained.  In addition, up to 
three, 15-30 minute semi-structured interviews will be completed with facilitators/stakeholders 
over the course of the pilot (anticipated 1.5 years). Interviews and surveys may be conducted 
together/at the same time with the survey or at separate times, depending on the preference of the 
staff participant.    
A summary of measures used and timing for staff is included in Table 1 below.  
 
Staff will not be recruited by their direct supervisor(s). 
 
Table 1- Instruments used and timing of assessments 
Maternal Assessments 
Pre-session 
Post Session (1-2 weeks) 
6 months post-session 
-Demographic information 
-Stigma Concerns Mental 
Health Care (SCMHC)  
-Adapted Personal Stigma 
Scale 
-Adapted Depression 
Post-measures 
-SCMHC  
-Adapted Personal Stigma 
Scale 
-Adapted Depression 
Knowledge Measure  
-6 month follow-up survey 
-SCMHC  
-Adapted Personal Stigma 
Scale 
-Adapted Depression 
Knowledge Measure  

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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Knowledge Measure (Rapid 
Risk Factor Surveillance) 
-Perceived Social Support 
-History of Mental Health 
Treatment 
-PPD knowledge (Rapid Risk 
Factor Surveillance) 
-Intention/Willingness to 
seek tx if developed PPD 
-PROMIS self-efficacy to 
manage negative emotions 
 
-Intention/Willingness to 
seek PPD tx if needed 
-Intention to engage in own 
primary care 
-PROMIS self-efficacy to 
manage negative emotions 
 
Satisfaction questions 
-Single Session Intervention 
Satisfaction Questionnaire 
-Intervention Acceptability 
Measure 
 
Qualitative Interview 
 
-Intention/Willingness to 
seek PPD tx if needed 
-Intention to engage in own 
primary care 
-PROMIS self-efficacy to 
manage negative emotions 
Clinic Staff Assessments 
Baseline 
After 1st, 3rd, 6th session 
delivery 
 
Background/Baseline 
Questionnaire 
Quantitative 
-Intervention Appropriateness 
Measure -Feasibility of 
Intervention Measure 
Qualitative Interview 
 
 
 
 
Research staff will review electronic medical records (EMR) for children of participants from 
Bayview Medical Center Children’s Medical Practice (CMP) to examine healthcare utilization 
and related health outcomes. We will look at the child’s medical record at infant age 12 months. 
  
Participant/Infant data collected using EPIC will include: 
•           Patient demographics (age, gender, race/ethnicity, language, insurance coverage) 
• 
Up-to-date with age-appropriate, on-time well-child visits 
• 
Chief complaint/reason for episodic visits 
•           Number of ED or urgent care visit reports in chart and reason for visits 
• 
Visit Diagnoses and Problem List diagnoses 
•           Number of documented visits with the clinic family support services and primary reason 
for the visit 
• 
BMI or weight-for-length percentile  
•           My Chart enrollment 
• 
# of My Chart encounters documented 
•           Completion and results of recommended psychosocial screening (maternal depression, 
social needs) 
• Parent participation in clinic psychosocial programming offered by the clinic (e.g. 
support groups, parenting and stress management interventions) 
 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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b. If your study involves data/biospecimens from participants enrolled under other 
research studies with a written consent or under a waiver of consent, please list the 
IRB application numbers for those studies.  Please note:  Certificate of 
Confidentiality (CoC) protections applied to the data in source studies funded by NIH 
or CDC will extend to this new study if the funding was active in 2016.  If this 
situation applies, Section 36, question 6 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. N/A 
 
c. Study duration and number of study visits required of research participants. 
 
For Parents, there will be 4 contact points with research staff over approximately 6-8 
months, as detailed below 
 
(1) At the time of consent, complete a questionnaire prior to participation in group 
session this will be completed over the phone or via zoom, as we have successfully done 
in other studies providing intervention or preventive intervention about maternal 
depression (IRB00186999) 
 
(2) Attendance at the virtual group information session (60-75 minutes, sessions will be 
offered monthly at the clinic), prior to infant age 6 months 
 
(3) Complete post- intervention questionnaire and interview (scheduled by phone/zoom 
after the session) approximately 1-2 weeks post-session 
 
(4) Complete brief questionnaire at 6 months post-session (scheduled by phone). 
 
Infant medical record review will occur through the 12-month (or equivalent visit- 
allowing 18 months for delayed well-child visits) 
 
For clinic staff, the study duration will be a total of up to 1.5 years. In addition to having 
video group sessions observed by research staff, there will be up to 4 contact points with 
research staff. Associated visits include: 
(1) At the time of consent, complete baseline questionnaire 
(2) Completion of feasibility and appropriateness measures after delivery of 1st, 3rd and 
6th sessions.  
(3) Completion of up to 3 semi-structured interviews (after delivery of first session and 
up to 2 more times over a 1.5 year period). We will attempt to conduct interviews at the 
same time as the feasibility measures but will schedule as per the preference and 
availability of staff. 
 
The content and modality of assessments are shown in Table 1 above; specific measures 
are attached to the IRB protocol. 
 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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N/A 
 
e. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
N/A, this is offered as a clinic service in addition to routine care 
 
f. Justification for inclusion of a placebo or non-treatment group. 
N/A, being conducted as a single arm pilot 
 
g. Definition of treatment failure or participant removal criteria. 
Participant removal criteria include: development of parent condition that would 
preclude participation in group discussions clinically inadvisable; or parent 
preference to discontinue/exit group discussion prior to its conclusion. Staff will be 
removed from the study if they prefer to discontinue participation or if they no longer 
facilitate sessions. 
 
 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
As this is a single session intervention delivered as an adjunct to routine well-
child care, no additional actions are taken/required to be taken 
 
i. If biological materials are involved, please describe all the experimental procedures 
and analyses in which they will be used. 
N/A 
 
5. 
Inclusion/Exclusion Criteria 
Parent inclusion criteria 
-Parent of infant <6 months attending JHBMC CMP for pediatric primary care 
-Parent Identifies Spanish as preferred healthcare language (as sessions will be offered 
in Spanish) 
-Felt not to have a contraindication to participation (e.g., condition in the parent that 
would preclude the ability to reasonably participate in a virtual group session) at the 
initial social work assessment  
-For the purposes of the study, mothers are considered the study participants and fathers 
are not considered study participants. However, fathers may participate in the video 
information sessions  
 
Infant inclusion criteria:  
infant <6 months attending JHBMC CMP for pediatric primary care 
 
Staff Inclusion criteria  
Co-facilitating or participating in delivery of virtual information session 
 
 
6. 
Drugs/ Substances/ Devices 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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a. The rationale for choosing the drug and dose or for choosing the device to be used. 
N/A 
b. Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed. 
N/A 
c. Justification and safety information if non-FDA approved drugs without an IND will 
be administered.  
N/A 
 
7. 
Study Statistics 
a. Primary outcome variable. 
Feasibility of virtual group augmentation will be assessed by:  
-Reach (number approached who attend) 
-Provider/stakeholder survey (Feasibility of Intervention Measure) (7)  
-Provider/Stakeholder and parent semi-structured interview 
Acceptability of virtual group augmentation will be assessed by 
-Acceptability of Intervention Measure (completed by parents) (7)  
-Intervention Appropriateness Measure (completed by staff/stakeholders) (7) 
-Satisfaction survey  (See supplemental study documents) 
-Semi-structured interviews with parents and providers/stakeholders (see 
supplemental study documents) 
 
b. Secondary outcome variables. 
Parent-completed 
-Stigma Concerns About Mental Health Care (8)   
 -PPD Knowledge Measure (adapted from Rapid Risk Factor Surveillance Scale) (9)  
-(Adapted) Personal Stigma Scale (8) 
-Intention/Willingness to seek PPD tx if needed (see supplemental study documents) 
-Intention to engage in own primary care (see supplemental study documents) 
-Mental health and primary care services utilization (from National Latino and Asian 
American Study) (10) 
-Self-reported use of clinic website and/or services 
-Self-reported mental health and primary care service utilization 
 
 
 
c. Statistical plan including sample size justification and interim data analysis. 
Summary statistics will be used to describe participant characteristics, intervention 
implementation metrics, and outcome measures.  We will assess mean changes in 
selected parent measures (Stigma Concerns about Mental Health Care, Depression 
Knowledge, Intention/willingness to seek PPD treatment if needed). This is a pilot 
study designed to assess feasibility and acceptability of the intervention and is not 
powered to detect differences in outcome measures.  
 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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For qualitative data, the interviews will be digitally-recorded and then transcribed and 
translated (if applicable).  Prior to analysis names and other identifying factors in the 
interview will be removed or assigned a pseudonym.  We will explicitly ask for 
permission to record interviews, and will not audio record interviews if any 
participant does not feel comfortable with doing so. After completing an interview or 
visit, the digital file will be downloaded to a Safe Desktop site. Files will not contain 
identifying information but will be labelled with the participant unique identifying 
code. Audio recordings will be deleted from digital recorders as soon as successful 
downloading of the file has been confirmed.  Fidelity checklists and observation notes 
will also be included in the qualitative data collection and analysis. 
 
During analysis of qualitative study data, the study team will develop preliminary 
themes iteratively and through consensus. At least two investigators will 
independently code each text segment and then generate analytic conclusions with 
other study team members. 
 
 
 
d. Early stopping rules. 
As we are not using any drugs or medical devices we do not anticipate the need for 
early stopping except when desired by the participant.   
 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency. 
 
i. 
Risks associated with completing measures and interviews: Completing measures about 
sensitive topics (eg depression), or participating in interviews may be stressful for the 
participants.   
 
ii. Risks associated with participation in group discussions 
-Symptom/situation disclosure:  it is possible that parent participants will disclose 
psychosocial circumstances warranting concern and evaluation and that the provider may 
have difficulty managing multiple disclosures. 
-Group dynamics:  it is possible that parents will feel uncomfortable participating in group 
discussions 
-There are risks that other group members may discuss what happened in the group outside 
of that setting 
 
 
iii. Risks associated with Observation process 
Reactivity and Observer Bias – We are mindful of the reactivity effect (i.e. study participants’ 
behavior being influenced by the presence of observers). We note that several staff typically are 
present in other group interventions in the clinic as well as in the obstetric clinic (facilitator, co-
facilitator, MA/Nursing staff), which we believe may “normalize” the presence of additional staff to 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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some degree.  We will utilize unobtrusive observation and note-taking techniques to minimize this 
effect. Finally, we will regularly reinforce with group facilitators that the observation process will not 
affect job performance/evaluation. 
 
 
iv. Risks to confidentiality- Virtual discussion Risks associated with virtual group discussion, 
there is risk that discussion via Zoom groups may be “hacked”- this risk will be minimize by 
use of JHU professional accounts with password protection (a separate password for each 
group discussion).  Virtual groups are conducted as part of routine clinical care at CMP (e.g. 
parent support groups) and research studies (, thus we do not anticipate additional risk related 
to research. 
 
 
 
 
 
b. Steps taken to minimize the risks. 
 
Completing research measures or interviews: The PI or the trained research assistant 
will be available at all times while the participant is filling out questionnaires or 
participating in interviews.  Participants will be reminded that they do not have to 
answer any questions with which they feel uncomfortable.  Should a participant 
become distressed, the study staff member can provide reassurance, evaluate his/her 
concerns, and remind participant that he/she may stop at any time.  The participant 
will also be asked if he/she would like to discuss concerns with on-site clinic social 
work or mental health staff or with the Principal Investigator, Dr. Platt, a bilingual 
psychiatrist.  
Risks associated with participation in group discussions 
1.. Group discussion facilitators have been trained in Facilitative  Leadership 
through the Centering Healthcare Institute prior to  conducting any groups. We 
plan to have the CMP clinic social  worker, who is experienced in managing 
group psychotherapy and  
support groups (including parenting groups, 
general support groups, and groups focused on domestic violence in the Latino 
community), co-facilitate the discussions to minimize these risks. 
 
2.We have developed a proactive management plan for disclosures which  will 
include participation of relevant on-site staff (i.e.; embedded mental health 
providers and clinic social work staff).  During the study/group visits we will have 
a plan for availability of this staff to the provider (as well as the  PI, who is a 
bilingual psychiatrist) for additional support to group visit  facilitators.   JHBMC-
CMP has two embedded social workers who are available for “curbside” 
consultations and evaluation of risk, including suicidality.  We will also review 
and follow clinic protocols for management of positive maternal depression 
screens prior to study initiation (including further on-site evaluation and 
treatment, and referral sources). Clinic psychiatric emergency procedures will be 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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reviewed and detailed with both sites prior to the study.  The PI will also be 
available to providers and  study staff at all times for assistance and consultation 
and communication of concerns.  Required reporting procedures (e.g. child 
protective agency reporting or other reporting) will be followed and these 
reporting requirements will be described in the participant consent script 
 
3. Ground Rules” for the group, which include not discussing issues brought up in 
the group with individuals outside of the group, will be reviewed at the start of 
each session 
 
 
Risks associated with observation process: 
We will utilize unobtrusive observation and note-taking techniques to minimize this effect. 
Finally, we will regularly reinforce with group facilitators that the observation process will not 
affect job performance/evaluation. If participants do not wish to have visits observed, we 
will have providers complete the fidelity checklist after the visits 
 
Risks associated with participating in group sessions via Zoom 
-We will require a meeting password for all Zoom sessions. This password will only be 
shared with participants and the study team.  
-Participants will be asked to join the sessions from a private space, if possible. 
-When we go over “ground rules” at the beginning of each session, we will remind 
participants to be careful about what they share since everyone in the group is joining 
from their home and there is a risk that something they say could be heard by someone 
not in the group such as a child, spouse or other family member 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
The research staff and involved providers will be trained and instructed on the need to report to 
the investigator any indication that an adverse event has occurred.  When the PI learns of an 
adverse event, she will investigate until they understand as many details of the adverse event as 
possible. Staff will make an excel sheet to summarize any adverse event by type of adverse event 
and by study condition, stored on secure internal drive (e.g. onedrive).  The investigator will 
review this excel sheet periodically.  We will follow JHU’s IRB’s definition for an adverse event 
and will report any adverse events to both the Johns Hopkins University School of Medicine IRB 
B promptly (within 5 working days).    
 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
Risks to Confidentiality- research material: There are risks that the confidentiality of participants 
could be violated and the participant’s involvement in the study could be revealed to people not 
involved in the study such as friends, family members, or colleagues (for a description of data 
confidentiality procedures see protection against risks below). This could have a negative impact 
on the participant if they wished to keep their involvement in the study private.   
   
  

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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Confidentiality Risks of Data and Materials: Although all notes/data will be stored in a secure 
and confidential manner, and we will code all stored data and store it separate from any direct 
participant identifiers, accidental breaches of confidentiality are technically possible.   
 
Steps taken to address risk include: 
-Precautions against loss of or breach of collected data will include making sure that no data 
forms or data files ever contain identifying information and that any files identifying participants 
are protected and destroyed as soon as possible.  Identifiable data will never be stored on 
portable devices unless this is for the purpose of locking those devices in secure physical storage.  
Appropriate firewalls, encryption, and password protection will be used for network-connected 
devices used to store or manipulate data.   
-Parent participant name and contact information will be securely and separately stored in a 
locked location during the duration of the pilot so study team members can contact participants 
to provide information to connecting to the session, or for follow up with consent from the 
participant. After the pilot has ended, all contact information will be destroyed unless families 
wish to have it retained for contact in future studies. Confidentiality of data will be assured using 
subject identification numbers for all data collection and analyses.  Parents will receive a unique 
ID number.  Audio recorded data will be identifiable only by a group ID number and originals 
will be stored in a locked cabinet; no names or individual ID#s will be attached to these 
recordings.  Questionnaires will be completed over the phone, directly entered by research staff, 
or will be sent via RedCap, as per participant preference 
-Survey Data will then be housed in a secure database (i.e.; REDCAP) and accessed on secure 
workstations connected to servers that are accessible by study members who hold authenticated 
logins and passwords, and data will be backed up by the candidate and the research staff 
regularly.  
 
-Interview data will be collected by staff in a secure private area or over the phone and audio 
recorded using a device that is passcode protected and that automatically encrypts files.  The 
interviews will be digitally-recorded and then transcribed and translated (where applicable) by an 
approved transcription/translation service with experience with confidential research data. Prior 
to analysis, names and other identifying factors in the interview will be removed or assigned a 
pseudonym/ID number. All material will be collected specifically for the proposed research 
project. 
-To protect confidentiality all research participants will be identified by a unique identifier of the 
participant’s initials and a sequentially assigned participant number for forms and data files, and 
not the participant’s name.  All research data will be stored in a locked area that is only 
accessible to research staff and will not be left unattended.  Any documents with confidential 
information will be shredded before being discarded.  Confidential information will not be given 
to anyone outside of the research study, unless there is concern about risk to self or others.  All 
staff will be trained in these procedures.  All data files and analyses will be performed on 
research computers using only code numbers to identify participants.  Audio will be recorded on 
a device that is passcode-protected and encrypted.  Only summaries of group data will be 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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reported in any publications or presentations, with no identification of individuals. 
  
 Confidentiality- EMR data: Failure to maintain confidentiality of data collected on caregiver-
patient dyads would be associated with breach of confidentiality. We will keep the child’s name 
and date-of-birth in a separate, secure file within the REDCap database used to manage survey 
and collected EMR data. We will maintain a separate file with a link to study ID with personal 
health information for each participant (child name, date of birth, MRN, phone number, parent 
name, address) which will also have the participant ID. This file will be encrypted and password 
protected and will be accessed only by trained study staff. Once study participation and EMR 
review concludes, all PHI for that participant will be removed and their data will only be 
available by participant ID in REDCap. REDCap is a well-respected established platform for 
securely storing research data.  Once the electronic medical record has been located and 
reviewed, these child identifiers will be removed from the database. For participants who consent 
to be contacted for future research their contact information will be kept in a separate, encrypted 
file. 
 
 
 
e. Financial risks to the participants. 
-Risks associated with participation include charges on the cell phone bill associated with 
participation in consenting, completing measures, and participating in the group sessions via 
video conferencing, which will require either internet access or use of smartphones with data 
plans.  Participants will be provided with remuneration that is expected to cover potential cell 
phone charges for completing measures.  We will assess technology access and for individuals 
without internet access or unlimited data plans, will allow participation/call-in via phone 
-As the clinic plans to offer these information sessions as part of the menu of services available 
within the clinic and has budgeted staff time appropriately, there will not be loss of income to 
staff facilitating the intervention  
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
-For the parents participating in the pilot, there is no guarantee of benefits to any of the 
participants.  However, benefits to participation may include an increase in knowledge about 
postpartum depression as well as about clinic and community resources, and improvements in 
engagement in well-child care, and social support through participating in the intervention.  
 
-There are no direct benefits to stakeholders participating in the pilot. However, it is possible that 
delivery of information in groups may decrease the need for time spent delivering information to 
individual parents 
 
We believe that this project can serve as a replicable and accessible model for care delivery 
Spanish-speaking population in Baltimore, and to health care systems more generally through a) 
identifying an intervention method that is acceptable and feasible in a non-clinical as well as a 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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clinical setting and b) developing mechanisms for increasing access to Latino mental health 
services. 
 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
-Participants will be compensated for time spent completing research measures.  
Participants will receive $20 for completing the baseline survey measures,  $20 for completing 
follow-up survey measures, and $20 for completing 6-month survey measures 
-Stakeholders/clinic staff will be compensated for time spent completing research measures. 
Staff will receive $5 for completing appropriateness and feasibility measures  
-Participants and staff will receive $40 for each interview completed 
- Compensation will either be mailed or electronically delivered to intervention 
participants, depending on their preference. 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them. 
 
The potential costs to the participants include time spent in visits and study activities. 
Remuneration for the study is designed to partially offset this potential loss of income.    
Additionally, there may be cellular phone charges to participants for any phone communication 
or use of data plan to connect virtually to the group sessions during the study. There is no cost to 
the participants for the surveys for any source of data collection. 
 
There is no associated cost of the study procedures, as the clinic staff anticipate that delivery of  
the program will be part of the regular menu of services offered by the clinic, within the scope of 
current clinic/personnel responsibilities 
 
 
 
12. 
Transfer of Materials 
Transfer of biospecimens from Johns Hopkins to another organization for research 
purposes and receipt of biospecimens from an outside organization for your research 
must adhere to JHU policies for material transfer (https://ventures.jhu.edu/faculty-
inventors/forms-policies/ ) and biospecimen transfer 
(https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.622
324232879).  
N/A 
Please complete this section if your research involves transfer or receipt of biospecimens.- 
NOT APPLICABLE 
 
a. Will you receive biospecimens from an external entity for this research? [Yes/No].  
 
If “Yes”, please confirm you will secure an MTA/research agreement from the 
appropriate office  (JHTV/ORA) prior to transfer.  
 
See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/ . 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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b. Will you transfer biospecimens to an external entity as part of this research? [Yes/No] 
 
If “Yes”, please address each of the following: 
1) Describe the nature of the research collaboration with the external entity and the 
rationale for the transfer. (Include an explanation of your intellectual contribution to 
the design of the research study, resulting data and sharing, and participation in the 
planned publications.) 
2) Please confirm you will secure an MTA through the appropriate office (JHTV or 
ORA) prior to transfer. 
(See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/.) 
  
3) If the biospecimens you intend to transfer were obtained through clinical or research 
procedures at Johns Hopkins and “Other” is selected in Item 4, Section 23, please 
submit the following items in that Section: 
 
a. A pdf version of a completed JHTV Online “Material Transfer Agreement 
Request Form for Outbound Material” https://ventures.jhu.edu/technology-
transfer/material-transfer-agreements/ OR a copy of the COEUS PD (Proposal 
Development Summary). 
b. A completed Biospecimen Transfer Information Sheet 
https://www.hopkinsmedicine.org/institutional_review_board/forms/.   
c. A signed and dated “De-identified Human Subject Certification” 
https://www.hopkinsmedicine.org/institutional_review_board/forms/  
d. Approval documents from recipient site, if applicable. 
e. Copies of the consent forms associated with the IRB protocols under which 
the biospecimens were collected, with language appropriate to this transfer 
highlighted.  
f. The name of the specialist you are working with in ORA to complete a 
contract/MTA. 
Please see the following website for more information about transferring human 
biospecimens to outside entities: 
https://www.hopkinsmedicine.org/institutional_review_board/news/announcement_transf
er_human_biospecimens_outside_entities.html/ .   
 
REFERENCES 
 
1. Gaynes BN, Gavin N, Meltzer-Brody S, et al. Perinatal depression: prevalence, screening 
accuracy, and screening outcomes. Evidence report/technology assessment (Summary). Feb 
2005;(119):1-8. 
 
2. Lara-Cinisomo S, Girdler SS, Grewen K, Meltzer-Brody S. A Biopsychosocial Conceptual 
Framework of Postpartum Depression Risk in Immigrant and U.S.-born Latina Mothers in the 
United States. Women's health issues : official publication of the Jacobs Institute of Women's 
Health. May-Jun 2016;26(3):336-43. doi:10.1016/j.whi.2016.02.006 

 
Date: _____2/1/2023_______________ 
Principal Investigator: _____Rheanna Platt___________ 
Application Number: ___ IRB00310939__________ 
 
 
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3. National Research Council and Institute of Medicine. Depression in Parents, Parenting, 
and Children: Opportunities to Improve Identification, Treatment, and Prevention. 
Committee on Depression, Parenting Practices, and the Healthy Development of 
Children. Board on Children, Youth, and Families. Division of Behavioral and Social 
Sciences and Education. Washington, DC: The National Academies Press, 2009. 
 
4. Bethell  C,  Reuland  CH,  Halfon  N,  Schor  EL.    Measuring  the  quality  of  preventive  and  
developmental services  for  young  children: national  estimates  and  patterns  of  clinicans’  performance.   
Pediatrics.2004  Jun;113(6  Suppl):1973-83 
 
5. DeCamp L, Choi L, Davis MM.  Medical Home Disparities for Latino Children by Parental Language of 
Interview.  J Health Care Poor Underserved 2011 Nov; 22(4): 1151–1166. 
 
6. Platt RE, Acosta J, Stellmann J, Sloand E, Caballero TM, Polk S, Wissow LS, Mendelson 
T, Kennedy CE. Addressing Psychosocial Topics in Group Well-Child Care: A Multi-
Method Study With Immigrant Latino Families. Acad Pediatr. 2021 May 13:S1876-
2859(21)00253-9. doi: 10.1016/j.acap.2021.05.001. Epub ahead of print. PMID: 
33992841; PMCID: PMC8589857. 
7. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko 
H. Psychometric assessment of three newly developed implementation outcome 
measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. 
PMID: 28851459; PMCID: PMC5576104. 
8. Lopez V, Sanchez K, Killian MO, Eghaneyan BH. Depression screening and education: 
an examination of mental health literacy and stigma in a sample of Hispanic women. 
BMC Public Health. 2018 May 22;18(1):646. doi: 10.1186/s12889-018-5516-4. PMID: 
29788998; PMCID: PMC5964638. 
9. Adapted from Ontario Rapid Risk Factor Surveillance System. Retrieved 12/19/2021 at 
https://www.rrfss.ca/questionnaires 
10. National Latino and Asian American Study Documents, Services Used - Massachusetts General Hospital, 
Boston, Ma (2002). Retrieved 12/19/2021 from 
https://www.massgeneral.org/disparitiesresearch/Research/pastresearch/NLAAS-documents.aspx