Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
Phase: NA
Conditions: Postpartum Depression, Parenting, Parent-Child Relations
Sponsor: Children's Hospital of Philadelphia

 
 
  
Title: 
The Social Media-Based Parenting Program for Women with 
Postpartum Depressive Symptoms 
Short Title 
The Parenting with Depression Study 
Drug or Device 
Name(s): 
N/A 
Regulatory Sponsor: 
National Institutes of Health (NIH) 
eIRB Number 
19-016174 
Protocol Date: 
12/2/2020 
Amendment 1 Date:  
Amendment 3 Date:  
Amendment 2 Date: 
Amendment 4 Date: 
 
 
James Guevara MD, MPH 
Division of General Pediatrics                                                      
Children’s Hospital of Philadelphia 
Philadelphia, PA 19104 
Phone 215-590-1130 Fax: 267-426-0380 
email: Guevara@email.chop.edu 
 

  
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms............................................................................. iv 
Abstract .................................................................................................................................. v 
Table 1: Schedule of Study Procedures1 ............................................................................. vi 
Figure 1: Study Diagram ..................................................................................................... vii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 2 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ..................................... 3 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 3 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 5 
2 
STUDY OBJECTIVES .............................................................................................................................. 5 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 5 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 5 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 5 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 5 
3.1.1 
Screening Phase .............................................................................................................................. 6 
3.1.2 
Study Treatment Phase (start of the study intervention) ................................................................. 7 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 7 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 8 
3.3.1 
Duration of Study Participation ...................................................................................................... 8 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 8 
3.4 
STUDY POPULATION ............................................................................................................................. 8 
3.4.1 
Inclusion Criteria ............................................................................................................................ 8 
3.4.2 
Exclusion Criteria ........................................................................................................................... 8 
4 
STUDY PROCEDURES ............................................................................................................................ 9 
4.1 
SCREENING VISIT ................................................................................................................................. 9 
4.2 
STUDY TREATMENT PHASE .................................................................................................................. 9 
4.2.1 
Visit 1 (Baseline) ............................................................................................................................. 9 
4.2.2 
Visit 2 (1-month follow up) ............................................................................................................ 10 
4.2.3 
Visit 3 (2-month follow-up) ........................................................................................................... 10 
4.2.4 
Visit 4 (3-month follow-up) ........................................................................................................... 10 
4.3 
UNSCHEDULED VISITS ........................................................................................................................ 10 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 11 
4.4.1 
Early Termination Study Visit ....................................................................................................... 11 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 11 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 11 
5.1.1 
Medical Record Review of Child ................................................................................................... 11 
5.1.2 
Other Evaluations, Measures ........................................................................................................ 11 
5.2 
SAFETY EVALUATION ......................................................................................................................... 14 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 15 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 15 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 15 
6.3 
STATISTICAL METHODS...................................................................................................................... 15 
6.3.1 
Baseline Data ................................................................................................................................ 15 
6.3.2 
Efficacy Analysis ........................................................................................................................... 15 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 15 

 
 
 
 
 
 
iii
7 
SAFETY MANAGEMENT ..................................................................................................................... 16 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 16 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 16 
8 
STUDY ADMINISTRATION ................................................................................................................. 16 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 16 
8.1.1 
Randomization............................................................................................................................... 16 
8.1.2 
Blinding ......................................................................................................................................... 16 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 17 
8.3 
CONFIDENTIALITY .............................................................................................................................. 17 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 18 
8.4.1 
Data and Safety Monitoring Plan ................................................................................................. 18 
8.4.2 
Risk Assessment ............................................................................................................................. 18 
8.4.3 
Potential Benefits of Trial Participation ....................................................................................... 19 
8.4.4 
Risk-Benefit Assessment ................................................................................................................ 19 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 19 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 20 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ..................................................................................................... 20 
8.7.1 
Reimbursement for travel and parking .......................................................................................... 20 
8.7.2 
Compensation for cellular data charges ....................................................................................... 20 
8.7.3 
Payments to parent for time and inconvenience (i.e. compensation) ............................................ 21 
8.7.4 
Gifts ............................................................................................................................................... 21 
9 
PUBLICATION ........................................................................................................................................ 21 
10 
REFERENCES ......................................................................................................................................... 22 
Appendix ............................................................................................................................... 29 
  

  
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
AE 
 
Adverse event 
PSI-SF 
 
The Parenting Stress Index-Short Form 
PSOC 
 
The Parenting Sense of Competence Scale 
PCERA 
 
Parent-Child Early Relational Assessment 
MSPSS 
 
Multi-dimensional Scale of Perceived Social Support 
EPDS 
 
Edinburgh Postpartum Depression Scale 
NCS 
 
National Comorbidity Survey 
PPD 
 
Postpartum Depression 
TFI-8 
 
Therapeutic Factors Inventory-8 
BDI-II 
 
Beck Depression Inventory-II 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
v
ABSTRACT 
Context: (Background) 
Our long-term goal is to develop effective parenting strategies to facilitate optimal child 
development for mothers suffering with PPD symptoms. Our overall objective for this 
application is to study whether this program combined with online depression treatment 
leads to more responsive parenting (target) and signals improved child language, 
socioemotional and cognitive development (outcomes) compared to depression treatment 
alone. 
Objectives: (primary and important secondary objectives) 
1. 
To determine whether a social media-based parenting program can improve 
responsive parenting (target) among mothers with PPD symptoms. 
a. 
Hypothesis 1: Mothers who participate in the parenting program will 
demonstrate greater improvement in responsive parenting than those who receive 
online depression treatment alone. 
Study Design:  
A prospective, randomized comparative group treatment trial to determine whether the 
social media-based parenting program can improve responsive parenting among women 
with PPD symptoms. 
Setting/Participants: 
The proposed study will occur at up to 6 primary care practices (initially starting at 3-4) 
affiliated with a large urban children’s hospital (The Children’s Hospital of Philadelphia).  
In the first phase, 75 ethnically and racially diverse mother-child dyads will be recruited 
who screen positive for PPD symptoms (EPDS score>9) at their child’s well visit and have 
infants < 8 months of age. 
Study Interventions and Measures:  
Participants will be randomized to receive the parenting program plus online depression 
treatment or online depression treatment alone to assess target engagement. 
The results of this application would be expected to contribute important new knowledge 
and inform a future trial on parenting strategies to better assist mothers with PPD symptoms 
and improve child developmental outcomes. 
 

 
vi  
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES1  
Study Phase 
Month 0 
Month 1 
Month 2 
Month 32 
Visit Number 
1 
2 
3 
4 
Informed Consent 
X 
 
 
 
Randomization 
X 
 
 
 
Demographics 
X 
 
 
 
PSI-SF  
X 
 
 
X 
PSOC  
X 
 
 
X 
PCERA 
X 
 
 
X 
MSPSS 
X 
 
 
 
Poverty 
X 
 
 
 
BDI-II 
X 
 
 
X 
EPDS 
X 
X 
X 
X 
NCS Item 
 
X 
X 
X 
MoodGym Acceptability 
Survey 
 
 
 
X 
TFI-8 
 
 
 
X (Intervention arm only) 
Acceptability Survey 
 
 
 
X (Intervention arm only) 
Parenting Program 
 
X (Intervention arm only) 
X (Intervention arm only) 
 
MoodGym 
 
X 
X 
 
. 
 
1All visits may be conducted either in-person or remotely 
 
 
2As necessary, Visit 4 may occur as late as Month 6 

 
page vii 
  
 
FIGURE 1: STUDY DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Visit 1: 
Screening 
Screen 
Failures 
Visit 1: 
Randomize 
Baseline Measures 
N=75 
Visit 3: 
Parenting Measures 
Intervention Group 
N~38 
Visit 4: 
Parenting Measures 
Intervention Group 
N~34 
Visit 2: 
Parenting Measures 
Control Group 
N~37 
Visit 3: 
Parenting Measures 
Control Group 
N~37 
Visit 4: 
Parenting Measures 
Control Group 
N~26 
Visit 2: 
Parenting Measures 
Intervention Group 
N~38 
MoodGym Alone 
 
Parenting 
Program + 
MoodGym 

 
  
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
Postpartum depression (PPD) is prevalent following the birth of a child, occurring in 12-
24% of women.1-4 Depressive symptoms are relatively uncommon among women prior to 
puberty, rise markedly during a woman’s childbearing ages, and then fall during older 
adulthood.5 For example in a study among women of childbearing ages 24 to 44 years old, 
19% endorsed depressive symptoms compared with 8% of older women.6 Young mothers 
are particularly vulnerable to depression; studies report varying prevalence rates of 12% to 
50% among mothers of young children.7-11 The occurrence of depression following the birth 
of a child has a strong genetic component,12-14 is likely related to the stress of childbirth and 
parenting, and may be related to hormonal fluctuations during the postpartum period.7,9 
Environmental stressors such as poverty and social isolation also contribute additional risk 
to the development of depression following childbirth.7,15-17  
PPD symptoms adversely impact responsive parenting, i.e. a mother’s ability to nurture and 
care for her children.18,19,20,21Depressed mothers lack knowledge of and self-efficacy in 
healthy parenting practices, e.g. recommended sleep practices for infants.22-24 They are less 
likely to display positive parenting behaviors, e.g. delivering praise, and more likely to 
endorse negative parenting behaviors, e.g. yelling and spanking, than non-depressed 
mothers.24-26 In addition, depressed mothers ineffectively model emotional expression, 
which may contribute to emotional dysregulation and higher stress levels in infants and 
children.27,28 Overall, the literature suggests that depression adversely affects the mother-
child relationship, leads to less responsive parenting, and contributes to disorganized infant 
attachment with mothers.29-31  
As a result of these maladaptive parenting behaviors, infants and toddlers may experience 
cognitive, language, and socioemotional delays as early as 12-18 months of age.28,32-35 
Affected children are also at greater risk to develop behavioral problems by age three than 
children of non-depressed caregivers.18,28,30,31,34,36 These behavioral problems encompass 
both internalizing disorders such as anxiety and depression and externalizing disorders 
including oppositional-defiant disorder and conduct disorder. The longer, persistent, and 
more severe a mother’s depression, the greater the behavioral impairment in children.37 As a 
result, PPD has been considered by Bright Futures, a leading pediatric health supervision 
guideline, as “one of the greatest risk factors for child behavioral and mental health 
problems”.38  
Treatment strategies for women with PPD have demonstrated varying effects on mothers 
and their children.39,40 The US Preventive Services Task Force and clinical experts have 
endorsed antidepressant treatment and psychotherapies targeting mothers.1,41,42 However, 
recent reviews show little evidence that effective treatment of maternal mood alone 
improves mother-infant interactions and results in improved child outcomes.43,44 More 
intensive psychotherapeutic interventions that specifically target mothers and their 
interactions with their children have demonstrated improved infant development, emotional 
regulation, and attachment security.45-53 However, these intensive interventions incur 
substantial costs and participant time commitments which limit their impact and scalability. 
Parenting programs aimed at improving a mother’s parenting knowledge and skills have 
shown beneficial effects on mother-child relationships and child behaviors and 
development.54-65 Unlike intensive psychotherapeutic interventions, they require a modest 

 
  
 
2
commitment of time and energy on the part of new mothers and have been widely 
disseminated and scaled up across the US. However, the effects of parenting programs have 
received little study among women with PPD.66-68  
1.1 Introduction 
It isn’t clear whether parenting programs tailored to women with PPD can improve mother-
child interactions and ultimately child development and behavior. In previous studies, we 
and other investigators found that depressed women who attended group parenting programs 
reported improved parenting practices and decreased depressive symptoms.66-68 A 
systematic review and meta-analysis of 48 clinical trials of parenting programs (not 
specifically targeting depressed parents) also found that group-based parenting programs 
were associated with significant short-term (<6 months) benefits on maternal mood and 
psychosocial well-being.69 However, these few studies provide no information on the 
downstream effects of parenting programs targeting women with PPD on child development 
and behavior. In addition, given the potential short-term effects of parenting programs on 
maternal psychosocial well-being, it isn’t clear whether sustained improvements in 
depressive symptoms are necessary to affect improvements in child development and 
behavior. 
Observational studies of women with PPD and chronic depression help inform this 
application. They show that responsive and sensitive parenting mediates the effects of 
maternal depression on early child development, school readiness, and child behavior.30,31,70 
This suggests that responsive parenting can serve as a target engagement for studies of 
parenting interventions designed to improve child development among mothers with PPD. 
In addition, observational studies have shown that poverty and social support are important 
and likely moderate the association between PPD and child development.70,71 Therefore, 
studies investigating parenting programs should investigate whether poverty and social 
support moderate effects on responsive parenting.  
In a preliminary study that informs this proposal, we examined the effects of an adapted 
parenting program on parenting practices among mothers with depressive symptoms.66,72 We 
adapted the Incredible Years (IY) Parents, Babies, and Toddlers program, an evidence-based 
parenting program, for use with depressed parents by the inclusion of depression 
psychoeducation.73 We enrolled and randomized 61 mother-toddler dyads to immediate or 
delayed in-person group intervention. Those in the immediate intervention group received 
the adapted 12-week program and reported greater improvements in parenting disciplinary 
practices (Parenting Scale adjusted difference -0.4, 95% CI  -0.7 to -0.1)) but similar 
changes in depressive symptoms (Beck Depression Inventory-II adjusted difference -3.4, 
95% CI -8.7 to 1.9), social support (Multidimensional Scale of Social Support adjusted 
difference 0.3, 95% -0.4 to 0.9), and parenting stress (Parenting Stress Index Short Form 
adjusted difference -1.8, 95% CI -11.2 to 7.4) as women in the delayed intervention group. 
Although most (59%) women in the immediate intervention group attended at least one 
parenting session, few (10%) attended all 12 sessions with the mean number of sessions 
attended being 3.7 (range 0-12). Women reported multiple barriers to attendance including 
unstable housing, changing work schedules, and other children in the household to attend to. 
Our results suggest that a strategy utilizing parent training programs may improve the 

 
  
 
3
parenting skills of depressed women and potentially improve child development, but 
adaptations are needed to improve participation among women with PPD.  
1.2 Name and Description of Investigational Product or Intervention 
Social Media-Based Parenting Program:  
The parenting program consists of 8 weekly sessions using a Facebook platform with the 
following topics: depression psychoeducation and behavioral activation, infant 
temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. 
Participants are enrolled in Facebook secret user groups, administered by a trained 
facilitator, in order to permit participants to view and comment on posted materials. Content 
and user identity are restricted to invited participants to maintain privacy. For each topic, we 
organize educational materials into video vignettes, narrated PowerPoint presentations, and 
written materials. The facilitator reviews and comments on postings daily, provides 
feedback to participants, and removes inappropriate postings if they occur. Facebook 
analytics for the secret groups are available to group administrators and will provide 
information on any sessions viewed (engagement) and counts of sessions viewed and 
comments posted (dosage). 
 
MoodGym: 
The Moodgym program is an evidence-based online cognitive behavioral treatment program 
that has been shown be effective at reducing depression symptoms in a meta-analysis of 11 
trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive 
exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio 
files that can be completed online without therapist interaction. We will supplement 
Moodgym with a facilitator contact by texting or email to check-in and encourage 
completion of intervention.  MoodGym will provide information on the number of sessions 
completed by participants (engagement and dosage). 
1.3 Relevant Literature and Data 
We developed content for the program through a review of the literature on early infant 
parenting topics and incorporated depression psychoeducation and behavioral activation 
strategies to the program.38,74-78 To validate content and format of the program, we convened 
two focus groups of women with PPD symptoms. Women were recruited using 
advertisements at participating practices and through direct referrals from clinicians. Focus 
groups lasted 1-2 hours and were conveniently held in the evenings at a participating 
practice. The focus groups were moderated by a trained facilitator using a previously piloted 
interview guide. Focus group participants were provided with an overview of the program, 
its format, and the topics derived from the literature review and were asked to submit 
comments and suggestions. Focus groups were audiotaped and transcribed. Based on focus 
group participant feedback, content for the program was revised and sessions reflecting the 
content were developed. 

 
  
 
4
We developed a program of 8 weekly sessions for a Facebook format with the following 
topics depression psychoeducation and behavioral activation, infant temperament, play, 
feeding, safety, sleep, parent-child interactions, and reading. Women who screened positive 
(score >9) on the Edinburgh Postpartum Depression Scale (EPDS) at their child’s two-
month well child visit were recruited to participate in the program. We used Facebook secret 
user groups to convey the program content to participants.79 A trained facilitator 
administered the Facebook secret user groups and permitted participants to view and 
comment on posted materials but restricted content and user identity only to invited 
participants to preserve privacy. For each topic we organized educational materials into 
video vignettes, narrated PowerPoint presentations, and written materials. Weekly content 
for each topic was released separately in three postings onto the Facebook site over the 
course of a week. The facilitator reviewed postings on a daily basis, commented on 
participants’ postings, provided encouragement to participants, and removed inappropriate 
postings if they occurred. 
We assessed feasibility through attendance and posting of comments on weekly Facebook 
groups. We assessed acceptability using a 5-point satisfaction scale at the conclusion of each 
weekly group. We recruited 18 eligible women from 3 urban practices in Philadelphia. 
Participants were predominantly African-American, single, with a high school education or 
less, or with a family income < $30,000. On average, 89% (range 78-100%) of participants 
attended weekly Facebook groups, and 69% (range 61-89%) of participants posted 
comments at weekly Facebook groups (Table 1). The mean overall satisfaction score was 
4.5 (range 3-5).  
We also examined preliminary outcomes of this Facebook parenting intervention on 
measures of parenting and depression.  We 
conducted a small randomized controlled trial with 
24 women with PPD symptoms. Participants were 
randomized to receive the parenting program through 
a social media or in-person group format.  Twenty of 
the 24 (83%) women completed assessments pre- and 
post-intervention. We evaluated target engagement 
of the intervention, parenting competence, using the 
Parenting Sense of Competence Scale (PSOC), a 
validated self-report of parenting efficacy, and 
maternal depressive symptoms using the Beck 
Depression Inventory-II (BDI-II).  Twenty-four mothers (mean age of 26 years; 
predominantly African American with limited economic resources) participated in the study.  
Linear regressions showed that the social media intervention resulted in significantly 
improved parenting competence (Effect Size 1.61) and decreased depression severity (Effect 
Size 0.96) compared to the in-person group (Table 2).  Weekly attendance in the social 
media group was much greater (mean 83% vs. 3%) than in the in-person group. These 
results suggest that a parenting program adapted for a social media platform was feasible 
and acceptable among a low-income urban minority population and can improve parenting 
practices and reduce depressive symptoms. However, a more objective measure of target 
engagement as well as a link to signal improved child development is needed in future study 
Table 2. Outcomes of Social Media-based 
Intervention 
Measure 
Social Media 
Group (N=12) 
In Person 
Group (N=8) 
BDI-II (SD) 
     Baseline 
     Post 
 
29.5 (2.3) 
20.2 (2.2) 
 
23.4 (3.3) 
23.3 (4.9) 
PSOC (SD) 
     Baseline 
     Post 
 
67.8 (2.6) 
76.3 (3.4) 
 
78.3 (3.0) 
73.6 (3.7) 

 
  
 
5
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: Consolidated Guideline 
approved by the International Conference on Harmonisation (ICH). All episodes of 
noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent, and will report unanticipated problems involving risks to subjects or others in 
accordance with The Children’s Hospital of Philadelphia IRB Policies and Procedures and 
all federal requirements. Collection, recording, and reporting of data will be accurate and 
will ensure the privacy, health, and welfare of research subjects during and after the study.  
2 
STUDY OBJECTIVES 
The overall objective is to assess the effects of this theoretically-driven social media-based 
parenting program on responsive parenting and child development, the outcome of interest 
among mothers with PPD symptoms. We will assess target engagement, responsive 
parenting, of the program using an objective measure. Responsive parenting has been 
identified empirically as a significant mediator of child developmental outcomes in this 
population.30,31,70 
2.1 Primary Objective (or Aim) 
To determine whether the social media-based parenting program can improve responsive 
parenting among women with PPD symptoms, using the PCERA to measure the quality of 
affect and behavior in parent-child interactions. 
2.2 Secondary Objectives (or Aim) 
Secondary outcomes, including changes in EPDS, BDI-II, PSOC, and PSI-SF scores 
measured between baseline and the 3-month follow-up between groups, will be explored to 
determine if the effects of the parenting program are consistent with preliminary pilot 
findings.  Descriptive statistics for demographic and poverty characteristics and PPD 
symptoms measured at baseline will be examined across the two treatment groups to assess 
the success of the randomization. . At the 3-month follow up, the intervention arm will be 
assessed with the TFI-8 to measure cohesion, and also be administered the Acceptability 
survey which measures feasibility of the parenting program. Additionally, at the 3-month 
mark, all participants will be administered the MoodGym Acceptability Survey to assess 
feasibility of the online depression treatment program. 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
To determine whether the social media-based parenting program can improve responsive 
parenting among women with PPD symptoms (Aim #1), we will conduct a prospective 
individually randomized group treatment trial. 75 eligible women who screen positive for 

 
  
 
6
PPD at their infants’ well child visit and their children will be consented, enrolled, and 
randomized as mother-child dyads 1:1 to receive a) the social media-based parenting 
program plus online depression treatment or b) online depression treatment alone. We chose 
a randomized design, because it is most effective in guarding against bias and will ensure 
that patients in both arms are similar in observed and unobserved characteristics. Treatment 
assignment will be done at the time of enrollment following informed consent and 
completion of the videotaped baseline PCERA. We will assess responsive parenting at 
baseline and 3 months post-enrollment. Cohesion will be measured for the intervention arm 
at 3 months post-enrollment. 
3.1.1 Screening Phase 
Families of eligible children will be recruited at the time of an office visit that results in a 
woman screening positive for PPD (EPDS score>9) at their infant’s well child visit at a 
participating practice. Screening for PPD at an infant’s well visit is standard of care at 
CHOP primary care practices. Recruitment will occur by telephone following an office visit 
using an electronic recruitment tool that permits clinicians to obtain permission for contact 
from families at an office visit. Electronic recruitment tools have become standard practice 
in PeRC and facilitate recruitment of patients across multiple studies. The electronic 
recruitment tool is an alert in EPIC that indicates that because the mother screened positive 
for PPD, she and her child may be eligible for a research study. If the mother provides 
permission to be contacted, her contact information will be sent securely through CHOP 
BusinessObjects to study staff. Potential subjects will be screened over the phone using the 
protocol inclusion and exclusion criteria. Caregivers of eligible children will be then 
scheduled for an in-person consent and will complete study visits at baseline, 1 month, 2 
months, and 3 months (Table 1). While informed consent can take place at a separate visit 
and location from the baseline visit according to participant preference, the baseline visit 
will occur at a CHOP site (primary care office or other CHOP site) in order to facilitate 
adequate video recording. In the event that the baseline visit cannot be completed in-person, 
an alternative method of obtaining informed consent will be used. Following the telephone 
screen, caregivers of eligible children will be sent the informed consent document 
electronically through REDCap. The study team will then go over the document in detail 
with the eligible caregiver by phone. The e-consent function in REDCap will be used to 
obtain the caregiver’s signature. The signed e-consent will then be stored within REDCap, 
and a copy of the form will be available to download and emailed securely to the caregiver. 
Additionally, baseline visit surveys may be administered online through REDCap and the 
PCERA video recording may be conducted remotely. If the PCERA is administered 
remotely, participants will be asked to videotape themselves free-playing with their child at 
home on a smart phone or tablet. They will then upload the video to a secure cloud-based 
service called BOX, that is available through a free mobile application and used by CHOP to 
securely store files. Instructions for recording home videos can be found in Appendix 14. 
Participants will also have the option of utilizing a secure video platform (e.g., Skype, 
BlueJeans, or other platform) where a study team member could record the mother and 
infant playing together. The recording would then be securely stored by the study team 
member. We will use all available means including letters, telephone calls, text messages, 
and emails to ensure data are collected thoroughly and systematically from all participants 
for follow-up measures. Participation incentives will include compensation to complete 

 
  
 
7
study measures, and child birthday card mailings all of which have been used in our prior 
work (see approved studies 18-014807 and 15-012456) with urban populations to maintain 
>80% participant follow-up.75 
3.1.2 Study Treatment Phase (start of the study intervention) 
Women will complete measures of demographic characteristics, family income, social 
support (MSPSS), depressive symptoms (EPDS, BDI-II), parenting competence (PSOC), 
and parenting stress (PSI-SF) at baseline. Parent-child dyads will be videotaped before 
initiation of the parenting program using the Parent-Child Early Relational Assessment 
(PCERA). Women in both study arms will be enrolled in MoodGym, an evidence-based 
online Cognitive Behavioral Therapy (CBT) program for depression. Women randomized to 
the parenting program will be invited to enroll in a Facebook secret user group and 
participate in the 8-week online parenting program. Women will complete monthly 
assessments of PPD depressive symptoms using the EPDS and mental health services use 
using a question from the National Comorbidity Study (NCS). At 3 months post-enrollment, 
women will complete measures of parenting competence and parenting stress, depressive 
symptoms, parent-child dyads will complete the PCERA, the Moodgym Acceptability 
Survey, and women in the intervention arm will complete the Therapeutics Factor 
Inventory-8 (TFI-8) and the Acceptability Survey. If Study Visits 1 and/or 4 cannot be 
completed in-person, surveys may be administered online through REDCap and the PCERA 
may be conducted remotely. If the PCERA is administered remotely, participants will be 
asked to videotape themselves free-playing with their child at home on a smart phone or 
tablet. They will then upload the video to a secure cloud-based service called BOX,that is 
available through a free mobile application and used by CHOP to securely store files. 
Instructions for recording home videos can be found in Appendix 14. Participants will also 
have the option of utilizing a secure video platform (e.g., Skype, BlueJeans, or other 
platform) where a study team member could record the mother and infant playing together. 
The recording would then be securely stored by the study team member. To assess 
feasibility, the Acceptability Survey will be administered to participants in the parenting 
program to assess their perceptions of the parenting program, the extent to which it meets 
their needs, and barriers that impeded their participation in the program. Using intention-to-
treat analysis, we will determine differences in change scores in responsive parenting 
(PCERA parenting subscales) between groups as the main outcome. We will also examine 
differences in parenting stress, parenting competence, and depressive symptoms as 
secondary outcomes. As a secondary analysis, we will examine effects of dosage (duration 
of participation and number of sessions completed) on PCERA parenting subscales and 
secondary outcome measures among those in the parenting group.  To analyze the 
Acceptability Survey, we will examine mean acceptability scores for each PWD session for 
participants in the intervention arm, and mean acceptability scores for the MoodGym session 
for all participants through the MoodGym Acceptability Survey. We will also qualitatively 
analyze the open-ended questions to help inform the acceptability scores. 
3.2 Allocation to Treatment Groups and Blinding 
Women will be recruited at the time of a well child visit for their < 8 months old infant using 
an electronic recruitment alert and will undergo written informed, either in-person or 
electronically, consent at their first study visit. Following informed consent and completion 

 
  
 
8
of the videotaped baseline PCERA, women will be randomized 1:1 to either the parenting 
program plus online CBT or online CBT alone. Randomization will be accomplished in 
advance by the study biostatistician using computer-generated random numbers. The initial 
randomization will be stratified by practice site to ensure balance at the practice level 
between groups. Allocation concealment (blinding of the treatment assignment) will be 
implemented using sealed, opaque envelopes, along with stratification, and randomly 
permuted blocks of unequal sizes (to prevent providers and patients from manipulating the 
randomization).   
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject will be approximately 3-6 months. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately 6 CHOP primary care practices, starting with 
3-4 sites. 
Recruitment will stop when approximately 75 mother-child dyads are enrolled. It is expected 
that approximately 75 dyads will be enrolled to produce 60 evaluable dyads.  
3.4 Study Population 
3.4.1 Inclusion Criteria 
Women who: 
1) Are >18 years old 
2) Screen positive for postpartum depression (score>9) on the EPDS at a participating 
pediatric practice 
3) Have an infant <8 months of age 
4) Speak and Read English 
5) Have Access to a smart phone or computer tablet with internet access 
6) Have completed an informed consent 
Children who: 
7) Are < 8 months old 
3.4.2 Exclusion Criteria 
Women who: 
1) Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at 
enrollment. 

 
  
 
9
2) Report severe depressive symptoms (EPDS>20) at enrollment. 
3) Have a substantiated report of child maltreatment 
Children who: 
1) Were born premature (estimated gestational age<35 weeks) 
2) Have been diagnosed with congenital malformations or genetic syndromes which place 
them at risk of developmental delays 
3) Are already currently receiving early intervention services for developmental delays at 
baseline 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1  Screening Visit 
List the timing and all of the procedures to be performed at the screening visit. This can be a 
simple bullet list. 
• Informed Consent 
• Medical Record Review 
• Review of Inclusion/Exclusion Criteria 
• Randomization 
4.2 Study Treatment Phase 
Over the course of each subject’s participation, the subject will have a baseline study visit 
and 3 monthly follow-up visits. After being screened at baseline, participants will complete 
demographics, BDI-II, PSI-SF, PSOC, PCERA, MSPSS, and poverty measures. At each of 
the three follow-up visits, measures of depression (EDPS) and an NCS item will be 
completed. At the final follow up, three months after enrollment, participants will complete 
the PSI, PSOC and PCERA measures again, the MoodGym Acceptability Survey and 
participants in the intervention arm will complete the TFI-8 and the Acceptability Survey.  
4.2.1 Visit 1 (Baseline) 
• Demographics Measure  
• EPDS 
• BDI-II 

 
  
 
10
• PSI-SF 
• PSOC 
• PCERA 
• MSPSS 
• Poverty 
• Review of child’s medical record 
4.2.2 Visit 2 (1-month follow up) 
• EPDS 
• NCS Item 
4.2.3 Visit 3 (2-month follow-up) 
• EPDS 
• NCS Item 
4.2.4 Visit 4 (3-month follow-up) 
• EPDS 
• BDI-II 
• NCS Item 
• PSI-SF 
• PSOC 
• PCERA 
• MoodGym Acceptability Survey 
• TFI-8 (Intervention arm only) 
• Acceptability Survey (Intervention arm only) 
4.3 Unscheduled Visits 
Unscheduled visits are not anticipated. 

 
  
 
11
4.4 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to the study visit schedule or any AEs.  The Investigator may also withdraw 
subjects who violate the study plan, or to protect the subject for reasons of safety or for 
administrative reasons. Additionally, if a subject is enrolled but does not complete the 
videotaped baseline PCERA before the start of the intervention, regardless of the group they 
were randomized to, they will be withdrawn from the study. It will be documented whether 
or not each subject completes the study. If the Investigator becomes aware of any serious, 
related adverse events after the subject completes or withdraws from the study, they will be 
recorded in the source documents and on the CRF. 
4.4.1 Early Termination Study Visit 
Subjects who withdraw from the study following screening may receive recommendations 
for follow up per their specific needs. 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review of Child 
Include a listing of the variables that will be abstracted from the medical chart (paper or 
electronic). 
• Date of birth 
• Gestational age 
• Sex 
• Problem list 
• Chart review for developmental assessments, depression screenings, child 
maltreatment 
• Contact information 
• Age of mother 
• Languages spoken/read 
5.1.2 Other Evaluations, Measures 
Measures proposed for this phase of the study correspond to our experimental therapeutics 
framework and will assess differences in responsive parenting as the measure of target 
engagement. This is consistent with observational studies which have shown that responsive 
parenting mediates the effects of maternal depression on early child development and can 

 
  
 
12
serve as a target for intervention engagement.30,31,70 Following written informed consent, 
women will complete a baseline visit. Measures of demographic and biological variables 
(age, sex, race/ethnicity, maternal education level, and family structure), social support, and 
poverty (family income level) will be collected by research staff at baseline to assess success 
of randomization. Depressive symptoms and outside mental health treatment will be 
measured monthly using the EPDS and an item from the National Comorbidity Survey 
(NCS) concerning any service use.96 Depressive symptoms will also be measured at baseline 
and at the 3-month follow up using the BDI-II. Women who report EPDS scores >20, BDI-
II scores 29-63, or who report suicidality (EPDS question #10, BDI-II question #9) will 
remain in the study and will be contacted immediately and provided with assistance in 
obtaining urgent mental health referrals. The research team will also contact women with 
severe depression (EPDS scores>20, BDI-II scores 29-63) or suicidality weekly to monitor 
their symptoms and treatment. Social support will be measured at baseline by the Multi-
dimensional Scale of Perceived Social Support (MSPSS), a 12-item scale that assesses 
perceived social support from family, friends, and a significant other.97 Parenting will be 
measured at baseline and at follow-up 3 months later using 3 separate instruments: The 
Parenting Sense of Competence Scale (PSOC), the Parenting Stress Index-Short Form (PSI-
SF), and the Parent-Child Early Relational Assessment (PCERA). At the 3-month follow up, 
cohesion will be measured with the TFI-8 and feasibility of the parenting program with be 
measured with the Acceptability Survey Additionally, feasibility of the online depression 
treatment program, MoodGym, will be measured at the 3-month follow up using the 
MoodGym Acceptability Survey. In the event that the baseline and/or 3-month follow up 
visits cannot be completed in person, study procedures may be conducted virtually. Surveys 
administered at baseline and at the 3-month follow up (see Table 1) may be administered 
online through REDCap. The PCERA may be conducted remotely as well. If the PCERA is 
administered remotely, participants will first be contacted by phone or email and asked to 
videotape themselves free-playing with their child at home on a smart phone or tablet. They 
will then upload the video to a secure cloud-based service called BOX, that is available 
through a free mobile application. BOX is used widely by CHOP as an institution to 
securely store files. Participants will also have the option of utilizing a secure video platform 
(e.g., Skype, BlueJeans, or other platform) where a study team member could record the 
mother and infant playing together. The recording would then be securely stored by the 
study team member.  Once uploaded, videos will be labeled with each participant’s 
corresponding identification number, to further protect their identifiable information. Only 
the study team will have access to these video files. Instructions detailing the process of 
recording and uploading the home videos will be emailed to each participant prior to 
completing the recordings. 
 
The PSOC is a validated 17-item self-report measure of parenting self-esteem and 
competence and consists of two factors: satisfaction and efficacy.98 The PSI-SF consists of 
36 items that measure parenting stress.99,100 The PCERA is a validated 65-item (29 parental, 
28 child, and 8 dyadic items) videotape assessment designed to measure the quality of affect 
and behavior in parent-child interactions and will serve as the primary measure of 
responsive parenting.101,102 The PCERA uses ratings that are based on observations of 5-
minute videotaped interactions with parent-infant dyads engaged in free play and is designed 
to measure therapeutic change and its effects on the parent-child interaction. The PCERA 

 
  
 
13
has been shown to possess good interrater reliability, internal consistency, discriminant and 
concurrent validity, and sensitivity to change.51,102-104 The PCERA contains 8 subscales (3 
parental, 3 child, 2 dyadic) of which we postulate that a parenting program will have a 
positive impact on three responsive parenting subscales: 1) Parental Positive Affective 
Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental 
Intrusiveness, Insensitivity, and Inconsistency. At the follow-up visit, we will also conduct 
brief audiotaped semi-structured interviews with participants in the parenting program to 
assess their perceptions of the parenting program, the extent to which it meets their 
parenting needs, and barriers that impede their participation in the social media-based 
program. This information can be used to revise the parenting program, particularly if target 
engagement is not met. An interview guide will be developed during this phase of the study. 
 
Edinburgh Postnatal Depression Scale (EPDS): Secondary, Baseline, 1 month, 2 months, 3 
months.  
 
The EPDS is a validated 10-item self-report measure of depressive symptoms with strong 
evidence for reliability, validity, and utility in varying populations. It has been used 
extensively in mental health research and provides cutpoints to determine the severity of 
depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will 
be used to monitor for suicidality. The total score will be used with scores of 10 or higher 
representing minor or moderate depression and scores of 20 or greater representing severe 
depression.   
 
Beck Depression Inventory (BDI-II): Secondary, Baseline & 3 months. 
The BDI-II is a 21-item self-report tool that measures the severity of depression and 
includes two subscales: cognitive and somatic. It has been well validated, and widely used, 
with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe 
depression. The total score will be used.  
Parenting Sense of Competence Scale (PSOC): Secondary, Baseline & 3 months. 
The PSOC is a validated 17-item self-report measure of parenting self-esteem and 
competence and consists of two factors: satisfaction and efficacy. Response categories are 
on a 6-point likert-scale from strongly disagree to strongly agree.  The total score (which 
includes the sum of the two factors) will be used.   
 
Parenting Stress Index-Short Form (PSI-SF): Secondary, Baseline & 3 months. 
The PSI-SF is a validated 36-item scale that measures parenting stress. It has been shown to 
have excellent internal consistency and to be positively associated with maternal 
psychological distress. Scores on the PSI-SF correlate well with the full PSI. The total score 
will be used.   
 
Patient Child Early Relational Assessment (PCERA): Primary, Baseline & 3 months. 
The PCERA is a validated 65-item (29 parental, 28 child, and 8 dyadic items) videotape 
assessment designed to measure the quality of affect and behavior in parent-child 
interactions and will serve as the primary outcome measure. The PCERA uses ratings that 
are based on observations of 5-minute videotaped interactions with parent-infant dyads 

 
  
 
14
engaged in free play at a research lab at CHOP or offsite at an appropriate location. The 
PCERA has been shown to possess good interrater reliability, internal consistency, 
discriminant and concurrent validity, and sensitivity to change. The PCERA contains 8 
subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective 
Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental 
Intrusiveness, Insensitivity, and Inconsistency. Mothers are instructed to play with their 
infant as they normally would using a set of age-appropriate toys provided for their use in 
the free play. Administration and coding will follow the PCERA manual. 
 
National Comorbidity Survey (NCS): Secondary, Baseline, 1 month, 2 months, 3 months. 
We will include a question from the NCS on prior mental health services use in the past 
month: “In the past month, did you receive treatment for problems with your emotions or 
nerves, or your use of alcohol or drugs?” We will consider mental health service use to have 
occurred in the past month if a mother responds affirmatively to this question. Additionally, 
if a mother responds affirmatively to the initial NCS item, a follow-up question will be 
asked to determine the specific types of services that were accessed: “If yes, what type of 
treatment did you receive?” 
 
Multi-dimensional Scale of Perceived Social Support (MSPSS): Secondary, Baseline. 
The MSPSS is a 12-item scale that assesses perceived social support from family, friends, 
and a significant other. Response categories are on a 7-point likert-scale from very strongly 
disagree to very strongly agree.  The total score will be used.  
 
 
MoodGym Acceptability Survey: 3 months. 
The Acceptability survey is a 1-item scale with 2 additional open ended questions that will 
be used to assess feasibility of the online depression treatment program, MoodGym. The 
total score will be used and the open ended questions will be qualitatively analyzed to help 
inform the acceptability scores. 
 
Therapeutic Factors Inventory-8: 3 months, Intervention arm only 
The TFI-8 is a validated 8-item scale that is used to measure cohesion and is continuous 
process monitoring for therapy groups. Scores on the TFI-8 correlate well with the full TFI. 
The total score will be used. 
 
Acceptability Survey: 3 months, Intervention arm only 
The Acceptability survey is a 10-item scaled with 3 additional open ended questions that 
will be used to assess feasibility of the parenting program. The total score will be used and 
the open ended questions will be qualitatively analyzed to help inform the acceptability 
scores. 
 
5.2 Safety Evaluation 
Subject safety will be monitored by adverse events reporting. As this study is not greater 
than minimal risk serious adverse events are not anticipated 

 
  
 
15
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The primary endpoint will be the change in responsive parenting (PCERA) between baseline 
and visit 4. 
6.2 Secondary Endpoints 
Secondary outcomes, including changes in EPDS, BDI-II, PSOC, and PSI-SF scores 
measured between baseline and the 3-month follow-up between groups, will be explored to 
determine if the effects of the parenting program are consistent with preliminary pilot 
findings. Mean scores on the Acceptability Survey and MoodGym acceptability Survey will 
be used to assess feasibility of the parenting program as well as the online depression 
treatment program. 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Descriptive statistics for demographic, behavioral, and environmental characteristics 
measured at baseline will be examined across the two treatment groups to assess the success 
of the randomization. 
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach and will include all 
subjects randomized at Visit 1.   
The primary efficacy endpoint will be the change in PCERA between Visit 1 and Visit 4.   
Secondary endpoints will include the changes in EPDS, BDI-II, PSOC, and PSI-SF scores 
measured between baseline and the 3-month follow-up between groups, will be explored to 
determine if the effects of the parenting program are consistent with preliminary pilot 
findings. Mean scores on the Acceptability Survey and MoodGym acceptability Survey will 
be used to assess feasibility of the parenting program as well as the online depression 
treatment program.  
6.4 Sample Size and Power 
Our target sample size accounting for clustering by practice site for dyads with complete 3-
month follow-up data is 60 mother-child dyads. Assuming at least 80% follow-up, the 
number needed to recruit this final sample size is 75 (30% of potentially eligible women 
across all 4 urban pediatric practices in 2016). Since a partial goal of the proposed 
intervention is to increase patient engagement in the parenting program, the rate of drop out 
is likely to be lower among the intervention group. If we conservatively assume that the 
attrition rate among control participants is triple (30% vs. 10%) that of intervention patients, 
the sample of patients with complete follow-up will consist of approximately 26 control 
dyads and 34 intervention dyads (Figure 2). Using changes in the PCERA parenting 
subscale scores as the primary outcome, we assert that the proposed parenting intervention 
would be successful if it results in an effect size (ES) 0.8 on one or more of the 3 subscales 

 
  
 
16
between intervention groups. This is similar to the difference in subscale scores observed 
between groups in a novel mother-infant therapy group trial and is half the difference 
(ES=1.6) we observed in PSOC scores in our preliminary study.51 Thus, based on the 
proposed sample size, we would obtain 80% power to detect an effect size between 0.79-
0.96 between groups assuming an interclass correlation coefficient (ICC) between 0.01 to 
0.1 among participating practices. Our target sample size of 34 mother-child dyads who 
complete the parenting intervention is sufficient for the qualitative interviews to obtain 
saturation of themes. 
7 
SAFETY MANAGEMENT 
7.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  
8 
STUDY ADMINISTRATION 
8.1 Treatment Assignment Methods 
8.1.1 Randomization 
75 eligible women will be consented, enrolled, and randomized 1:1 to receive the a) 8-week 
social media-based parenting program plus MoodGym or b) MoodGym alone. Women will 
complete measures of demographic characteristics, family income, social support, 
depressive symptoms, parenting competence, and parenting stress at baseline. Parent-child 
dyads will be videotaped before initiation of the parenting program using the Parent-Child 
Early Relational Assessment (PCERA). Women in both study arms will be enrolled in 
MoodGym, an evidence-based online CBT program for depression. Women randomized to 
the parenting program will be invited to enroll in a Facebook secret user group and 
participate in the 8-week online parenting program. Women will complete monthly 
assessments of PPD depressive symptoms using the EPDS and mental health services use 
using a question from the NCS. At the 3-month visit, all participants will complete the 
MoodGym Acceptability Survey. Women in the social media-based parenting program 
intervention will complete the TFI-8 and the Acceptability Survey at the 3 month visit.  
8.1.2 Blinding 
Allocation concealment (blinding of the treatment assignment) will be implemented using 
sealed, opaque envelopes, along with stratification, and randomly permuted blocks of 
unequal sizes (to prevent providers and patients from manipulating the randomization).   

 
  
 
17
8.2 Data Collection and Management 
All records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study.  
 
To ensure confidentiality of information, data will be stripped of potential identifiers, and all 
written and computerized files will be indexed by a unique identification number. Only 
research staff will have access to this information and to a separate master list. All data for 
these study procedures will be maintained on CHOP’s secure research server, and all 
analyses will be performed on de-identified data only. All collected study measures will be 
entered directly into a REDCap database maintained and protected on this secure research 
server. The unique identifiers will be used to track enrolled families over the course of the 
study. Confidentiality will also be maintained by use of subject code numbers in all 
presentations and publications. Each member of the research team, including investigators, 
research assistants, and stakeholder-investigators will receive appropriate training in human 
subjects research and patient confidentiality. 
 
Unique identifiers will be created for each subject in the study. REDCap will be used to 
store the data. A master list containing PHI and subject ID number will be kept separate 
from data forms (electronic and paper). The master list will be kept using password-
protected files. These files will be encrypted and maintained on the CHOP secure server to 
ensure security. Participants’ information will be stored in the REDCap database and 
configured to export data without PHI. All de-identified records will be retained forever. De-
identified data will be shared with the study sponsor. Stored data and patient identifiers will 
be kept for 6 years subsequent to the study completion, and possibly longer if required by 
the sponsor.  
8.3 Confidentiality 
All data and records generated during this study will be kept confidential and in accordance 
with institutional policies and HIPAA on subject privacy. Participation in all aspects of the 
proposed study is completely voluntary. The research team will institute strict procedures to 
maintain confidentiality. Subjects will be assigned a unique identification code that will be 
used as the sole identifier. The data will only be shared with the investigative team during 
the implementation of the study and results will only be presented in aggregate form.  Any 
results obtained cannot be related to the original source, so no results would be provided to 
the patient, healthcare provider, or insurance provider. All study information will be 
maintained on a secure password-protected server with regular backup. Per standard NIH 
guidelines, a Certificate of Confidentiality (CoC) will be automatically generated for this 
NIH-funded study.  
 
Every 6 months, the study sponsor NIMH requires a data transfer to the NIMH Data Archive 
(NDA). During the course of the study and after its completion, the research team will send 
de-identified data to the NDA repository where it will be stored and managed. Additionally, 
any necessary study data will be transmitted accordingly to Clinicaltrials.gov. 
 

 
  
 
18
8.4 Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
The investigative team will implement a data and safety monitoring plan to ensure the safety 
of study participants and their families and to ensure the integrity of the data collected. 
Research staff will provide reports of preliminary data and adverse events to the project 
Data and Safety Monitoring Board (DSMB) and on an annual basis throughout the duration 
of the study. The DSMB will be overseen by clinical investigators TBN from the CHOP 
Research Institute who are not investigators on the study.  
 
The DSMB will meet annually to review data integrity and patient safety, particularly with 
regards to reports of child maltreatment. The DSMB will make determinations regarding 
additional procedures to implement to protect the safety of study participants and to ensure 
integrity of data. The DSMB will also review current study procedures with regards to 
participant recruitment, retention, intervention procedures, and study measures and make 
recommendations to reduce participant burden and ensure the timely and efficient 
completion of study milestones. In the unlikely event of an adverse outcome associated with 
this study protocol, e.g. disclosure of patient information, it will be documented and 
discussed with the research team, and reported to the CHOP IRB and the NIMH, if 
appropriate, on an annual basis. Any serious adverse events, e.g. substantiated reports of 
child maltreatment or suicidality, will be reported to the CHOP IRB, the DSMB, and to 
NIMH within one business day of discovery (telephone, fax, email, eIRB) with a full report 
submitted in eIRB within 48 hours of the initial notification.  In addition, appropriate 
agencies, e.g. Child Protective Services, will be promptly notified of any serious adverse 
events to comply with mandated reporting requirements.  
8.4.2 Risk Assessment 
The research involves the collection of sensitive and protected health information from 
participants. The risk of participation is considered minimal. There is a potential risk of 
breach of confidentiality of information and study results about individuals. This risk is 
minimized by measures taken by the study team to ensure confidentiality: use of secure files, 
storing data on secure computers, using unique study identifiers, de-identification of data 
prior to analysis, and obtaining a Certificate of Confidentiality through NIH. A second risk 
is that participants may become uncomfortable in completing study measures. If this occurs, 
the protocol will allow participants to stop at any time. Should any specific concerns arise 
throughout the project period, the CHOP IRB will be promptly informed. Since the purpose 
of the intervention is to help women improve their parenting skills, we expect that adverse 
consequences due to the intervention will be extremely rare and unlikely. However, we 
recognize that there is a risk of suicidality, worsening depression, and child maltreatment 
among this population, so we will monitor for suicidality, worsening depression, and child 
maltreatment at all study visits, contacts, and intervention procedures with participants.  
 
Should suicidality or worsening depression be identified, we will implement a suicide 
prevention and depression treatment plan to assess immediate risk for harm and secure 
treatment. Should child maltreatment be suspected, we will implement a child abuse 
reporting plan to comply with all mandated reporting laws. 

 
  
 
19
8.4.3 Potential Benefits of Trial Participation 
Participating mothers may benefit directly from inclusion in this study if their depressive 
symptoms and parenting are improved as a result of the parenting intervention. In addition, 
participating infants may benefit directly from the study if their interactions with their 
mothers are improved as a result of the intervention. However, these benefits cannot be 
guaranteed. This parenting intervention may be replicated and scaled up in different care 
settings and thus generate generalizable knowledge.  Further, the information obtained will 
be disseminated as widely as possible, including publication in peer-reviewed journals and 
policy briefs and presentations at scientific and lay conferences.  
8.4.4 Risk-Benefit Assessment 
Given the minimal risk nature of the study, the risks are considered reasonable in relation to 
the potential benefit to be gained.  
8.5 Recruitment Strategy 
Potentially eligible urban pediatric practices affiliated with CHOP have all implemented 
PPD screening using the Edinburgh Postnatal Depression Scale at 1-, 2-, and 4-month well 
child visits. Eligible women who screen positive for PPD at their infant’s well child visit at a 
participating practice will be asked for permission for contact at the time of an office visit 
using an electronic recruitment tool. This tool permits clinicians to obtain permission for 
contact from eligible women at an office visit and to refer eligible patients to research staff. 
Electronic recruitment tools have become standard practice at CHOP and facilitate 
recruitment of patients across multiple studies. The electronic recruitment tool is an alert in 
EPIC that indicates that because the mother screened positive for PPD, she and her child 
may be eligible for a research study. If the mother provides permission to be contacted, her 
contact information will be sent securely through CHOP BusinessObjects to study staff. 
Those who consent for contact will be recruited by telephone by research staff who will 
explain the aims of the study, the nature of participation, risks and benefits of the study, and 
the voluntary nature of participation. Families who express interest based on this recruitment 
phone call will then be scheduled for an in-person meeting to complete written informed 
consent at their participating practice or a location of their choice before enrolling in the 
study. In the event that the baseline visit cannot be completed in-person, an alternative 
method of obtaining informed consent will be used. Following the telephone screen, 
caregivers of eligible children will be sent the informed consent document electronically 
through REDCap. The study team will then go over the document in detail with the eligible 
caregiver by phone. The e-consent function in REDCap will be used to obtain the 
caregiver’s signature. The signed e-consent will then be stored within REDCap, and a copy 
of the form will be available to download and emailed securely to the caregiver.  
Participants will only be randomized to treatment arms following informed consent. We will 
maintain enrollment data on the number of potentially eligible women who present at each 
practice, the proportion who consent for contact, and the proportion who enroll in the study 
in order to ascertain whether our recruitment strategy is successful.  
 
Among eligible urban practices in 2016, there were 250 women who screened positive for 
PPD. We would need to recruit 75 (30%) eligible mother-child dyads in phase 1 and 75 

 
  
 
20
(30%) eligible mother-child dyads in phase 2 of the study. This translates into 1-2 
participants being enrolled per week, which is similar to the number we successfully 
recruited into our preliminary pilot trial using the above recruitment strategy. We will 
monitor recruitment weekly by reviewing the proportion of eligible participants who consent 
for contact among those who screen positive for PPD at office visits and the proportion of 
participants who enroll in the study among those who consent for contact. We will also 
monitor the race/ethnicity of enrollees to ensure that we are achieving a sample 
representative of the participating practices (see enrollment tables). Should enrollment lag, 
we will consider expanding recruitment from 3-4 practices to all 6 urban pediatric practices 
affiliated with CHOP. We will also consider implementing in-person recruitment at offices 
should consent for contact lag. 
8.6 Informed Consent/Assent and HIPAA Authorization 
Following the screening via review of the medical record, eligibility for study participation 
will be explained via phone. During the research staff visit subsequent to the screening 
process, written informed consent will be completed. Research staff will discuss the study 
aims, procedures, risks and benefits, alternatives to participation, and confidentiality 
protocols with the parent. Research staff will speak to the parent about the voluntary nature 
of participation and provide the potential subject with the opportunity to ask questions about 
the study and its risks and benefits. Families who express interest based on this recruitment 
phone call will then be scheduled for an in-person meeting to complete two copies of the 
informed consent form: one will be kept for study purposes and the other will be provided to 
the consenting parent. In the event that the baseline visit cannot be completed in-person, an 
alternative method of obtaining informed consent will be used. Following the telephone 
screen, caregivers of eligible children will be sent the informed consent document 
electronically through REDCap. The study team will then go over the document in detail 
with the eligible caregiver by phone. The e-consent function in REDCap will be used to 
obtain the caregiver’s signature. The signed e-consent will then be stored within REDCap, 
and a copy of the form will be available to download and emailed securely to the caregiver.  
In order to give parental permission for the child to participate, the consenting mother must 
be at least 18 years old. Parents will be provided with plenty of time to ask questions and to 
decide whether they want to participate. Parents will be explicitly instructed that they are 
free to choose to participate and that their decision to participate will not affect the health 
care they or their children receive at participating practices.  
8.7 Payment to Subjects/Families 
8.7.1 Reimbursement for travel and parking 
Transportation with Lyft will be arranged for participants who have a car seat for Study 
Visits 1 and 4 through CHOP’s Family and Visitor services. In the event that the participant 
does not have a car seat, the participant will be reimbursed on their Clincard for their 
roundtrip travel based on mileage.  
 
8.7.2 Compensation for cellular data charges 
Participants will be compensated $50 a month for 3 months of cellular data charges. 

 
  
 
21
8.7.3 Payments to parent for time and inconvenience (i.e. compensation) 
Participants will be compensated $50 for completion of their baseline surveys, $5 a month 
for completion of three months for the monthly surveys, and $50 for completion of their 3-
month surveys. All payments will be made in the form of pre-paid, CHOP-issued debit 
cards. Additionally, if participants choose to arrange their own transportation to study visits, 
the study team will provide a courtesy parking pass that will be given to them at the time of 
the visit.    
8.7.4 Gifts 
No other gifts will be given.  
 
9 
PUBLICATION 
This study will be registered with ClinicalTrials.gov following IRB approval of the final 
protocol and before any potential patients and their families are enrolled in the study. All 
study data will then be reported to the ClinicalTrials.gov site. Additionally, all arising 
publications of Study data and analyses will follow the set of guidelines outlined in the 
CHOP publications policy manual. 
 
The research team plans to work closely with key stakeholders to disseminate and 
implement the findings of the research study into accessible and usable formats in research, 
clinical, and community-based settings. We will target findings to state and national 
policymakers, county EI agencies across the state, parent advocacy groups, and pediatric 
practices using social media, policy briefs, mass emails, and newsletters. We will work with 
PolicyLab at CHOP to develop dissemination plans. PolicyLab has extensive experience 
distilling research findings into policy-relevant summaries and disseminating research 
findings to end-users. We will also utilize traditional approaches such as peer-reviewed 
publications and presentations at national meetings to disseminate findings to other 
researchers. 

 
  
 
22
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APPENDIX 
See attached.