Digital Literacy Promotion Among Medicaid Children
Phase: NA
Conditions: Language Development, Literacy
Sponsor: Children's Hospital of Philadelphia

 
Digital Literacy Promotion among Medicaid Children v.14 8.10.2018 
Title: 
Digital Literacy Promotion among Medicaid Children 
 
Short Title 
 Digital Literacy Promotion 
Sponsor: 
Vanguard Charitable Endowment Program 
eIRB Number: 
16-013524 
Protocol Date: 
August 10, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
James Guevara MD, MPH 
Division of General Pediatrics 
The Children’s Hospital of Philadelphia 
Telephone: 215-590-1130 
Fax: 267-426-0380 
Email: Guevara@email.chop.edu 
 
 

2 
 
 
 
 
 
 
 
 
TABLE OF CONTENTS 
 
 
Abbreviations and Definitions of Terms 
3 
Abstract 
4 
 
 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
 
 
 
 
 
    6 
1.1 
INTRODUCTION 
6 
 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION 
6 
 
1.3 
RELEVANT LITERATURE AND DATA 
6 
 
1.4 
COMPLIANCE STATEMENT 
7 
 
2 
STUDY OBJECTIVES  
 
 
 
 
 
 
 
 
    8 
2.1 
PRIMARY OBJECTIVE (OR AIM) 
8 
 
2.2 
SECONDARY OBJECTIVES (OR AIM) 
8 
 
3 
INVESTIGATIONAL PLAN 
 
 
 
 
 
 
 
 
    8 
 
3.1 
GENERAL SCHEMA OF STUDY DESIGN 
8 
 
3.1.1 
Randomized Control Trial 
8 
 
3.1.2 
Video Sub-study 
10 
3.1.3 
Screening Phase 
11 
      3.1.3.1    Randomized Control Trial 
11 
     3.1.3.2    Video Sub-study 
11 
3.1.4 
Randomized Trial Treatment Phase (start of the study intervention) 
12 
 
3.1.5 
Video Sub-study Treatment Phase (start of the study intervention) 
13 
 
 
 
 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING 
      13 
 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES 
13 
 
3.3.1 
Duration of Study Participation 
13 
3.3.2    Total Number of Study Sites/Total Number of Subjects Projected 
13 
 
 
3.4 
STUDY POPULATION 
13 
 
3.4.1 
Randomized Control Trial 
14 
     3.4.1.1    Inclusion Criteria 
14 
             3.4.1.2    Exclusion Criteria 
14 
3.4.2 
Video Sub-study  
14 
     3.4.2.1    Inclusion Criteria 
14 
             3.4.2.2    Exclusion Criteria 
15 
 
 
 
4 
STUDY PROCEDURES  
 
 
 
 
 
 
 
 
  15 
4.1 
SCREENING /CONSENTING VISIT AND STUDY VISIT 1 
15 
 
4.2 
STUDY TREATMENT PHASE 
15 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
 
 
 
 
 
 
  16 

3 
 
 
 
 
 
 
 
 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS 
16 
 
5.1.1 
Parent Adversity (ACE) 
16 
 
5.1.2 
Parent Health Literacy (SAHL) 
16 
 
5.1.3 
Parent Depressive Symptoms (EPDS) 
16 
 
5.1.4 
Reading Activity (StimQ) 
16 
 
5.1.5    Early Reading Practices Questionnaire (ERPQ)                                                                            17 
5.1.6    Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) 
17 
5.1.7    Dialogic Reading Behaviors – Infant (DialogPR-I) 
17 
5.1.8    Demographic Questionnaire 
17 
5.1.9    Standard Text Messages 
17 
5.1.10  Audio-recording and Videotaping of Interviews 
17 
6 
STATISTICAL CONSIDERATIONS  
 
 
 
 
 
 
  17 
6.1 
PRIMARY ENDPOINT 
           17 
 
6.2 
SECONDARY ENDPOINTS 
18 
 
6.3 
STATISTICAL METHODS 
18 
 
 
 
7 
SAFETY MANAGEMENT  
 
 
 
 
 
 
 
  19 
7.1 
CLINICAL ADVERSE EVENTS 
19 
 
7.2 
ADVERSE EVENT REPORTING 
19 
 
 
 
8 
STUDY ADMINISTRATION 
 
 
 
 
 
 
 
  19 
8.1 
DATA COLLECTION AND MANAGEMENT 
19 
 
8.2 
CONFIDENTIALITY 
19 
 
8.3 
REGULATORY AND ETHICAL CONSIDERATIONS 
           20 
 
8.3.1 
Data and Safety Monitoring Plan 
20 
 
8.3.2 
Risk Assessment 
20 
 
8.3.3 
Potential Benefits of Trial Participation 
21 
 
8.3.4 
Risk-Benefit Assessment 
21 
 
8.4 
RECRUITMENT STRATEGY 
21 
    8.4.1    Randomized Control Trial 
21 
    8.4.2    Video Sub-study 
22 
 
8.5 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION 
22 
 
8.6 
PAYMENT TO SUBJECTS/FAMILIES 
23 
 
8.6.1 
Payments to parent for time and inconvenience (i.e. compensation) 
23 
 
8.6.2 
Gifts 
23 
 
 
9 
PUBLICATION 
 
 
 
 
 
 
 
 
 
   24 
10 
REFERENCES 
 
 
 
 
 
 
 
 
 
   26 
       APPENDICES                                                                                                                      28 
 
 

4 
 
 
 
 
 
 
 
 
    ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
ROR 
 
Reach Out and Read 
ACE 
 
Adverse Childhood Experiences 
SAHL 
 
Short Assessment of Health Literacy 
EPDS 
 
Edinburgh Postnatal Depression Scale 
StimQ 
ERPQ 
 
Measure of Cognitive Stimulation Provided in the Home 
Early Reading Practices Questionnaire  
BSID-III 
 
DialogPR-I 
 
 
Bayley Scales of Infant and Toddler Development, Third 
Edition 
Dialogic Reading Practices- Infant, parent-report pilot 
measure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

5 
 
 
 
 
 
 
 
 
ABSTRACT 
Context:   
Reach Out and Read (ROR) has become a standard evidence-based primary care practice to 
support early literacy development of young at-risk children. It utilizes board books which are 
distributed at pediatric well visits along with literacy promotion and reading modeling by 
pediatricians. However, digital reading utilizing e-books and apps for reading on electronic 
devices has become popularized. We would like to address the important question of whether 
digital reading with e-books is as effective as reading with standard board books on early 
development. For this 18-month investigation, we propose to recruit 100 parent-infant dyads 
from 3 CHOP primary care pediatric practices (Indian Valley, Cobbs Creek and Roxborough). 
Healthy infants at least five months of age who are Medicaid eligible and whose parents have 
access to smart phones and other mobile digital devices at those practices would be recruited and 
randomized 1:1 to early literacy promotion using either 1) standard early reader board books or 
2) digital electronic early reader books (e-books). Books would be distributed at 3 time points to 
coincide with well visits up to 13 months of age. Outcomes corresponding to reading behaviors 
(quantity and quality of joint reading) would be measured approximately 1 month after the 6, 9, 
and 12 month well visits. Child development would be measured when the child is between 12 
and 18 months, 30 days of age. A subset of up to 40 parent infant dyads will be recruited to 
participate in a videotaped interaction while reading both an e-book and standard board book. 
Parent and child behaviors during the reading task will be coded and analyzed for differences 
across book type.   
 Objectives:  
1) To test the effects of digital versus standard literacy promotion on early development 
using a randomized controlled trial design. 
2) To explore the reading practices and reading activities among children and their 
parents when comparing the use of e-books to traditional board books. 
3) To identify themes regarding dialogical reading behaviors among parents 
participating in the Video Sub-study. 
Study Design:  
A randomized controlled trial will be conducted comparing digital versus standard literacy. 
Participants will be stratified by clinic site and randomized to receive literacy promotion using 1) 
standard early reader board books or 2) digital electronic early reader e-books. Randomization 
sequences will be developed by the project biostatistician using computer-generated random 
numbers prior to enrollment and will be placed in sealed opaque envelopes. Randomization will 
ensure equivalence between groups on measured and unmeasured characteristics and is 

6 
 
 
 
 
 
 
 
 
considered to be the strongest protection against bias in study design. A total of 40 participants 
will be recruited between 9 and 12 months of age for the videotaped interaction and interview.  
Setting/Participants: 
In the randomized control trial, we will recruit and consent one hundred eligible parent-infant 
dyads, with the infant being between 5 and 7 months of age at enrollment. Eligible participants 
must have Medicaid insurance coverage, access to one of the three CHOP Care Network 
practices (Cobbs Creek, Roxborough and Indian Valley) for this 18-month trial. The video sub-
study will recruit up to 40 eligible parent-infant dyads. Eligible participants will be recruited 
from both the randomized control trial as well as external to the larger trial from a participating 
clinic. Eligible participants must have Medicaid insurance coverage, access to a digital device, 
and present to one of the three CHOP Care Network practices (Cobbs Creek, Roxborough and 
Indian Valley). 
Study Interventions and Measures:  
In this intervention, parent-infant dyads randomized to the digital arm will receive 
developmentally appropriate e-books. Those randomized to the standard arm will receive 
developmentally appropriate board books. Participants will receive either the e-book or board 
book for their 6, 9 and 12 month well visits. The developmentally appropriate books selected for 
each of the 3 well visits are as follows: Dr. Seuss’ Hop on Pop for the 6 month well visit, Sandra 
Boynton’s Barnyard Dance for the 9 month well visit, and Margaret Wise’ Goodnight Moon for 
the 12 month well visit.  
In addition to the books, parent-infant dyads in both arms will be provided information on the 
importance of early parent-child reading activity by pediatric clinicians using the Reach Out and 
Read framework. 
We will collect standard measures of demographics (child age, sex, race/ethnicity, maternal age, 
family structure, maternal education level, and family income category), maternal adversity (9 
ACE questions), maternal health literacy (SAHL), and maternal depressive symptoms (EPDS) at 
baseline. About 1 month after the infant has, or is age-eligible for, their 6 and 9 month well visits 
we will collect measures of reading activity (StimQ and ERPQ). Roughly 1 month after the 
infant has, or is age eligible for, their 12 month well visit, the infant will receive a developmental 
assessment (BSID-III), along with additional measures of reading activity (StimQ, ERPQ). They 
will additionally complete the paper-based DialogPR-I at this visit. A video recorded reading 
task will be obtained for up to 40 participants. These participants will be asked preliminary 
questions about their reading practices at home at the time of the video session.  
 

7 
 
 
 
 
 
 
 
 
1 BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Children who receive Medicaid are more likely to be at increased risk for language and cognitive 
delays. Such delays can lead to poor school readiness and disparities in educational outcomes 
when compared to children from middle and upper income strata. Reach Out and Read (ROR), a 
national program which promotes parent-child reading activities for children 6 months through 5 
years of age at pediatric well child visits, has been shown to improve at-risk children’s 
expressive and receptive language development. However, children who participate in ROR still 
demonstrate language outcomes that are below national averages. It is not clear whether digital 
literacy promotion, i.e. promotion of parent-child reading with the use of e-books, is as effective 
as standard literacy promotion and if it could improve poor urban children’s language and 
cognitive outcomes. 
The disparities that continue to exist among language development despite literacy promotion 
efforts suggest that other barriers and factors may exist that influences these disparities. While it 
has been demonstrated that reading to infants is imperative for appropriate language 
development, the differences between reading to children in an e-book format versus a standard 
board book format have not been explored. In a growing digital age access to e-books is ever 
present and investigating potential differences in early literacy outcomes is beneficial for 
families and pediatricians.  
 
1.2 
Name and Description of Investigational Product or Intervention 
The intervention will be an adapted version of the Reach Out and Read (ROR) Program, a 
national program that promotes parent-child reading activities for children 6 months through 5 
years of age at pediatric well child visits. It will be adapted for use with parents of children from 
5 to 18 months, 30 days. Digital literacy promotion will consist of the provision of 
developmentally appropriate standard and digital books selected specifically for all well visits 
from 5 months of age onwards. In this instance we define standard as the use of age appropriate 
board books in literacy promotion initiatives and digital as the use of mobile app based e-book 
versions of the same board books. It will also include follow-up contact with the parent to 
ascertain whether or not they encountered issues with the apps functioning, reminders to 
schedule and/or attend upcoming well visits, and for some parents, an interview and video 
recorded reading task with their infant.  
1.3 
Relevant Literature and Data 
Early childhood is a critical period in which young children attain developmental skills necessary 
for language function.1 Early stimulation of brain centers involved in language development 

8 
 
 
 
 
 
 
 
 
promotes critical neuronal connections leading to growth in language functioning. Unfortunately, 
language delays are common among children under age 3 years, particularly for children residing 
in impoverished communities.2 The cause of these language delays are multifactorial but in part 
result from deficits in parent-child verbal interactions.3 Twelve to sixteen percent of young 
children are estimated to have delays that affect language development.4,5 Differences between 
poor and advantaged children in language processing skills and vocabulary are evident by 18 
months of age.6 These delays contribute to social and emotional problems and result in poor 
educational and functional outcomes.7 Lifetime costs for individuals with developmental 
disabilities including language deficits has been estimated to exceed $60 billion in 2003 U.S. 
dollars.8  
Parent-child dialogic reading represents an important source of language stimulation and is rich 
in verbal interactions that can stimulate language development.9 Studies have found parent-child 
reading to be associated with improved language functioning and better school performance.10-12 
Based on this observation, the ROR Program was established to promote parent-child reading 
activity. ROR is based in pediatric clinical settings and provides developmentally appropriate 
books to young children and encourages a discussion of the importance of reading by pediatric 
clinicians at well child visits from 6 months through 5 years.13 Evaluations of ROR have shown 
beneficial effects on reading activity and language outcomes.14-16 These effects translate into an 
increase of 1 day/week of parent-child reading activity, a 4-fold increased likelihood of reporting 
reading  to their child,  and a 4 to 9 point increase in expressive and receptive language scores 
respectively (a 3-6 month advance in language) 16 For this reason, the American Academy of 
Pediatrics has recommended that pediatric clinicians promote early literacy development 
beginning in infancy.17 
 
Electronic or e-books for children have grown in popularity. They come in a number of 
formats including Nooks, Kindles, and iPads as well as a number of digital apps that are used on 
smart phones and tablets. They permit children to follow along with stories, activate games and 
sounds, and listen to music. Their popularity may be related to parental beliefs that e-books help 
promote child intellectual development.18 However, a recent study examining reading behaviors 
and comprehension among children using e-books found that e-books were associated with fewer 
dialogic language behaviors and lower reading comprehension compared to traditional books.19 
However, the study was limited by only enrolling middle to upper income preschool-aged 
children, so it isn’t clear that the findings are generalizable to younger children from low-income 
households. 
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. All episodes of noncompliance will be documented. 

9 
 
 
 
 
 
 
 
 
The investigators will perform the study in accordance with this protocol, will obtain consent and 
assent, 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 
2.1 
Primary Objective  
The primary objective of the study is to discover the effects of language development of young, 
at-risk children in digital versus standard literacy promotion using a randomized controlled trial 
design. In this instance we define standard as the use of age appropriate board books in literacy 
promotion initiatives and digital as the use of mobile app based e-book versions of the same 
board books in a literacy promotion intervention. 
Specific Aim 1: To determine the comparative effectiveness of digital literacy promotion to 
standard literacy promotion on early development among young Medicaid eligible children in the 
Philadelphia metropolitan area. 
2.2 
Secondary Objectives  
Specific Aim 2: To explore the reading behaviors and reading activities among children and their 
parents when comparing the use of e-books to standard board books. 
Specific Aim 3: To identify themes regarding dialogical reading behaviors among parents 
participating in the Video Sub-study.  
Specific Aim 4: To explore the impact of digital literacy on healthcare utilization 
3 INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
3.1.1 Randomized Control Trial 
We propose to test the effects of digital versus standard literacy promotion using a randomized 
controlled trial design. One-hundred eligible parent-child dyads, with infants between 5 and 7 
months of age, who present to one of the three CHOP Care Network practices (Cobbs Creek, 
Roxborough and Indian Valley) will be recruited and consented to participate in this 18-month 
long study. Participants will be stratified by clinic site and randomized to receive literacy 
promotion using 1) standard early reader board books or 2) digital electronic early reader e-
books. Randomization sequences will be developed by the study team using computer-generated 
random numbers prior to study enrollment and will be placed in sealed opaque envelopes. 

10 
 
 
 
 
 
 
 
 
Randomization will ensure equivalence between groups on measured and unmeasured 
characteristics and is considered to be the strongest protection against bias in study design.  
Participants randomized to the digital arm will receive the e-book version of Dr. Seuss’ Hop on 
Pop for the 6 month well visit, Sandra Boynton’s Barnyard Dance for the 9 month well visit, and 
Margaret Wise’ Goodnight Moon for the 12 month well visit. Additionally they will receive 
information on the importance of early parent-child reading activity by pediatric clinicians using 
the Reach Out and Read framework. The appropriate e-books will be electronically gifted to the 
participants. Parents must have an appropriate mobile digital device such as a smart phone or 
tablet to download and open the digital e-books. 
Participants randomized to the standard arm will receive the board book versions of Dr. Seuss’ 
Hop on Pop for the 6 month well visit, Sandra Boynton’s Barnyard Dance for the 9 month well 
visit, and Margaret Wise’ Goodnight Moon for the 12 month well visit. Furthermore, participants 
will be provided information on the importance of parent-child reading activity by pediatric 
clinicians using the Reach Out and Read framework.  
Participants in both study arms will be followed every 3 to 4 months until the infants are between 
the ages of 12 and 18 months, 30 days. Information on reading activities and developmental 
outcomes will be collected in concert with scheduled well child visits. Differences in reading 
activities and developmental outcomes will be assessed between groups using intention-to-treat 
analysis. Parents will complete measures of demographics, health literacy, and maternal 
depressive symptoms at baseline. Parents will also complete measures of reading activity with 
their infant about 1 month after the child has, or is age-eligible for, their 6, 9, and 12 month well 
visits. The infant will also receive a developmental assessment at the second study visit which 
will happen about 1 month after they have, or are age-eligible for, their 12 month well visit. At 
this time the infant should be between 12 and 18 months, 30 days old. Secondary data to address 
these study questions does not exist, which will necessitate the collection of new data as 
proposed here. We anticipate that this collection of rich new data will support a careful 
assessment of the effects of digital vs. standard literacy promotion.  The HER will be reviewed 
for children in both arms to count the number of well child visits and examine their vaccination 
history. 
We anticipate collecting this data in conjunction with well child visits. In our experience, low-
income families can be difficult to reach for study visits, even with appropriate study incentives. 
By coordinating data collection with the 6, 9, and 12 month well child visits timeframes, we can 
increase the probability of families attending both the well visits (to receive the Reach Out and 
Read Program materials) and the study visits (to collect measures of reading activity and 
development). In a previous study of 2100 children enrolled in a study of developmental 
screening, we were able to achieve a >90% follow-up rate by coordinating data collection with 
well child visits. In addition, our research staff can check the clinic schedule to ensure families 
have made timely well child visit appointments and then make reminder calls to families prior to 
these visits to encourage parents to attend. Study visits will be held at a location that is preferred 

11 
 
 
 
 
 
 
 
 
and most convenient for the parent, including but not limited to: the clinic, a separate CHOP-
based facility, the Temple Infant and Child Lab, or another location based on availability and 
parent preference. 
 
3.1.2 Video Sub-study 
Up to 40 participants will be additionally recruited to participate in an interview and video 
recorded reading task. Participants will be recruited both from the larger RCT as well as from 
external sources (see Section 8.4). Dyads enrolled in the randomized control trial who agreed to 
participate in the sub-study at the time of their initial consent, and who are in the control 
(Traditional board book) arm, will be approached by telephone call, or the method of 
communication that they prefer, immediately following the time that they become age-eligible 
for their 9-month well visit. Participants meeting eligibility criteria and recruited external to the 
randomized control trial will be approached for participation at clinic appointments at one of the 
study sites. Participants will be continuously recruited until either the enrollment goal (40 dyads) 
is reached or until saturation of themes is achieved for this qualitative sub-study. Sessions, 
lasting approximately 45 minutes, will be held at a location that is preferred and most convenient 
for the parent, including but not limited to: the clinic, a separate CHOP-based facility, the 
Temple Infant and Child Lab, or another location based on availability and parent preference. 
For participants recruited from the larger study, no additional demographic data will be 
collected, as it will be accessed from the previously reported data. Participants recruited 
externally for the sub-study will complete the demographic and screening questionnaires that 
were previously collected by the larger study participants upon enrollment. These externally 
recruited participants will not participate in or be consented for participation in the larger 
randomized control trial. 
On the day of the video sub-study session, all parents (regardless of whether or not they were 
recruited from within or external to the main RCT) will first be instructed to read a book with 
their child. This reading task will be video recorded by a member of the study staff. Parents will 
be asked to read to their child in the same manner that they had learned from their provider 
during their well-child check as part of Reach Out and Read. Parents will be receiving this 
instruction on dialogic reading, regardless of study arm, as part of the larger study. The selected 
book will be Sandra Boynton’s Barnyard Dance, which is the same book that the participants 
recruited from the main RCT study will have received for their 9-month well visit. All 
participants will read the same book with electronic books provided on a tablet device. 
Participants will be randomized on the order they read the types of books (print book, basic e-
book and enhanced e-book).  
Following the video-recorded reading tasks, all parents will participate in a 20-minute, semi-
structured, audio-recorded interview with a member of the study staff. An interview guide will 
be developed and piloted with parents of infants prior to use within the study. In the interview, 

12 
 
 
 
 
 
 
 
 
parents will be asked their behaviors (frequency, duration, style) and perceptions on reading to 
their infant and whether this would vary based on using print books and electronic books. All 
participants will be asked the same questions.  
 
3.1.3 Screening Phase 
3.1.3.1 
Randomized Control Trial 
About 16% of the children seen at CHOP Primary Care Roxborough, 21% of those seen at 
CHOP Primary Care Indian Valley and 50% of those seen at CHOP Cobbs Creek have Medicaid. 
Children will be eligible to participate in this study if they were born ≥35 weeks estimated 
gestational age, without neurodevelopmental disabilities or congenital malformations, with 
Medicaid insurance (proxy measure for poverty), and at least 4 months of age at the time of 
enrollment. Children who are born premature <35 weeks EGA, who have neurodevelopmental 
disabilities, or who have congenital malformations are at increased risk of language delays and 
will be excluded. In addition, we will exclude families who do not speak English or Spanish, as 
the main measures of reading activity (StimQ, Appendix 5) and language development (Bayley 
Scales of Infant Development-III, Appendix 7) are only available in English and Spanish.  
Potential subjects will be identified at the time of their four month well child visit using the 
electronic health record (EHR). The pediatrician or nurse overseeing the wellness visit will 
receive a notification to inquire whether the parent-child dyad would be interested in 
participating in the study. If the parent indicates interest, one of our research staff will be in 
contact to explain the study procedures, and arrange to meet with the parent-child dyad at a time 
before their 6 month wellness visit while the child is between 5 and 7 months of age. Research 
staff will obtain written informed consent from participants. Participants will be randomized to 
either the digital literacy arm or the standard literacy arm based on random assignment. 
Randomization sequences will be developed by the study team using computer-generated 
random numbers prior to study enrollment and will be placed in sealed opaque envelopes. 
Randomization will ensure equivalence between groups on measured and unmeasured 
characteristics and is considered to be the strongest protection against bias in study design.  
 
Written informed consent will be obtained in person prior to any study related procedures being 
performed. The consenting process will include a discussion of study rationale, procedures, 
measures, benefits, risks, and alternatives to participation. After consent, subjects will either be 
assigned to the digital literacy arm or the standard literacy arm of the study. Regardless of their 
assignment, once they have consented to participate, they will complete a demographic 
questionnaire (Appendix 1), questionnaires about adverse childhood experiences (Appendix 2) 
and health literacy (Appendix 3), and the Edinburgh Postnatal Depression Scale (EPDS) 
(Appendix 4). 

13 
 
 
 
 
 
 
 
 
3.1.3.2 
Video Sub-study 
Children will be eligible to participate in this sub-study if they were born ≥35 weeks estimated 
gestational age, without neurodevelopmental disabilities or congenital malformations, with 
Medicaid insurance (proxy measure for poverty), and, for participants being recruited externally, 
at least 9 months and 0 days and no more than 12 months and 0 days at the time of enrollment. 
As in the randomized control trial, children who are born premature <35 weeks EGA, who have 
neurodevelopmental disabilities, or who have congenital malformations will be excluded, as they 
are at increased risk of language delays. In addition, we will exclude families who do not speak 
English for this sub-study, as resources are not available in this pilot to execute and code video 
data in additional languages. 
Potential subjects will be identified from 1) participants in the randomized control trial that 
previously consented to participate in the sub-study, were randomized into the control group 
(traditional board book arm), and are age-eligible for their 9 month well visit, and 2) eligible 
patients recruited from the Cobbs Creek clinic who are 9 to 12 months old. For participants 
recruited external to the randomized control trial, study staff will identify eligible participants 
and, when on-site at the time of the appointment, approach participants in person at the clinic 
before or after their appointment with the clinician. At that time, a member of our study staff will 
explain the study procedures and consent the parent and infant for participation. The consenting 
process will include a discussion of study rationale, procedures, measures, benefits, risks, and 
alternatives to participation. Once they have consented to participate, they will complete a 
demographic questionnaire (Appendix 1), questionnaires about adverse childhood experiences 
(Appendix 2) and health literacy (Appendix 3), and the Edinburgh Postnatal Depression Scale 
(EPDS) (Appendix 4). They will also schedule the parent and child for a study visit at that time if 
the parent is able. Parents who are unable to be scheduled for participation at that time will be 
contacted by study staff via telephone to schedule the study visit.  
3.1.4 Randomized Controlled Trial Treatment Phase (start of the study 
intervention) 
Once recruited and enrolled, the parent-child dyads will be randomized into either the digital or 
standard literacy arm. Parent-infant dyads randomized to the digital literacy arm will receive the 
digital e-book version of Dr. Seuss’ Hop on Pop for the 6 month well visit, Sandra Boynton’s 
Barnyard Dance for the 9 month well visit, and Margaret Wise’ Goodnight Moon for the 12 
month well visit. Moreover, they will receive information on the importance of early parent-child 
reading activity by pediatric clinicians. Information on early literacy will be standardized and 
age-based and will be provided to parents by pediatric clinicians at the well visits. 
 
Parent-infant dyads randomized to the standard literacy arm will receive Dr. Seuss’ Hop on Pop 
for the 6 month well visit, Sandra Boynton’s Barnyard Dance for the 9 month well visit, and 
Margaret Wise’ Goodnight Moon for the 12 month well visit. In addition, they will be provided 
information on the importance of parent-child reading activity by pediatric clinicians. 

14 
 
 
 
 
 
 
 
 
Information on early literacy will be standardized and age-based and will be provided to parents 
by pediatric clinicians at the well visits. This conforms to the ROR National Program 
recommendations and is considered standard of care at these 3 clinics. 
To prevent contamination in which pediatric clinicians inadvertently provide books and 
instruction on reading activity to the different arms of the study, an automated alert will appear 
on the screen of the eligible child’s EHR at each well visit with a reminder to the health 
professional. This will ensure that books and reading instructions are consistent with their 
assigned study arm. Phone call or text message reminders will be used throughout the course of 
the study. The initial reminder will be made within the first week to participants in the digital 
literacy arm to verify that the participant was able to download the e-book if this was not already 
confirmed during the initial visit. Another reminder will be sent out about 1 month after the 
infant has, or is age-eligible for, their  6, 9 and 12 month well visit, either to remind the 
participant to complete the emailed REDCap survey, or for other study-related reminders.  
Children in both study arms will be followed every 3 to 4 months until they are between 12 and 
18 months, 30 days. Parents will complete study measures consisting of demographic 
characteristics, postpartum depression symptoms, health literacy, and adverse childhood 
experiences at the initial study visit. Parents will complete measures of reading activity at 
baseline, and via the REDCap survey sent by email, or completed in person, about 1 month after 
the infant has, or is age-eligible for, their 6, 9 and 12 month well visits. Differences in reading 
activities and language outcomes will be assessed between groups using intention-to-treat 
analysis. 
 
Parents of children who are participating in the study will be informed of the results of their 
BSID-III testing in writing and/or by phone. Those whose child scores less than 1.5 standard 
deviations below the mean will be informed that their child's development is within the average 
range. Parents whose child scores 1.5 standard deviations or greater below the mean will be 
informed that their child is exhibiting delays in an area of their development. In addition, we will 
recommend that the parent inform their child's clinician of the results. 
3.1.5 Video Sub-Study Treatment Phase (start of the study intervention) 
Parents and their infant who are enrolled to participate in the video recorded task will be 
observed during an unstructured reading task, using both an e-book and a standard book, in a 
pre-scheduled visit, outside of their primary care visits. They will not receive any additional 
instruction at this visit. Parents will also participate in a brief, semi-structured interview 
following the reading task. 
3.2 
Allocation to Treatment Groups and Blinding 
Participants will be stratified by clinic site and randomized to receive literacy promotion using 1) 
standard early reader board books or 2) digital electronic early reader e-books. Randomization 
sequences will be developed by the study team using computer-generated random numbers prior 

15 
 
 
 
 
 
 
 
 
to study enrollment and will be placed in sealed opaque envelopes, assigning participants to one 
of the two treatment arms.  
Participants in the video sub-study will also be randomized to determine the order in which they 
are asked to read the three versions of the selected book (print, basic e-book, enhanced e-book). 
As with the larger trial, randomization sequences will be developed by the study team using 
computer-generated random numbers prior to study enrollment and will be placed in sealed 
opaque envelopes, assigning participants to receive one of the six possible orders of the three 
book types. 
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration for the randomized control trial per subject will be approximately 7 months 
following enrollment. The study duration for the video sub-study will be one day of 
participation. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The randomized control trial will be conducted at three CHOP Care Network Practices: 1) 
Roxborough, located in Philadelphia, Pennsylvania, 2) Indian Valley located in Souderton, 
Pennsylvania and 3) Cobbs Creek, located in Philadelphia, Pennsylvania. These sites have been 
individually recruited to participate (see PeRC letter of support) and have agreed to participate. 
Recruitment for the randomized control trial will stop when approximately 100 subjects (100 
dyads of parent and infant) are enrolled. Recruitment for the video-taped component will stop 
when approximately 40 participants have completed the video and interview task. 
 
3.4 
Study Population 
3.4.1 Randomized Control Trial 
3.4.1.1 
Inclusion Criteria 
1) English or Spanish speaking 
2) Child who is between 5 months 0 days and 7 months 0 days at time of enrollment 
and born ≥ 35 weeks estimated gestational age. 
3) Parent (if mother) must be 15 years or older at the start of the study. Parent (if father) 
must be 18 years or older at the start of the study. 
4) Parental permission for the child's participation and consent of the parent for their 
participation 
5) Child with Medicaid Insurance 

16 
 
 
 
 
 
 
 
 
6) Parent has access to a smartphone and/or tablet  
3.4.1.2 
Exclusion Criteria 
1) Children with neurodevelopmental disabilities or congenital malformation at 
increased risk of language delays 
 
3.4.2 Video Sub-study 
3.4.2.1 
Inclusion Criteria 
1) EITHER enrolled in the randomized control trial and age-eligible for their 9 month 
well visit OR (for patients recruited externally) >9 months 0days, but <12 months 0 
days old and born ≥ 35 weeks estimated gestational age 
2) Parent (if mother) must be 15 years or older at the start of the study. Parent (if father) 
must be 18 years or older at the start of the study 
3) Parental permission for the child's participation and consent of the parent for their 
participation 
4) Child with Medicaid Insurance 
5) Parent has access to a smartphone and/or tablet  
3.4.2.2 
Exclusion Criteria 
1) Parent does not speak English 
2) Children with neurodevelopmental disabilities or congenital malformation at 
increased risk of language delays 
 
 
 
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/Consenting Visit and Study Visit 1 
● Identify eligible 4-month old infants at the time of their well child visit using the 
electronic health record (EHR)  
● Recruit and consent eligible parent-child dyads at or before child’s 6 month well visit. 
● Randomize parent-child dyads into intervention and control groups. 
● Collect baseline demographic, parent adversity, and parent mental health information. 

17 
 
 
 
 
 
 
 
 
 
4.2 
Study Treatment Phase  
● Implement an EHR alert to remind clinicians which arm (digital or standard) the 
patients are in at time of well visits at 6, 9 and 12 months. 
● Provide developmentally appropriate standard books or e-books and a bookmark to 
clinicians to give to participants at 6, 9, and 12 month well visits. 
● Parents will complete measures of reading activity (StimQ and ERPQ) via REDCap 
survey sent to their email about 1 month subsequent to the time the child has, or is age-
eligible for, their 6 and 9 month well visits. 
● Phone calls and/or text messages will be made to all participants throughout the study 
to remind them to schedule and/or attend well visit, and for other study-related 
reminders.  
● Selected parents will complete a videotaped reading task at a scheduled time 
convenient to the participant and after the participant becomes age-eligible for their 9 
month well visit. For parents enrolled external to the larger randomized control trial, 
this will be the only study visit completed by these participants. These participants will 
complete the study related questionnaires, including the demographic questionnaire, 
the ACE, SAHL, EPDS, StimQ and ERPQ, at the time of this study visit. Participants 
enrolled in the sub-study (either within the RCT or externally) will additionally 
complete the paper-based DialogPR-I at the time of their video sub-study visit. 
● Contact participant after the child has, or is age-eligible for, the 12 month well visit to 
schedule the second study visit. 
● At the second study visit, about 1 month after the child has, or is age-eligible for, the 
12 month well visit, parents will complete measures of reading activity (StimQ,ERPQ 
and DialogPR-I) in addition to a measure concerning depressive symptoms (EPDS), 
and their child will receive a developmental assessment (BSID-III) administered by the 
study’s Early Childhood Assessor. 
 

18 
 
 
 
 
 
 
 
 
5 STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Parental Adversity (ACE) 
The 9 ACE questions query adults as to their exposure to 9 different adverse childhood 
experiences (economic hardship, domestic violence, parent mental health, discrimination, parent 
substance abuse, divorce, parent death, parent incarceration, and neighborhood violence) and are 
contained in the 2011-12 National Survey of Children’s Health, a nationally representative 
telephone survey.  
5.1.2 Parental Health Literacy (SAHL) 
The Short Assessment of Health Literacy (SAHL) is a validated measure of health literacy for 
English- and Spanish-speaking populations.  
5.1.3 Parental Depressive Symptoms (EPDS) 
The Edinburgh Postnatal Depression Scale (EPDS) is a validated 10-item scale for postpartum 
depression symptoms with scores ≥9 having a sensitivity of 97% and specificity of 43% for 
major or minor depression. 
5.1.4 Reading Activity (StimQ) 
The StimQ is an office measure of cognitive stimulation at home available in Spanish and 
English, and the Read subscale of the StimQ contains questions on the frequency of parent-child 
reading activity and the number and variety of books at home.24 Psychometric analysis of the 
StimQ shows high internal consistency (Cronbach’s Alpha=0.89) and test-retest reliability 
(r=0.84) and moderate correlation with the Bayley Scales of Infant Development (r=0.52, 
p<0.001). 
5.1.5 Reading Practices (ERPQ) 
A series of questions designed by the study team to get a better understanding of the reading 
practices between parents and their babies. 
5.1.6 Language Development (BSID-III) 
The Bayley Scales of Infant Development, Third Edition (BSID-III) is a validated, examiner-
administered assessment of cognitive, language, and motor development. It is designed for 
children 1 to 42 months of age. 
5.1.7 Dialogic Reading Practices (DialogPR-Infant) 
The DialogPR-I is a pilot measure, expanding upon the DialogPR, previously validated in 
children 3-4 years old. This series of parent self-report questions assesses parent self-reported 
dialogic reading practices. This Infant subscale is modified from the main, validated scale to 

19 
 
 
 
 
 
 
 
 
incorporate non-verbal parent/child dialogic reading interactions, and will be piloted with all 
enrolled participants, either at the second study visit, or at their video sub-study visit, whichever 
comes first.  
5.1.8 Demographic Questionnaire 
A brief set of questions used to collect demographic information about the participants. 
5.1.9 Standard Text Messages 
Standard text messages will be sent out to participants throughout the study. These text messages 
include an initial text message to welcome participants to the study, as well as text message 
reminders of upcoming well-child visits, to complete the emailed surveys, to download the e-
book (digital arm participants only), and to schedule the final study visit. Additionally, text 
messages will be sent out to subjects who consented to participate in the videotape sub-study,                               
reminding them of their study visit. 
5.1.10 Audio-recording and Videotaping of Interviews 
Parent-infant dyads recruited into the videotape sub-study will participate in a video recorded 
reading exercise and a brief, audio-recorded semi-structured interview. Parents will be 
videotaped while reading a print book and two versions (basic and enhanced) of an electronic 
book with their infant. As part of this exercise, parents will also be audio recorded while 
participating in a semi-structured one-on-one interview with a study team member. Videotaped 
book readings will be analyzed without transcription. Interview audio recordings will be 
transcribed by ADA Transcription (http://www.adatranscription.com/). Audio recordings will be 
de-identified and sent via their secure server, and subsequent transcripts will be saved on a 
secure server accessed only by members of the study team. 
 
6 STATISTICAL CONSIDERATIONS 
6.1 
Primary Endpoint 
The primary endpoint for the randomized control trial will be the BSID-III scores at the second 
study visit when the child is between 12 and 18 months, 30 days of age.  
6.2 
Secondary Endpoints 
Secondary endpoints will be the difference in StimQ scores, and the information about reading 
practices and activities from the ERPQ, collected approximately 1 month after the infant has, or 
is age-eligible for, their 6, 9, and 12 month well visits for the randomized control trial, the 
DialogPR-I collected between 9 and 18 months, 30 days, as well as themes derived from the 
transcripts of the video and audio-recordings in the Video Sub-study. The Video Sub-study is 
contributing to the main study’s exploration of dialogic reading behaviors when comparing e-

20 
 
 
 
 
 
 
 
 
books to standard board books, and determining the comparative effectiveness of digital literacy 
promotion to standard literacy promotion on parent-child language interaction and parent reading 
behaviors.  
6.3 
Statistical Methods 
Summary statistics will be obtained, and differences between digital and standard arms will be 
assessed using intention-to-treat analysis. Cross-sectional differences in StimQ scores between 
digital and standard groups at the 6, 9 and 12 month well visits will be assessed using t-tests. To 
determine how the effects of digital versus standard literacy is associated with language 
development, we will develop regression models using longitudinal data methods that adjust for 
correlation in BSID-III scores over time and for potential confounding by demographic 
characteristics.  To explore the impact of digital literacy on healthcare utilization, the EHR will 
be reviewed to identify a subjects’ number of well visits and their vaccination history.  
 
To determine whether parent adversity, health literacy, and/or parent mental health modify the 
effects of digital versus standard literacy on language development, we will develop similar 
regression models using longitudinal data methods, but we will also fit interaction terms between 
study group and ACE score (≥4), SAHL (high or low) and EPDS score (>10). To determine if 
parent-child reading activity mediates the association of intervention group assignment and 
language development, we will use mediation analysis with separate models regressing group 
assignment on language development, parent-child reading activity on group assignment, and 
group assignment on language development adjusted for parent-child reading activity.  
 
Assuming a mean cognitive subscale on the BSID-III of 96, a power of 0.70, an alpha of 0.05, 
and a clinically significant difference of 7.5 points on the BSID-III between groups, we estimate 
that we will need to recruit a total sample size of 100 eligible children (50 in each group) to 
participate in the main RCT study (Figure 1). To attain thematic saturation in the Video Sub-
study, we will recruit up to 40 participants 9-12 months of age. These 40 participants may be 
recruited external to the main study if we are unable to recruit up to 40 from the 100 enrolled in 
the main study in a timely fashion. All analyses will be conducted using Stata Statistical 
Software, version 13 (College Station, TX). 
Figure 1 
Assuming a mean cognitive subscale of the BSID-III, an alpha 
of 0.05, and an SD of 15. 
 
 
Power 
n 
0.60 
80 
0.65 
90 
0.70 
100 

21 
 
 
 
 
 
 
 
 
7 SAFETY MANAGEMENT 
7.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study. The main risks are 
disclosure of private health information (PHI) and study responses and discomfort with 
answering sensitive questions concerning childhood trauma or depressive symptoms. 
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. We will query 
participants concerning any disclosures of PHI at each study visit. We will only query 
participants once concerning childhood trauma at the baseline visit and twice concerning 
depressive symptoms at the baseline and second (final) study visit. 
8 STUDY ADMINISTRATION 
8.1 
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.  
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.  
Any paper copies of research instruments will be stored using the patient’s ID code and will be 
kept in the department of General Pediatrics at The Children’s Hospital of Philadelphia. 
 All audio and video recordings will be destroyed within three years of data analysis completion. 

22 
 
 
 
 
 
 
 
 
8.2 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the study 
with the exception of mandatory reporting requirements for child maltreatment.  
No identifiable data will be used for future study without first obtaining IRB approval. The 
research staff will obtain a data use agreement between the provider (the PI) of the data and any 
recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to 
dates and zip codes).  
8.3 
Regulatory and Ethical Considerations 
8.3.1 Data and Safety Monitoring Plan 
Monitoring of adverse events, mainly disclosure of PHI from medical records and study 
assessment responses, will be ongoing during the intervention period until all data have been de-
identified. Participants will be asked whether they know of any breaches of confidentiality at all 
contacts with subjects.  All non-serious adverse events including disclosure of information will 
be reported to the CHOP IRB at the time of continuing review and to the funding agency 
annually. The PI will be responsible for overseeing the monitoring plan. Trained research 
assistants under the supervision of the Principal Investigator will conduct monitoring of data and 
safety twice annually.  
8.3.2 Risk Assessment 
There is minimal risk for harm to the participants in this study. Some information collected from 
the study participants on the study assessments is sensitive information and may cause the 
subjects discomfort, e.g. questions concerning childhood trauma or depressive symptoms. This 
could include assessment of caregiver’s suicidal ideations and a screening of caregiver’s suicide 
risk in primary care flow. The results of the screener will be reviewed soon after completion (See 
Appendix 4). Dr. Marsha Gerdes, PhD, is a co-investigator and child-psychologist who has 
expertise in early child development and measurement. She will serve as the licensed 
psychologist to contact if screener is positive or suicide risk is high. This risk is considered 
minimal and no more than what is normally associated with being in a physician’s or mental 
health practitioner’s office. Furthermore, families incur a risk of disclosure of private health 
information to individuals not connected with this study. This could occur through inadvertent 
disclosure of PHI by research staff. This risk will be minimized by using the study identifier on 
all study instruments and the research database as well as storing identifying information in a 
separate place than study information.  
 
Unique identifiers will be created for each subject in the study. Any paper forms used will be 
stored in a locked file cabinet. REDCap will be used to store the data. A master list containing 

23 
 
 
 
 
 
 
 
 
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.  
8.3.3 Potential Benefits of Trial Participation 
Parents or guardians of the participants in either arm may not benefit from the digital literacy 
promotion intervention. Parents and their children may benefit from initiating parent-child 
reading activity earlier with the potential for improved language development. Information from 
this study could be used to generate generalizable knowledge to reshape the views on digital 
literacy initiatives, the ROR program and provide information for other early literacy campaigns 
such as Philadelphia’s Read! By 4th and the Great Start Collaborative’s Early to Read 
Campaign. If results from this study favor the digital book arm, then administrators of the ROR 
program and other local and national literacy campaigns can encourage the distribution of 
developmentally appropriate e-books in conjunction with standard books. Nationally, pediatric 
clinicians may benefit by knowing evidence of whether there is a difference in effectiveness of 
language development in children who are read to by their parents via digital or standard book. 
This may have an impact in environments where access to books may be limited by financial, 
geographical, or time constraints on parents. Locally, pediatric clinicians could benefit by having 
CHOP’s ROR program expanded to additional areas in the Philadelphia metropolitan area. 
Information from this study can be used by policymakers and grant funders to increase funding 
support to expand the ROR program and other local and national literacy campaigns to infants. 
8.3.4 Risk-Benefit Assessment 
The risks to participants are minimal and further minimized through protections. The benefits of 
parents receiving advice and materials through the support of the digital literacy promotion 
program outweigh the risks of participation. Therefore, the risk-benefit ratio is considered 
favorable. 
8.4 
Recruitment Strategy 
8.4.1 Randomized Control Trial 
We will have an EHR recruitment prompt sent only to potentially eligible children with 
Medicaid at their 4 month well visit at the CHOP Primary Care Roxborough, PA, CHOP Primary 
Care Cobbs Creek and CHOP Primary Care Indian Valley. Parents who are conceivably 
interested in participating will be contacted by research staff. Research staff will briefly explain 
the study procedures, guided by the information set forth in the approved consent form. This 
includes reading the inclusion criteria to the potential participant, and asking whether or not this 
individual is interested in participating. Research staff will then schedule a time to meet with the 
parent in person. This will happen at a time before their infant’s 6 month well visit in order to 
obtain informed consent, confirm that all of the inclusion criteria are met, and randomize the 

24 
 
 
 
 
 
 
 
 
participant into either the digital or standard book group. In the event that the research staff is 
unable to confirm that all inclusion criteria are met after the participant has been enrolled, the 
participant will no longer be able to participate. Additionally, potentially eligible 5 to 7 month 
olds that have been identified by study staff on EPIC as potentially eligible by screening via 
review of the medical record, may be approached in person before or at the time of their 6 month 
well visit. These potentially eligible participants will be screened, consented and enrolled into 
the study prior to the child’s time with the provider. 
We may also hang recruitment flyers in the hallways at both clinics giving information about the 
study and contact information for the study coordinator in case they are interested and we miss 
their names in the screening process. 
8.4.2 Video Sub-study 
Participants previously screened for the randomized control trial will be made aware of the video 
sub-study at the time of consent and can elect at that time to include the video sub-study in their 
consent procedure. These participants will be contacted once they have become age-eligible for 
their 9-month well child visit to schedule the video sub-study visit.  
Additionally, infants and parents not previously enrolled in the randomized control trial 
presenting to the Cobbs Creek site will be approached to participate in the video sub-study. 
These participants will be identified by study staff on EPIC as potentially eligible by screening 
via review of the medical record. Study staff will screen and consent these participants in person 
prior to the child’s time with the provider. 
8.5 
Informed Consent/Assent and HIPAA Authorization 
Following the screening via review of the medical record, eligibility for study participation will 
be explained, either in person or 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. Parents who consent to participate and who give parental 
permission for the child’s participation, will sign 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 order 
to give parental permission for the child to participate, the consenting mother must be at least 15 
years old, or the consenting father 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.  
Similarly, Spanish-speaking participants will be contacted and recruited to participate in the 
main RCT only (Parent who does not speak English is part of the Exclusion criteria for eligibility 

25 
 
 
 
 
 
 
 
 
to participate in the Video Sub-study;see section 3.4.2.2) either in person or via phone by a 
Bilingual member of the study team. When it is time to consent the participant, an interpreter 
will be present and will carry out the Spanish Short Form Consent process with the Spanish-
speaking subject.  
Participants in the randomized control trial who agree to participate in the video sub-study will 
provide their consent by indicating whether or not they would be willing to participate in this 
additional study visit in a section of the consent form for the randomized control trial. 
Participants recruited for the video sub-study who are enrolled external to the larger trial will 
complete a consent form at the time of enrollment. This consent will be for participation limited 
to the video sub-study.  Study staff will follow the procedures outlined above to consent 
participants into this sub-study. Of note, non-English speaking participants will not be enrolled 
in the sub-study (see exclusion criteria), as it is infeasible at this time to conduct and analyze 
these qualitative data in languages other than English. 
 
8.6 
Payment to Subjects/Families 
8.6.1 Payments to parent for time and inconvenience (i.e. compensation) 
All participants will be paid up to $70 total for their participation. They will receive $20 upon 
completion of the initial study visit. They will then receive $5 upon completion of each of the 
two surveys emailed to them. At the second (final) study visit, they will receive $40. All 
payments will be made in the form of pre-paid, CHOP-issued debit cards.  
Participants recruited to participate in the video-taped reading task will receive an additional $50 
pre-paid card at the completion of the visit.   
8.6.2 Gifts 
Participants will receive three books over the course of the study, one for each well visit (6 
months, 9 months and 12 months).  All parents will receive a small non-monetary gift of a Reach 
Out and Read tote bag filled with 3 additional books to thank them for participating at the end of 
the final study visit. Participants in the video sub-study will receive an additional book at the 
time of their participation.  
 
9 PUBLICATION 
We propose a multipronged dissemination strategy for this study that will have the goal of 
distributing study results to scientific audiences, lay audiences, policy audiences, and parents. If 
funded, we will work with the Strategy Team at Policylab at CHOP to implement this 

26 
 
 
 
 
 
 
 
 
dissemination strategy. We will present findings from this study at the Pediatric Academic 
Societies annual meeting, where pediatric clinicians, early literacy experts, and Reach Out and 
Read advocates attend. We will also develop as many as 3 peer-reviewed manuscripts for 
publication and target them to pediatric and child health journals in order to reach a clinical and 
scientific audience. One manuscript will report the overall results of the randomized controlled 
trial of digital literacy promotion vs. standard literacy promotion. A second paper will detail the 
analyses of the video recorded data, while a potential third will cover the methodology of 
validating parent reported data to the observed video-taped behaviors.  
To reach lay and policy audiences with findings from this study, we will place a summary of the 
results of the study on the Policylab website (http://policylab.chop.edu/ ) and tweet the results to 
our Policylab twitter followers. This latter group is a diverse group of individuals from policy, 
advocacy, government, and clinical fields. We will also prepare an Evidence-to-Action (ETA) 
policy brief, which attempts to capture the policy implications of the study findings. ETA briefs, 
which are developed at Policylab, are mailed and/or emailed to policymakers and child health 
advocates on our distribution list. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

27 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3 Hart B, Risley TR. Meaningful differences in the everyday experience of young 
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4 Rosenberg SA, Zhang D, Robinson CC. Prevalence of developmental delays and 
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5 Boyle, C., P. Decoufle, et al. (1994). “Prevalence and health impact of developmental 
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127. 
 

28 
 
 
 
 
 
 
 
 
8 CDC. Economic costs associated with mental retardation, cerebral palsy, hearing loss, 
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13 Klass P, Needlman R, Zuckerman B. Reach Out and Read Program Manual, 2nd Ed. 
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14 Needleman R, Fried LE, Morley DS, Taylor S, Zuckerman B. Clinic-based intervention 
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29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX 
See attached.