Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic Reading Training
Phase: NA
Conditions: Literacy, Child Development, Parenting
Sponsor: Children's Hospital Medical Center, Cincinnati

 
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CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER 
INSTITUTIONAL REVIEW BOARD – Protocol 
and 
Community Health Center, Inc IRB 
Protocol Template  (HRP-212) 
 
 
1) Protocol Title 
 
Rx for Success: A Randomized Controlled Trial of Technology-Based Dialogic 
Reading Training Incorporated Into Reach Out and Read 
 
2) Principal Investigators 
 
Overall: John S. Hutton, MS MD FAAP  
Cincinnati Children’s Hospital Medical Center 
Division of General and Community Pediatrics 
Reading and Literacy Discovery Center 
 
On-site at CHC: Dr. Catherine Wiley, MD  
Community Health Center at Connecticut Children’s Hospital 
 
Other staff: Amy Kerr (coordinator, CCHMC), Dr. Tom DeWitt MD (co-I, CCHMC), 
Dr. Nikki Shearman, PhD (consultant, Reach Out and Read National Office (MA)), Tom 
Hatton (consultant, Children, Inc.).  A primary research coordiator will be hired to 
conduct this study at the primary care clinical site in CT. 
 
3) Funding Source 
 
The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation 
The Grossman Family Foundation 
 
4) Objectives* 
 
Specific Aim 1 (Rx for Success; RS): To explore the efficacy of incorporating dialogic 
reading training via the RS application into ROR during well-child visits for infants (6-12 
months old) and toddlers (18-24 months old), compared to standard ROR practice.   
Hypothesis 1a (language): Language scores (LENA Snapshot) will be higher in 
children whose caregivers are provided with the RS app.     
Hypothesis 1b (social-emotional): Social-emotional development scores 
(DECA-I/T items) will be higher in children whose caregivers are provided with 
the RS app.  
Hypothesis 1c (dialogic quality): Dialogic reading quality scores (DialogPR-I/T) 
will be higher in caregivers presented with the RS app. 
Hypothesis 1d (attitudes): Attitudes towards shared reading at home (items from 
StimQ-P READ and PVR) will be higher in families provided with the RS app. 
 
 
Specific Aim 2 (exploratory): 

 
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Hypothesis 2a: Reported screen-based media use (ScreenQ) will be lower in 
families provided with the RS app, reflecting greater emphasis on interactive 
shared reading. 
Hypothesis 2b: Language (LENA Snapshot) and social-emotional (DECA-I/T 
items) scores will be higher for children with less reported screen-based media 
use (ScreenQ). 
 
5) Background* 
 
Literacy is a major public health issue, the cost of low attainment estimated at over $300 
billion in the United States and over $1.2 trillion worldwide, disproportionately affecting 
low-socioeconomic status (SES) populations.29 While an estimated 5-12% of reading 
difficulty has an organic cause (e.g. dyslexia),30 the majority is attributable to inadequate 
resources, motivation and/or stimulation required to learn to read.29 As of 2015, 64% of 
US 4th graders scored below proficient in reading, largely unchanged from prior 
reports,28and scores skewed lower for low-SES and minority children.28, 31 The seeds of 
environmental reading difficulty are planted early; many children arriving at school at a 
substantial disadvantage in readiness and increasingly unlikely to catch up with peers as 
academic demands accelerate.31, 32 Environmental illiteracy is considered “heritable,” 
fueling cycles of poverty and poor academic, vocational and health outcomes.33 
Prevention and early intervention offer tremendous cost savings in terms of health and 
productivity.34-36  
 
The American Academy of Pediatrics (AAP) recommends literacy promotion in primary 
care settings beginning at birth, and increased funding for reading promotion programs 
such as ROR, provider training, and research.4 The bases for these recommendations are 
enduring cognitive, social-emotional and neurobiological20, 37 benefits of nurturing shared 
reading environments during the critical developmental span of early childhood.4 
Children’s books serve as catalysts for verbal and social-emotional engagement26, 38, 39 
and foster positive attitudes towards reading.4, 40 However, the quality of shared reading 
tends to moderate  - or negate, if deficient - these important benefits.13, 21 Dialogic 
reading is a method of shared reading developed to promote reciprocal dialogue between 
a caregiver and child,8  particularly in low-SES households where such dialogue is often 
lacking.6 Behavioral evidence suggests that dialogic reading may confer substantial 
cognitive benefits beginning in infancy,10, 11 including oral language,12, 13 narrative 
comprehension,14 print concepts,12 and attention15- foundational emergent literacy 
skills.16 Social-emotional benefits have also been shown, including increased parent-child 
bonding, pro-social behavior11 and enjoyment of reading.17, 18  
 
The major objective of ROR is to improve emergent literacy and social-emotional 
health during the span of rapid brain growth and development between birth and 
age 5, particularly in low-SES families at risk for adverse outcomes. Thus, in 
addition to providing children’s books and literacy-related developmental 
screening, ROR encourages pediatric providers to model dialogic reading during 
well-child visits. However, this critical aspect of shared reading quality deserves 
greater reinforcement than is generally feasible in a standard office visit, given 
time and reimbursement constraints.41, 42 Furthermore, there is currently a gap in 
knowledge as to optimal, effective means to improve shared reading quality and 
developmental outcomes involving families of very young children. This study is 

 
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highly significant in that it for the first time explores the efficacy of amplifying 
dialogic reading training delivered via the established ROR program using a 
novel, inexpensive, scalable smartphone-based application (Rx for Success) 
during this critical span of development. 
 
The Rx for Success (RS) application integrates professionally produced 
instructional videos and interactive content tailored to age and developmental 
level into a smartphone-based application, to clearly and consistently reinforce 
dialogic reading. The RS app features ethnic, gender and economic diversity, is 
free and simple to download onto a variety of mobile platforms, and fun and 
intuitive to use. To increase the “dosage” of the message, and encourage ongoing 
learning and practice, the app sends text reminders with tips about reading aloud, 
and an embedded gamification component provides enjoyable feedback. If shown 
effective, RS would be an impactful enhancement to the ROR program, allowing 
pediatric providers a convenient, inexpensive means to provide dialogic reading 
instruction to families in busy clinical settings, in addition to books, 
developmental guidance, and other aspects of the program. The RS app could be 
integrated into ROR via its existing infrastructure involving over 5,900 sites and 
29,000 providers across the US. No similar study has been conducted, to our 
knowledge. 
Overview/Rationale: Our strategy is to conduct an innovative experiment that is 
achievable within 15 months, providing data for a larger, longer-term longitudinal study 
exploring the impact of “enhanced” ROR on home reading environment and cognitive 
and social-emotional development. This study involves a low-SES population of infants 
and toddlers at-risk for adverse cognitive and social-emotional outcomes, during a 
foundational period of early brain development, who stand to benefit from effective early 
intervention to improve the quality of cognitive stimulation and nurturing in the home. 
Such innovation is needed, given challenges to providing consistent, effective dialogic 
reading training in busy clinical settings, where such at-risk families are uniquely 
accessible. The resources and infrastructure are in place via ROR for this work to 
commence expeditiously with high probability of success. 
 
Preliminary data: A pilot process evaluation field test of 26 predominantly African-
American and Urban Appalachian low-income families enrolled in ROR, demonstrated 
an overwhelmingly positive response to the RS app with 100% of participants rating the 
video as motivational and 95% rating the reminders as helpful. Quotes from participants 
included: 
 
“The video talked about singing and when I did that she seemed to really like it 
and become engaged.” 
 
“My grandson loves it. He’s really interested and we are happy to get the 
reminders.” 
 
“We all know that it’s important to read to your child, but we don’t always 
remember every day….having the reminders helped me to actually do the reading more.” 
 
A separate pilot study involving ROR families found that those who already knew about 
the importance of reading aloud considered videos incorporated into the RS app to be 
valuable in explaining how to read more interactively with their young children. By 
contrast, a recent MRI-based study involving video observations of 22 low-SES mothers 

 
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reading with their preschool-age children found low verbal interactivity and engagement 
despite prior access to home visiting and ROR, suggesting a need for improved dialogic 
training.20  
 
Other recent work that will support this proposed project includes initial validation of 
brief measures assessing shared/dialogic reading quality (DialogPR) and screen-based 
media use in the home (ScreenQ).46 
 
6) Setting of the Human Research 
 
This study, including will be conducted at Community Health Center, Inc. at Connecticut 
Children’s (CHC@CCMC), a high volume, primary care clinic affiliated with 
Connecticut Children’s Medical Center, a major academic teaching hospital. Dr. 
Catherine Wiley will be the primary on-site supervisor for the CRC, and clinical contact 
at CHC@CCMC, including oversight of patient-related issues such as distress during 
evaluation. Recruitment, behavioral testing, surveys and intervention, will take place in 
exam rooms during regularly scheduled clinic visits, mindful to place minimal burden on 
participating families and clinic staff. Data analysis will be conducted in Cincinnati, OH 
via Children, Inc, under the supervision of the principal investigator. This study will be 
submitted to and adhere to guidelines specified by the CCMC Institutional Review Board 
(IRB), as well as those of Cincinnati Children’s Hospital Medical Center IRB. 
 
7) Resources available to conduct the Human Research 
 
Team Experience: The proposed project combines the skills and resources of the 
RS developer, principal investigator, and team of co-investigators and 
collaborators at the ROR host site at CHC@CCMC. Since 1972, Community 
Health Center, Inc. has been one of the leading healthcare providers in the state of 
Connecticut, building a world-class primary care system committed to caring for 
uninsured and underserved populations. CHC@CCMC is a patient-centered 
medical home providing a full suite of pediatric services, is a well-established 
ROR site, and employs an electronic medical record system.  
 
The RS developer (Tom Lottman) has considerable experience developing 
developmentally robust, multimedia content for young children.43 The recently published 
report from the Harvard Graduate School of Education and the Wallace Foundation 
named Children, Inc.’s Before the Bullying AFTER program44 as one of the top 25 
research-based social and emotional learning programs (Jones, et al., 2017). 
 
Dr. Nikki Shearman, Chief of Network Strategy and Evaluation with the ROR national 
office based in Massachusetts, will serve as a consultant for this study regarding the 
logistical implementation of the RS intervention within the ROR program.  
 
The principal investigator (Hutton) is a primary care pediatrician who has conducted 
innovative, reading-related research involving young children with a high degree of 
success, including randomized trials of home reading environment45, development of 
clinic-based screening tools,46 video observations of parent-child reading quality,19, 20 and 
the application of functional MRI to explore the effects of home reading environment, 

 
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including shared reading quality, on the developing brain.19, 20, 37 Addressing younger 
infants and toddlers in this study during critical stages of early brain development is a 
natural extension of this work, and would build on a cohesive eco-bio-developmental 
model47 of the influence of home reading environment on emergent literacy. Prior to the 
launch of this study, the principal investigator will travel to the CHC@CCMC host site to 
discuss and train the study team in this protocol, specifically the research coordinator, 
including practice “role play” sessions. 
 
A full-time clinical research coordinator (CRC) will be recruited for this study in 
cooperation with the Weitzman Institute, a community-based research center affiliated 
with CHC@CCMC dedicated to quality improvement and research in primary care for 
the underserved. The CRC will be trained in this study protocol via the principal 
investigator (Dr. Hutton), the on-site medical director and co-principal investigator (Dr. 
Wiley), and a co-investigator from the national ROR program (Dr. Shearman). The CRC 
will then recruit the 248 children in our desired age ranges (124/category) via 
convenience sampling during regularly scheduled well-child visits. Full enrollment 
within 6 months is feasible given historical well-visit volumes for these ages (40/month 
meeting enrollment criteria) at the participating clinic at CHC@CCMC. The CRC will 
optimize enrollment efficiency factoring scheduled well-visit volumes and demographic 
needs (age), via advance communication with clinic managers. Biostatisticians affiliated 
with Children, Inc., will perform all required statistical analyses, accessing data via a 
secure REDCap database housed at CCHMC Divison of Biomedical Informatics. 
Application developers aligned with Children, Inc., will be available to perform any 
required technical modification or “troubleshooting” of the RS application. 
 
Rx for Success Application (RS): The RS mobile application (app) was developed by 
Children, Inc. The app is designed to be informational and motivational with both video 
and cueing content. The app uses a, “View It, Cue It, Do It” model that allows parents to 
quickly download the free smartphone app, view brief videos of the age-indexed, 
research-based language enrichment practices; and regulate a text message cueing 
program.  The app uses three motivational strategies in the cueing program: 1) 
Personalization; 2) Gamefication; and 3) Social media.  Videos embedded in the RS app 
provide a summary of DR tailored for the child’s age, and suggestions for encouraging 
verbal interactivity and social-emotional engagement through dialogic reading. Key 
behaviors reinforced by the app include discussing the story before reading to build 
interest and enthusiasm, followed by interactive reading modeled by the acronym PEER:9 
1) Prompt the child to say something about the story, 2) Evaluate what the child says or 
does, 3) Expand on what the child says or does, and 4) Repeat and reinforce associations 
or responses. The acronym CROWD reflects simple types of prompts that can encourage 
the child’s involvement in the story, which gradually apply with age and development: 1) 
Completion (of a sentence), 2) Recall earlier aspects of the story, 3) Open-ended 
questions, 4) Wh- questions, and 5) Distancing (relate the story to the child’s life). 
Finally, the RS app encourages the caregiver to review the story with the child after it is 
finished to reinforce the book sharing experience. 
 
While highly impactful independently, this research will also provide valuable 
pilot data for a larger, longitudinal study exploring means to improve home 

 
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reading environment during early childhood via the ROR model incorporating 
traditional and novel technologies, especially in underserved populations. 
 
8) Study Design 
 
Study Design: This is a prospective, randomized controlled trial involving 2 age 
categories of low-SES caregiver-child dyads served by the ROR program, each followed 
for 6 months. For each category, a baseline assessment (pre-) and an outcomes 
assessment (post-) will be conducted, to explore effects of “enhanced” ROR using the RS 
app. Category 1 will involve 6 month-old infants, followed until they are 12 months old.  
Category 2 will involve 18 month-old toddlers, followed until they are 24 months old. 
Recruitment, informed consent, behavioral testing and intervention will take place at a 
high-volume primary care clinic based in a major, urban academic medical center in 
Connecticut (Community Health Center, Inc. at Connecticut Children’s Medical Center; 
CHC@CCMC). Providers in the clinical sites are trained in child development and the 
administration of ROR during well-child visits between birth and age 5, including those 
involved with our study at 6, 12, 18, and 24 months old.  
 
A graphic of our study design is provided in Figure 1 below. Families assigned to the 
control arm in each age category will receive customary ROR, including the provision of 
an age-appropriate children’s book, and reading-related developmental surveillance and 
anticipatory guidance. In addition, control families will receive a new children’s book 
reinforcing AAP screen-based media recommendations.48 Families in the intervention 
arm in both age categories will receive “enhanced” ROR involving the provision of the 
Rx for Success (RS) application at the baseline visit (6 months old and 18 months old, 
respectively). No additional intervention will take place, other than text messages and 
other content built into the RS application.  
 
 
a) Recruitment Methods 
 
Sample Size/Power Analysis: Via our CRC, we will recruit 248 children in 2 age 
categories: approximately 6 months old (infants, n=124), and approximately 18 months 
old (toddlers, n=124) via convenience sampling in the CHC@CCMC clinic waiting room 
Figure 1 

 
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during regularly scheduled well-child visits. This study will be powered based on the 
primary language outcome measure (LENA Snapshot). For a two-group 
(intervention/control), pre-post repeated-measure analysis with two age categories (6-12 
months, 18-24 months), an ANCOVA model will be applied for both age categories and 
their interaction, to assess the difference in language scores between intervention and 
control groups. For this study, at least 180 subjects will be needed to have 80% statistical 
power to detect slightly greater than medium effect size (Cohen f=0.30), controlling for 
the baseline pre-measurement with a two-sided significance level of 0.05. This effect size 
was determined considering the 2008 National Early Literacy Panel Report, which 
examined 16 studies and reported an effect size of 0.6 for dialogic reading on language 
outcomes (d=0.6; Shanahan, et al).49 A separate meta-analysis of 18 studies that tested 
dialogic reading intervention found average effect size for language outcomes and 
vocabulary of 0.29 and 1.02, respectively.8 However, these reports largely involved 
preschool- and school-age children, and no studies to our knowledge have reported effect 
sizes of dialogic reading for language in infants and toddlers. 
 
We anticipate that full enrollment for this study within 6 months is feasible given 
historical well-visit volumes for these ages (40/month meeting enrollment criteria) at the 
participating clinic at CHC@CCMC. The CRC will optimize enrollment efficiency 
factoring scheduled well-visit volumes and demographic needs (age), via weekly 
communication regarding clinic schedules with clinic managers. The CRC will identify 
the arrival and registration of potential participants by monitoring the daily schedule (in 
Centricity) to identify well child visits for children of the appropriate age groups, and will 
greet them in the waiting room. For enrolled patients only, the CRC will also monitor 
scheduled encounters (in e-Clinical Works) to identify upcoming appointments for the 
follow-up (post-intervention) visit, and will monitor arrival in Centricity. The CRC will 
approach families in the waiting area, confirm that the child meets inclusion criteria by 
age, and present the major aims of the study in plain language:  
 
“We are conducting a research study looking at how different ways of providing 
tips about reading with young children affects attitudes towards reading and early child 
development. This will involve a little extra time at today’s checkup to ask some 
questions, and at another checkup in 6 months. You will be compensated for your time. 
Would you be interested in learning more?”  
 
For those expressing interest, written informed consent will then be administered via the 
CRC in a quiet area of the clinic waiting room, or private room if available, during the 
same visit where basline data collection and intervention will take place.  The CRC will 
review the form in plain language, including details about inclusion/exclusion, aims, 
incentives, and that participation is voluntary.   
 
Participants will receive a gift card valued at approximately $25 as compensation for time 
and travel, with $10 provided at enrollment (pre-) and $15 provided at follow-up testing 
(post-), each taking place during normally scheduled well-child visits. All children will 
receive a new children’s book per standard ROR practice. Participants in the control arm 
will receive an additional, new, age-appropriate children’s book reinforcing screen-based 
media reduction (Baby Unplugged: Play), retail value $7.99.   
 
Study Advertisement: To optimize enrollment and reduce the burden of surprise for 
families being approached in the waiting room, a brief postcard developed by Reach Out 

 
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and Read will be distributed to eligible families at well-child visits immediately 
preceding those for of our study (i.e. at 4 month visit and 15 month visit, respectively).  
This will advise them that at their next visit, they may be eligible to participate in this 
study, describe the study in very general terms, and also note the financial incentive. 
 
Inclusion and Exclusion Criteria: Accounting for a potential 10% attrition rate, 
at least 200 subjects with 100 in each age category is recommended for this study. 
We anticipate that 248 should be ample, given variation in effect sizes reported, 
uncertainty for those in younger children, and higher than usual attrition for this 
high-risk population.  
 
Inclusion criteria for this study are:  
• Gestation of at least 34 weeks, 
• Age at initial screening 6 months (5.75 months-7.5 months) or 18 months old 
(17-21 months). 
• No documented history of major neurological insult such as intracranial 
hemorrhage or V-P shunt. 
• Comfortable speaking English during their WCC and 
reviewing/comprehending study materials without a translator, including 
informed consent. 
• Functional literacy in at least one primary caregiver, defined as the ability to 
navigate the RS application, read prompts provided by the RS application 
(targeted 6th grade reading level as estimated via the Readable.io website), and 
understand/provide informed consent, administered in English. 
• Possession of a smartphone or tablet device capable of downloading, 
installing and utilizing the RS application. 
 
Twins will be excluded from the study, to minimize confounding.     
 
In the case of 2 eligible siblings presenting at the same visit (i.e. 6 month old and 18 
month old), both may be enrolled, though will be randomized to the same group to 
minimize confusion and confounding.   
 
In the case of an eligible sibling presenting after another sibling has been enrolled, 
this second child (and any other siblings) will be ineligible, to minimize confounding 
via a training effect. 
 
 
b) Study Endpoints* 
 
Outcomes of interest for this study (6 months post-intervention) are as follows: 
 
 
a) Descriptive Statistics: Descriptive statistics will be used to summarize parent-
child demographics, language and social-emotional testing scores (LENA Snapshot, 
DECA-I/T exerpted items), home reading environment/dialogic reading/cognitive-
language attitudes (StimQ-P READ and PVR excerpted items, DialogPR-I/T), and screen 
time (ScreenQ). Group-wise comparisons will be performed to determine any differences 

 
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between randomization groups. Spearman’s rank correlation will then be used to assess 
correlation between variables of interest at baseline and 6-month follow-up visits, 
applying age and gender as covariates.  
 
b) Pre-post intervention cognitive-behavioral outcomes: Outcomes of interest 
will involve group-wise statistical comparisons pre-post intervention of language, social-
emotional development, and home reading practices/attitudes measures. All repeated 
measures (LENA, DECA-I/T exerpted items, StimQ READ and PVR excerpted items, 
DialogPR, ScreenQ, reading attitudes) will be examined via paired t-test, Wilcoxon 
signed-rank test, and McNemar’s tests. Association between home reading environment 
and screen time and language and social-emotional testing scores will be assessed by 
correlation coefficient and applied in general linear regression models, applying age and 
gender as covariates. 
 
c) Satisfaction with RS and frequency of use: responses on surveys 
administered to caregivers at the 6-month follow up visit (12 or 24 months old) will be 
analyzed, including frequency and ease of use (e.g number of “push” notifications). 
 
d) Feasibility: Caregiver satisfaction with RS will be conducted via closed and 
open-ended survey items administered via the CRC, including barriers to use (e.g. cell 
phone minutes, clinical flow, data plan), time of administration, and suggested means of 
improvement.  
 
There are no safety endpoints involved with this study. 
 
c) Procedures involved in the Human Research* 
 
Randomization: Following agreeing to participate and providing informed consent, 
families in both age groups (infant and toddler) will be assigned to either the intervention 
or control cohort (62 in each cohort for each group) by research coordinators using a 
spreadsheet with assignment codes determined by computer-generated random numbers 
provided by a biostatistician (Group A and Group B).  Participants will be blinded as to 
group assignment and not advised as to differences in intervention between groups, for 
the purposes of the research. The CRC will not be blinded, as this is infeasible.  
Statisticians will be blinded as to the definition of Group A or B (i.e. which is the 
intervention), to ensure objectivity in analyses. 
 
Testing and Surveys: Testing and survey administration will be performed in a private 
part of the waiting area or clinic exam room, in the following order of preference, 
mindful of patient/clinic flow:  
 
1) Before seeing the provider for the scheduled WCC. 
 
2) After the provider has completed their exam, but before lab tests or shots. 
 
3) After lab tests and shots, if needed.  
 
Of note, all surveys and measures are administered to the parent (i.e. parent 
report), none directly administered to or involving the child. 
 
At all times, deference will be given to clinic staff and the family to maintain the 
flow of the visit. The CRC will approach the clinic manager, supervising nurse, or 
clinical provider in charge of clinic flow on the morning of each clinic session, to discuss 
preferred strategies, including designated exam room for consent and survey 
administration. If unable to complete all data collection, the family will be free to go at 
their discretion and data collected will be utilized to the extent possible.  The order of 
administration will prioritize items that are most important to achieve our study aims, 

 
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particularly demographics, home reading/language environment (StimQ READ/PVR 
items), language (LENA), and social-emotional development (DECA exerpted items). 
 
Estimated testing/survey administration time is approximately 17 minutes. 
Administered at baseline (pre-intervention; approximately 6 and 18 months old): 
 
1) Demographic Surveys (3 minutes): During the first visit only, demographic 
information will be obtained from custodial parents including contact information, type 
of smartphone or tablet to be utilized including data plan (e.g. unlimited vs limited data), 
household income, parental education, history of reading difficulty including dyslexia or 
functional illiteracy, who usually reads to the child at home, primary language spoken at 
home, daycare attendance, and number of occupants in the home.  Estimated 
administration time for this survey is 3 minutes.  
 
2) LENA Snapshot (6 minutes) is a validated, 52-item, evaluation of language 
skills for infants and toddlers by parental report focusing on well-established milestones 
associated with expressive and receptive language skills, with a standardized score under 
77 suggesting risk for delay. It provides developmental age and percentile ranking 
information compared to age-matched peers. Correlations with standard measures such as 
PLS-4 and test-retest correlations average 0.93.  Estimated administration time is 3 
minutes. Of note, this measure is not directly administered to the child. 
 
3) Devereux Infant/Toddler Early Childhood Assessment (DECA-I/T items; 2 
minutes) is a measure of social and emotional health validated for use in children 
between 1 month through 36 months, which are strength-based, nationally standardized, 
and easy to use. The DECA has 4 scales: Attachment/Relationships (18 items), Initiative 
(11 items), Self-Regulation (7 items), and Total Protective Factors composite. The infant 
form (1-18 months old) has 33 items, and the toddler form (18-36 months old) has 36 
items. To keep our administration time as brief as possible, we will exerpt 5 items from 
the attachment subscale (those most likely to be influenced by shared reading) for this 
study, and add these item scores to determine a total score. Estimated administration time 
for these items is 2 minutes.  
 
4) StimQ-Infant/Toddler (exerpts, 2 minutes) is a validated assessment of 
cognitive stimulation in the home. For this study, to keep administration time brief, 5 
items excerpted from the READ and Parental Verbal Responsivity subscales will be 
administered, assessing access to books, frequency of shared reading, and verbal 
interactivity in the home. In addition, caregivers will be asked to list their 3 favorite 
activities to do with their child at home (open ended, coordinators noting whether reading 
is included), as in Needlman, et al (2005). Estimated administration time is 2 minutes.   
 
5) DialogPR-I/T (2 minutes) is an 8-item parental report assessment of shared 
reading quality created by the principal investigator for caregivers of children age 18 
months and up, and a related version for younger infants (DialogPR-I/T) based on a 
dialogic reading conceptual model. Initial validation involving a low-SES population46 
showed strong psychometric properties.  Estimated administration time is less than 2 
minutes. 
 
6) ScreenQ (2 minutes) is a novel assessment of screen-based media use in the 
home developed by the principal investigator, consisting of 10 evidence-based50-52 items 
reflecting access to screens, frequency of use, content, and interactivity. This measure 
was recently pilot tested and psychometrically refined in a diverse sample of preschool-
age children, and is applicable for ages 0-9 years. Estimated administration time is 2 
minutes.  
 

 
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A flow diagram summary of enrollment, consent, and baseline testing is provided below: 
 
 
 
Administered at the follow-up visit (post-intervention; approximately 12 and 24 
months):  
 
At the 12-month (11 to 15 month) or 24-month (23-27 month) well-child visit, the 
LENA, DECA-I/T items, StimQ-I/T items, DialogPR, and ScreenQ will be repeated. 
Caregiver surveys of frequency and ease of use of the RS app will also be administered. 
The CRC will contact families by phone and text message approximately 1 month in 
advance of the follow-up visit to remind them of the date and time, and importance to 
attend this visit.  Estimated administration time is ~16 minutes. 
 
A flow diagram summary of follow-up testing is provided below: 
 

 
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Dialogic Reading Intervention (DRI): For families assigned to the DRI group, in 
addition to customary ROR procedure in the clinic, the DRI will involve:  
 
a) Training in DRI: At the baseline well-child visit (approximately 6 or 18 
months), the CRC will assist participating families in downloading and installing the RS 
app onto their mobile device, and briefly review its use. This is anticipated to take 
approximately 5-7 minutes. After downloading RS, the CRC will confirm that caregivers 
were able to open it, activate the videos, and address any questions. A postcard with 
simple, picture-based instructions (target 6th grade reading level) will also be provided, 
created by ROR. This handout/card will also convey contact information for the CRC in 
the event of a change in participant phone number or other contact information. Care will 
be taken to make the instruction process as brief as possible, to simulate how a pediatric 
provider or support staff would function in a busy, real-world clinical setting. The CRC 
will record administration time, qualitative feedback from families, and any major 
logistical concerns. 
 
b) Rx for Success Application (RS): The RS mobile application (app) was 
developed by Children, Inc., available for free download via the iTunes or Android App 
stores (search term: Rx for Success). The app is designed to be informational and 
motivational with both video and cueing content. The app uses a “View It, Cue It, Do It” 
model that allows parents to quickly download the smartphone app (no iTunes or other 
account is needed, and installs on a variety of platforms), view brief videos of the age-
indexed, research-based language enrichment practices; and regulate a text message 
cueing program. The app uses three motivational strategies in the cueing program: 1) 
Personalization; 2) Gamefication; and 3) Social media.  Videos embedded in the RS app 
provide a summary of DR tailored for the child’s age, and suggestions for encouraging 
verbal interactivity and social-emotional engagement through dialogic reading. To 
achieve this, approximately 2 “push” notifications will be generated by the app per day 

 
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(not via cellular text message so will not count against participant’s data plan). Key 
behaviors reinforced by the app include discussing the story before reading to build 
interest and enthusiasm, followed by interactive reading modeled by the acronym PEER:9 
1) Prompt the child to say something about the story, 2) Evaluate what the child says or 
does, 3) Expand on what the child says or does, and 4) Repeat and reinforce associations 
or responses. The acronym CROWD reflects simple types of prompts that can encourage 
the child’s involvement in the story, which gradually apply with age and development: 1) 
Completion (of a sentence), 2) Recall earlier aspects of the story, 3) Open-ended 
questions, 4) Wh- questions, and 5) Distancing (relate the story to the child’s life). 
Finally, the RS app encourages the caregiver to review the story with the child after it is 
finished to reinforce the book sharing experience. 
c) Monitoring adherence and “dose” of DRI: At the 12 or 24-month follow-up 
visit, a survey of frequency and ease of use of the RS app, developed by the principal 
investigator, will be administered to the child’s primary caregiver.  
 
Families assigned to the Control group will receive a new children’s book regarding 
limiting screen-based media use (Baby Unplugged: Play, Hutton/Jones, blue manatee 
press), which lists AAP screen time recommendations on the back cover.48   This will be 
briefly reviewed by the CRC, in addition to customary ROR procedure in the clinic. A 
postcard will be provided conveying contact information for the CRC in the event of a 
change in participant phone number or other contact information. Care will be taken to 
make the instruction process as brief as possible, to simulate how a pediatric provider or 
support staff would function in a busy, real-world clinical setting. 
 
d) Data management* 
 
Power Analysis: We will recruit 248 children in 2 age categories: approximately 6 
months old (infants, n=124), and approximately 18 months old (toddlers, n=124) via 
convenience sampling in the CCMC clinic waiting room during regularly scheduled well-
child visits. This study will be powered based on the primary language outcome measure 
(LENA Snapshot). For a two-group (intervention/control), pre-post repeated-measure 
analysis with two age categories (6-12 months, 18-24 months), an ANCOVA model will 
be applied for both age categories and their interaction, to assess the difference in 
language scores between intervention and control groups. For this study, at least 180 
subjects will be needed to have 80% statistical power to detect slightly greater than 
medium effect size (Cohen f=0.30), controlling for the baseline pre-measurement with a 
two-sided significance level of 0.05. This effect size was determined considering the 
2008 National Early Literacy Panel Report, which examined 16 studies and reported an 
effect size of 0.6 for dialogic reading on language outcomes (d=0.6; Shanahan, et al).49 A 
separate meta-analysis of 18 studies that tested dialogic reading intervention found 
average effect size for language outcomes and vocabulary of 0.29 and 1.02, respectively.8 
However, these reports largely involved preschool- and school-age children, and no 
studies to our knowledge have reported effect sizes of dialogic reading for language in 
infants and toddlers. 
 
Confidentiality will be maintained by storing all data on secure, password-protected 
servers hosted by the Cincinnati Children’s Division of Bimedical Informatics. The CRC 
at CHC@CCMC will log in to this database via a password to enter study data, as is 

 
14
customary for off-site studies. REDCap software will be used for data capture and is a 
secure, HIPAA-capable web-based data management tool, and is provided at no cost by 
Cincinnati Children’s via a grant to its Center for Clinical and Translational Science 
(CCTST). Access to REDCap data and the servers is limited to personnel directly 
involved in the study. All hard copy records including consent forms will be securely 
stored by the CRC at CHC@CCMC, access restricted to study related personnel. All 
potentially identifying data will be destroyed within 3 years of study completion. 
 
e) Provisions to monitor the data for the safety of subjects* 
 
This study involves minimal risk, and such provisions are not required.  
 
f) Withdrawal of subjects* 
Subjects may advise the CRC or investigators of their desire to withdraw from 
this research at any time, prior to their second (final) study visit.  Following the 
second visit, their data will be deidentified, and will not be able to be removed. 
The investigators may remove subjects who do not complete the second visit (i.e. 
missing data), do not present for their scheduled well-child visit, or are lost to 
follow up. 
9) Risks to subjects* 
 
As reading with children is considered to be helpful for their development, this study 
involves minimal to no risk to subjects.  However, the following risks/inconveniences are 
possible: 
 
• Financial risks may involve the use of cell phone data minutes, though these are 
expected to be small. 
• The well-child visit (checkup) may take longer than usual, due to time spent 
completing surveys. We will try to finish these during normal waiting time before the 
doctor is ready to see participating families, so that inconvenience is minimal, and the 
visit goes smoothly. We will be working with clinic staff to help make sure this 
happens.  
• Increased screen-based media use is possible via encouraging use of a smartphone-
based application (RS app), and this possibility is explored via one of our study aims. 
By contrast, families in the control group will receive a specially designed children’s 
book discussing alternatives to screen time. 
 
10) 
Potential benefits to subjects* 
 
Potential benefits to subjects include: 
• 
Increased knowledge of healthy reading practices to try at home (very likely). 
• 
Increased knowledge about the child’s emotional and language development 
(likely). 
• 
Improved emotional and language development through more healthy reading 
practices to try at home (possible, the purpose of the study). The mechnism of reading 
instruction (RS app) is unproven at this time.  
 

 
15
11) 
Provisions to protect the privacy interests of subjects 
Subjects will be approached as discretely as possible via a trained CRC in the 
clinic waiting area, and invited to discuss the study in an area that is as quiet and 
private as possible.  For those expressing interest, written informed consent will 
be obtained in either a private area of the waiting room or in a private exam room, 
and all data will be collected in a private exam room. As this study involves 
minimal risk, initial discussion of the aims of the study or eligibility requirements 
in the waiting area does not represent a major risk to subject privacy, though the 
CRC will be advised to be as discreet as possible.  
12) 
Provisions to maintain the confidentiality of data 
Screening and survey data will be directly entered by the CRC into REDCap 
(www.REDCap.org), a secure, HIPAA-capable web-based data management tool, 
to the greatest degree possible (demographics and select parental surveys). All 
paper-based data will be transcribed into REDCap as expeditiously as possible. 
All subjects will be assigned a unique Study ID in REDCap, and at the conclusion 
of data collection for all subjects, all identifying information such as names and 
phone numbers will be deleted. Biostatisticians at Children Inc. and the principal 
investigator will only download deidentified data via REDCap for analysis, and 
then store this data on password-protected servers at their respective institutions 
(Children Inc. and CCHMC). REDCap data will be stored on secure, password-
protected servers hosted by Cincinnati Children’s Division of Biomedical 
Informatics, with state of the art security features. Hard copy records will be 
restricted to IRB-approved study personnel in locked cabinets at CHC@CCMC. 
Hardcopy data will be destroyed within 3 years of conclusion of the study. 
13) 
Medical care and compensation for injury 
This study involves minimal risk, and such provisions are not required. 
14) 
Cost to subjects 
There are no costs involved with participation in this research, other than use of 
smartphone data minutes using the RS application (if applicable; would not result 
in any cost in the case of increasingly common unlimited data plans), expected to 
be minimal.  The RS application is completely free, with no special accounts 
needed.   
15) 
Consent process 
• Written informed consent will be administered via a trained CRC 
in a private section of the waiting area or private exam room at 
CHC@CCMC.  
• A single CRC to be hired via the Weitzman Institute will be solely 
responsible for informed consent.  
• Informed consent will cover all aspects of the study included on 
the consent form, in plan English, anticipated to take less tha 5 
minutes.  The ability to comprehend the informed consent 
documents in plain English without a translator is a requirement 
for inclusion in this study. 

 
16
• Non-English speaking families are excluded from this pilot study 
due to restrictions on time, budget, and the need to minimize 
covariates such as language spoken at home in our analyses, 
especially as bilingual children are known to have short-term 
language delays likely to influence our findings. The RS app is 
also not currently available in Spanish. In the future, we plan to 
expand our research to non-English speaking households. 
• As this study involves convenience sampling in the waiting area, 
there is no lag expected between approach for consent, 
administration of consent, and enrollment in the study for those 
interested.  
• The CRC administering informed consent will emphasize that 
participation in this study is optional and voluntary, and that their 
child will receive the same well-child care regardless of 
participation, including via the Reach Out and Read program.  
• Consent from one custodial parent is all that will be required for 
this research.  “Custodial” parent will be defined as with necessary 
permission to accompany the child to the doctor at the current visit, 
and who lives with the child at home and would have the 
opportunity to consistently read to them. As reading with children 
is generally considered to be beneficial, we feel that permission 
from one parent is adequate for our study design. If, by small 
chance, the second parent or custodial caregiver protests this 
enrollment and requests removal, the child will be removed from 
the study.  
• If the child is accompanied by another family member such as an 
aunt or grandparent, they will not be enrolled in this study, unless 
this family member has full-time legal custody of the child, 
authorized by a court order. 
• This study clearly involves children (age 6-12 months and 18-24 
months old), by any definition. Children of this age can not 
reasonably be expected to provide consent or assent, and will not 
be asked to do so.  
16) 
Process to document consent in writing 
Written informed consent will be documented on the IRB-approved consent form 
accompanying this application, written in plain English per specifications and 
summarized in person via the CRC. One copy of this form will be given to the 
consenting family member, and the other securely stored in a locked cabinet 
dedicated to this study at CCMC. 
17) 
Vulnerable populations 
This research involves young children under the care of their parent(s) or 
custodial caregiver, who will be delegated responsibility to make an informed 
consent on their behalf.  As this study involves minimal risk, and shared reading 
is generally considered beneficial, the child’s vulnerabilty to harm is negligible. 

 
17
18) 
Drugs or Devices 
This study does not involve drugs or devices. 
19) 
Multi-site Human Research* 
All data collection and intervention for this study will take place at a single site at 
CHC@CCMC. Data will be securely stored in a REDCap database hosted at 
Cincinnati Children’s Division of Biomedical Informatics, accessed via the CRC 
using a unique password, and other access restriced to IRB-approved study 
personnel.  All data downloaded for analysis by biostatisticians at Children Inc. or 
the principal investigator will be in deidentified form, and then stored in 
password-protected servers at the respective institutions (Children Inc. and 
CCHMC).  
20) 
Sharing of results with subjects 
 
Results from this study will not be directly shared with subjects. For children identified 
as being at risk for language delay via LENA Snapshot scores at their second study visit 
(standard scores <77), their primary pediatric provider will be notified by Dr. Wiley from 
CHC@CCMC, to discuss with families as soon as possible. 
 
21) 
In the Event of Distress 
 
In the unlikely event that a participant in this study becomes distressed, such as vomiting, 
the CRC will notify clinic staff at CHC@CCMC immediately to address the issues.   No 
further evaluation or testing will be attempted unless specifically requested by the family 
and poses no discomfort to the child.  Dr. Wiley will be notified via the most efficient 
means possible to advise of such an event, to follow up with the family and clinical 
providers as appropriate.