Literary Promotion Using Automated Hovering to Improve Development in Young Low-Income Children
Phase: NA
Conditions: Parent-Child Relations, Parenting, Literacy
Sponsor: Children's Hospital of Philadelphia

 
 
Title: 
Literary Promotion Using Automated Hovering to Improve 
Development in Young Low-Income Children 
Short Title 
 Literacy Promotion using Automated Hovering 
Regulatory Sponsor: 
Leonard Davis Institute of Health Economics 
eIRB Number: 
19-017184 
Protocol Date: 
Oct 4, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
James Guevara MD, MPH 
Division of General Pediatrics                                                       
Children’s Hospital of Philadelphia 
Philadelphia, PA 19104 
Phone 215-590-1130 Fax: 267-426-0380 
email: Guevara@email.chop.edu 
 
 
 

  
 
 
 
  
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ............................................................................................................ ii 
Abbreviations and Definitions of Terms ........................................................................ iv 
Abstract .......................................................................................................................... v 
Table 1: Schedule of Study Procedures ........................................................................ vii 
1 
BACKGROUND INFORMATION AND RATIONALE .......................................................................... 1 
1.1 
INTRODUCTION ........................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INTERVENTION ............................................................................................ 2 
1.3 
COMPLIANCE STATEMENT ......................................................................................................................... 2 
2 
STUDY OBJECTIVES.................................................................................................................................... 2 
2.1 
PRIMARY OBJECTIVE (OR AIM) ................................................................................................................. 2 
2.2 
SECONDARY OBJECTIVES (OR AIM) .......................................................................................................... 3 
3 
INVESTIGATIONAL PLAN ......................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN...................................................................................................... 3 
3.1.1 
Phase 1 .................................................................................................................................................. 3 
3.1.2 
Phase 2 .................................................................................................................................................. 4 
3.1.3 
Randomized Trial.................................................................................................................................. 4 
3.2 
ALLOCATION TO TREATMENT GROUPS ..................................................................................................... 5 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ...................................................................... 5 
3.3.1 
Duration of Study Participation........................................................................................................... 5 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................... 5 
3.4 
STUDY POPULATION................................................................................................................................... 5 
3.4.1 
Inclusion Criteria.................................................................................................................................. 5 
3.4.2 
Exclusion Criteria................................................................................................................................. 6 
4 
STUDY PROCEDURES ................................................................................................................................. 6 
4.1 
PHASE 1 RAPID-CYCLE DESIGN ................................................................................................................ 6 
4.2 
PHASE 2 SCREENING/ENROLLMENT (BASELINE) VISIT ............................................................................ 7 
4.2.1 
Phase 2 Two Month Follow-Up ........................................................................................................... 7 
4.3 
STUDY TREATMENT PHASE ....................................................................................................................... 7 
4.4 
UNSCHEDULED VISITS ............................................................................................................................... 7 
4.5 
SUBJECT COMPLETION/WITHDRAWAL...................................................................................................... 7 
5 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................. 8 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS .................................................... 8 
5.1.1 
Medical Record Review ........................................................................................................................ 8 
5.1.2 
Other Evaluations, Measures............................................................................................................... 8 
5.2 
SAFETY EVALUATION ................................................................................................................................ 8 
6 
STATISTICAL CONSIDERATIONS .......................................................................................................... 9 
6.1 
PRIMARY ENDPOINT................................................................................................................................... 9 
6.2 
SECONDARY ENDPOINTS............................................................................................................................ 9 
6.3 
CONTROL OF BIAS AND CONFOUNDING .................................................................................................... 9 
6.4 
STATISTICAL METHODS ............................................................................................................................. 9 
6.4.1 
Baseline Data ........................................................................................................................................ 9 
6.4.2 
Sample Size Justification ...................................................................................................................... 9 
6.4.3 
Analysis of Primary Outcomes of Interest.........................................................................................10 
7 
SAFETY MANAGEMENT ..........................................................................................................................10 
7.1 
CLINICAL ADVERSE EVENTS ...................................................................................................................10 
7.2 
ADVERSE EVENT REPORTING ..................................................................................................................10 

 
 
 
 
  
 
 
 
iii
8 
STUDY ADMINISTRATION ......................................................................................................................11 
8.1 
TREATMENT ASSIGNMENT METHODS .....................................................................................................11 
8.1.1 
Randomization ....................................................................................................................................11 
8.1.2 
Blinding ...............................................................................................................................................11 
8.2 
DATA COLLECTION AND MANAGEMENT ................................................................................................11 
8.3 
CONFIDENTIALITY....................................................................................................................................12 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS .....................................................................................12 
8.4.1 
Risk Assessment ..................................................................................................................................12 
8.4.2 
Potential Benefits of Trial Participation ...........................................................................................12 
8.4.3 
Risk-Benefit Assessment .....................................................................................................................13 
8.5 
RECRUITMENT STRATEGY .......................................................................................................................13 
8.5.1 
Subjects................................................................................................................................................13 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ...............................................................14 
8.6.1 
Payments to parent for time and inconvenience (i.e. compensation) ..............................................14 
8.6.2 
Gifts......................................................................................................................................................15 
9 
PUBLICATION ..............................................................................................................................................15 
10 
REFERENCES ......................................................................................................................................15 
Appendix....................................................................................................................... 17 
 

  
 
 
 
  
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
ROR 
 
Reach Out and Read 
LDI 
AH 
NICHD 
 
StimQ 
PSI-SF 
CDI 
DECA 
 
Leonard Davis Institute 
Automated Hovering 
National Institute of Child Health and Human 
Development  
Measure of Cognitive Stimulation Provided in the Home 
The Parenting Stress Index-Short Form  
MacArthur Communicative Development Inventory 
Devereux Early Childhood Assessment  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
  
 
 
 
v
ABSTRACT 
Context: 
Early childhood is a sensitive period in which young children develop language and socio-
emotional skills foundational for school readiness. Unfortunately, poor vulnerable children 
experience disparities in these critical areas of development. Parent-child shared reading can 
help ameliorate these disparities, yet low-income parents do not consistently engage in this 
activity. Behavioral economics approaches utilizing automated hovering (AH) have the 
potential to increase parent-child shared reading through text messages and financial 
inducements.  
Objectives: 
1) To assess the feasibility and acceptability of 3 novel AH interventions of 
increasing complexity hypothesized to increase the frequency of parent-child 
shared reading. 
2) Explore relevant outcomes related to parenting stress, the home reading 
environment, and language and socio-emotional development. 
Study Design: 
The study design has two phases, Phase 1 and Phase 2.  Phase 1 is a brief, rapid cycle design 
process. Phase 2 is a prospective, randomized comparative group trial to test the effects of 
AH approaches to increase parent-child shared reading. 
Setting/Participants: 
We plan to recruit 3-4 urban CHOP-affiliated pediatric practices from CHOP’s Pediatric 
Research Consortium (PeRC) to participate in the study. These practices care for a diverse, 
complex urban population and have onsite social workers to assist with family crises. 
A total of 65 eligible children and their parents will be recruited from participating practices 
to achieve a diverse sample of children. Ten will participate in Phase 1 and 55 will 
participate in Phase 2. Inclusion and exclusion criteria for Phase 1 will be the same as Phase 
2. Children will be eligible to participate if they are 6-24 months old, and have a parent with 
daily access to a smart phone in order to receive and send text messages. Children born <35 
weeks EGA or with congenital anomalies or genetic syndromes that place them at high risk 
for developmental disabilities will be excluded. 
Study Intervention and Measures: 
Ten participants in phase 1 will undergo an audio-recorded qualitative interview that will be 
used to develop coaching tips for phase 2. 
Forty-five participants in phase 2 will be randomized to receive one of the 3 AH 
interventions: daily text message reminders, daily text message reminders with coaching or 
daily text message reminders with coaching and weekly lottery entries. The weekly lottery is 
related to principles of behavioral economics so that participants in this group will be 
externally motivated. The lottery is testing a methodology and is not a non-permissible form 

  
 
 
 
  
 
 
 
vi
of payment.  There will be 15 participants per group to adequately assess feasibility and 
acceptability. 
The result of this application would be expected to inform future R01 applications on the 
effects of AH to improve parent-child shared reading in a larger and more diverse 
population of low-income children. 

 
vii  
 
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
 
Study Phase 
Screening/ 
Study Visit 1 
(Baseline) 
Intervention Period 
(8 weeks) 
Follow-up Study 
Visit  
(8-12 weeks) 
Phase 1 
 
 
 
Informed Consent 
X 
 
 
Review Inclusion/ 
Exclusion Criteria 
X 
 
 
Audio-recording of 
Qualitative Interview  
X 
 
 
Phase 2 
 
 
 
Informed Consent 
X 
 
 
Review Inclusion/ 
Exclusion Criteria 
X 
 
 
Randomization 
X 
 
 
8 Weeks of Daily Text 
Messaging +/- Coaching 
+/- Weekly Lottery 
 
X 
 
Demographics 
X 
 
 
StimQ-Read 
X 
 
X 
PSI-SF 
X 
 
X 
CDI 
 
 
X 
DECA 
 
 
X 
Satisfaction Rating  
 
 
X 
 Parent Questionnaire  
 
 
X 

1 
 
 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
Early childhood is a sensitive period in which young children develop foundational skills 
necessary for communication.1 Early stimulation of brain centers involved in language 
processing promotes the development and sustainment of critical neuronal connections leading to 
growth and proficiency in language and social functioning.1 Unfortunately, language and socio-
emotional delays are common among children under 3 years of age,2 particularly for children 
residing in impoverished communities.3 These delays contribute to poor educational and 
functional outcomes later in childhood and represent an important cause of disparities in child 
educational achievement.4 Lifetime costs for individuals with resulting disabilities have been 
estimated to exceed $60 billion in 2003 U.S. dollars.5 The etiology of these delays are 
multifactorial but have been associated with deficits in early parent-child verbal interactions.6,7  
Parent-child shared reading represents an important source of language stimulation that can 
enhance language and socio-emotional development in young vulnerable children and help 
mitigate disparities in later educational achievement.8 Previous studies have found that parent-
child shared reading is associated with improved language functioning, better school 
performance, less harsh parenting, and fewer disruptive behaviors especially for children from 
low-income families.9-12 Yet parents of young children from low-income communities do not 
consistently engage in reading activities with their children until they are older, due to numerous 
barriers such as lack of time, lack of understanding of importance, difficulty developing daily 
reading habits, stress and fatigue, and competing priorities.13 From an economics viewpoint, 
these barriers can impose a time bias that discounts future language and socio-emotional benefits 
in favor of the current costs of shared reading.  
Early shared reading strategies, such as Reach Out and Read (ROR) and Imagination Library, 
promote parent-child shared reading and distribute board books to low-income children.8,14  
These strategies have demonstrated greater interest in shared reading and improved child 
language development compared to usual care among poor children and their families.  However 
despite these beneficial effects, low-income children and their families engaged in these 
programs have only shown modest improvements in the frequency of shared reading and still lag 
behind their higher income peers in language development.15  
1.1 
Introduction 
The overall goal of this LDI pilot grant proposal is to incorporate behavioral economics 
approaches using automated hovering (AH) to improve the frequency of early parent-child 
reading behaviors among low-income families. Such approaches have previously shown benefit 
in medication adherence, smoking cessation, immunization rates, health care utilization, and 
weight management and have the potential to shape parent-child reading behaviors and improve 
language and socio-emotional development in young children.16-21 This application addresses the 
care of vulnerable populations, one of LDI’s four priority research areas. If successful, 
behavioral economics approaches can be incorporated into current early literacy promotion 
strategies to maximize their potential and further improve early language and socioemotional 
development. For example, children participating in ROR at participating pediatric practices can 
be signed up to receive automated text message reminders with or without financial inducements 
at the same time as they receive a board book and reading promotion counseling from their 
pediatric clinician at a corresponding well child visit. 

2 
 
 
 
 
1.2 
Name and Description of Intervention 
The intervention will incorporate behavioral economic approaches utilizing AH to improve 
frequency of early parent-child shared reading through text messages. The intervention consists 
of daily text messages for 8 weeks in 3 AH intervention groups. The text messages were part of 
the aforementioned trial on early literacy promotion (see Appendix 1).  
Group 1 of the program will consist of daily text messages on shared reading, which will be sent 
to participants using the Way to Health Platform. Participants will be asked to reply to the text 
message on daily shared reading activities including the titles of the books and time spent 
reading (see Appendix 1).  
Group 2 will consist of Group 1 plus personalized coaching. Personalized coaching content will 
be made available to participants through links in the text messages. 
Group 3 will consist of Group 2 personalized coaching plus availability of a weekly lottery. The 
lottery is related to principles of behavioral economics so that participants in group 3 will be 
externally motivated. The lottery is testing a methodology and is not a non-permissible form of 
payment. Participants who report back that they read on a particular day will be entered into a 
weekly drawing to receive $20. Each reported daily reading behavior will provide a single lottery 
entry so that participants who report they read all 7 days in a given week will have 7 entries in 
the weekly drawing. Lottery entries will begin on Mondays and close at 12:00 AM on Sundays 
for all 8 weeks of the program. The following Monday morning the lottery will be drawn. The 
participants in Group 3 will begin their 8- week intervention the first Monday after enrollment.   
1.3 
Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: Consolidated Guideline 
approved by the International Conference on Harmonization. All episodes of noncompliance will 
be documented. 
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 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 
Our long-term goal is to test the effects of AH approaches to promote child language and socio-
emotional development. As such, we will incorporate behavioral economic approaches using 
automated hovering (AH) to improve the frequency of parent-child shared reading in low-income 
children and help ameliorate disparities for school readiness. 

3 
 
 
 
 
2.1 
Primary Objective (or Aim) 
Specific Aim 1: To determine the feasibility and acceptability of automated hovering of varying 
intensity designed to improve the frequency of parent-child reading behaviors among low-
income families.  
2.2 
Secondary Objectives (or Aim) 
Specific Aim 2: To explore differences in reading frequency, the home reading environment, 
parenting stress, and child language and socio-emotional development by the intensity of the 
automated hovering strategy among low-income families. 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
To be eligible to participate, children must be aged 6-24 months old, and have a parent with daily 
access to a smart phone in order to receive and send text messages. Inclusion and exclusion 
criteria for Phase 1 will be the same as Phase 2. In our previous study utilizing text messaging 
with low-income families for a study of early literacy promotion, only 28 (18.9%) of 148 eligible 
participants approached for recruitment were ineligible because they didn’t have access to a 
smart phone. Children and their parents will be recruited from participating practices at any 6 
through 24-month well child visit in which parents receive board books and reading promotion 
from their child’s clinician as part of the ROR program. 
3.1.1 Phase 1 
Prior to conducting the RCT, we will develop the text messages and personalized coaching that 
we will employ in the RCT. The text messages were previously developed as part of the 
aforementioned trial on early literacy promotion (see appendix). Using a rapid-cycle design 
process developed by Dr. Buttenheim, data from brief interviews with N=10 parents will be used 
to identify specific behavioral barriers to more frequent reading with children, and to edit 
reminder messages and develop coaching content to target those barriers with behaviorally-
informed solutions. Personalized coaching will consist of a menu of various instruction and tips 
on reading that participants can select based on their needs. The interviews will be audio 
recorded and transcribed in order to analyze content. In the event that the baseline visit cannot be 
completed in-person, an alternative method of obtaining informed consent will be used, and the 
interview will be completed over the phone. All interviews will be audiotaped and transcribed 
for analysis. Interview transcripts will be analyzed and coded using NVivo, a qualitative 
software. The information can inform the motivational tips in phase 2 to address barriers to 
shared reading. 
Following the telephone screening, caregivers of eligible children will be sent the 
informed consent document electronically through REDCap. The study team will then go over 
the document in detail with the eligible caregiver by phone and use the e-consent function to 
obtain their signature. The signed e-consent form will be stored within REDCap and a copy will 
be made available to download and email securely to the caregiver. 

4 
 
 
 
 
3.1.2 Phase 2 
After conducting the rapid-cycle design for phase 1, forty-five eligible children and their parents 
will be consented and enrolled in the study. In the event that the baseline visit cannot be 
completed in-person an alternative method of obtaining informed consent electronically through 
REDCap will be used. Following informed consent and completion of baseline surveys, 
participants will be stratified by site and randomized 1:1:1 to receive one of the 3 AH 
interventions for an 8-week duration. Using a similar recruitment strategy, we were able to 
successfully recruit 120 (81%) of 148 low-income infants and their parents who were 
approached for the aforementioned study on early literacy promotion. 
Group 1 will consist of daily text messages on shared reading, which will be sent to participants 
using the Way to Health Platform. Participants will be asked to reply to the text message on daily 
shared reading activities including the titles of books and time spent reading. Group 2 will 
consist of Group 1 plus personalized coaching. Personalized coaching content will be made 
available to participants through links in the text messages and will provide comparisons of their 
reading frequency with that of other participants. These comparisons will be blinded to preserve 
confidentiality. Finally, Group 3 will consist of Group 2 plus availability of a weekly lottery. 
Group 3 participants who report back that they read on a particular day will be entered into a 
weekly drawing to receive $20. Each reported daily reading behavior will provide a single lottery 
entry so that participants who report they read all 7 days in a given week will have 7 entries in 
the weekly drawing. 
3.1.3 Randomized Trial 
All participants across groups will be asked to report on daily reading behaviors by replying to 
daily text messages. In addition, participants will be asked to complete study measures using a 
RedCap survey at baseline and following the 8-week intervention period. Responses to daily 
reading text messages will be provided by the Way to Health platform and will be assessed as the 
mean overall number of days/weeks of reading for each group. Participants will also be provided 
with an opt out of the daily text messages option if they no longer desire to receive daily text 
messages. Participants will be queried at follow-up on their overall satisfaction (5-point Likert 
scale) with their intervention group and asked to answer survey questions regarding likes and 
dislikes concerning the intervention group they received following the intervention period. The 
survey questions at the end of phase 2 will be based on input from the rapid-cycle design process 
of phase 1 interviews. 
At baseline, parents will complete a measure of demographics (child and parent age, 
race/ethnicity, sex, highest education completed, and family income category) (see Appendix 2). 
To explore differences in the home reading environment, parents will complete the Read 
subscale of the StimQ, a validated 14-item parent report measure of the home reading 
environment, at baseline and follow-up.23 To explore differences in parenting stress, participants 
will complete the Parenting Stress Index-short form (PSI-SF), a validated 36-item parent report 
of parenting stress, at baseline and following the 8-week intervention in order to assess 
changes.24 Finally to explore differences in child language and socio-emotional development, 
parents will complete at follow-up the MacArthur Communicative Development Inventory 
(CDI), a validated parent-report scale of early language development, and the Devereux Early 

5 
 
 
 
 
Childhood Assessment (DECA), a validated 33-item parent report of socio-emotional 
problems.25,26  
3.2 
Allocation to Treatment Groups  
Participants will be recruited at the time of a well child visit for their infant using a recruitment 
flyer and will undergo written informed consent at their first visit. Caregivers of eligible children 
will be consented in person or electronically through REDCap. Following informed consent and 
completion of the baseline surveys participants will be randomized 1:1:1 to one of 3 AH groups: 
1) daily text message reminders on shared readings using the Way to Health Platform or 2) daily 
text message reminders plus personalized coaching and social comparisons through links in the 
text messages or 3) daily text message reminders, coaching and the availability of a weekly 
lottery. Randomization will be accomplished in advance using computer generated numbers. 
Allocation concealment (blinding of the treatment assignment) will be implemented and sealed, 
opaque envelopes, along with stratification, and randomly permuted blocks of unequal sizes (to 
prevent providers and patients from manipulating the randomization). 
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration for Phase 1 of the study will be approximately 30 minutes. For Phase 2, the 
intervention duration will be 8 weeks for the intervention, but total study duration will last 12 
weeks to allow for completion of follow-up measures. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately 3-4 CHOP primary care practices in Philadelphia. 
Recruitment will stop when approximately 55 subjects are enrolled.  
3.4 
Study Population 
We plan to recruit 3-4 urban CHOP-affiliated pediatric practices from CHOP’s Pediatric 
Research Consortium (PeRC) to participate in the study. These practices care for a diverse, 
complex urban population and have onsite social worker to assist with family crises. Using well-
established methods that have proven effective in multiple large-scale trials, 3-4 practices located 
in Philadelphia will be recruited to participate using letters of invitation and in-person 
presentations. Incentives to participate will include provider education on parent-child shared 
reading. A total of 55 eligible children and their parents will be recruited from participating 
practices to achieve a diverse sample of children. Inclusion and exclusion criteria for Phase 1 
will be the same as Phase 2. Children will be eligible to participate if they are 6-24 months old, 
and have a parent with daily access to a smart phone in order to receive and send text messages. 
3.4.1 Inclusion Criteria 
Parent who: 
1) Have an infant aged 6-24 months  
 
 
2) Have access to a smart phone with text messaging capabilities  

6 
 
 
 
 
 
3) Have completed an informed consent 
 
Children who: 
4) Are aged 6-24 months old 
 
3.4.2 Exclusion Criteria 
Parents who: 
1) Non-English speaking 
 
Children who: 
1) Were born premature (estimated gestational age < 35 weeks) 
 
2) Have been diagnosed with congenital malformations or genetic syndromes which place 
them at risk for developmental 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 
Phase 1 Rapid-Cycle Design 
Informed Consent: Parents will participate in-person consent visits. In the event that the baseline 
visit cannot be completed in-person an alternative method of obtaining informed consent 
electronically through REDCap will be used. Modified Verbal consent will be collected if the 
COVID-19 pandemic persists to limit study staff exposure. Parents will be called to obtain verbal consent 
for participation using the written informed consent document. Parents who agree will be sent the written 
consent form for signature through RedCap. In the event that the baseline visit is conducted remotely, 
parents will be given the option to complete the interview over the phone. 
Review of Inclusion/Exclusion Criteria 
Interview: The interviews will be audio recorded and transcribed. We will be using ADA Transcription 
services. The outline of content of the interview will use open-ended questions to identify specific 
behavioral barriers to more frequent reading with children (see appendix 3 for Interview Guide). Data 
from the interview will be used to edit reminder messages and coaching content in phase 2 to address 
perceived barriers. The interviews will occur in the primary care practice following the completion of 
their child’s well visit.or over the phone if COVID-19 is still ongoing to limit study staff exposure.  
Demographics 

7 
 
 
 
 
4.2 
Phase 2 Screening/Enrollment (Baseline) Visit 
Informed Consent: in-person 
Review of Inclusion/Exclusion Criteria 
Demographics 
Measure of Cognitive Stimulation Provided in the Home – (StimQ-Read)  
Parenting Stress Index- short form (PSI-SF) 
4.2.1 Phase 2 Two Month Follow-Up 
Measure of Cognitive Stimulation Provided in the Home – (StimQ-Read)  
Parenting Stress Index- short form (PSI-SF) 
CDI 
DECA 
Satisfaction Rating 
Survey 
4.3 
Study Treatment Phase 
Over the course of each subject’s participation, the subject will have a baseline and a 2-month 
follow-up visit. After being screened at baseline, participants will complete demographics, 
StimQ-Read and PSI-SF. At the follow-up visit, StimQ-Read, PSI-SF, CDI, DECA, Satisfactory 
rating and survey questions will be completed. If the baseline and follow up study visits cannot 
be completed in-person, surveys may be administered online through REDCap. 
4.4 
Unscheduled Visits 
Unscheduled visits are not anticipated. 
4.5 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They may 
also be discontinued from the study at the discretion of the Investigator for lack of adherence to 
the study visit schedule or any AEs.  The Investigator may also withdraw subjects who violate 
the study plan, or to protect the subject for reasons of safety or for administrative reasons.  
Additionally, if a subject is enrolled but does not complete the baseline surveys within 30 days of 
enrollment, they will be disenrolled from the study. It will be documented whether or not each 
subject completes the study. If the Investigator becomes aware of any serious, related adverse 
events after the subject completes or withdraws from the study, they will be recorded in the 
source documents and on the CRF. 

8 
 
 
 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review 
Date of birth 
Gestational age, sex, developmental assessments 
5.1.2 Other Evaluations, Measures 
At the start of phase 2, following written informed consent, participant families will complete a 
baseline visit. In the event that the visit cannot be completed in person, study procedures may be 
conducted virtually online through REDCap. Measures of demographic and biological variables 
(child age, sex, race/ethnicity, family income, maternal education level, and family structure), 
parenting stress, and the home reading environment will be collected by research staff blinded to 
randomization assignment at this visit (See Appendix 2). 
The Read subscale of the StimQ is a validated 14-item parent self-report questionnaire designed 
to measure of the home reading environment, at baseline and follow-up for children ages 5 to 72 
months of age.23 The StimQ contains 4 subscales (availability of learning materials, reading, 
parental involvement in 1developmental advance, parental verbal responsivity) and is available 
in English and Spanish. Internal consistency (Cronbach =0.88-0.93) and test-retest reliability 
(ICC=0.93) of the StimQ is excellent, and it correlates well (r=0.55) with the IT-HOME 
Inventory, another measure of the home environment.78 Poverty will be assessed by examining 
family income (<100% of the Federal Poverty Level) and maternal education status ( High 
School). Parenting stress will be measured at baseline and at follow-up 2 months later using the 
Parenting Stress Index-Short Form (PSI-SF). 24 
Parenting Stress Index-Short Form (PSI-SF): Baseline and follow-up. The PSI-SF is a validated 
36-item scale that measures parenting stress. It has been shown to have excellent internal 
consistency and to be positively associated with maternal psychological distress. Scores on the 
PSI-SF correlate well with the full PSI. The total score will be used.   
MacArthur Communicative Development Inventory (CDI): 2-month follow-up. CDI is a 
validated parent-report scale of early language development which captures important 
information including language comprehension, production and grammar. 26 
Devereux Early Childhood Assessment (DECA): 2-month follow-up. DECA is a validated 33-
item parent report of socio-emotional problems used to identify children at risk for language 
deficits. 25 
5.2 
Safety Evaluation 
Subject safety will be monitored by adverse events reporting. As this study is not greater than 
minimal risk serious adverse events are not anticipated.  

9 
 
 
 
 
6 
STATISTICAL CONSIDERATIONS 
6.1 
Primary Endpoint 
For phase 1, the primary endpoint will be the qualitative interview responses used to inform texts 
and survey for phase 2. For phase 2, the primary endpoints will be acceptability and feasibility of 
the intervention. To determine feasibility and acceptability of the intervention, we will assess the 
number of participants who complete the daily text messages and query participants on their 
overall satisfaction measure (5-point Likert scale) with their intervention group and provide 
survey questions regarding likes and dislikes concerning the intervention group they received 
following the intervention period.  
6.2 
Secondary Endpoints 
Secondary outcomes will be explored in phase 2 to determine the differences in reading 
frequency, the home reading environment, parenting stress, and child language and socio-
emotional development at 2 months.  
6.3 
Control of Bias and Confounding 
Randomization and allocation concealment are the primary means of avoiding bias. Analytic 
strategies will also be used to control for residual confounding: (1) Stratification will control for 
imbalance not controlled by design. (2) Additional potential confounders will be evaluated for 
any residual association with treatment and included in model as needed. (3) Post randomization 
effects: The primary source of bias will arise after randomization from dropout and loss to 
follow-up. To address this problem and avoid missing data, we shall implement the following 
measures: (a) incentives to each family to complete the study, (b) collection of multiple contact 
numbers and tracking of changes, and (c) contact all randomized participants, even if they do not 
continue with their clinical contacts. 
6.4 
Statistical Methods 
6.4.1 Baseline Data 
Descriptive statistics for demographic, home reading environment, and parenting stress measured 
at baseline will be examined across the three groups to assess the success of the randomization. 
6.4.2 Sample Size Justification  
The planned sample size for Phase 1 is 10 participants and for Phase 2 is 15 participants per 
group. Ten participants in phase 1 will be sufficient to provide information to develop coaching 
tips and identify the main obstacles to parent child reading in phase 2. Our target sample size for 
phase 2 is 45 participants with 15 participants per group. This sample size is based on the 
availability of funds and ability to complete the study within a 1 year time period.. These sample 
sizes were determined to adequately assess feasibility and acceptability. As a pilot study, a power 
calculation is not necessary. 

10 
 
 
 
 
6.4.3 Analysis of Primary Outcomes of Interest 
6.4.3.1 Specific Aim 1 
Primary outcomes: 
To determine the feasibility of each group of the intervention, we will assess the proportion of 
participants who receive and report a daily reading behavior each week across all groups, the 
proportion of participants who access coaching content in group 2 & 3, and the proportion of 
participants who participate in the weekly lottery in group 3. To determine acceptability of the 
intervention, we will assess the number of participants who opt out of the daily text messages 
and query participants on their overall satisfaction (5-point Likert scale) with their intervention 
group and provide survey questions regarding likes and dislikes concerning the intervention 
group they received following the intervention period. The survey questions at the end of phase 2 
will be based on input from the rapid-cycle design process of phase 1 interviews. Differences in 
weekly reading frequency and satisfaction scores between groups will be assessed using standard 
inferential statistics and intention-to-treat analysis. Survey question responses will be assessed 
using qualitative methods in which codes will be developed and emerging themes identified by 
consensus of investigators using NVivo software. 
Secondary outcomes: 
To explore differences in reading frequency, the home reading environment, parenting stress, 
and child language and socio-emotional development, we will examine differences in mean 
weekly reading frequency, mean changes in StimQ Read Subscale scores and PSI-SF scores, and 
mean CDI and DECA scores between groups using standard inferential statistics and intention-
to-treat analysis. In addition, effect sizes will be computed to assess differences between Group 1 
and each of the other 2 groups and to power future studies. 
7 
SAFETY MANAGEMENT 
7.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study. The main risks of 
participation are disclosure of PHI and distress with answering study measures. 
 
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 CHOP 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.  
 

11 
 
 
 
 
8 
STUDY ADMINISTRATION 
8.1 
Treatment Assignment Methods 
8.1.1 Randomization 
Children and their parents will be randomized following informed written consent 1:1:1 to 1) 
daily text message reminders on shared readings using the Way to Health Platform or 2) daily 
text message reminders plus personalized coaching through links in the text messages or 3) daily 
text message reminders, coaching and the availability of a weekly lottery. 
  
8.1.2 Blinding 
Allocation concealment (blinding of the treatment assignment) will be implemented using sealed, 
opaque envelopes, along with stratification, and randomly permuted blocks of unequal sizes (to 
prevent providers and patients from manipulating the randomization). Participants will not be 
blinded to their treatment assignment. However, research will be blinded to treatment assignment 
when collecting study data. 
 
8.2 
Data Collection and Management 
All records generated during this study will be kept confidential in accordance with Institutional 
policies and HIPAA on subject privacy. The Investigator and other site personnel will not use 
such data and records for any purpose other than conducting the study.  
 
To ensure confidentiality of information, data will be stripped of potential identifiers, and all 
written and computerized files will be indexed by a unique identification number. Only research 
staff will have access to this information and to a separate master list. All data for these study 
procedures will be maintained on CHOP’s secure research server, and all analyses will be 
performed on de-identified data only. All collected study measures will be entered directly into a 
REDCap database maintained and protected on this secure research server. The unique 
identifiers will be used to track enrolled families over the course of the study. Confidentiality 
will also be maintained by use of subject code numbers in all presentations and publications. 
Each member of the research team, including investigators, research assistants, and stakeholder-
investigators will receive appropriate training in human subject research and patient 
confidentiality. 
 
For all data collection and management of audio recordings, a digital audio recorder will be used 
and all digital audio files will be stored on a CHOP server for the study. All audio files will be 
sent to ADA Transcription services for transcription with deletion of any identifying 
information. The de-identified transcripts will be returned and maintained on CHOP’s secure 
research server. The ADA Transcription services is a CHOP approved vendor that have been 
used before for other research studies at CHOP and will continue to be used in the future. 
 
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’ 

12 
 
 
 
 
information will be stored in the REDCap database and configured to export data without PHI. 
All de-identified records will be retained forever. De-identified data will be shared with the study 
sponsor. Stored data and patient identifiers will be kept for 6 years subsequent to the study 
completion, and possibly longer if required by the sponsor.  
 
8.3 
Confidentiality 
All data and records generated during this study will be kept confidential and in accordance with 
institutional policies and HIPAA on subject privacy. Participation in all aspects of the proposed 
study is completely voluntary. The research team will institute strict procedures to maintain 
confidentiality. Subjects will be assigned a unique identification code that will be used as the 
sole identifier. The data will only be shared with the investigative team during the 
implementation of the study and results will only be presented in aggregate form.  Any results 
obtained cannot be related to the original source, so no results would be provided to the patient, 
healthcare provider, or insurance provider. All study information will be maintained on a secure 
password-protected server with regular backup. 
 
8.4 
Regulatory and Ethical Considerations 
8.4.1 Risk Assessment 
The research involves the collection of sensitive and protected health information from 
participants. The risk of participation is considered minimal. For both phases of the study there is 
a potential risk of breach of confidentiality of information and study results about individuals. 
This risk is minimized by measures taken by the study team to ensure confidentiality: use of 
secure files, storing data on secure computers, using unique study identifiers, de-identification of 
data prior to analysis.  
 
For participation with the rapid response phase of the study, there is a risk that participants may 
become uncomfortable answering questions. In addition, participants responses may be 
inadvertently disclosed outside of research. If participants feel uncomfortable answering 
questions, they may skip any question or stop the interview at any time. Additionally, the study 
team will take the necessary steps to ensure no breach in confidentiality with the audio-
recordings as well. The study team will make sure to keep participant’s information secure after 
the initial recording by using secure files, storing data on secure computers, using unique study 
identifiers and de-identifying all recording. No one other than the research team and the person 
who writes down the answers will hear the recordings. Also, if someone’s name is mentioned, it 
will not be included on any notes made by the researchers. The transcripts will have all 
identifying information deleted. 
 
For participation in the pilot clinical trial, there is a risk that participants may become 
uncomfortable in completing study measures. If this occurs, the protocol will allow participants 
to stop at any time. Should any specific concerns arise throughout the project period, the CHOP 
IRB will be promptly informed. Since the purpose of the intervention is to help parents improve 
parent-child shared reading, we expect that adverse consequences due to the intervention will be 
extremely rare and unlikely. 

13 
 
 
 
 
8.4.2 Potential Benefits of Trial Participation 
There are no direct benefits to subjects. The results of this study may assist health care providers 
and researchers in testing the effects of AH approaches. The use of AH to test its effect to 
increase parent-child shared reading in a larger more diverse population of low-income children. 
This model may be replicated in different care settings and thus generate generalizable 
knowledge.  Further, the information obtained will be disseminated as widely as possible, 
including publication in peer-reviewed journals and policy briefs and presentations at scientific 
and lay conferences. Given the minimal risk nature of the study, the risks are considered 
reasonable in relation to the potential benefit to be gained. 
8.4.3 Risk-Benefit Assessment 
Given the minimal risk nature of the study, the risks are considered reasonable in relation to the 
potential benefit to be gained.  
8.5 
Recruitment Strategy 
8.5.1 Subjects 
Eligible children and their parents will be identified in the clinic by either research staff or clinic 
providers through the use of a recruitment flyer (see Appendix 8). The flyer will be used to 
deliver information of the study to eligible children and parents. If permitted, research staff will 
recruit in person at the clinic. Parents who verbally agree to be contacted will be asked to scan 
the QR code on the flyer to complete a REDCap referral form (see Appendix 9). The contact 
form will be stored within REDCap and will then be available for research staff to use. Medical 
records of the potentially eligible subjects will be screened and assessed for eligibility prior to 
contacting the subject. Subsequent to screening the medical record, the subject will be called by 
the research staff to explain the study and arrange for a study visit. 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- or remotely to complete the baseline visit. At this visit, parents will be 
asked to provide written informed consent to participate in the study. In the event that the 
baseline visit cannot be completed in-person, an alternative method of obtaining informed 
consent will be used. Following the telephone screen, caregivers of eligible children will be sent 
the informed consent document electronically though REDCap. The study team will go over the 
document in detail with the eligible caregiver by phone. The e-consent function in REDCap will 
be used to obtain the caregiver’s signature. The signed e-consent will then be stored within 
REDCap and a copy of the form will be available to download and emailed securely to the 
caregiver.  
 
The rationale for the involvement of children in the study is that the investigation addresses child 
development in pediatric care settings. The study does not involve any other special class of 
subjects. 
 

14 
 
 
 
 
8.6 
Informed Consent/Assent and HIPAA Authorization 
Following the screening via review of the medical record, eligibility for study participation will 
be explained via phone. During the research staff visit subsequent to the screening process, 
written informed consent will be completed. Research staff will discuss the study aims, 
procedures, risks and benefits, alternatives to participation, and confidentiality protocols with the 
parent. Research staff will speak to the parent about the voluntary nature of participation and 
provide the potential subject with the opportunity to ask questions about the study and its risks 
and benefits. 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 the event that the baseline 
visit cannot be completed in person, informed consent may be obtained electronically through 
REDCap. 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. Participants who are already enrolled in the study and need to be reconsented due to 
study changes (such as the implementation of certain measures), will be contacted by study staff 
and re-consented over the phone (or in person if that is the preferred method of the participant). 
No information sheet or copy will be offered to subjects who are verbally re-consented due to the 
fact that these subjects already have a copy of the main consent form. 
All activities stated in this proposal will be performed in accordance with the Health Insurance 
Portability and Accountability Act (HIPAA).  CHOP personnel, including research staff and 
stakeholders, must complete training on the privacy measures of HIPAA. This training reviews 
the HIPAA policies relevant to research practice to protect the confidentiality of patients and 
research subjects.  The protection of human subjects training provides formal, comprehensive 
education in order to protect children, adolescents, and parents from the risks associated with 
participating in research, and to reduce the risk to investigators and the institution that are 
associated with non-compliance.  Training covers institutional policies and procedures, federal 
regulations and critical aspects of study implementation.  These training requirements are 
fulfilled by completing the Collaborative Institutional Training Initiative (CITI) Course in the 
Protection of Human Subjects, an online program that covers the history and ethics of human 
subject research, the organizational structure and procedures of the Institutional Review Board, 
the protocol process, HIPAA for clinical research, and standards for conducting clinical research 
at CHOP.  
 
8.6.1 Payments to parent for time and inconvenience (i.e. compensation) 
Participants in Phase 1 will be paid up to a total of $25 for their participation.  
Participants in Phase 2 will be paid up to a total of $75 for their participation. They will receive 
$25 upon completion of the initial study visit (Baseline). At the final study visit (2-month follow-
up) they will receive $50. Group 3 participants will be entered into a weekly drawing with the 
opportunity to receive $20 for up to 8-weeks of lotteries. Participants in Group 3 have the 
opportunity to receive additional payments up to $160. All payments will be made in the form of 
pre-paid, CHOP-issued debit cards.  

15 
 
 
 
 
8.6.2 Gifts 
No other gifts will be given.  
 
9 
PUBLICATION 
This study will be registered with ClinicalTrials.gov following IRB approval of the final protocol 
and before any potential patients and their families are enrolled in the study. All study data will 
then be reported to the ClinicalTrials.gov site. Additionally, all arising publications of Study data 
and analyses will follow the set of guidelines outlined in the CHOP publications policy manual. 
 
The research team plans to work closely with key stakeholders to disseminate and implement the 
findings of the research study into accessible and usable formats in research, clinical, and 
community-based settings. We will target findings to state and national policymakers, county EI 
agencies across the state, parent advocacy groups, and pediatric practices using social media, 
policy briefs, mass emails, and newsletters. We will work with PolicyLab at CHOP to develop 
dissemination plans. PolicyLab has extensive experience distilling research findings into policy-
relevant summaries and disseminating research findings to end-users. We will also utilize 
traditional approaches such as peer-reviewed publications and presentations at national meetings 
to disseminate findings to other researchers. 
 
 

16 
 
 
 
 
 
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APPENDIX 
See attached.