Treinta Millones de Palabras-Visitas al Hogar Pilot Randomized Controlled Trial
Phase: NA
Conditions: Language Development
Sponsor: University of Chicago

Protocol version: 02/08/19 
 
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NCT03076268: TREINTA MILLONES DE PALABRAS-VISITAS AL HOGAR RCT 
 
 
PROTOCOL TITLE: TREINTA MILLONES DE PALABRAS-VISITAS AL HOGAR RCT 
 
PI: Dana Suskind, M.D. 
 
FUNDING: External funding from Heising-Simons Foundation 
 
SPONSER: Private Industry 
 
TYPE OF RESEARCH: Longitudinal Randomized Control Trial  
 
INTERVENTION: Experimental Technique To Change Knowledge And Beliefs 
 
PROTOCOL VERSION DATE: 2/8/2019 
 

Protocol version: 02/08/19 
 
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TREINTA MILLONES DE PALABRAS-VISITAS AL HOGAR RCT 
PROTOCOL NARRATIVE 
 
1.  INTRODUCTION  
A. 
BACKGROUND AND RATIONALE 
a) 
Background 
A child’s early language exposure is a primary component in language development and 
in ultimate educational and intellectual achievement (Bruner, 1981; Chapman, 2000; 
Gallaway & Richards, 1994; Hart & Risley, 1995; Huttenlocher, Haight, Bryk, Selzer, & 
Lyons, 1991; Rowe, 2008).  Betty Hart and Todd Risley (1992) conducted a landmark 
study that demonstrated the tremendous impact of a child’s early language milieu on 
future learning, revealing a significant correlation between the number of words to which 
a child is exposed between the ages of 0-4 years and his/her ultimate IQ and academic 
success (Hart & Risley, 1992; 1995).  Their findings were both significant and alarming, 
demonstrating the critical and time-sensitive role that early language exposure plays in a 
child’s life.  Their follow-up with the same children at 9-10 years of age confirmed that 
preschool and elementary school interventions came too late to alter these trajectories; the 
reverberations of early linguistic deprivation were likely to follow these children 
throughout their lives. 
 
Children born into poverty experience an overwhelming inequality in their early language 
experience.  Hart and Risley’s study revealed a steep socioeconomic gradient in early 
exposure to language.  At the end of their third year of life, children from high-
socioeconomic status (SES) families heard approximately forty-five million words while 
children from low-SES backgrounds heard only approximately thirteen million.  The 
tragedy for these children is not unalterable.  It is neither genetics nor a lack of potential 
that lies at the heart of this inequality.  Rather, it is inadequate parental knowledge of 
child language development.  Rowe (2008) demonstrated that the relationship between 
SES and parental communication ability is mediated by parental knowledge.  Other 
studies have corroborated this, showing that the effect of SES on a child’s vocabulary 
was primarily dictated by maternal speech (Hoff, 2003).  Encouragingly, studies have 
also demonstrated that a well-planned parent-directed language intervention may increase 
low-SES parents’ use of facilitative language with their children (Oneil-Pirozzi, 2009; 
Suskind et al., 2013).  The Thirty Million Words Initiative was founded, in part, to 
develop and implement such an intervention, via the TMW Curriculum. 
 
The TMW Curriculum was developed to address the disparity in low-SES children’s 
early language environments by increasing parent knowledge, impacting beliefs about 
language, and motivating behavior change.  The TMW Curriculum is comprised of 1) 12 
educational modules, 2) animations and videos of real parent-child interactions to teach 
parents about the science behind child brain development, and model strategies for 
improving parents’ child-directed speech, 3) video modeling and collaborative goal 
setting, and 4) quantitative linguistic feedback from Language Environment Analysis 
(LENA) recordings.   
 

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The LENA system is a technology that provides day-long audio recordings from a digital 
recorder that is placed in the front pocket of specially-designed children’s clothing. This 
‘word pedometer’ records all of the child’s vocalizations and everything spoken near the 
child continuously for 16 hours. Audio data are automatically analyzed using speech 
recognition technology, and reports are generated that provide daily and hourly 
summaries of: 1) the number of adult words spoken near the child, 2) the number of turn-
taking interactions in which the child engaged with an adult, and 3) the amount of 
television to which the child was exposed.  The processing software also produces a 
report on the general audio environment, including information about the amount of time 
TV/electronic media was audible in the recording. This technology makes it possible to 
obtain an objective and representative picture of the early language experiences of infants 
and toddlers. Given prior research on the importance of early language exposure, the 
device’s feedback reports can be used as an intervention tool to measure and influence 
parental behavior. Research on the efficacy of the LENA feedback reports, in conjunction 
with information about strategies for language environment enrichment, shows that the 
system may have a substantial effect on parent behavior, influencing them to talk and 
interact more with their children (Gilkerson & Richards, 2008; Suskind et al., 2013).  
 
Although the literature suggests that the LENA technology provides useful quantitative 
feedback to parents, the underlying costs of the technology prevent it from being used on 
a wide-scale. Thus, we seek to develop an innovative mobile word counting application 
to incorporate into the TMW intervention. The Three T’s App is built on completely free 
open-source speech recognition algorithms, and when completed, the mobile application 
will provide quantitative feedback to parents and introduces them to the TMW 
intervention. This application was developed by Luai Zakaria, a medical student in the 
Pritzker School of Medicine at the University of Chicago. The ability to provide accurate 
quantitative feedback has yet to be evaluated. By including this new technology into the 
intervention, the application can be further tested and evaluated.  
 
Research shows that language exposure and usage appear to play a significant role in 
Spanish-English bilingual children’s language development, including vocabulary 
learning, phonological awareness, etc. (Hammer, Hoff, Uchikoshi, Gillanders, Castro, & 
Sandilos, 2014). Yet, findings in the current literature are still preliminary. Moreover, 
there is no conclusive findings regarding early environments in Spanish-English bilingual 
young children’s math understanding. Future research is needed to better understand 
factors promoting early language environments in order to foster language learning and 
math understanding among Spanish-English bilingual young children during toddlerhood. 
 
b) 
Past research  
TMW conducted a randomized, controlled feasibility trial with 23 low-SES families to 
evaluate whether the curriculum improved parents’ knowledge of child language 
development and changed the way parents talk with their toddlers. The TMW Curriculum 
was delivered to 12 treatment families in eight weekly one-on-one home visits.  Home 
visits included educational module review, video modeling, collaborative goal setting, 
and quantitative linguistic feedback from weekly LENA recordings.  The control 

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condition received a nutrition pamphlet at short weekly home visits to control for a 
possible attentional effect experienced by those in the treatment group.   
 
The results of the feasibility trial suggest that the intervention has a significant impact on 
parent knowledge of child language development and parent-child language behavior.  
During the intervention period, families receiving the TMW Curriculum demonstrated a 
significant increase in 1) parent knowledge of child language development, 2) parent 
language input, 3) parent-child conversational turns, and 4) child vocalizations, as 
assessed through surveys, coded video interactions of parent-child natural play, and 
LENA recordings.  Taken together, the LENA recordings and video-coding results 
suggest that parent-directed language enrichment interventions can change home 
language environments of children from low-SES backgrounds.  Posttest assessments 
revealed a significant increase in parent utterances, word types (unique words), and word 
tokens (all words combined, including repetitions) as well as child word types.  At a four-
month follow-up assessment, intervention effects were significant for parent knowledge 
of child language development.  For all other measures, effects were positive, but not 
statistically significant, possibly due to the small sample size and relatively short follow-
up period. While we did see an increase in child vocalizations during the intervention 
period (which were not sustained post-intervention), as well as significant gains in child 
word types (with a marginally significant effect post-intervention), the sample was not 
sufficiently large, nor was the study period sufficiently long to see the long-term effects 
of the intervention.   
 
The feasibility trial represented a first step toward developing a parent-directed 
curriculum that has the potential to improve the language learning trajectories and 
subsequent academic readiness of low-SES children.  The results indicate the potential to 
change both parent-child language interactions and child language learning trajectories 
during and immediately after the administration of the curriculum.  Overall, the results 
show that the curriculum can provide parents with the tools to successfully enrich their 
child’s early home language environment, thereby reducing academic disparities among 
low-SES children.  A longitudinal study with a sufficiently large population is the next 
step in determining the effectiveness of the curriculum. 
 
c) 
Rationale for conducting this research 
Treinta Millones de Palabras (TMP) Visitas al Hogar is a cultural and linguistic 
adaptation of the TMW-Home Visiting curriculum into Spanish.  The 12-module 
curriculum has been translated into Spanish and adapted to address concerns that are vital 
to mono- and bilingual Spanish-speaking families, including when to introduce a second 
language to a child and the benefits of bilingualism.  TMW-Español Home Visiting will 
be delivered one on one with a trained TMW home visitor and a participant. 
 
We will deliver the TMP Curriculum to 45 Treatment families, and we will be following 
the families for one year to determine the impacts of the translation and cultural 
adaptation of the Home Visiting curriculum.  We will deliver a Nutrition Curriculum to 
45 Control families in order to control for the possible attentional effects experienced by 
those in the Treatment group. Moreover, as an ethical consideration we wish to also 

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provide families in the Control condition with valuable education that may enhance their 
children’s development. 
 
d) 
Rationale for research design and population 
The research design (i.e. a randomized controlled trial) is necessary to determine the 
efficacy of the TMW Intervention. Incorporating knowledge gained from the feasibility 
and longitudinal trials, the intervention has been translated into Spanish and adapted to 
address concerns that are vital to mono- and bilingual Spanish-speaking families, 
including when to introduce a second language to a child and the benefits of bilingualism.  
 
Participants in both the Control and the Treatment condition will receive text messages to 
remind them to complete their LENA recording on the day that they had previously 
scheduled. For the Treatment group only, a text message reminder for a specific goal will 
be sent as well. This will help parents be mindful of their goals at the time that they plan 
to achieve them by reminding parents to engage linguistically with their children. This 
text reminder portion of the study will piggy-back on the goal setting portions in which 
the parent will set specific, personalized goals. Reminders of these goals will be sent to 
their phones at a day and time that parents choose. Both the Treatment and Control 
participants will be given the option to opt out of the text messaging if they do not wish 
to receive these messages.  
 
The sample size (i.e. 45 dyads in the Treatment group and 45 dyads in the Control group) 
was determined based on a Monte Carlo simulation power analysis has been conducted 
based on the frequency of token (during parent-child video-tape observation) pre- and 
post-intervention as a function of group (TMW vs. Nutrition) and child gender, using the 
existing data from the TMW-Longitudinal Home Visiting study.  The effect size of the 
intervention on token count is estimated to be very large (cohen's d = 1) and the attrition 
rate is assumed to be 25%.  The estimated sample size is 91 dyads in total at the 
beginning of the study. 
 
 
B.  OBJECTIVES  
a) 
Hypothesis 
We hypothesize that the primary effects of the TMW Intervention will significantly 1) 
improve low-SES Spanish-speaking mothers’ knowledge of child language development 
and beliefs about the malleability of intelligence, 2) increase mothers’ linguistic 
interaction, responsiveness, and overall engagement with their children; and 3) increase 
children’s language outcomes, as measured by the LENA (child vocalization count, 
conversational turn count), coded video interaction (number of types, tokens, and 
utterances for both children and adults), and a battery of assessments targeting linguistic 
and cognitive development. Furthermore, we hypothesize that increased parental 
interaction will result in 4) an improvement in children’s social-emotional development, 
as measured through the ASQ-SE, and 5) an improvement in children’s math skills, as 
measured through the “Give N Task”.  
 
2.  STUDY DESIGN  

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a) 
Type of study, duration of study, and schedule of events  
Thirty Million Words-Español Home Visiting Pilot RCT is a randomized control trial that 
will take place over the course of one and a half years. The study will consist of two 
groups, the Treatment group and the Control group. During the Recruitment Phase, a 
TMW research assistant (RA) will recruit participants for the study. If interested in 
joining the study, participants will complete the Preliminary Enrollment Consent either in 
their home or in a convenient public space of their choosing. To follow the completion of 
the Preliminary Enrollment Consent, the participant will complete a recorded video 
session with their child, two questionnaires and a home language environment survey.  
RAs will facilitate the collection of these measures.  Following satisfactory completion of 
the baseline measures, participants will move on to the Enrollment Phase 2 weeks later at 
which point they will complete the Enrollment Consent. Additionally, participants will 
complete three questionnaires administered by an RA. This RA will also go over how to 
use the LENA device. Following the Enrollment Phase, participants will move on to the 
Intervention Phase. During the Intervention Phase, participants will first complete 
Assessment 1. A fully trained TMW Assessor will conduct this and all subsequent 
assessments. Following Assessment 1, participants in the treatment group will receive 12 
bi-weekly home visits over a six-month period from trained TMW Home Visitors. The 
Treatment group will receive the TMW Curriculum. The control group will receive 
informational packets dropped off every 6 weeks by a TMW RA. The control group will 
receive the alternative Nutrition Curriculum, which provides information about the 
importance of healthy nutrition for child development, strategies for healthy eating, and 
meal preparation.  
In addition to receiving the home visits, participants will also complete LENA recordings 
on a regular basis. Treatment participants will complete 3 LENA recordings in between 
the enrollment consent and Assessment 1. Then they will complete 12 LENA recordings 
on a bi-weekly basis in between their home visits as a behavioral feedback tool 
incorporated in the home visits.  They will complete one final LENA recording in 
between Assessments 2 and 3, for 16 total LENA recordings. The control group will also 
complete three LENA recordings before Assessment 1, one before Video Session 2, one 
before Assessment 2, and the final one before Assessment 3.  
 
b) 
Summary of sequence and duration of all study periods, including follow 
up periods (as applicable) 
The Recruitment Phase will take place in a rolling manner throughout the first six months 
of the study until the full sample of n=91 is reached. Sequence and duration of all study 
periods are subject to recruitment needs and will be extended accordingly if necessary. 
The Preliminary Consent and Baseline Measures Phase of the study will last at least six 
months. For each individual participant, this phase will take place over a 2-week period 
before the official start of the study. Because of the rolling recruitment, the Enrollment 
Phase will last at least one year. Participants will go through the Enrollment Phase 1 
week before the official start of the study. The Intervention Phase marks the official start 
of the study and will take place during a minimum of 12 months. Each individual 
participant will receive the intervention for 6 months. The Follow-up Phase will take 
place between month 6 and 12. Individual participants’ schedules may vary and will be 

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adjusted based on their availability. The Data Analysis/Publication Phase begins in Year 
2 and will last indefinitely.  
 
c) 
Discuss randomization processes and use of controls  
Participants (i.e. parent-child dyads) will be randomly assigned to one of two groups: 1) 
Treatment group (i.e. TMW Curriculum) or 2) Control group (i.e. Nutrition Curriculum) 
just before the enrollment consent meeting.  Participants will be randomly assigned to 
either the Treatment or Control. Assignment to Control or Treatment of each member is 
decided through a randomization table.  The website Research Randomizer will be used 
to generate a set of 91 unique, unsorted numbers.  The resulting numbers will be entered 
into an excel spreadsheet where the 91 unique, unsorted numbers will be sorted into the 
two groups: Treatment group and Control group. The range of data in the columns will be 
sorted in excel using the “Sort” function to ensure equal sample sizes per group. 
 
 
3. STUDY PROCEDURES  
a) Methods and procedures 
The study consists of 4 phases: Pre-intervention, (including recruitment, preliminary 
consent baseline measures (Month 0) and enrollment), Intervention (Month 1 through 
Month 6), Follow-up (Month 7 through Month 12), and Data Analysis/Publication 
(Month 12 through Month 24). Please refer to the following timelines and the detailed 
descriptions of each phase.  
 
   

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1. Recruitment Phase  
 
Recruitment 
A member of Dr. Suskind’s research team will speak with potential participants in person 
at Recruitment Sites or over the phone.  
 
Additionally, recruitment advertisements will be placed on some Chicago CTA bus and 
train routes.  Note: the advertisement is a general advertisement that is used for recruiting 
families for multiple studies. Based on the language they speak and the age of their child, 
the participant is funneled to the appropriate study line.   
 
 
Screening 
If potential participants are interested in participating in the study, a member of the 
research team will obtain verbal consent and administer the Screening in order to 
determine eligibility. If potential participants are eligible, they will move on to the 
Preliminary Consent and Baseline Measures Phase (for eligibility requirements, see 
Subject Selection and Withdrawal). 
 
2. Preliminary Consent and Baseline Measures Phase 
Preliminary Informed Consent 

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The participant will first complete the Preliminary Informed Consent Form.  This form 
explains the purpose of the study, potential risks and benefits, and the measures taken to 
ensure confidentiality.  
Home Language Interview 
This survey probes about which languages are spoken in the home and how frequently. It 
is conducted via interview with a trained member of the study team. 
 
Measurements 
Participant will complete two questionnaires at the preliminary consent meeting, which 
will include a Breastfeeding survey and the Theories of Intelligence (TOI) survey.  The 
Breastfeeding questionnaire asks parents about their child’s weight at birth and their 
decisions about breastfeeding their child as an infant.  We will also ask parents to 
complete the Theories of Intelligence (TOI) questionnaire to understand participant’s 
preconceived ideas about intelligence. 
 
Video 1 
An RA will complete Video 1 in the participant’s home. The parent and child will engage 
in a 15-minute videotaped session consisting of Natural Play and Book Read. During 
Natural Play, the parent and child will engage in undirected, unstructured play. During 
Book Read, the parent will read a book to the child. During Video 1 and all subsequent 
Videos (2-4), the 15-minute session will be simultaneously recorded by the new mobile 
phone application, the Three T’s App. The extra recording taken with the Three T’s App 
will be explained to the participants, detailing that “the app” functions like the LENA, 
except it links to a Bluetooth microphone and a mobile device, instead of the LENA 
recorder. The TMW staff member will set up the Three T’s App recording, and the 
participant will not see the application itself or be told the full name of the application, as 
these characteristics are related to the Treatment condition. 
 
3. Enrollment Phase 
Following successful completion of the preliminary phase measures, participants will be 
randomized into either Control or Treatment group and move on to the Enrollment Phase 
of the study. The Enrollment Phase of the study will take place in the participant’s home 
or other location preferred by participant (University of Chicago offices, public library, 
etc.) by a member of Dr. Suskind’s research team.  
 
Enrollment Informed Consent 
The parent will first complete the Enrollment Informed Consent Form. 
 
Demographics Questionnaire 
The parent will then complete the Schedule and Demographics Questionnaire (see 
Appendix I. This questionnaire gathers information about the participants’ race and 
ethnicity, the family’s childcare schedule, household information (including housing 
stability and household makeup) and contact information.  
 
Measurements 
To follow, the parent will complete measurements including the Center for 
Epidemiologic Studies Depression Scale (CESD-10) (see Appendix J), because severe 

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depression may be a confounding variable. (However, evidence of parental depression 
will not exclude participants from the study.) They will also complete the Family Life 
Events Questionnaire (FLE), which collects data regarding adverse events experienced by 
the child. 
At the enrollment meeting, families will receive the first 3 LENAs to be recorded within 
a 3 week timeframe.  Baseline LENA redos will only be done in the case that a 
participant has not recorded a LENA- as long as a LENA has some data on it, we will 
accept it with whatever amount of time (no redos).  No LENA redos will be accepted for 
recordings following baseline LENAs 
 
4. Intervention Phase  
Following enrollment, participants will move on to the Intervention Phase, which will last 
six months. The Intervention Phase consists of three components: Assessment 1, Home 
Visits for Treatment participants or Nutrition packet drop offs for control participants, 
and LENA recordings. 
 
Assessment (Survey Meeting) 1  
A TMW Assessor will conduct Assessment 1 in the participant’s home. Assessment 1 
will take approximately 90 minutes to complete.  
 
 
Assessment 1 Measures 
At this assessment meeting, the parent will complete six different measures. The mother 
will complete the Survey of Parental Expectations and Knowledge (SPEAK), which 
assesses parents’ understanding of children’s learning process. Then, the mother will 
complete the Woodcock Johnson Picture Vocabulary and Oral Comprehension subtests in 
both English and Spanish. Then, the mother will complete the TOPSE questionnaire 
(measures parental self-efficacy), the nutrition questionnaire, the future vs. present bias 
questions, and finally the ASQ-SE. Child’s Body Mass Index (BMI) will also be 
measured by collecting their height and weight. At this time, the RA will also pick up the 
completed baseline LENA recordings.  
 
Home Visits 
Home Visitors will deliver the TMW Curriculum (Treatment group) biweekly over the 
course of the six-month Intervention Phase, for a total of 12 Home Visits. Visits are 
scheduled biweekly, and will be completed by a TMW home visitor in the participants 
home or another agreed upon meeting place. TMW Home Visits will last approximately 
60 minutes.  
TMW Curriculum: The TMW Curriculum consists of 12 modules, one per home 
visit, and will be implemented in the following way:  
1) The Home Visitor delivers the educational module, one per Home Visit.  
2) The Home Visitor and the parent have a discussion to review and 
reinforce the parent’s understanding of the concepts.  
3) The Home Visitor does the Showtime activity (video modeling) with the 
parent, which demonstrates how to put concepts into practice. During 
modules 5 through 12 parents participate in a social network mapping 
activity during Showtime.  

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4) The Home Visitor discusses LENA feedback reports with the parent. 
LENA feedback reports are generated based on the previous week’s LENA 
recordings. Based on the report, the parent sets goals for the forthcoming 
week. In support of these goals, the Home Visitor discusses strategies for 
increasing word counts, increasing conversational turns, and reducing 
TV/electronic media.  
5) The parent and the Home Visitor collaboratively set goals for his/her next 
week’s recording. Parents will set up a time and day that they would like to 
be reminded of their LENA recording day and their specific goal. This goal 
and recording reminder will then be sent to their phone via text message the 
day of their LENA recording.  
6) Home visitor will leave behind a Fidelity of Implementation (FOI) 
questionnaire that will be filled out by participant after the home visit is 
complete and sealed in an envelope for complete confidentiality of 
completed questionnaire.  The FOI questionnaire is used to assess whether 
the curriculum is being implemented as intended.  
 
Nutrition Curriculum: The Nutrition Curriculum consists of 4 printed handout 
packets that provide education to parents about the importance of healthy 
nutrition for child development, strategies for healthy eating, and meal 
preparation. The Nutrition Curriculum will be implemented in the following way:  
1) Over the course of the 6-month intervention phase of the study, a trained 
RA will deliver informational nutrition packets to the participant’s home and 
review them with the parent every 6 weeks.  The first packet will be dropped 
off and reviewed with the participant at the end of Assessment 1.  The 
packets will include nutrition information and resources to help support 
child’s healthy development. 
 
LENA Recordings 
Participants in the treatment group will complete 16 LENA recordings (3 before home 
visiting begins, 12 bi-weekly recordings over the course of the six-month intervention 
phase, and 1 before Assessment 3).  Recordings will be 8 hours long each.  Each 
recording will be completed during the week following a Home Visit.  
The control group complete 6 LENA recordings total. Three before Assessment 1, one 
before Video Session 2, one before Assessment 2, and one before Assessment 3. 
 
Video 2  
Videos 2 will be conducted half way through the Intervention Phase. An RA will 
complete Video 2 in the participant’s home. The parent and child will engage in a 15-
minute videotaped session consisting of Natural Play and Book Read. During Natural 
Play, the parent and child will engage in undirected, unstructured play. During Book 
Read, the parent will read a book to the child. The 15-minute session will be 
simultaneously recorded by the new mobile phone application, the Three T’s App. The 
extra recording taken with the Three T’s App will be explained to the participants, 
detailing that “the app” functions like the LENA, except it links to a Bluetooth 
microphone and a mobile device, instead of the LENA recorder. The TMW staff member 

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will set up the Three T’s App recording, and the participant will not see the application 
itself or be told the full name of the application, as these characteristics are related to the 
Treatment condition. 
 
5. Follow-up Phase  
This is the final phase requiring participant involvement.  The Follow-up Phase will last 6 
months. The Follow-up Phase consists of the following components: Video Sessions, 
Assessments, and LENA recordings. 
  
 
 
Assessment 2/Video Session 3 
Assessment (Survey Meeting) 2  
A TMW Assessor will conduct Assessment 2 in the participant’s home. Assessment 2 
will take approximately 90 minutes to complete.  
 
Assessment 2 Measures 
At this assessment meeting, the parent will complete eight different measures. The 
mother will complete the Survey of Parental Expectations and Knowledge (SPEAK), 
which assesses parents’ understanding of children’s learning process. Then, the mother 
will complete the Family Life Events (FLE), TOPSE, Nutrition questionnaire, the Future 
vs. present bias questions, the ASQ-SE, TOI, and CESD-10. At this time, the RA will 
also collect child’s height and weight for BMI measurement and pick up the completed 
LENA recording.  
Video 3  
An RA will complete Video 3 in the participant’s home. The parent and child will engage 
in a 15-minute videotaped session consisting of Natural Play and Book Read. Following 
the 15-minute videotaped session, parent and child will engage in a 5-minute teaching 
task (NCAST). The NCAST Parent-Child Interaction Teaching Scale is an activity that 
measures parent-child interaction in a teaching situation where parent chooses a task to 
teach their child in 5 minutes or less.  The 15-minute session will be simultaneously 
recorded by the new mobile phone application, the Three T’s App. The extra recording 
taken with the Three T’s App will be explained to the participants, detailing that “the 
app” functions like the LENA, except it links to a Bluetooth microphone and a mobile 
device, instead of the LENA recorder. The TMW staff member will set up the Three T’s 
App recording, and the participant will not see the application itself or be told the full 
name of the application, as these characteristics are related to the Treatment condition. 
 
 
 
Assessment 3/Video Session 4 
Assessment (Survey Meeting) 3  
A TMW Assessor will conduct Assessment 3 in the participant’s home. Assessment 3 
will take approximately 120 minutes to complete.  
 
 
Assessment 3 Measures 
At this assessment meeting, the parent will complete seven different measures. The 
mother will complete the Survey of Parental Expectations and Knowledge (SPEAK), 
which assesses parents’ understanding of children’s learning process. Then, the mother 
will complete the parent ACE questionnaire which assesses adverse childhood 
experiences (ACE) a parent might had experienced as a child, a Social Determinants of 
Health (SDoH) survey which screens for essential social needs a participant may have, 

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the Nutrition questionnaire, the ASQ-SE, the Family Life Events (FLE) questionnaire 
that measures child’s exposure to adverse experiences, and the BRIEF-P questionnaire 
which assesses child’s executive function behaviors. The child will complete the 
ROWPVT measure to assess child’s receptive language ability, Test:1 (Analogies) and 
Test: 3 (Picture Vocabulary) from the Woodcock-Muñoz Language Survey III (WMLS 
III), and the Give N Task. The child’s BMI will be measured at this time and, the RA will 
also pick up the completed LENA recording.  
 
Video 4  
An RA will complete Video 4 in the participant’s home. The parent and child will engage 
in a 15-minute videotaped session consisting of Natural Play and Book Read. The 15-
minute session will be simultaneously recorded by the new mobile phone application, the 
Three T’s App. The extra recording taken with the Three T’s App will be explained to the 
participants, detailing that “the app” functions like the LENA, except it links to a 
Bluetooth microphone and a mobile device, instead of the LENA recorder. The TMW 
staff member will set up the Three T’s App recording, and the participant will not see the 
application itself or be told the full name of the application, as these characteristics are 
related to the Treatment condition. 
 
6. Data Analysis/Publication  
Dr. Dana Suskind will serve as the PI. Dr. Suskind and her research team will publish the 
primary findings of the initiative. Dr. Suskind and her research team will co-author 
publications with select collaborators. These collaborators will Dr. Erika Hoff at Florida 
Atlantic University.  
 
b) Scales, Assessments & Questionnaires: 
 
The following Scales, Assessments & Questionnaires will be used throughout the course 
of the study:  
Center for Epidemiologic Studies Depression Scale (CESD-10): The CESD-10 
screens for parental depression.  
Family Life Events Questionnaire (FLE): The FLE collects data regarding adverse 
events experienced by the child. 
Theories of Intelligence (TOI) Questionnaire: The TOI questionnaire collects data 
regarding parent’s ideas of intelligence. 
Breastfeeding Survey: The Breastfeeding survey collects background health 
information of the child participating in the study, as an infant. 
Survey of Parental Expectations And Knowledge (SPEAK): SPEAK is a 
questionnaire that assesses parents’ understanding of children’s learning process. 
Woodcock-Johnson Psycho-Educational Battery (WJ): The WJ assesses an adult’s 
cognitive abilities, scholastic aptitude, and performance in the areas of reading, 
mathematics, and written language.  
Nutrition Questionnaire: The Nutrition Questionnaire assesses parents’ 
understanding about healthy eating habits and healthy nutrition for children. 

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Ages & Stages Questionnaire: Social-Emotional (ASQ: SE): The Ages & Stages 
Questionnaire: Social-Emotional is a series of questions that aims to identify any 
social or emotional problems in a developing child.  
Future vs. Present Bias: These questions assess an individual’s preference for 
instant gratification or delayed rewards. 
Home Language Environment Questionnaire: These questions assess which 
languages are spoken in the home and in what frequency.  
      
 Video Recordings:  
        Natural Play: The parent and child will engage in natural play. 
        Book Read: The parent will read a book to the child. 
        NCAST: parent and child will engage in a 5-minute teaching task of their choice. 
 
         TOPSE: This standardized measure assesses parental self-efficacy. 
ROWPVT: This standardized measure assesses an individual’s receptive 
vocabulary.  
Give N Task: in this math assessment, the task will ask child to generate sets of a 
given number. Child will be given a set of objects (15 plastic fish) and will be asked 
to give a certain number of the objects to the stuffed animal.  This assessment 
measures procedural knowledge vs. conceptual knowledge in their math ability.  
Parent ACE questionnaire: parent ACE questionnaire assesses adverse childhood 
experiences (ACE) a parent might have experienced as a child.  
Social Determinants of Health (SDoH): this questionnaire screens for essential 
social needs a participant may have. 
Woodcock-Muñoz Language Survey III (WMLS III): This standardized measure 
is a set of individually administered tests that provides a broad sampling of 
academic language proficiency in areas of speaking, reading, comprehension, and 
writing for ages 3 years+.  Only two of the eight tests will be administered to collect 
data for receptive and expressive child language in both English and Spanish.  The 
two tests that will be administered are Test 1: Analogies and Test 3: Picture 
Vocabulary. 
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P): The 
questionnaire is for parents of preschool-aged children (ages 2 years-5 years 11 
months) to assess executive function behaviors.    
   
The Three T’s App Recordings: The Three T’s App is an educational tool for parents 
participating in the Thirty Million Words Initiative. The application is being developed, 
tested, and evaluated by Luai Zakaria, a student of the Pritzker School of Medicine at the 
University of Chicago. In this study, the application will only be used by TMW 
researchers to take an additional recording of all families at all Video Sessions (1-7) to 
further evaluate and test the recording and results capacity of the application. The name 
of the application will not be disclosed to participants, as it directly relates to the 
treatment condition. Additionally, only a trained TMW staff member will be able to set 
up the recording device and connect it to the application, as the interface of the 
application contains features directly related to the treatment condition, such as a note 
that says “Research shows that the more words your child hears, the smarter they will 

Protocol version: 02/08/19 
 
15 
be!” For all participants, the Three T’s App will only be referred to as “the app” and that 
“the app” functions like the LENA device, but the recording is taken using a Bluetooth 
microphone headset that links to a mobile device instead of the LENA recorder. Only the 
recording and results features of the application will be used by the TMW staff to further 
evaluate and test the Three T’s App.  
c) 
Contact between study visits 
Participants in both the Treatment and Control group will be able to contact members of 
Dr. Suskind’s research team between study visits in order to reschedule visits as needed.  
Moreover, the research team will send periodic postcards and make periodic phone calls 
to both the Treatment and Control Group in an effort to maintain engagement with 
participants, thereby reducing attrition.  
d) 
Future contact regarding research studies  
We will request permission from participants to keep their contact information on file in 
order to contact them about their participation in this study and to inform them about 
future research opportunities.   
 
4.  SUBJECT SELECTION AND WITHDRAWAL  
a) 
Number of subjects 
The study will consist of 91 participants. ‘Participants’ refers to the parent/child dyad. 
(182 individuals) 91 participant dyads will be randomly assigned to the Treatment group 
and Control group.  
b) 
Gender of subjects 
Only female caregivers will be eligible for the study, but their children can be any 
gender.  
c) 
Age of subjects 
Children will be between the ages of 24-30 months old at the start of the study. 
Mother/female caregivers will be at least 18 years old.  
d) 
Racial and Ethnic Origin 
Participants of all racial and ethnic origins will be accepted into the study.  
e) 
Inclusion Criteria 
Inclusion criteria includes 1) participants (i.e. parents and their children) who live at or 
below 200% of the federal poverty line, 2) female caregivers with a child between the 
ages of 24-30 months old, 3) whose preferred home language is Spanish, 4) whose 
education level is less than or equal to a bachelor’s degree.  
f) 
Exclusion Criteria 
Exclusion criteria is as follows: 1) participants (i.e. parents and their children) who live 
over 200% of the federal poverty line, 2) parents under the age of 18, 3) non-female 
primary care giver 4) children younger than 24 months old or older than 30 months old 
(at start of study), 5) parents who do not have legal custody of their child, 6) parents 
whose child does not live with them, 7) parents who are not with their child at least two 
full days per week, 8) parents who are unable to commit to the intervention requirements, 
9) foster parents, 10) children with significant cognitive or physical impairments, 
(specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, 
Down Syndrome and blindness), 11) parents who have earned or are currently working 
toward a graduate or professional degree (e.g. M.A., M.S., M.B.A), and 12) parents 
whose preferred home language is not Spanish.  
g) 
Subject Identification & Recruitment 

Protocol version: 02/08/19 
 
16 
91 low-SES participants in the Chicago area will be recruited for the study from Chicago 
Commons, SGA, and other community sites in the Chicagoland area. Recruitment will 
take place at these sites 1) with the in-person recruitment script and 2) via CTA 
advertisements. Participants that call in after seeing this ad will go through the incoming 
call recruitment script.  
h) 
Location where research is to be conducted (building, floor, clinic/suite 
number) 
The TMW Curriculum, video recordings and Assessments will be conducted in 
participants’ homes or another agreed location (i.e., community sites) if family is unable 
to meet in their home. Data analysis will occur at the TMW office. 
  
The TMW office is located at: 
University of Chicago Medical Center 
5841 S. Maryland Ave, MC 1035 
Lying-in Hospital, Room L161 
Chicago, IL 60637 
 
i) As applicable, the coordination of any interdepartmental faculty, and where 
necessary, the inclusion of those faculty as participants 
TMW will collaborate with the following individuals and organizations: 
Center for Research Informatics (CRI) at the University of Chicago: CRI will 
host, maintain, and support the web platform that hosts the TMW Curriculum, facilitates 
intervention delivery, and securely stores intervention and assessment data.  The web 
platform has been built by One-Six Solutions, an outside vendor, and is built to industry 
standards for data security and HIPAA compliance. 
Chicago Commons: TMW will collaborate with Chicago Commons sites to 
recruit participants.   
SGA: TMW will collaborate with SGA sites to recruit participants.   
 
j) 
Describe plans for remuneration to subject, as applicable: 
Participants in the Treatment and Control groups will be compensated equally. 
Participants can receive up to a total of $175. If participants complete the study, they are 
guaranteed $175 in cash ($25 post-Preliminary Consent and Baseline Measures, $25 post- 
Assessment 1, $25 post-Video Session 2, $40 post-Assessment 2/Video Session 3, and 
$60 post-Assessment 3/Video Session 4.).  
Subjects that decide to meet at the TMW offices will be offered one way bus passes or 
parking validation to ease the costs of transportation.  
k) Informed consent process 
The participant will be given written consent forms and taken through the informed 
consent process with a member of the research team.  The member of the research team 
will verbally review the written consent form with the participant prior to signing. 
Participants will be given ample time to review the consent form and ask the member of 
the research team any questions before they decide to participate in the study. Participants 
will first complete the Preliminary Informed Consent Form.  If he/she continues past the 
Preliminary Phase to enroll in the full study, the participant will then complete the 
Enrollment Informed Consent Form. There will be two versions of the Enrollment 

Protocol version: 02/08/19 
 
17 
Consent Form, as subjects in these groups will complete different activities. All informed 
consents explain the purpose of the study, potential risks and benefits, and the measures 
taken to ensure confidentiality.  
l)       Method of withdrawing participants before completion (i.e., early 
termination) 
Participants will be removed from the study at the discretion of the Principal Investigator 
after demonstration of repeated nonadherance to study protocol (i.e.: multiple incomplete 
or unsuccessful LENA recordings; multiple unsuccessfully completed Home Visits or 
Assessments; unable to contact after significant effort by research team).  If participants 
choose to no longer be in the study and do not want any of their future health information 
to be used, participants can inform the research team in writing.  
 
5.  STATISTICAL PLAN AND CONSIDERATIONS   
An interrupted time series design (i.e. regression discontinuity) will be used to analyze 
data from this study. The goal of the statistical analyses will be to assess the effects of the 
TMW Curriculum. The interrupted time series design will allow us to model children’s 
growth as a function of time and development while modeling the independent effects of 
receiving the intervention.  
 
The outcome measures (LENA, assessments, video) will be entered into a regression that 
includes children’s demographic variables as covariates (e.g. child age in months) as well 
as dummy variables for each time point data was obtained. Separate analyses will be 
carried out for parents and children because some data will only be collected on parents 
and some data will only be collected on children.  
 
Further, because some data are only collected at pre- and post-intervention, separate 
repeated measures ANOVAs and paired tests will be carried out on these data. The aim of 
these analyses will be to 1) examine within-subject change from pre to post-intervention 
in the Treatment and Control conditions and 2) compare change in the Treatment 
condition with change in the Control condition. 
 
The new mobile phone application, the Three T’s App, linguistic feedback data will be 
statistically compared to the manual transcription of all video recording sessions. The 
exact number of words and turns transcribed will be correlated with the amount estimated 
by the mobile phone application. An average error rate and a linear regression for the 
mobile application will be calculated. This will allow us to further evaluate and develop 
the Three T’s App. 
 
6.  RISKS AND BENEFITS 
a) 
Risks associated with study intervention and any study procedures  
Given the nature of this research, minimal risks are anticipated. All audio data on the 
LENA recording device is encrypted so confidentiality will not be breached even if the 
recorder is lost or stolen. Data remains encrypted until processed using the LENA System 
software.  Risks include a theoretical loss of confidentiality related to recording language 
via the LENA recordings. However, the LENA audio data will not be listened to by any 
member of the research staff. It will be kept for 7 years past the end of the study for 

Protocol version: 02/08/19 
 
18 
possible re-analysis with improved analytical algorithms. Non-audio data will be kept 
indefinitely. Risks also include a theoretical loss of confidentiality related to Home 
Visitors, TMW assessors, and RAs entering participants’ homes.  To minimize these 
risks, all research personnel will be trained to maintain the utmost confidentiality.  
Moreover, data will be carefully monitored to ensure the privacy of participants is 
protected. Data will be kept in a locked cabinet with the participant names replaced with 
numerical codes.  LENA Recording audio and data files will be stored on a password-
protected computer in a locked office.  Master lists of participant names, consent forms, 
and the key to the numerical codes will also be kept under lock and key. 
 
All of the audio data recorded by the mobile phone application will be on encrypted iPod 
Touches owned by the Thirty Million Words Initiative. Thus, these recordings will be 
handled in the exact same way as the LENA audio recordings have been handled in the 
past. All audio data and devices used to record the data will be stored in the 
aforementioned locked office. 
 
There is one instance in which confidentiality will not be maintained.  In the consent 
form, participants are notified of the legal responsibility of Dr. Suskind and members of 
her research team to report any suspicion of child abuse or neglect to DCFS.  Every 
member of Dr. Suskind’s research team who will have contact with participants will 
complete the DCFS Mandated Reporter online training 
(https://www.dcfstraining.org/manrep/index.jsp) prior to interaction with participants.  
The abuse reporting hotline (1-800-25-ABUSE) will be made readily available to the 
research team at all times. 
 
b) 
Potential direct benefits to participant 
Benefits will include increased parental knowledge regarding healthy child development.  
Moreover, we hope the information learned from this study will benefit other low-SES 
children and families in the future. 
 
c) 
Describe how the benefits in this research justify the potential risks. 
The benefits to both individual participants and, potentially, the broader low-SES 
population, outweigh the minimal risks involved in the study.  
 
7.  SAFETY AND ADVERSE EVENTS 
Adverse events and safety information will be monitored and analyzed on an ongoing 
basis. Serious and unexpected adverse events will be immediately reported to the IRB. 
Given the educational nature of this study, there is a low likelihood of adverse events.  
 
8. DATA HANDLING AND RECORD KEEPING  
Data will be carefully monitored on an ongoing basis to ensure the privacy of participants 
is protected. Data will be kept in a locked cabinet with the participant names replaced 
with numerical codes.  LENA Recording audio and data files will be stored on a 
password-protected computer in a locked office. LENA audio data will not be listened to 
by any member of the research staff. It will be kept for 7 years past the end of the study 
for possible re-analysis with improved analytical algorithms. Non-audio data will be kept 

Protocol version: 02/08/19 
 
19 
indefinitely.  Master lists of participant names, consent forms, and the key to the 
numerical codes will also be kept under lock and key. Depending on the measurement, 
data will be collected in both paper and electronic form. Electronic data will be entered 
via the TMW Web Platform and in REDCap, an online, secure database. Both online 
databases are password protected and only accessible by TMW staff. Paper data will be 
stored in locked cabinets in a locked office only accessible by the TMW research team.  
All audio data from the new mobile phone application will be stored with the exact same 
precautions as the LENA audio recordings. 
9.  FINANCIAL CONSIDERATIONS 
a) 
Remuneration to subject 
Participants in the Treatment and Control groups will be compensated equally. 
Participants can receive up to a total of $175. If participants complete the study, they are 
guaranteed $175 in cash ($25 post-Preliminary Consent and Baseline Measures, $25 post- 
Assessment 1, $25 post-Video Session 2, $40 post-Assessment 2/Video Session 3, and 
$60 post-Assessment 3/Video Session 4.).  
There are no financial costs to participants.  
 
10.  ETHICAL CONSIDERATIONS 
 
a) Confidentiality 
Data will be carefully monitored to ensure the privacy of participants is protected. Data 
will be kept in a locked cabinet with the participant names replaced with numerical 
codes.  LENA Recording audio and data files will be stored on a password-protected 
computer in a locked office.  Master lists of participant names, consent forms, and the 
key to the numerical codes will also be kept under lock and key. Depending on the 
measurement, data will be collected in both paper and electronic form. Electronic data 
will be entered via the TMW Web Platform and REDCap. Both online databases are 
password protected and only accessible by TMW staff. 
 
There is one instance in which confidentiality will not be maintained.  In the consent 
form, participants are notified of the legal responsibility of Dr. Suskind and members of 
her research team to report any suspicion of child abuse or neglect to DCFS.  Every 
member of Dr. Suskind’s research team who will have contact with participants will 
complete the DCFS Mandated Reporter online training 
(https://www.dcfstraining.org/manrep/index.jsp) prior to interaction with participants.  
The abuse reporting hotline (1-800-25-ABUSE) will be made readily available to the 
research team at all times.  
 
11.  CONFLICT OF INTEREST    
There is no COI with regard to the conduct of this study.  
 
12.  PUBLICATION PLAN   
Discuss the following in detail: 
a) Who expects to publish results from this research? 
Dr. Dana Suskind will serve as the PI. Dr. Suskind and her research team will publish the 
primary findings of the initiative. Dr. Suskind and her research team will co-author 

Protocol version: 02/08/19 
 
20 
publications with select collaborators. These collaborators Dr. Erika Hoff at Florida 
Atlantic University.   
b) When are results expected to be submitted for publication? 
First results will be submitted for publication during or after the second year of the study.  
 
 
 

Protocol version: 02/08/19 
 
21 
 
13.  REFERENCES  
 
Bruner, J. S. (1981). The social context of language acquisition. Language & 
Communication, 1, 155–178. 
 
Chapman, R. (2000). Children’s language learning: An interactionist perspective. Journal 
of Child Psychology and Psychiatry, 41, 33–54. 
 
Fenson, L., Dale, P.S., Reznick, J.S., Thal, D., Bates, E., Hartung, J.P., Pethick, S., & 
Reilly, J.S. (1993). The MacArthur Communicative Development Inventories: 
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Gallaway, C. & Richards, B. J. (1994). Input and interaction in language acquisition. 
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Gilkerson, J., & Richards, J.A. (2008c). The Power of Talk: 2nd Edition. (Infoture 
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Hart, B., & Risley, T. R. (1995). Meaningful differences in the everyday experience of 
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environments. Developmental Pyschology, 28, 1096–1105. 
 
Hoff, E. (2012). Interpreting the early language trajectories of children from low-SES and 
language minority homes: implications for closing achievement gaps. 
Developmental Psychology, 49(1), 4-14. 
 
Hoff, E. (2013). Proceedings from White House meeting on “Bridging the Thirty-
Million-Word Gap.” Early language gaps: Sources and solutions. Washington, 
DC. 
 
Hoff, E., & Tian, C. (2005). Socioeconomic status and cultural influences on language. 
Journal of Communication Disorders, 38(4), 271-278. doi: 
10.1016/j.jcomdis.2005.02.003 
 
Huttenlocher, J., Haight, W., Bryk, A., Selzer, M., & Lyons, T. (1991). Early vocabulary 
growth: Relation to language input and gender. Development Psychology, 27, 
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Nelson, K. (1973). Structure and strategy in learning to talk. Monographs of the Society 
for Research in Child Development, 38, 1-135.    
 

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Rowe, R. L. (2008). Child-directed speech: relation to socioeconomic status, knowledge 
of child development and child vocabulary skill. Journal of Child Language, 35, 
185–205 
 
Rowe, M. L., & Goldin-Meadow, S. (2009). Differences in early gesture explain SES 
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