Thirty Million Words Initiative Newborn Implementation Trial
Phase: NA
Conditions: Language Development
Sponsor: University of Chicago

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TMW-Newborn Implementation 
 
PROTOCOL TITLE: TMW-Newborn Implementation 
 
PI: Dana Suskind, M.D. 
 
FUNDING: External funding from Hemera Foundation 
 
SPONSER: Private Industry 
 
TYPE OF RESEARCH: Randomized implementation trial  
 
INTERVENTION: Experimental Technique to Change Knowledge and Beliefs 
 
PROTOCOL VERSION DATE: 3/5/2018 
 

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Thirty Million Words Initiative Newborn Implementation Trial 
Protocol Narrative 
 
The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health 
effort aimed at increasing awareness about the importance of a child’s early language 
environment in his or her first years of life. This one-time educational intervention will be 
impacting maternal awareness and knowledge about the importance of children’s early 
language environment, between ages 0 and 3. We envision the intervention to be carried out in 
the immediate postpartum period because we seek to provide language enriching tools parents 
can use with their babies from the start. The educational intervention will be delivered in 
conjunction with the Universal Newborn Hearing Screening (UNHS) in partnering hospitals, an 
existing public health infrastructure and a routine part of postpartum care. 
 
Background  
The Newborn Initiative is both an extension and a focused adaptation of the larger Thirty 
Million Words initiative. TMW-Newborn is grounded in three main bodies of literature and 
avenues of research. The first is research on early childhood language acquisition, child 
development, and child behavior. The foundation of our evidence-based research derives from 
the differences found in children’s language environments, which largely depend on socio-
economic status (Hart and Risley 1995). Second is research on maternal health education and 
health literacy, specifically on prenatal, perinatal and post-natal education. Third is research 
and data on the Universal Newborn Hearing Screening (UNHS), which occurs during post-
partum care. The UNHS is a critical point in time to both deliver the TMW message and to 
increase follow up for those newborns not passing the initial screening by focusing on the 
importance of a child’s early language environment and the impact of hearing loss on cognitive 
development. 
Our effort therefore lies in bringing these three main bodies of research together to craft a 
public health intervention, which relies on existing initiatives while adding an important 
educational component. TMW-Newborn not only aims to impact parents’ beliefs about how 
crucial their role is in creating a stimulating and enriching language environment for their baby, 
but also seeks to improve rates of re-screening (loss to follow-up) for the universal newborn 
hearing screening. By emphasizing the importance of talk (and hearing) for cognitive and 
language development, we seek to encourage families to follow up after the screening if their 
newborn does not pass. 
Importance of Language Acquisition on Cognitive Development: 
A child’s early language exposure is increasingly acknowledged as pivotal in language 
development and, more importantly, in ultimate educational and intellectual achievement 
(Bruner, 1981; Chapman, 2000; Gallaway & Richards, 1994; Hart & Risley, 1995; Huttenlocher, 
Haight, Bryk, Selzer, & Lyons,1991; Rowe, 2008). Hart and Risley’s landmark study 
demonstrated the tremendous impact of a child’s early language milieu on future learning, 
revealing a significant correlation between the number of words a child is exposed to between 
ages 0-3 and his/her ultimate IQ and academic success (Hart & Risley, 1992; 1995). Their 

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findings were both significant and alarming, demonstrating the critical and time-sensitive role 
that early language exposure plays in a child’s life. 
The tragedy for children born into poverty is the overwhelming inequity in their early language 
experience. Hart and Risley’s study revealed a steep socioeconomic gradient in early exposure 
to words/language. At the end of their third year, children from high socioeconomic status (SES) 
families heard approximately forty-five million words; children from economically impoverished 
backgrounds heard only approximately thirteen million. Hart and Risley found that “with few 
exceptions, the more parents talked to their children, the faster children’s vocabularies were 
growing and the higher their children’s IQ test scores at age three and later.” Their follow-up 
with these children at 9-10 years of age confirmed that preschool/school interventions came 
too late to alter these trajectories; the reverberations of early linguistic shortfall were likely to 
follow these children throughout their lives.   
But the tragedy for these children is not unalterable. It is neither genetics nor a lack of potential 
that lies at the heart of this inequity; it is parental knowledge. In 2008, Rowe demonstrated that 
that the relationship between socioeconomic status and parental communication ability is 
mediated by parental knowledge (Rowe 2008). Other studies have corroborated this, showing 
that the effect of socioeconomic status 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 in low-income populations may have a positive 
effect with parents increasing their use of facilitative language with their children (Oneil-Pirozzi, 
2009). 
Universal Newborn Hearing Screening and Early Hearing Detection and Intervention: 
Since 2000, the number of infants screened for hearing loss at birth has dramatically increased. 
According to 2011 data (Centers for Disease Control and Prevention, 2013), 97.9 % of all babies 
in the United States receive the Universal Newborn Hearing Screening. However, 1.8 % of 
newborns (59,161) do not pass the screening, 35.3% (20,857) of which are not rescreened, 
failing to receive the next step of treatment. The CDC groups these failed re-screenings into two 
categories: “Loss to Follow-Up (LFU)” and “Loss to Documentation (LTD)”. For infants who did 
not pass the newborn hearing screening, LFU refers to a failure to receive the next step of 
treatment, be it rescreening or comprehensive audiologic evaluation. Families are contacted 
but do not follow up, or cannot be contacted. LTD refers to failure to report the results from 
hearing screening, rescreening, diagnostic services, and/or treatment services which are 
needed for comprehensive surveillance and monitoring by Early Hearing Detection and 
Intervention (EDHI) and the medical home. 
In Illinois, all birthing hospitals perform the newborn hearing screening, and 99.4% (156,376 in 
2011) of newborns are screened for hearing loss (Centers for Disease Control and Prevention, 
2013). According to 2011 data however, of the 2,714 infants not passing the test, 64% (1,736) 
are LFU or LTD. This is nearly double the national average. The high incidence of newborns not 
returning for a complete audiologic screening is worrying and constitutes a concern for 
newborn developmental health. An infant who does not pass his/her newborn hearing 

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screening has a potential developmental emergency because of the tremendous impact 
language has on the developing brain. 
A Participatory Model of Educational Intervention: 
The educational intervention is currently being designed and planned with iterative 
participation and feedback from the audience we seek to have an impact on. Exploratory and 
formative qualitative research informs the intervention, drawing insights from pregnant 
mothers, mothers in immediate post-partum, parents, and healthcare providers. Our 
intervention is currently being developed with focus groups and individual interviews with 
mothers and parents, consultation with medical professionals (RNs, OB GYNs, Pediatricians), 
and visits to community health centers and birthing hospitals in Pensacola, FL to understand 
the feasibility of implementation of the intervention around the time of the newborn hearing 
screening.  
The TMW-Newborn translates the TMW message into a shorter-format one-time educational 
intervention that can be delivered to new parents in the hospital as part of routine postpartum 
care. As a large-scale public health approach, it has the potential for a significant impact on SES-
disparities in language development. While the earlier TMW intervention was developed for 
toddlers, the TMW-Newborn intervention will be tailored for parents of newborns. It will 
include messages and strategies specifically for children from birth to one year of age with a 
focus on preverbal communication and mother-child attachment. It will also include video 
modeling of parents utilizing both spoken and sign language. Given the novelty of this 
intervention, it will be important to evaluate its acceptability and feasibility with low-SES 
families and objectively examine evidence of its efficacy. The TMW NI video will be available in 
both English and Spanish.   
The significance of the Newborn Intervention as a Public Health Initiative 
The Thirty Million Words Initiative Newborn Intervention is a public health effort to raise 
awareness about the critical importance of early childhood language development. It will occur 
at the beginning of a baby’s life and during a special time for his or her parents, right after 
delivery. TMW-Newborn is situated at the intersection of multiple public health initiatives: the 
Universal Newborn Hearing Screening and Early Hearing Detection and Intervention are crucial 
public health interventions to timely screen and detect hearing loss. For the intervention, 
TMW-Newborn will be integrated as part of routine postpartum care in the hospital stay. In the 
future, we envision having key information about child language development as part of the 
discharge packet every mother receives after birth. We also seek to have key information of 
language development milestones in newborns be part of prenatal classes and be included in 
prenatal educational material.  
 
Previous Research 
We conducted two randomized controlled trials to evaluate the feasibility and efficacy of TMW-
Newborn in two large Chicago birthing hospitals.  Over 600 English- and Spanish-speaking 
participants were randomly assigned to receive the TMW-Newborn video or a control group 
educational video about Sudden Infant Death Syndrome (SIDS).  

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Results showed a significant increase in knowledge survey scores between pre- and post-
intervention for participants in the TMW-Newborn treatment group. There was no significant 
increase in the control group’s average scores. The increase for treatment participants 
remained significant 4 to 6 weeks after the intervention.  
 
In addition to the Knowledge Survey, participants were asked a few questions concerning the 
UNHS and the video. We found that nearly 92% percent of all participants in the study stated 
that they understood what the UNHS hearing results meant for them and their infant after 
watching the video. Furthermore, in response to the questions about the video, 99% of 
participants found the information in the video helpful.  98% of them reported learning 
something new from the video and expressed willingness to recommend the video to a friend.  
97% of all participants planned to try out strategies from the video at home and 87% of them 
agreed that it was convenient to view the video during the UNHS. 
 
In summary, mothers of newborns who receive the TMW-Newborn educational intervention 
show increased knowledge and demonstrate an improved understanding of the critical 
importance of their newborn’s early language environment for cognitive development and 
school readiness (Suskind et al., 2017). 
 
Purpose 
The purpose of the proposed research is to perform testing of the Thirty Million Words 
Initiative Newborn Intervention (TMW-Newborn) with the primary goal of evaluating various 
implementation methods. 
 
We hypothesize that the TMW-Newborn intervention will: 
1.  Significantly impact parent knowledge regarding the importance of UNHS follow-up  
2. Significantly impact parent knowledge of child development 
 
Additionally, we hypothesize that: 
3. The 7-minute version of the video with questions interspersed will most significantly 
improve parent knowledge of child development 
4. There will be no significant differences in effectiveness of the Spanish and English 
versions of the TMW-Newborn intervention 
 
The hypotheses rely on the existing research data supporting the idea that parental 
understanding and beliefs will alter parental behavior, and consequently, that increased 
parental linguistic input will impact their child’s cognitive development.   
 
Protocol 
We propose to perform a randomized implementation trial to evaluate the efficacy of various 
implementation methods of the TMW-Newborn educational intervention. The study will be 

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conducted in temporal proximity to the administration of the universal newborn hearing 
screen.  
 
After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72 
hours. At Sacred Heart Hospital, study participation will be offered to every postpartum mother 
prior to discharge by a hearing screening technician, registered nurse, or registered hospital 
volunteer during the patient’s hospital stay. Study participation will be offered to every mother 
whose child is receiving the hearing screening at the University of Chicago Medicine and Baptist 
Hospital-Pensacola. At the University of Chicago Medicine, study participation will be offered by 
a research assistant or hearing screening technician. At the Baptist Hospital-Pensacola, study 
participation will be offered by a nurse. The technician, nurse, or registered volunteer will give 
each mother an electronic tablet with the HIPAA Compliant TMW-Newborn Tech Platform that 
houses the TMW-Newborn intervention.  
 
The patient experience through the TMW-Newborn intervention within the TMW Tech Platform 
is as follows:  
• Participant selects language (English or Spanish) for viewing videos and completing 
surveys;  
• Participant views Welcome and Consent Video, in which Dr. Suskind (in English) or 
another health professional (in Spanish) introduce the study, explain participation, 
outline risks;  
• Participants who agree to participate will then be randomized into one of four 
conditions:  
o Long TMW-Newborn intervention video without questions interspersed, 
o Long TMW-Newborn intervention video with questions interspersed, 
o Short TMW-Newborn intervention video without questions interspersed, or 
o Short TMW-Newborn intervention video with questions interspersed.  
 
• Participant completes pre-intervention surveys: Baby SPEAK and non-identifying 
demographics items. These surveys take approximately 10 minutes to complete.  
• Participant views TMW-Newborn intervention video, according to her randomized 
assignment outlined above.  
• Participant completes post-intervention surveys: Baby SPEAK, UNHS, and fidelity of 
implementation.  
 
The hearing screener, nurse, or volunteer will be notified via the TMW Tech Platform to pick up 
the tablet from the participant upon intervention completion or whenever the participant opts 
out.  
No identifying information is collected within the TMW-Newborn web platform, and the 
hearing screening technicians will not be able to see or access any of the participants’ 
responses. 

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This study protocol will only be used at Sacred Heart Hospital, University of Chicago Medical 
Center, and Baptist Hospital-Pensacola.  
 
Randomization 
The hearing screener, nurse, or volunteer will drop off tablets with participants, and only after 
the participants agree to participate by completing the tablet based consent will they be 
assigned to one of the four treatment conditions. The TMW-Newborn Web Platform will house 
the randomization tool that will randomize each participant into one of four treatment groups: 
1. Long TMW-Newborn intervention video without questions interspersed, 
2. Long TMW-Newborn intervention video with questions interspersed,  
3. Short TMW-Newborn intervention video without questions interspersed, or 
4. Short TMW-Newborn intervention video with questions interspersed.  
 
There is equal likelihood of each randomization condition occurring.  
 
Participants 
Participants will include a goal of 10,000 new mothers at Sacred Heart Hospital, University of 
Chicago Medical Center, and Baptist Hospital-Pensacola. 2,500 will be randomized into each of 
the four implementation conditions outlined above.  
 
Exclusion criteria 
Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical 
Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will 
not be eligible for this study. 
 
Payment  
Participants will not be compensated. 
 
Risks and Benefits 
Risks are minimal as testing only involves answering a questionnaire and providing 
demographic information. The data will be stored in password-protected computers and stored 
in locked file cabinets. Benefits include increased knowledge of the importance of early 
childhood language and cognitive development, and increased understanding of the Universal 
Newborn Hearing Screening and the importance of prompt follow-up after failed hearing 
screens.  
 
Analysis 
Paired t-tests will be used to analyze total survey scores before and after intervention. ANOVAs 
will be used to evaluate differences in outcomes based on SES and other variables in various 
experimental groups.   
 
 
Consent 

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Prior to enrollment, all participants will view a video of the PI, Dr. Dana Suskind (in English), or 
another healthcare professional (in Spanish), explaining the study, what is involved, and its 
risks. Written text of this consent message appears below this video.  After watching the video 
and reviewing the consent text, mothers who want to participate may select the “I Agree” 
button, and will be randomized into the study. Those who do not wish to participate may select 
the “I Do Not Agree” button and return the tablet to the hearing screening technician. We 
request that a traditional written informed consent be waived, as collecting patient signatures 
would require us to collect identifying information in an otherwise de-identified study. 
No identifying information is collected in this study. All information collected is de-identified, 
and will be stored under a coded numerical variable name that is not linked to any identifying 
information.   
 
Hearing screening techs, research assistants, and nurses who implement the study are trained 
to address patient questions as outlined in the Quick Guide.  Patients with questions not 
immediately resolved per the Quick Guide guidelines will be referred to the TMW study team. 
 
Confidentiality 
The raw data will only be made available to the PI and study personnel listed on the protocol. 
Survey participants’ will be stored under numerical codes and will not contain any identifying 
information. The data will be carefully monitored to protect patient privacy.  
 
Recruitment  
The hearing screening tech, research assistant, or nurse will offer participation to all 
eligible subjects on the maternity ward. All mothers on the maternity ward or present in 
the NICU at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist 
Hospital-Pensacola during the study protocol will be eligble to participate. 
There will be no use of advertisements or additional materials for recruitment purposes. 
The hearing screening tech or research assistant will offer study participation to 
mothers in their rooms at the start of the newborn’s hearing screening.  The Welcome 
and Consent Video in the TMW Tech Platform will describe the study in detail. 
 
 
 

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Research Methodology: 
 
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