Early Communication Intervention for Toddlers With Hearing Loss
Phase: PHASE2
Conditions: Hearing Loss, Bilateral
Sponsor: Northwestern University

Page 1 of 20
Revised: May 25, 2018
PROTOCOL TITLE:
Communication Intervention for Toddlers with Hearing Loss
PRINCIPAL INVESTIGATOR:
Megan Y. Roberts, PhD, CCC-SLP
Communication Science and Disorders
CO-INVESTIGATOR:
Nancy Young, M.D.
Lurie Children's Hospital
VERSION DATE:
1.04.22
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 2 of 20
Revised: May 25, 2018
1.0
Purpose of the study:
While children with hearing loss (HL) are experiencing greater gains in spoken 
language than ever before, considerable variability exists and many children with HL 
continue to have poorer language skills than their hearing peers. Critical to reducing this 
variability is the identification of: (a) effective early communication interventions for 
children with HL and (b) child and parent characteristics that influence intervention 
outcomes (moderators and mediators). However, to date, only the pilot study for this 
proposed study has directly examined the effects of an early communication intervention 
for children with HL within the context of a randomized clinical trial. The overarching 
goals of the proposed study are to: (a) evaluate the effects of teaching parents to use 
communication support strategies on child communication outcomes and (b) examine 
parent and child characteristics that moderate and mediate intervention outcomes. The 
central hypothesis is that systematic parent training will result in greater parental use of 
communication support strategies, greater child prelinguistic behaviors, and greater child 
spoken language outcomes. The specific aims include: (a) comparing parent use of 
communication support strategies and child prelinguistic outcomes between intervention 
and control groups during and immediately following intervention, (b) examining parent 
(communicative insightfulness) and child (sensitivity to social contingency; attention to 
spoken language) moderators of intervention outcomes; (c) comparing parent use of 
communication support strategies and child spoken language outcomes between 
intervention and control groups after intervention (from T7 to T24 months); and (d) 
examining parent (use of communication support strategies) and child (prelinguistic 
skills) mediators of intervention outcomes. The proposed study will enroll 96 children 
with mild to profound bilateral hearing loss. 
2.0
Background / Literature Review / Rationale for the study:
Although advances in hearing aid (HA) and cochlear implant (CI) technology 
have improved language outcomes for children with hearing loss (HL), these children 
continue to have poorer language outcomes than their hearing peers. Children with HL 
produce significantly fewer communicative acts, take longer to acquire their first 50 
words, have poorer vocabulary knowledge, have difficulty using grammatical structures 
in writing and in spoken language, have poorer narrative outcomes, and fail to achieve 
age-appropriate reading levels in high school. These persistent language difficulties 
extend beyond those children with the highest degrees of HL. Children with mild to 
moderate levels of HL also experience poorer language outcomes than children with 
typical hearing. Determining effective early interventions is essential for maximizing 
communication outcomes for children with HL. A critical step in this process is 
understanding child and parent factors that predict response to intervention, as not all 
dyads respond equally well to the same intervention.
However, only the pilot study for the proposed study has examined the effects of 
an early communication intervention for children with HL within the context of a 
randomized clinical trial.
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 3 of 20
Revised: May 25, 2018
3.0
Inclusion and Exclusion Criteria:
Child inclusion criteria include: (a) have bilateral HL (b) enroll in the study 
between 12 and 18 months of age (c) have no known additional disabilities (e.g., Down 
syndrome, cerebral palsy, seizure disorder, blindness etc.) as measured by parental report, 
(d) have English as the primary language spoken at home, (e) a parent or caregiver that is 
willing to participate who understands spoken English, and (f) are exposed to some 
degree of spoken language by parents (total communication, auditory/oral). 
Children inclusion criteria for typically developing children include (a) no hearing 
loss, (b) no known disabilities or developmental concerns, (c) less than 14 months old 
and (d) have English as the primary language spoken in the home. 
4.0
Sample Size:
The sample consists of 96 children with bilateral hearing loss and one of their 
caregivers (mother, father, grandparent). Children of all races and genders will be 
included in the sample. All children will be between 12 and 18 months of age) at the start 
of the study. Children will have a diagnosis of bilateral hearing loss. This age was chosen 
for several reasons. First, this is the age at which intentional communication usually 
emerges and prelinguistic communication skills develop. As such, this age is necessary to 
study the effects of early intervention on prelinguistic skills for young children with 
hearing loss. Second, children are typically seen for an audiology visit during this time, 
so it is an easy time to enroll study participants. Third, the majority of children are 
wearing hearing aids at this time. Fourth, 12 months is an age when we are able to test 
developmental processes that may influence response to intervention. Fifth, parents may 
be more likely to participate in research when their baby is older and after they have had 
time to process the diagnosis. Children will start the study around 12-18 months of age 
and continue in the study for 24 months.
Given a sample size of 86 (96 recruited participants with 10% attrition), we 
project greater than 99% power for main effects of the intervention (Aim 1) as large as 
those shown in our pilot study (d=1.07) (see Justification and Feasibility in Research 
Strategy). We further project 80% power for effects as low as d=.61 and 90% for d=.71. 
Each of the three previous estimates assume control for pre-test and 10% attrition (e.g., 
n=86). Our research group has maintained greater than 95% retention in comparable 
studies over the last two years. We would retain power for smaller effect sizes of d=.58 
(80% power, down from d=.61) and d=.67 (90% power, down from d=.71) if no attrition 
occurs.
5.0
Research Locations:
All study procedures will occur in the homes of participants or at the Early 
Intervention Research Group at Northwestern University under the supervision of the 
principal investigator (Dr. Roberts). Video conferencing services (such a zoom) will be 
used for all sessions, with the exception of “baseline only” activities and “eye tracking” 
activities. 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 4 of 20
Revised: May 25, 2018
6.0
Multiple sites: NA
7.0
Reliance Agreements/Single IRB: Dr. Matthew Hall, Dr. Stephanie DeAnda, 
and Dr. Derek Houston have Individual Investigator Reliance Agreements on this 
IRB.
8.0
Procedures Involved:
This study will use a parallel stratified randomized clinical trial design with 
repeated measures to examine the effects of a parent-implemented communication 
treatment (PICT) on parent use of communication support strategies and on pre-symbolic 
communicative acts and spoken language outcomes for children with HL. Children and 
their caregivers will be randomized to either PICT or a business-as-usual (BAU) control 
group. Children assigned to the PICT group will receive weekly, hour-long intervention 
sessions in their homes for 6 months. Parents and children will be assessed prior to 
intervention (at baseline, T0, pre), immediately after intervention (at T7, 7 months after 
baseline, post), 18 months after intervention (at T24, 24 months after baseline, follow-
up), and monthly using abbreviated measures for the entire study (T0 – T24).
Parent-child dyads will be randomized individually following phone screening, 
completion of baseline assessments, and determination of hearing device status and 
communication mode. Randomization will be stratified by hearing device status (hearing 
aid or bone conduction device, cochlear implant) and communication mode (spoken only, 
sign + spoken). Given that hearing profiles will likely vary among participants, we chose 
to use hearing device as a stratification factor because it is categorical (hearing aid/bone 
conduction device or cochlear implant). Children who are a cochlear implant candidate 
will be assigned to the cochlear implant stratum. In addition, a child with one hearing aid 
and one cochlear implant will be assigned to the cochlear implant stratum. 
Parents in both the intervention and BAU control groups will continue to receive 
early intervention services according to their individualized family service plan. Figure 2 
illustrates the order of study procedures and stratification factors.  
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 5 of 20
Revised: May 25, 2018
All study activities will take place virtually, via a video call, with the exception of 
the eye tracking tasks, which will take place in the EIRG lab. After consent (explained 
below), all participants will complete the following pre-test child assessments, outlined in 
the table below. Given the nature of home testing the numbers of visits may vary based 
on timepoint and family. Baseline only for children without hearing loss: Children 
within the same age range who are typically developing without hearing loss will be 
invited to participate in pre (T0) testing only. Testing will remain in person (if allowed) 
for baseline only children.
Following pre-test, the naïve assessor and parent will complete monthly 
assessment visits with each child and parent in their home via video call for the entirety 
of the study (T1 – T24). During these visits, the assessor will collect a 12-minute 
language sample and a 12-minute parent child interaction. Parents will also complete 
parent surveys, which will be sent via email and include a REDCap link. 
In addition to the monthly assessment sessions, the naïve assessor will also 
complete additional assessments with parent assistance at T0 (baseline, T7 (post-test) and 
T24 assessment (follow-up) via video call.
The parent and child will also participate in recorded video sessions with their 
speech therapist (SLP) two times throughout the study. For parents in Illinois, they parent 
and child will also be asked to participate in a video session with the child’s 
developmental hearing therapist (DTH). This will not be done with parents in other 
states, since DTH services can vary by state. The parent videotape a typical early 
intervention session that takes place in the home. The video recorded sessions will be 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 6 of 20
Revised: May 25, 2018
stored with all other research data, on password protected servers and drive. This 
component of the study allows researchers to see what other services parents and children 
are receiving in the community. After each early intervention therapy visit, the parent 
will also complete several surveys about the visit and the therapist. 
The child's SLP and/or DTH will be consented separately. They will each 
complete separate video-taped sessions up to 2 times over the course of the child's 
participation in the study – around month 4 and when the child is 30 months old. After 
each session, the therapist will be asked to complete surveys. If the child is not receiving 
speech or developmental services in the home, or if the therapist does not consent to this 
research, the child and parent can still participate in this research study. 
Table 1. Summary of assessments
Assessment
Description 
Participant
Duration
Location
Time Point
Communication and 
Symbolic Behavior 
Scales (CSBS)
The child is presented with toys and 
activities designed to elicit prelinguistic 
communication. The interaction is video 
recorded and then scored. 
Parent and 
Child
30 min.
Home or 
Lab
Pre (T0)
Post (T7)
Preschool Language 
Scale - Fifth Edition 
(PLS-5)
The child is presented with different 
receptive and expressive tasks such as 
following simple directions and labeling 
pictures until the child provides an incorrect 
response to six consecutive items for both 
auditory comprehension and expressive 
communication subscales
Child
30 min.
Home or 
Lab
Pre (T0)
Post (T7)
Follow-
up (T24)
Language Sample
The child plays with four different sets of 
toys and looks at a wordless picture book, 
while the parent engages with the child but 
does not talk.
Child
12 min. 
Home or 
Lab
Pre (T0)
Monthly 
Parent-Child 
Interaction 
The child and parent play “as they usually 
would” with a  set of toys for 12 minutes. 
Parent and 
Child
12 min.
Home or 
Lab
Pre (T0)
Monthly
TELE-ASD-PEDS
Virtual screening assessment for autism, 
Parents will be offered this assessment if the 
parent or the clinical team has concerns the 
child may have autism during the regular 
course of the study. Parents will also have 
the opportunity to consent to this 
assessment at 36-months.
Parent and 
Child
35-60 min.
Home
At parent request 
or with parent 
consent at 36-
months
Parent Surveys (for 
children with 
hearing loss)
The MacArthur-Bates Communicative 
Development Inventories (MCDI): Words 
and Gestures or Words and Sentences (the 
parent selects which words their child says 
and understands out of 680 words).  English, 
Spanish, and American Sign Language 
versions (if applicable)
Use of Community-Based Intervention 
Services and Hearing Device Log (the 
parent answers  questions about how many 
and what types of other therapy services 
their child received in the last month;  
indicates how often the child wears their 
hearing device across 8 different routines, 
such as meal times)
LittlEars Auditory Questionnaire (the parent 
Parent
Surveys
(90 mins)
Home
Pre (T0)
Post (T7)
Follow-up (T24)
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 7 of 20
Revised: May 25, 2018
answers 35 questions about how their child 
responds to different auditory stimuli such 
as music or distant sounds)
Demographics Survey (the parent answers  
questions about demographic information 
such as occupation, level of education, 
family members living in the home).
Communication Decision Making – Survey 
about parent's believes about 
communication
Intervention surveys  - Questionnaire for the 
treatment group about their expectations and 
experiences with the research intervention.
CSBS parent questionnaire – Asks for 
parent report of child communication.
Cognitive survey – There will be one 
standardized cognitive development survey 
to gather information about cognition at two 
timeponits. The Ages and Stages 
questionnaire - ASQ (standardized) at T0 
and the Parent Report of Children’s Abilities 
-  PACA (standardized) when the child is 24 
months old.
Parent Feedback about research – Survey 
asking parents for feedback about 
experience after major timepoints
ASD screening survey – Survey asking 
parents about common behaviors associated 
with ASD. Completed when child is 20 
months and 24 months old. This is 
completed by the parent to inform the 
clinical team if the parent has some 
developmental concerns about their child.
Exit Survey (T24 only) – Gather thoughts 
from the family about their participation and 
preferences. 
Parent Interview
The Deaf Language Exposure Assessment 
Tool (the parents report on language 
exposure across the day by different 
speakers. The number of questions depends 
on the number of language and number of 
speakers). (Video/Phone Interview)
DLEAT 
(60 mins)
Video call
Pre (T0)
When child is 24 
months old
When Child is 36 
months old
Follow-up (T24) – 
only if child is 
older than 38 
months old at study 
exit
Parent Interview
Receptive-Expressive Emergent Language 
Scale-3 (REEL-3) parent report
REEL (30 
mins)
Pre (T0)
Post (T7)
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 8 of 20
Revised: May 25, 2018
Video call
Parent 
Surveys/Interviews 
(for children 
without hearing 
loss)
The MacArthur-Bates Communicative 
Development Inventories (MCDI): Words 
and Gestures or Words and Sentences (the 
parent selects which words their child says 
and understands out of 680 words)
Demographics Survey (the parent answers  
questions about demographic information 
such as occupation, level of education, 
family members living in the home).
Parent
Surveys
(40 mins)
Home
Pre (T0)
Monthly Parent 
Surveys/Interviews
The MacArthur-Bates Communicative 
Development Inventories (MCDI): Words 
and Gestures or Words and Sentences (the 
parent selects which words their child says 
and understands out of 680 words). English, 
Spanish, and American Sign Language 
versions (if applicable)
Use of Community-Based Intervention 
Services and Hearing Device Log (the 
parent answers  questions about how many 
and what types of other therapy services 
their child received in the last month;  
indicates how often the child wears their 
hearing device across 8 different routines, 
such as meal times)
Child's Communication – Survey about 
child's communication
Parent
60 min.
Home
Monthly
Visual Reception 
scale of the Mullen 
Scales of Early 
Learning (MSEL)
The child is presented with different non-
verbal tasks such as looking for a ring under 
a washcloth until the child fails to complete 
three consecutive tasks correctly.
Child
20 min.
Home or 
Lab
Post (T24)
Goldman-Fristoe 
Test of Articulation 
– 3rd edition (GFTA-
3)
The GFTA-3 will take 20 minutes to 
administer. The GFTA-3 measures 
phonological skills by assessing an 
individual’s articulation of the consonant 
and consonant cluster sounds of Standard 
American English. It provides information 
about an individual’s speech sound ability 
by sampling both spontaneous and imitative 
sound production in single words and 
connected speech. GFTA-3 provides age-
based normative scores separately for 
females and males for the Sounds-in-Words 
and Sounds-in-Sentences tests. 
Intelligibility is reported as a percentage 
score, and Stimulability information is 
reported in table format.
Child
20 min.
Home or 
Lab
Follow-up (T24)
Attention to Speech 
vs Sine-Wave Eye-
Tracking Task
Children will be presented with two types of 
trials: speech sounds, and sinewave-
transformed complex sounds.  Once the 
child is attending to the screen, a trial will 
begin.  Children will see either a red and 
white checkerboard pattern or a red and 
white bullseye.  On speech trials, children 
will hear a random sequence of syllables 
(“lif” and “neem”).  On sinewave trials, 
Child
(Chicagolan
d 
participants 
only)
5 min.
Lab (if 
allowed 
by the 
state)
Pre (T0)
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 9 of 20
Revised: May 25, 2018
children will be presented with a similar 
sequence of sinewave-transformed sounds.  
Once children look away from the screen 
for 2 seconds, the trial will stop and an 
attention getter will be displayed on the 
screen.  When the child fixates on the 
attention getter, the next trial will begin.  
There will be ten trials total, and the 
experiment will stop after the 10 trials are 
completed.
Preference for 
Pantomime vs ASL 
Eye-Tracking Task
Children will be presented with two side-
by-side videos.  In one video, a female adult 
will convey a story about an everyday 
activity (getting in the car, brushing her 
teeth, etc.) through pantomime.  In the other 
video, the same adult will describe similar 
events using American Sign Language 
(ASL).  Each trial will be approximately 45 
seconds in length, and a short attention 
getter will be displayed on the screen 
between trials.  The side on which each type 
of video will change from trial to trial to 
control for infants’ side bias.  Six trials will 
be presented, and the experiment will last 
approximately 6 minutes altogether. 
Child 
(Chicagolan
d 
participants 
only)
6 min
Lab (if 
allowed 
by the 
state)
Pre (T0)
Concept Formation 
from ASL Eye-
Track Task
Children will be presented with 10 trials 
total.  On the first and last trial, children will 
see an image of a fish and of a dinosaur on 
the left and right sides of the screen.  After 
the initial trial, children will be presented 
with images of either different fish or 
different dinosaurs.  Images will alternate 
between the left and right side of the screen.  
During each of these 8 trials, a video of an 
adult female will appear on the top of the 
screen.  The adult will point to the fish or 
dinosaur on the screen and produce a phrase 
in American Sign Language (ASL), such as 
“Look at that!  It’s a fish.”  After these 8 
trials, children will be presented with a test 
trial of a fish and a dinosaur on the screen.  
The experiment will last approximately 8 
minutes. 
Child 
(Chicagolan
d 
participants 
only)
8 min
Lab (if 
allowed 
by the 
state)
Pre (T0)
Social Engagement 
Eye-Tracking Task
The child participates in two consecutive 
engagement conditions with animal hand 
puppets as the stimuli: (a) joint attention, (b) 
unavailable. Each condition includes six 
trials (six different puppets coming out of an 
opening). In the joint attention condition, 
the caregivers will respond only after the 
child vocalizes or gestures by looking back 
and forth between the puppet and the child 
and talking about the puppet. In the 
unavailable condition, the caregiver will 
read a book silently and will ignore all child 
communicative behavior.
Child 
(Chicagolan
d 
participants 
only)
5 min.
Lab (if 
allowed 
by the 
state)
Pre (T0)
Communicative 
Insightfulness 
Assessment 
The parent watches video clips of their child 
and determines when and why their child is 
communicating. 
Parent 
(Chicagolan
d 
participants 
30 min.
Lab (if 
allowed 
by the 
state)
Pre (T0)
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 10 of 20
Revised: May 25, 2018
only)
Word Learning 
Eye-Tracking Task
Children will be presented with 29 trials 
total. On the first two trials, children will be 
familiarized to the task by seeing two 
familiar objects on the screen and asked to 
find one of them. Children will then be 
presented with images of two novel objects 
in order to familiarize them with the objects. 
Following this, children will see 2 movies, 
each 24 seconds long, that teach the child 
the name for reach of those new objects 
(“blick” and “modi”).  After this, children 
are presented with four blocks of test trials. 
In each test block, children are given 4 test 
trials in which they are asked to find one of 
the new objects, and two reminder trials, 
where the new objects are shown and named 
in isolation. 
Child 
(Chicagolan
d 
participants 
only)
6 min
Lab (if 
allowed 
by the 
state)
Follow-up (T24)
Audiology Record 
Requests
Audiology records will be obtained to 
confirm degree of hearing loss. The parent 
will be asked to sign a specific hospital 
release form, so that we can request the 
child's audiology records. 
Parent
NA
NA
Pre (T0)
Post (T7)
Follow-up (T24)
SLP/DTH Measures
Early Intervention 
Therapist 
Observation (SLP, 
DTH)
The parent and child will participate in their 
typical therapy session with their SLP or 
DTH in their home and the session will be 
video recorded.
Parent/Careg
iver and 
Child and 
SLP or DTH
60 min.
Home
Beginning of study 
(~T4)
End of study (~30 
months old)
Early Intervention 
Therapist 
Observation 
Surveys for parent
Parents will complete the following surveys 
after each individual observation with either 
their SLP or DTH: (1) About my SLP, (2) 
Satisfaction Survey, (3) Working Alliance 
Short Form, (4) Measure of Process of Care, 
(5) Communication Method Advice
Parent or 
Secondary 
Parent
30 min.
Home -
but not 
during 
the home 
visit
Beginning of study 
(~T4)
End of study (~30 
months old)
Early Intervention 
Therapist 
Observation 
Surveys for 
therapist
After the videotaped session, the E.I. 
therapist will be emailed several surveys 
asking about their clinical background and 
experience, knowledge of evidence-based 
practice, and rapport with the parent. 
Surveys could include: Working Alliance 
Short Form, Believe About Participation-
Based Practices, SLP/DTH Demographics, 
SLP/DTH Background, SLP/DTH 
Approach, Hearing Loss Education and 
Experience, Hearing Loss Approach, 
Communication Method Advice 
SLP or DTH
60 min
Home -
but not 
during 
the home 
visit
Beginning of study 
(~T4)
End of study (~30 
months old)
Participants assigned to the PICT condition will receive weekly 60-90 minute 
long intervention sessions in their home via video call for 6 months. Parents will learn 
four sets of communication support strategies: (a) visual (e.g., modeling language within 
the child’s line of sight), (b) interactive (e.g., following the child’s attentional focus), (c) 
responsive (e.g., responding to all communicative attempts), and (d) linguistically 
stimulating (e.g., modeling language targets, expanding child communication). 
Intervention sessions will include the following components: 
1. CCX: a 6-minute parent child interaction
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 11 of 20
Revised: May 25, 2018
2. Teach: 10 minutes  of the therapist describing the target intervention 
strategy
3. Video Feedback: 8-15 minutes of video feedback for the parent to watch 
themselves practicing the strategies (review phase only)
4. Model: 6-10 minutes of watching standard video clips of parents using the 
strategy
5. Coach: 20 minutes of the parent practicing the strategy with their child 
with coaching from the therapist 
6. Review: 5-10 minutes of the therapist reviewing the session with the 
parent, summarizing the session, and answering the parent’s questions 
After intervention (post), parents in the PICT condition will complete an 
intervention satisfaction survey. This measure has been used in previous studies of 
parent-implemented interventions and includes questions about how comfortable parents 
feels using the communication support strategies, their perceptions about their child’s 
progress, and their rating of different parent instructional methods such as coaching and 
modeling. Participants assigned to the control group will not receive the PICT 
intervention. Participants in both groups will continue to receive early intervention 
services according to their Individualized Family Service Plan. 
Participants will be asked if they would like to complete an additional, optional 
phase of the study around the time their child is 34-36 months old. At the 3rd DLEAT 
interview, parents will discuss the study with the lab manager and will be asked if they 
would like to participate. Participation would include an optional 1-hour appointment to 
complete the TELE-ASD-PEDS with research staff for $50. If the research team has 
concerns, it will be recommended that a formal evaluation is scheduled in the 
participant’s home state. This will help researchers understand more about social 
communication delays in deaf and hard of hearing populations.
Data obtained from participants will include standardized, observational, and 
parent-report measures. All standardized and observational measures will be conducted 
by independent observers and assessors naïve to the experimental condition. Pre-test 
assessments will be administered in the participant’s home via video call, with the 
exception of eye tracking measures for local participants. All additional time points will 
be conducted in the family’s home. All standardized assessments and observational 
measures will be video recorded and coded. Parent report surveys will be collected using 
REDCap online surveys. Parents will be sent a unique link that gives them access to their 
unique list of surveys to be completed for that study time point. All surveys and 
assessments should be completed within a 10-day window to ensure data accuracy at 
each timepoint. Personal identifiable information (PII) (name, address, phone number, 
email address) will be collected on all parent/child dyads for the purposes of scheduling 
assessment visits, for conducting home intervention sessions, and for collecting survey 
data. Images of the face will be collected by video for the purpose of transcribing and 
coding parent-child interactions. Date of birth will be collected to determine child age at 
each time point so that we may include age in months in statistical analyses. 
We propose a set of statistical analyses that firmly integrate our hypotheses and 
research design into a structural equation modeling framework to create a cohesive 
analytic plan that spans all study aims. Our aims further bridge the divide between 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 12 of 20
Revised: May 25, 2018
clinical trials and mechanistic research via our multivariate longitudinal design. Defined 
clinical trial endpoints provide structure to our analyses and support the rigor of classic 
analytic methods for clinical trials to assess the extent to which the proposed treatment 
has an effect on parent (parent use of communication support strategies) and child (pre-
symbolic communicative acts, spoken language) outcomes. The use of advanced 
multivariate longitudinal methods allows us to assess not only the extent to which the 
intervention works (Aims 1 and 3), but for whom (Aim 2) and how (Aim 4) the 
intervention improves communication outcomes in children with hearing loss. All 
statistical models will be fit within a structural equation modeling (SEM) paradigm. Our 
proposed models vary in complexity, from simple linear regressions of main intervention 
effects to longitudinal mediation analyses. Providing a unified modeling framework for 
all models will allow for comparability of related analyses due to identical model 
assumptions. While SEM was traditionally developed as covariance structure analysis, 
modern or extended SEM (xSEM) can flexibly handle both linear and non-linear 
relationships between sets of continuous and categorical raw data. This flexibility allows 
us to specify SEMs that are equivalent to alternatives ranging from linear regression to 
mixed-effect models to complicated mediation analyses, all using the same state-of-the-
art optimization and data handling methods. Our multi-method approach requires data 
reduction and integration within and across time points. We will create a set of 
continuous latent indicators of child spoken language outcomes and parent use of 
communication support strategies. We will create these latent indicators using 
confirmatory item factor analyses, which allow us to combine the categorical data 
handling of an item response model with the flexibility to incorporate 
multidimensionality and specific measurement hypotheses common to factor analyses. 
We will further use multi-trait, multi-method approaches and related bifactor models 
when constructs span multiple modes of assessment (observational, elicited, parent 
report). 
 
9.0
Incomplete Disclosure or Deception: NA
10.0
Recruitment Methods:
Children will be recruited through Lurie Children’s Hospital, pediatricians, Early 
Intervention providers, conferences, and online advertising. Participants are recruited in 
the Chicagoland area and nationally in the U.S. Clinicians who work with families of 
young children with hearing loss will be given a flyer to give to potentially eligible 
families. Clinicians may also direct them to our eligibility screener via the text-to-contact 
number on the flyer, where the caregiver will answer basic self-reported eligibility 
questions and give permission for EIRG study staff to contact them about their potential 
study participation. Study staff will then contact families that may be eligible for the 
study. Interested families may also contact EIRG directly via email, phone, or completing 
a recruitment survey on the EIRG website. Baseline only for children without hearing 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 13 of 20
Revised: May 25, 2018
loss: Parents of children without hearing loss and with typical development will be 
invited to participate in baseline testing only.
11.0
Consent Process: 
All consent forms will be approved by Northwestern University’s Institutional 
Review Boards (IRB). All informed consent documents will contain the following: (a) an 
explanation of the purpose of the research, (b) expected duration of participation, (c) a 
description of research procedures, (d) foreseeable risks, discomforts, and benefits, (e) 
confidentiality and privacy of records and data, (f) contact information for who to contact 
to answer questions about the research process or participant rights and, and (g) a 
statement that participation is voluntary and that refusal will not result in penalty or 
change in their clinical services. Additional consent elements will also include financial 
information, alternative treatments, funding source, mandated reporter language, clinical 
trial information, and optional elements. All consent documents will contain layman’s 
terminology when possible and use language appropriate to an 8th grade reading level. 
Consent documentation will include the date of IRB approval. 
The consent form will be discussed over the phone or a video call and sent to the 
parent via email prior to their first visit, when their child is 12-18 months old. 
Participants will receive a blank copy of the consent form in their email before the 
consent phone call, once the signature is obtained, parents will download the e-consent 
directly. An additional "consent guide" is to the parent, which is a supplemental 
document that will help to explain important elements of the study. The consent 
discussion will occur over the phone or via call. Parents will pick a time that is 
convenient for them and will receive a copy of the full consent before the call so that they 
have an opportunity to review and discuss questions and concerns before they schedule 
their first appointment. The consent form will be reviewed again and officially signed in 
person at NU’s EIRG lab, in the participant's home or online via the REDCap e-consent 
module. Participants will be consented by a trained research staff member. Parents who 
are completing baseline testing only will sign the consent form at their first T0 visit.
The participating caregiver will sign an online consent form using REDCap’s e-
consent module. The e-consent framework mirrors the paper copy exactly and will have a 
place where the participant can complete their name, their child’s name, and provide an 
electronic signature using their mouse pad or finger. The e-consent will also note the date 
that the IRB approved the consent at the top of the form. Participants will also then have 
the option to download the consent form for their records directly on their device. They 
will then “verify” that the consent form is correct and accurate. Once a consent form is 
verified, it is automatically archived in the database and this copy cannot be manipulated, 
even if the database version changes.  Research personnel will review the consent form 
with all participating caregivers over the phone or a video call before any study visits 
occur, and caregivers will be a given a chance to ask questions about their participation 
before signing the consent. The caregiver will have the option to download the consent 
form directly from REDCap after they sign the form. The consenting staff member will 
sign the form after the consent form has been reviewed with the parent.  Consent forms 
will be stored electronically on a secure and password protected server and on REDCap, 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 14 of 20
Revised: May 25, 2018
and a hard copy will be kept in a locked filing cabinet behind a locked door. Child assent 
will not be sought due to the child’s age. Although permission for child participation is 
obtained from the caregiver, children will be watched for dissenting behaviors. 
Caregivers will also remain with or be able to view the child at all times so they can 
monitor their child. 
Parents will also agree or disagree to four optional elements at the time of full 
study consent: 1) The researcher may contact me in the future to see whether I am 
interested in participating in other research studies by the principal investigator of this 
study; 2) Video recordings of my participation and my child’s participation may be 
shown to researchers, students, educators, and clinicians at workshops, seminars, 
trainings, and conferences; 3) Video recording clips (1-2 minutes) of my participation 
and/or my child’s participation may be shown to future families participating in the Early 
Intervention Research Group’s research studies; and 4) If in the Chicagoland area, 
participant is willing to complete eye-tracking activities at the start of the study and at the 
end of the study, for an additional $50 per visit ($100 total); and 5) Data collected in this 
study may be used for future research questions and analysis. These data could include 
video recordings, survey data, or assessment data. These data will not be connected to 
your name or contact information. Your data will not be shared with anyone outside of 
the research team. The video clips will be used for training purposes to demonstrate and 
explain strategies that parents can use with their children.
Early Intervention therapists will be consented separately from the parent. A 
research staff member will call, text, or email the early intervention provider(s) to explain 
the procedures.. Texting will be the preferred method of contact via Mosio. If the 
therapist is unresponsive, their number will be deleted from the Mosio platform. Parents 
will be asked to give the therapist study flyer to their therapist. The therapists will be 
texted a link to the FAQ guide for therapists and sent a link to agree or decline study 
participation. Online consent will be obtained. Therapists will have the option to reply to 
a text message that they do not want to proceed if they are not interested in participating 
or to schedule a call with the research coordinator to discuss questions.  
The child’s other caregiver may also be consented electronically if they 
participate in the child’s typical speech or developmental hearing sessions in the 
community. This ensures that the research team has their consent to video record them 
and complete surveys about the video-recorded community session. Second caregivers 
will be sent an electronic version of the consent form to sign and date. This will only be 
obtained if the primary study parent is not also the primary parent who participates in the 
other sessions. 
Parents will also have the opportunity to opt-in to an additional portion of the 
study to complete an autism screening when their child is 34-36 months old. Parents will 
discuss the additional procedures with the lab manager during their DLEAT appointment 
(which takes place around 34-36 months) and asked if they would like to participate. If 
so, they will sign a separate REDCap electronic consent. Parents do not have to 
participate in this additional phase of the study.
12.0
Financial Compensation:
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 15 of 20
Revised: May 25, 2018
Parents will be paid $100 for T0, T7, and T24, which involve more assessments. 
For all other timepoints (T1-T23), parents will receive $25 for completing assessments 
and surveys for a total of $950. Parents in the Chicagoland area will be paid $50 for 
coming to the lab to complete eye-tracking at T0 and T24, if they wish. Additionally, 
parents will receive an additional $25 for completing surveys about their SLP and DTH 
Early Intervention therapists if they have one at the beginning and end of the study for up 
to an additional $100. For parents who agree to complete the TELE-ASD-PEDS at 36-
months, parents will be compensated an additional $50 for this appointment. If parents 
complete all activities, they could be compensated up to $1200 over the two-year study. 
All payments are made using the Stored Value Card Program (virtual card) 
(http://www.northwestern.edu/controller/treasury-operations/depository-services/stored-
value-visa-card-program.html). Participants will receive payment within one week of 
signing their receipt and completing the research activity.  
Parents will also receive a tablet with accessories (case, headphones, tripod, and 
cellular service, if needed) to use throughout their time in the study to aid with gathering 
quality video data. Participants may receive a cellular enabled tablet, after completing an 
internet speed test, if their internet is not ideal for video calls, which would require a 
stable internet connection with high upload speeds. The participant will sign a contract 
provided by NU IT acknowledging that it is property of Northwestern and that they are 
responsible for loss or damage. Participants will keep the tablet and accessories as an 
incentive, if they complete the entire 24-month study.
Participating therapists will be paid $50 for completion of surveys at the 
beginning and end of the study. Each therapist has the potential to be compensated up to 
$100 per participant over the two year study. 
13.0
Audio/Video Recording
All testing and intervention sessions will be video recorded via a video platform 
(such as zoom) or on lab cameras if at the EIRG. All video and audio recordings will be 
stored on the Roberts Lab server. These files will be stored by ID number. Hard copies 
and video cameras will be stored in a locked lab office until upload. Following upload to 
the server video files on the audio and video recorders will be deleted. 
14.0
Potential Benefits to Participants: 
Benefits to parents who participate in the intervention are expected to include: (a) 
improved strategies for working on their child's language and communication skills and 
(b) more accurate perceptions of the child's language and communication abilities. 
Parents have rated our training as helpful to them and their children and they have 
reported high levels of satisfaction with the training protocol. Parents in the control group 
will have the benefit of additional language development results. After each major 
assessment period at T0, T7, and T24 months, all parents will receive a comprehensive 
report describing their communication skills.
15.0
Risks to Participants:
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 16 of 20
Revised: May 25, 2018
There are no obvious serious risks for any of the participants. The time involved 
in the study for families assigned to the PICT group is considerable; however, the 
perceived benefits outweigh the costs to families in personal time. Parents have rated our 
parent training as helpful to them and their children. The only potential risk to study 
participants associated with this project is the risk of confidentiality being violated. There 
are safeguards in place, as described below in section 16 to protect against breach of 
confidentiality. Given these safeguards, the likely impact of this risk of breach of 
confidentiality to participants is minimal. No risks to the participant’s physical, 
psychological, social, cultural, financial, or legal risks are anticipated. Overall, the risks 
associated with this study are very low.
16.0
Provisions to Protect the Privacy and Confidentiality of Participants and the 
Research Data:
All data, including assessment protocols, surveys, and video recordings are 
stored by a unique identification number assigned to each study participant. All study 
data will be stored using: (a) REDCap (Research Electronic Data Capture) a secure, 
web-based, and HIPAA compliant system for collecting and managing data and (b) a 
secure password-protected server at each research site and also on Northwestern 
University’s server for cross-site monitoring and data analysis. Only study research 
personnel will have password-protected access to both the databases and the secure 
server. Two separate databases will be created in REDCap in order to keep personal 
identifying information and study ID number separate. The first database includes de-
identified study data, which is stored by ID number. The link between name/contact 
information and ID number is stored in a separate second database to which only the PI 
and research personnel have access.
All hard copies of study documents will only contain the child’s unique study 
identification number. All hard copies will be scanned onto a secure server and 
uploaded electronically to REDCap. Hard copies and video cameras will be stored in a 
locked lab office until upload. Following upload, data entry, and verification, the hard 
copies will be shredded and the electronic files on the audio and video recorders will be 
deleted. Research Personnel will be responsible for these data management tasks. All 
hard copies of the informed consent will be kept in a locked filing cabinet behind a 
locked door that only research personnel can access. 
As a part of downloading and using the video software (such as Zoom), personal 
data may be collected to enhance the user experience. Any videos recorded will be 
downloaded directly on a research staff member’s computer (or saved on a HIPPA 
compliant cloud), then saved to our password protected and encrypted server, and then 
deleted from the desktop
Videos may also be shared with the participant (of themselves or of other families 
who have consented to using their video clips) through a secure platform to enhance 
video quality, which often suffers on video platforms. These platforms may include 
Northwestern Box, which is only accessible through a link or through sharing rights 
directly with the participant. We may also use another video streaming service, such as 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 17 of 20
Revised: May 25, 2018
vimeo or youtube, with password protection enabled if unable to use box for some 
reason.
Research staff that have access to study information include: the principal 
investigators, research assistants, research clinicians, the statistician, and the project 
manager. We foresee no circumstance in which personal identifiable information would 
be released to a third party, including the funding agency or representatives of the 
University’s IRB. If any data are shared with a third party, no personal identifiable 
information will be included and participants will only be identified by their unique 
identification number. 
Should we incidentally discover other developmental or medical concerns, we 
will refer the child to the appropriate medical professional. Should we incidentally 
discover signs of suspected child abuse or neglect, we will call the Illinois or Tennessee 
Department of Children and Family Services 24-hour child-abuse hotline.
Data will be stored for at least seven years after the completion of the study. 
Findings will be reported in the aggregate with no individual identification associated 
with any reported data. Should the results of the project be presented at conferences, 
seminars, and/or workshops, the identity of the participants will not be disclosed. The 
video recordings will be shown only if permission is obtained from the specific parent for 
that purpose.
Participant communication will take place via phone call, email, and text. In order 
to accommodate that most families respond to texting more quickly, we will utilize the 
web-based program, Mosio which will allow staff to text via the online platform about 
upcoming study activities. This eliminates the need for staff to use their personal cell 
phones and allows the team to use a password protected platform that only research 
personnel can access. Inside Mosio, data is stored in security-controlled, HIPAA-
compliant servers. Personal information is never shared outside Mosio without 
permission. 
17.0
Data Monitoring Plan to Ensure the Safety of Participants:
Safety Monitoring 
Overall framework for safety monitoring. Adverse events (AE), serious adverse events 
(SAE), unanticipated problems, and unusual participant behavior will be documented in 
an online database (REDCap) after every assessment or intervention session with the 
parent/child. Adverse events include: (a) parental psychological stress (parent crying that 
last more than 2 minutes), (b) child distress (crying for more than 5 minutes), and (c) 
child injury (e.g., an injury such that results in a child crying for more than 5 minutes or 
the parent expressing concern about the incident). In this trial a serious adverse events 
include hospitalization or death of the parent or child. 
Frequency of monitoring, interim analysis and stopping rules. Safety monitoring reports 
will be gathered every Thursday, placed into a central document, and reviewed by the PI 
every Friday during weekly research meetings. 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 18 of 20
Revised: May 25, 2018
Process for managing and reporting adverse events. After each assessment or 
intervention visit, research staff will complete a session log in which they are prompted 
to report if an adverse event occurred. Adverse events are predefined before the start of 
the study (as described above) and research staff are prompted for specific AEs. These 
session logs are monitored weekly by the project manager and discussed with the PI. 
Additionally, all study staff members will be trained at the start of the study that when an 
AE occurs, they should inform the PI and project manager immediately. We will follow 
up on all adverse events by calling or emailing the parent within 24 hours. Any adverse 
events without a causal relationship with the intervention will be reported to the NIDCD 
Program Officer and Northwestern University’s IRB within 15 calendar days. Any 
serious adverse event (SAE) will be reported to the NIDCD Program Officer and 
Northwestern University’s IRB within 24 hours. In addition, a detailed written report will 
be submitted within 7 days to NIDCD and the Northwestern University’s IRB.
Data Monitoring 
The data will be monitored by the staff statistician and Dr. Roberts. They will 
conduct the randomization, oversee data entry procedures, manage the database, train 
study staff on data entry procedures, and be responsible for maintaining the quality and 
integrity of the database as outlined below. Data entry will be completed using a 
centralized internet-based system (REDCap), which makes the project database instantly 
available to all authorized researchers in the system and permits access from any 
computer with an internet connection from multiple locations (via password protected 
logon). Summary reports (e.g., recruitment, assessment progress) can be generated 
immediately and are automatically updated with additional data. Reports can be created 
that document participant progress to-date and track missing data. These missing data 
reports will be reviewed weekly by the study team, such that we may try to acquire 
missing data in a timely manner (re-emailing or calling study participants to complete 
surveys; re-administering test items in the event that not all items were completed). 
All data will be independently entered by two different research staff. 
Discrepancies between records will be automatically identified and verified. Additional 
quality assurance checks will be completed to check for missing data, range, and outliers. 
Once the data have been verified, they will be stored in a second “clean” dataset. 
Summary reports of the “clean” dataset will be organized by time point and measure. The 
“clean” dataset and summary reports will be reviewed quarterly by the independent 
biostatistician on the Data and Safety Monitoring Board. Outcomes by experimental 
condition assignment (intervention, control) will not be included in any interim reports. 
Risks related to incorrect or biased scoring of measures will be minimized in the 
following ways. All standardized and observational measures will be conducted by 
independent observers and assessors naïve to the experimental condition. All testing 
sessions will be video recorded and procedural fidelity for test administration will be 
measured monthly to assess and ensure accuracy of test administration. Observers for 
all observational measures will be trained to point-by-point reliability of 90% for three 
consecutive administrations prior to coding the observational data. A second 
independent observer will code 20% of the observational measures. When reliability 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 19 of 20
Revised: May 25, 2018
falls below 90%, coders will discuss discrepancies and document additional rules as 
needed. Furthermore, scoring of all norm-referenced assessments will be verified by a 
second person. 
Staff fidelity and reliability training is also tracked using a project management 
tool that outlines all training procedures and notifies other research personnel when 
tasks are completed. If at any time a research member is consistently producing errors, 
they will be re-trained on all procedures with oversight from the project manager. All 
reliability and fidelity training and monitoring will be documented in a database that 
captures each research member’s fidelity score. 
18.0
Data, and if applicable, Specimen Banking: 
Data will stored for at least seven years after the end of the study. Study data will 
be banked in a statistical file in which all identifying information on each participant will 
be separated from the data; the only identifiers available on the statistical records will be 
a random research number. The statistical file will be located on a password-protected 
secure server. 
19.0
Data Sharing: 
The proposed research will include data from 96 children with hearing loss and 
their parents. The final dataset will include elicited, parent-report and observational data 
of child prelinguistic skills and spoken language. The dataset will also include 
observational measures of parent use of communication support strategies. All baseline, 
intervention and follow-up data for covariates, moderators, and outcomes will be 
included. Data from both treatment and control participants will be included. The final 
dataset will not include video recordings, which could results in identification of 
participants. The final dataset will be stripped of identifiers prior to release for sharing. 
However, we believe that there remains the possibility of deductive disclosure of 
participants with unusual characteristics. Thus, we will make the data and associated 
documentation available to users only under a data-sharing agreement that provides for 
a commitment: (a) to use the data only for research purposes and not to identify any 
individual participant; (b) to secure the data using appropriate computer technology; (c) 
to destroy or return the data after analyses are completed; and (d) to cite the grant and 
key publications describing the database and measures in any resulting presentations 
and publications.
Transcripts from parent-child and assessor-child language samples will also be 
deposited into the Child Language Data Exchange System 
(http://childes.psy.cmu.edu), an international repository of child language data. Access 
to the data will be openly available. Researchers who access the transcripts will be 
expected to abide by the established guidelines for use of TalkBank data 
http://talkbank.org/share/irb/options.html.
Because we will not be able to complete our aims until all longitudinal data are 
collected and analyzed, we will archive all files at the end of Year 5. Data archiving and 
sharing will be overseen by Dr. Roberts. All raw datasets will be archived for at least five 
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022

Page 20 of 20
Revised: May 25, 2018
years after the completion of this project. We will document all data files using 
standardized, high-fidelity methods to increase efficiency in accessing and manipulating 
archived data. We will use the Inter-University Consortium for Political and Social 
Research (ICPSR) Guide to Archiving, which defines industry standards for data 
archiving documentation (http://icpsr.umich.edu/ICPSR/access/dataprep).
For participants enrolled in the at Robert H. Lurie Children’s Hospital, “Neural 
Predictors of Language Outcomes in Young Children with Cochlear Implants” (IRB 
2018-1959), the Language Exposure Assessment Tool will be shared. Only de-identified 
data (only scores) will be shared and videos will not be shared.
20.0
Qualifications to Conduct Research and Resources Available:
Dr. Roberts is a clinician who serves children with developmental delays and their 
families. Dr. Roberts is a licensed speech-language pathologist with 10 years of 
experience working with children from birth to 36 months of age. Dr. Roberts is a 
certified Early Intervention Provider for the state of Illinois and she has worked on three 
federally funded intervention research projects involving children from birth to 60 
months of age. Dr. Roberts teaches a graduate class on advanced issues in family 
intervention in which she routinely teaches graduate students how to work with young 
children and their families.
Dr. Nancy Young, the PI of the subcontract at Lurie Children’s Hospital, is Head 
of Otology & Neurotology and the Medical Director of Audiology & Cochlear Implant 
Programs.
Dr. Derek Houston, a consultant on the project, is associate professor in the 
Department on Otolaryngology at Ohio State University. Dr. Houston specializes in early 
language development for children with hearing loss and will act as a consultant on the 
eye-tracking methodology for the project. 
Dr. Matthew Hall is assistant professor in the Department of Psychology at 
University of Massachusetts, Dartmouth. Dr. Hall specializes in language and 
psycholinguistics. Dr. Hall will be interacting with participants by administering the D-
LEAT for several participants, as well as training EIRG staff on how to administer the 
measures. Dr. Hall will have access to PII, as he is interacting directly with participants. 
Dr. Hall will also help the study team analyze data from the D-LEAT.
Dr. Stephanie DeAnda is assistant professor in Communication Disorders and 
Sciences at the University of Oregon. Dr. Stephanie DeAnda is a licensed speech-
language pathologist. Dr. DeAnda will be interacting with participants by administering 
the D-LEAT for several participants, as well as training EIRG staff on how to administer 
the measures. Dr. DeAnda will have access to PII, as he is interacting directly with 
participants. Dr. DeAnda will also help the study team analyze data from the D-LEAT.
IRB #: STU00208785-MOD0042 Approved by NU IRB for use on or after 1/18/2022