Incorporating Strategy Training Into Naming Treatment to Improve Generalization in Aphasia
Phase: NA
Conditions: Aphasia
Sponsor: MGH Institute of Health Professions

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Cover page for clinicaltrials.gov 
 
 
 
Study Title 
Incorporating strategy training into naming 
treatment to improve generalization in 
aphasia 
NCT Number 
Not yet assigned  
Document Description 
Protocol and statistical analysis plan 
Document Date 
March 3, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PARTNERS HUMAN RESEARCH COMMITTEE  
DETAILED PROTOCOL 
 
Study Title: Incorporating strategy training into naming treatment to improve generalization in 
aphasia 
I. BACKGROUND AND SIGNIFICANCE (including progress report and preliminary studies) 
 
a. 
Historical background 
 
Aphasia is an acquired communication disorder that results from damage to brain regions 
responsible for various language processes63. Aphasia is a common sequela to stroke2,63 and can 
result in partial or total loss of spoken and written communication ability2,62. Despite improvements 
over the past several decades in the treatment of aphasia, roughly 1 in every 250 people in the 
United States is currently living with aphasia63, many of whom will live with the disorder for the 
rest of their lives. People living with aphasia often become dependent on their caregivers28, do 
not return to work28, experience depression4, and withdraw from activities that bring them joy and 
fulfillment21. Therefore, it is urgent to identify treatments that will result in meaningful 
improvements in the language abilities of people with aphasia (PWA). 
There are eight clinical subtypes of aphasia, distinguished from one another by differences in their 
degrees of impairment in verbal fluency, auditory comprehension, and word/phrase repetition2,62. 
Despite these differences, all PWA experience one common impairment: naming36. Naming, also 
referred to as ‘lexical retrieval’ or ‘word finding,’ refers to one’s ability to verbally identify objects65. 
Successful naming requires a person to recognize a concept/object and then retrieve the word 
that matches the concept from their mental lexicon65. Not only is successful naming essential to 
effective communication, but the severity of a PWA’s naming impairment has been shown to be 
associated with the overall integrity of the language system7 as well as with measures of 
connected speech72,73. The centrality of naming to effective communication and various language 
processes make naming an extremely common focus of aphasia treatment. 
b. Previous Studies and Research Rationale 
 
Nearly all naming treatments for PWA can be categorized as either restorative or 
compensatory32,50. Restorative naming treatments target language-processing systems5 at the 
word level and reflect the impairment-focused ‘body structures and functions’ domain of the 
International Classification of Functioning Disability and Health32,91 (ICF). Research shows that 
most restorative treatments improve PWAs’ naming ability for objects that are explicitly trained 
during treatment, as well as objects that were not trained but are semantically related to those 
that were10,12,17,18,50,54. However, most restorative naming treatments do not improve PWAs’ ability 
to name objects that are not semantically related to the trained objects29,70. As it is impossible to 
train the entire universe of objects during a PWA’s course of treatment, the lack of consistent 
generalization to untrained objects brought about by restorative naming treatments is a critical 
limitation. There is also inconsistent evidence that restorative naming treatments improve PWAs’ 
word finding ability during spontaneous, connected speech (e.g., conversation)10,12,15,17,29. 
Considering that PWA and their family members identify improved conversational speech as a 
highly desired rehabilitation outcome19,90,92, the lack of generalization to connected speech is 
another critical limitation of restorative naming treatments.  
In contrast to restorative treatments, compensatory treatments aim to help PWA overcome their 
naming deficit by training the use of verbal and/or non-verbal acts to supplement their verbal 

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output or mend communicative breakdowns, such as gesture training, circumlocution, 
augmentative-alternative communication methods, and the Life Participation Approach16,44,71,79. 
Compensatory treatments take a function-focused approach to improving PWA’s language 
abilities and reflect the ‘activity’ and ‘participation’ domains of the ICF32,91. While researchers 
agree that compensatory acts are effective in improving functional communication, evidence 
shows that PWA most consistently use these acts during treatment, but do not transfer their use 
to spontaneous, everyday communication5,76,79. Therefore, as with restorative intervention, 
compensatory treatments most reliably lead to treatment-specific gains, but do not result in 
consistent generalization into everyday communicative contexts. 
Several recent studies have explored the potential value of combining restorative and 
compensatory approaches as a way to engage multiple language systems at once and improve 
generalization14,47,71. Promisingly, these studies show that combined approaches result in gains 
at both the impairment and functional communication levels14,32,47,71, providing critical support for 
this type of practice. Research has also begun exploring the relationship between treatment 
outcomes and different learning processes60,61,78,88 and approaches31,85 in PWA. Learning is the 
primary mechanism by which individuals reacquire old skills and acquire new skills, and thus is a 
critical component of rehabilitation43. Our recent work suggests that PWAs’ outcomes and ability 
to generalize new knowledge and behaviors depends on whether or not they develop effective 
strategies that support learning31,85. 
Vallila-Rohter and Kiran (2015) conducted a study in which they compared learning outcomes 
and natural strategy development between PWA and age-matched controls who completed an 
implicit categorization task85. In the task, participants had to categorize a series of stimuli into two 
categories. Since each stimulus had ten physical features, participants had to consider multiple 
features before making their decision. Those who were able to consider multiple features 
together, which is considered the optimal strategy34,58, would learn to categorize more accurately. 
The authors examined what strategy the PWA and controls naturally developed during the task, 
as no strategy instructions were given. They found that while some PWA (~10%) naturally 
developed the optimal learning strategy, the majority (~90%) did not85. The authors also found 
that PWA achieved lower categorization accuracy than their age-matched peers, likely due to 
their predominant use of suboptimal strategies85. These findings provide evidence that PWAs’ 
overall learning success depends on their ability to develop optimal strategies during the learning 
process, although they are unlikely to develop these strategies on their own.  
Gallée and colleagues (2020) conducted a study in which they compared outcomes between two 
groups of PWA who completed a course of tablet-based naming treatment31. One group of PWA 
was trained to employ an optimal strategy, which was to engage in effortful word retrieval during 
treatment tasks (considered an optimal behavior), and the other group did not receive this 
training31. The goals of the study were to examine (1) whether an optimal behavior such as 
engaging in effortful word retrieval could be trained successfully in PWA, and (2) whether strategy 
training would lead PWA to use the optimal behavior both in the clinic and in their home 
environment. The authors found that the strategy-trained group successfully learned the optimal 
behavior, as evidenced by decreased cue use and increased response time during task 
completion31. They also found that measures of cue use and response time in the strategy-trained 
group did not differ between the clinic and the home environment, indicating that the strategy-
trained group engaged in the optimal behavior even when a clinician was not present to 
encourage them to do so, which in turn led to superior gains31. This recent work from our lab 
provides evidence that PWA (1) have the ability to learn an optimal strategy as a result of strategy 
training, and (2) have the capacity to carry-over use of the strategy beyond the clinic environment, 
which offers the potential to enhance treatment outcomes.  

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c. Rationale Behind the Proposed Research 
We predict that a treatment approach that incorporates restorative, compensatory, and strategy 
training components would greatly improve generalization in PWA. Therefore, we propose a 
treatment protocol that involves: (1) a restorative component aimed at improving PWAs’ naming 
ability, and (2) a strategy training component aimed at improving generalization of a 
compensatory verbal behavior. In the proposed study, the restorative treatment component will 
be Semantic Feature Analysis 11,12,50,93 (SFA), a well-regarded naming treatment. The 
compensatory behavior will be circumlocution, a verbal behavior in which PWA describe an 
object’s features if they are unable to name it2. Circumlocution is known to facilitate naming29 and 
assist listener comprehension3,29,84. The features PWA often produce when circumlocuting 
overlap with many of the features included in SFA. The strategy training component will consist 
of explicit teaching about when and how to use circumlocution, and practice applying it in 
moments of naming difficulty. We believe that strategy training will aid in PWAs’ consistent and 
effective adoption of circumlocution as a compensatory behavior to facilitate naming and improve 
listener comprehension. The results of this study are expected to demonstrate that incorporating 
strategy training into naming treatment has the power to promote generalization of impairment- 
and participation-level gains in aphasia. Quick identification of naming difficulty and use of 
circumlocution will lead PWA to spend less time searching for specific words (improved efficiency) 
and more time producing informative speech (improved informativeness), which will increase their 
ability to confidently participate in conversation.  
 
II. 
SPECIFIC AIMS 
 
Aim 1. Evaluate the effectiveness of naming treatment that incorporates strategy training 
on naming outcomes. Approach: We will administer a 176-item naming assessment pre- and 
post-treatment. 
1a. Measure patients’ naming accuracy for trained and untrained objects. Hypothesis: 
Consistent with prior studies, we expect that naming treatment will yield medium to large 
effects for trained objects55,66,70. Additionally, we hypothesize that strategy training will result 
in an increase in circumlocution-facilitated naming for untrained objects, and yield medium 
effects for untrained objects. 
1b. Determine whether patients with aphasia learn the strategy and consequently 
demonstrate a change in their language behavior in moments of naming difficulty. 
Hypothesis: We hypothesize that strategy training will lead PWA to correctly identify the 
strategy’s components post-treatment. We also hypothesize that strategy training will lead 
PWA to produce more feature words (i.e., engage in circumlocution) during moments of 
naming difficulty. Specifically, we expect to find medium to large effects on the number of 
feature words PWA produce during naming attempts post-treatment. 
Aim 2. Evaluate the effect of strategy training on patients’ language production during 
connected speech. Approach: We will collect and transcribe connected speech samples, 
including spoken descriptions of pictures, weekly activities, and personal memories73, pre- and 
post-treatment. Hypothesis: We hypothesize that strategy training will lead PWA to produce more 
object and feature words during connected speech. We expect medium to large effects on object 
words, feature words, and measures of communicative effectiveness64.  
 
III. 
SUBJECT SELECTION 
 
a. Inclusion/exclusion criteria.  

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Eligible individuals will: 
- 
Experienced a single left-hemisphere stroke,  
- 
Have aphasia due to stroke,  
- 
Be in the chronic stages of their aphasia, at least 6 months post onset of stroke, 
- 
Be between the ages of 18 and 89 years of age, and 
- 
Be a proficient English speaker,  
- 
Have no history of neurodegenerative disease, severe motor speech disorder, significant 
mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that 
could influence their cognitive, language, and memory systems.  
 
Participants may have concomitant medical problems such as heart disease or diabetes; 
however, at the time of their participation they will be medically and neurologically stable and at 
least wheelchair ambulatory. 
Participants with a history of minor head injury or short-term loss of consciousness are eligible to 
participate, however a brief history of these instances will be obtained in order to control for 
potential secondary impacts to learning and memory systems.  Similarly, history of developmental 
learning 
disorders 
will 
be 
obtained, 
as 
this 
can 
affect 
learning 
and 
strategy 
development/compensatory systems, which are a focus of our research study. 
Additional inclusion/exclusion criteria include the following: Eligible individuals must achieve a 
score of 4 or greater on the Auditory Verbal Comprehension Score, which is a subtest of the 
Western Aphasia Battery-Revised (WAB-R) for full enrollment/participation in the study. Eligible 
individuals must also name 1-146 of the 176 items correctly on the initial administration of the 
naming assessment for full enrollment/participation in the study. Individuals who name 0, or 
greater than 146 items will be excluded. These criteria will be assessed at the initial study visit, 
after informed consent has been obtained. 
b. Source of subjects and recruitment methods 
 
Individuals with aphasia will be recruited by referral from physicians, speech-language 
pathologists, and neuropsychologists.  We will mail and email recruitment letters to neurologists 
and speech pathologists in the greater Boston area. Interested professionals will describe the 
study to the potential participants and ask them to contact the researcher if they are interested in 
participating in the experiment.  
 
Individuals with aphasia will also be recruited from the MGH Institute of Health Professions 
Aphasia Center. SLPs will share study flyers with individuals with aphasia and ask if individuals 
are interested in meeting a member of the research team to learn more about the study. If they 
express interest, a member of the research team will be invited to come to the end of an upcoming 
scheduled therapy session to talk more about the study, or Aphasia Center staff can coordinate 
a meeting between the individual and a member of the study staff. It will be clearly communicated 
that the treating Speech language pathologist has no affiliation to the research study and that 
expressing or not expressing an interest to speak to research staff, in no way impacts the therapy 
services they receive in the MGH IHP Aphasia Center.  
 
In addition, individuals with aphasia will be recruited via word of mouth, flyers, flyers/presentations 
at local aphasia centers, and emails to community health centers and via listservs (the American 
Speech-Language Hearing Association (ASHA) Special Interest Group 2 Neurogenic 

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Communication Disorders listserv, as well as the ASHA Special Interest Group 14 Cultural and 
Linguistic Diversity listserv). We will also recruit via Rally and the MGH IHP IRB-approved 
Recruitment Database. 
 
IV. 
SUBJECT ENROLLMENT 
 
a. Methods of enrollment. We plan to enroll 20 individuals with aphasia in a single-subject design 
intervention study in which all participants receive the same intervention protocol. 
 
b. Procedures for obtaining informed consent. Once interest in participating in the study is 
expressed, one of the co-investigators involved in this study will establish contact with potential 
participants over the phone or via email. The research project will be explained and interested 
persons will be invited to the research site to discuss the study. The purpose, procedures, possible 
benefits and risks of the study will be explained to all potential participants.  Potential participants 
will also be instructed that they can withdraw from the experiment at any time. 
A trained study staff member, who is not a member of the participant’s medical team, will present 
eligible participants with information describing the purpose of the project, the experimental 
procedures, potential risks and benefits, and time required. Informed consent will be completed 
during this meeting. The participant will be given a copy of the signed informed consent, and the 
original document will be retained by the PI and stored in a locked filing cabinet in the PI’s lab. 
The participant and his/her spouse/next of kin will be invited to the laboratory to discuss the 
experiment with a member of the research team with expertise in aphasia. In this meeting, 
research staff will explain the experiment using simple language. She/he will also have sample 
materials from the experiment such as pictures of stimuli to help explain experimental paradigms. 
Extra care will be taken to ensure that subjects understand the nature of the experiment. We will 
offer to read the consent form to these individuals as reading can be difficult and information will 
be reiterated verbally. Individuals and family members will be encouraged to interrupt, ask 
questions, and seek clarifications. They will be given time to assess presented information and 
formulate questions. Individuals with aphasia are considered capable of making informed 
decisions and provide consent as indicated in the National Aphasia Association Bill of Rights 
(2005). Therefore, family members may be present when experimental procedures are explained, 
but individuals with aphasia will be giving or declining to give written informed consent. Regarding 
consent for video/audio recording, participants will be informed that they can participate even if 
they do not consent to video/audio recording. 
Though we do not anticipate this to occur frequently, if a participant cannot write or is physically 
unable to sign the consent form, they can make their mark on the signature line in the consent 
form. People who cannot make their mark on the consent form can indicate consent by other 
means, e.g., orally, nodding their head, etc. The means by which consent was given by the 
subject will be documented in the consent form and research record. 
For participants participating via Enterprise Zoom, the consent form will be reviewed with the 
participant and their family member in the same manner, and virtual consent will be confirmed via 
screenshare. The participant will be sent a copy of the signed consent form via mail.  
 

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c. Treatment assignment and randomization. All study participants will receive the same 
treatment procedures. No assignment or randomization is required. 
 
V. 
STUDY PROCEDURES 
 
a. Study visits and parameters to be measured: Participants will have the option to participate 
at the MGH IHP, at their home, or via Enterprise Zoom.  
 
Once participants are consented, the typical study sequences include (also in Figure 1): Each 
step is described in additional detail in the section that follows.  
1) Pre-treatment: Completion of pre-treatment cognitive-linguistic assessments, naming 
probes, and spontaneous speech probes (sessions approximately 2 hours in length over 
an average of 3-5 days to mitigate any effect of fatigue on assessment performance).  
 
2) During Treatment: Participation in the treatment for a period of eight weeks. All participants 
will receive the same treatment. Participants will receive in-person therapy at the MGH 
Institute of Health Professions, home visits, or virtual sessions (via Zoom). Participants 
will attend three 70-minute treatment sessions per week for eight consecutive weeks. 
Treatment sessions will be conducted by a certified SLP. Starting on Week 2, the first 
treatment session of each week will begin with a 30-minute assessment, consisting of a 
naming probe, a connected speech probe, and a strategy knowledge probe, in which the 
participant will be asked to provide the six strategy components. Treatment will stop at the 
end of the eight weeks, or after three consecutive naming probe performances over 90% 
accuracy, whichever occurs first.  
 
3) Post-treatment re-administration of assessments: Participants will complete the same 
cognitive-linguistic assessments, naming probes and spontaneous speech probes as they 
did pre-treatment within 20-30 days following the last treatment session. Sessions will last 
approximately 2 hours in length over an average of 3-5 days.  
 
4) Post-treatment tests of retention: Participants will attend two additional post-treatment 
sessions one month and two months after the final treatment session. During each post-
treatment session, participants will complete a 176-item naming assessment, one 
connected speech probe, and a strategy knowledge probe.  
 
Phase 1) Pre-treatment:  
a) Cognitive-linguistic assessments. Eligible and consented participants will complete a battery 
of standardized cognitive-linguistic assessment, including:  

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- 
The Western Aphasia Battery-Revised (WAB-R)46,  
- 
General Health Questionnaire-1235,  
- 
Stroke and Aphasia Quality of Life Scale41, 
- 
Subtests of the Cognitive Linguistic Quick Test-Plus (CLQT+)39,  
- 
The Metalanguage in Aphasia Assessment40 (MetAphAs), 
- 
The Communication Confidence Rating Scale for Aphasia (CCRSA), 
- 
The Scenario Test86 
All assessments will be administered via paper and pencil, unless the participant is participating 
remotely. If they participate remotely, a fully encrypted device will be utilized but all responses will 
still be collected via paper and pencil. 
b) Naming assessments and connected speech probes: Participants will complete three pre-
treatment naming assessments to establish a stable baseline83 (Figure 1). During each baseline 
session, participants will complete a 176-item naming assessment and one connected speech 
probe. The 176-item naming assessment has objects from eight categories: animals, clothing, 
household 
objects, 
fruits 
and 
vegetables, 
occupations, 
other 
foods, 
tools, 
and 
transportation37,45,51. Participants will be asked to name each object. To elicit connected speech, 
we will ask participants to verbally describe a picture, weekly activity, and/or personal memory 
(e.g., Tell me all about your weekend). Naming assessment and connected speech probe coding: 
We will calculate naming accuracy from the naming assessments and transcribe participants’ pre-
naming verbalizations in order to later analyze and characterize their pre-treatment naming 
attempts. We will also transcribe and analyze participants’ connected speech samples using 
Correct Information Unit (CIU) analysis64, which provides measures of communicative efficiency 
and informativeness. Treatment and naming probe object selection: Participants’ performance on 
the three pre-treatment naming assessments will determine which objects are either: trained 
during treatment, included in weekly naming probes, or untrained and used to test for 
generalization post-treatment. Any objects a participant is unable to name on one, two, or three 
assessments will be included in the participant’s object list. Of the included objects, we will create 
separate treatment and naming probe object lists taking into account the objects’ semantic 
category and complexity. 
Phase 2: Treatment  
Each treatment session will have three sections:  
• 
Strategy Education (~ 15 minutes),  
• 
Naming Treatment Plus Strategy Application (~40 minutes),  
• 
Strategy Debrief (~15 minutes).  
Strategy Education. The clinician will:  
• 
(a) provide education on object naming,  
• 
(b) work with the participant to develop strategies to quickly identify instances in which 
they are unable to name an object,  
• 
(c)teach the participant to immediately begin generating feature words, i.e., 
circumlocuting, once they realize they are unable to name an object, and  
• 
(d1) teach the participant the six types of feature words they can produce during 
circumlocution (i.e., the six SFA framework components, Figure 2 below). The clinician 
and the participant will work together to learn and memorize the six components. Once 
the participant is able to independently identify four of the six components across three 
sessions, Strategy Education will change as follows.  

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o The clinician will review steps (a – c) and then,  
o (d2) ask the participant to list the components. The clinician will provide 
reinforcement and cues for any strategy components the participant is unable to 
independently identify. The clinician will also ask the participant to describe any 
recent instances in which they had success using the strategy at home or out in 
the community.  
 
 
 
Naming Treatment Plus Strategy Application.  
• 
(e) The clinician will place a picture of an object from the treatment list in front of the 
participant and ask whether the participant can name it. If the participant says no, the 
clinician will ask them what they should do next (circumlocute) and encourage them to do 
so. If the participant says yes, they will name the object and the clinician will ask the 
participant what they would have done had they been unable to name it (circumlocute) 
and encourage them to do so. 
• 
(f) The clinician will encourage the participant to provide as many features as they can 
during circumlocution. This step engages the participant in independent feature 
generation, identified as the “active ingredient,” of SFA37.  
• 
(g) The clinician will ask the participant to identify which of the strategy’s components their 
description included (e.g., If they described a dog as, “an animal that barks,” they would 
identify their description as having included the category and action strategy 
components). This step reinforces their knowledge of the strategy’s components.  
• 
(h) The clinician will ask the participant to identify which of the strategy’s components were 
not included in their description (in this example, description, location, association, and 
function), and to generate one additional descriptive feature using the remaining strategy 
components. This step reinforces the strategy’s components and gives the participant 

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additional opportunities for independent feature generation. The clinician will give the 
participant another opportunity to name the object if they had been unable to name it 
during (e) above.  
This process (e – h) will be repeated for approximately eight treatment objects (~5 minutes per 
object). Alternate methods. If/when a participant is unable to independently produce any feature 
words about an object, the clinician will provide cues to guide them. Cues will be given from least 
to most facilitative, starting with general questions (e.g., What does it do?), to a binary choice 
(e.g., Does it bark or meow?), and eventually providing the correct feature response (e.g., It 
barks.)37.  
Strategy Debrief. The final portion of the session will include a debrief, which is regarded as a 
critical step in the learning process and enables learners to gain insight from direct experience 
and apply it to future situations52,77.  
• 
(j) The clinician will ask the participant for their reaction and opinion about the treatment 
session.  
• 
(k) The clinician will provide positive reinforcement26 by describing at least two instances 
during Naming Treatment Plus Strategy Application in which the participant effectively 
applied the strategy.  
• 
(l) Finally, the clinician and participant will identify opportunities at home in which the 
participant could envision employing the strategy. The purpose of the debrief is to reinforce 
the strategy’s applicability in all environments. 
 
Phase 3 Post-treatment re-administration of assessments: Participants will complete the 
same cognitive-linguistic assessments, naming probes and spontaneous speech probes as they 
did pre-treatment within 20-30 days following the last treatment session.  
 
Phase 4 post-treatment tests of retention: Participants will attend two additional post-treatment 
sessions one month and two months after treatment completion to evaluate retention. During 
these study visits, participants will complete naming assessment and a connected speech  
connected speech task in which we will ask participants to verbally describe a picture, weekly 
activity, or personal memory description (e.g., Tell me all about your weekend). 
 
b. Drugs to be used: N/A 
 
c. Devices to be used: N/A 
 
d. Procedures/surgical interventions: N/A 
 
e. Data to be collected and when data is to be collected 
 
Pre- and post-treatment data: All pre-treatment and post-treatment cognitive-linguistic 
assessment data will be collected during pre- and post-treatment assessment sessions. This data 
will be collected on each respective assessment material’s proper test booklet. Data from pre- 
and post-treatment naming probes will include naming accuracy and circumlocution attempts (i.e., 
naming attempts). Data from pre- and post-treatment spontaneous speech probes will include 
verbatim transcriptions of each participant’s responses to the spontaneous speech probes (e.g., 
Tell me all about your weekend). Naming and spontaneous speech probe data will be collected 

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during the three pre-treatment and six post-treatment sessions. Audio recordings of naming 
probes will be randomized and coded for accuracy. 
During treatment data: During treatment, we will collect treatment session data and weekly probe 
data. Weekly probe data will be the exact same as the pre- and post-treatment naming and 
spontaneous speech probe data (naming accuracy, circumlocution attempts, verbatim 
transcriptions), in addition to strategy knowledge data probes (i.e., asking participants to identify 
as many of the six strategy components as possible). These weekly probes will occur once per 
week for the eight weeks of treatment. During the Strategy Education section of treatment, data 
will include quantification of strategy component knowledge (out of a possible six). During the 
Naming Treatment Plus Strategy Application section of treatment, data will include: Percent of 
items participant correctly identified whether they would be able to name the object before 
attempting to name it, naming accuracy before feature generation, number of features generated 
by the participant per item, number of correctly matched features with feature types per item, 
number of additionally identified feature types per item, and naming accuracy after feature 
generation. During the Strategy Debrief section of treatment, data will include: transcription of 
participant’s reaction and opinion of treatment session and number of home-based opportunities 
identified by the participant in which they could use the strategy.  
VI. 
BIOSTATISTICAL ANALYSIS 
 
a. Specific data variables being collected for the study.  
 
Cognitive-linguistic assessments (pre-treatment and post-treatment): Language and 
cognitive assessments will be scored based on standardized norms and methods of 
administration and scoring provided in testing manuals.  Cognitive-linguistic assessments and in-
person treatment sessions will be videotaped to provide a measure of reliability of scoring and 
administration of assessments and treatment. 
Naming, spontaneous speech, and strategy knowledge probes (pre-treatment, during 
treatment, and post-treatment): We will collect (1) naming accuracy, (2) verbatim pre-naming 
verbal naming attempts, (3) verbatim responses to spontaneous speech probes, and (4) number 
of identified strategy components. 
Treatment data: We will collect data on: (1) number of identified strategy components and (2) 
number of feature words during moments of naming difficulty. 
b. Study endpoints. The participant’s participation with the study will end when they request to 
withdraw from the study, or after the post-treatment assessments have been completed, 
whichever occurs first. 
 
c. Statistical methods. 
 
We will use visual inspection68, mixed-effects modeling, and effect size calculations to analyze all 
results. For visual inspection, we will use the conservative dual-criterion method20,27,82. We will 
use mixed-effects modeling to estimate the extent to which treatment-specific factors (fixed 
effects), pre-treatment cognitive-linguistic measures (random effects), and participant-specific 
factors (random effects) explain post-treatment naming and connected speech outcomes. We will 
calculate effect sizes by subtracting a participant’s average pre-treatment score from their 
average post-treatment score and dividing by the pre-treatment standard deviation8.  
 

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Aim 1a. Measure PWAs’ naming accuracy for trained and untrained objects. We will 
calculate effect sizes to measure the effect of treatment on participants’ naming accuracy for 
trained objects, untrained semantically-related objects, and untrained semantically-unrelated 
objects between pre- and post-treatment. Hypotheses: Consistent with prior studies, we expect 
that naming treatment will yield medium to large effects for trained objects. Additionally, we 
hypothesize that strategy training will result in an increase in circumlocution-facilitated naming for 
untrained unrelated objects and yield medium effects for all untrained objects, regardless of 
semantic relatedness.  
 
Aim 1b. Determine whether PWA learn the strategy and consequently demonstrate 
a change in their language behavior in moments of naming difficulty. Analyses: We will use 
visual inspection to examine participants’ identification of the strategy components from 
Treatment Week 2, to Week 8, to post-treatment sessions. We will calculate effect sizes to 
measure the effect of treatment on the total number of feature words produced during naming 
assessments and on the average number of feature words produced per naming attempt during 
assessments, from pre- to post-treatment. Hypotheses: We expect that strategy training will result 
in participants’ ability to identify all six strategy components by Week 8 and at least four of the 
strategy components during maintenance/retention sessions. We also hypothesize that strategy 
training will lead PWA to produce more feature words (i.e., engage in circumlocution) during 
moments of naming difficulty. Specifically, we expect to find medium to large effects on the 
number of feature words PWA produce during naming attempts. 
 
Aim 2. Evaluate the effect of strategy training on patients’ language production 
during connected speech. Statistical Analyses: We will calculate effect sizes to measure the 
effect of treatment on number of object words, feature words, CIUs, and CIUs/minute participants 
produce during connected speech tasks. Hypotheses: We hypothesize that strategy training will 
lead PWA to produce more object and feature words during connected speech. We expect 
medium to large effects on object words, feature words, CIUs, and CIUs/minute during connected 
speech from pre- to post-treatment. 
 
Additional analyses: We will create mixed-effects models using treatment-phase data (e.g., 
strategy component identification) as fixed effects, and pre-treatment cognitive-linguistic 
measures (e.g., CLQT+ results) and participant characteristics (e.g., aphasia severity) as random 
effects to further understand post-treatment outcomes. We will calculate normalized change 
scores to measure participants’ overall improvement relative to their baseline performance and 
maximum possible change56. We will report changes between participants’ pre- and post-
treatment WAB-R Aphasia Quotient46 scores using the benchmarks proposed by Gilmore and 
colleagues33. 
d. Power analysis (sample size, evaluable subjects). We will recruit 20 PWA subsequent to 
single left-hemisphere stroke with the goal of collecting complete data on ten participants, which 
is adequate for single-subject design68,69. 
 
VII. 
RISKS AND DISCOMFORTS 
 
a. Complications of surgical and non-surgical procedures. Language and cognitive 
assessments and therapy tasks are noninvasive and pose no medical risks. Participants may 
experience some frustration during the course of the study, however, this frustration is not 
expected to be more than that what would be faced in situations requiring focused, sustained 

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attention for learning. A researcher will be present to answer any questions or concerns 
participants might experience. 
All materials (history forms, data obtained during behavioral tasks) are for research purposes only 
and will be kept in confidence.  Forms containing personally identifying information (history forms 
and data collected during cognitive-linguistic assessments) will be kept in a locked filing cabinet 
at the MGH IHP to which only the PI and approved study staff have access.  
 
In-person sessions will occur in The Aphasia Center at 2 Constitution Wharf, Boston, MA, 02129, 
or in quiet rooms in building 79/96 the MGH IHP’s research building. Rooms are equipped with 
wall-mounted cameras (Eagle 1.3 Megapixel camera), which will be used to video/audio recording 
assessment and treatment sessions. For in-person and at-home sessions, video/audio recordings 
will be collected using password-protected Enterprise Zoom on an encrypted, password protected 
laptop. For virtual sessions, video/audio recordings will be collected using password-protected 
Enterprise Zoom, and study staff will launch the video conferencing in a private and secure 
area.  All digital data (i.e., video/audio recordings) will be transferred to a secure network or web-
based electronic lab notebook, LabArchives, and/or Dropbox, maintained by Partners, which can 
only be accessed by the PI and approved study staff via electronic ID.  These digital files will be 
coded with identification codes and will not contain personally identifiable information. Deidentified 
standardized assessment scores will be transferred from paper forms to digital forms in RedCap. 
Video data will be recorded and kept on a secure network maintained by Partners and accessed 
only by approved researchers. Deidentified video clips will be kept for education purposes 
(teaching within MGB only). If we do utilize videos, participant faces will be blurred/obscured as 
to remain de-identified.  Video and audio recordings will be retained for seven years and then be 
destroyed.  
b. Drug side effects and toxicities: N/A 
c. Device complications: N/A 
d. Psychosocial (non-medical) risks: N/A 
e. Radiation Risks: N/A 
VIII. 
POTENTIAL BENEFITS 
 
a. Potential benefits to participating individuals. It is hoped that the treatment will result in 
behavioral gains for around 80% of enrolled subjects, as demonstrated through improved 
performance on naming batteries and cognitive-linguistic assessments administered post-
treatment.   
 
b. Potential benefits to society (e.g. increased understanding of disease process). The 
current study is designed to address the important issue of language rehabilitation after 
aphasia-inducing stroke. Speech-language therapy is the treatment for aphasia, and relies 
heavily on behavioral therapies that implicitly engage systems of learning.  Additional research 
is needed to demonstrate which types of therapies are efficacious for patients and how 
potential modifications to instruction method might impact therapy outcomes.  
 
IX. MONITORING AND QUALITY ASSURANCE 
 
a. Independent monitoring of source data  
 

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The PI or study staff will conduct ongoing review of data to ensure completeness, accuracy and 
compliance with protocols.  Quarterly review will ensure that participant inclusion is in adherence 
with enrollment criteria, that records of subject enrollment are up to date, and that procedures and 
study visits are being completed as proposed.  Review will be completed by the PI or study staff.  
In the event of an adverse event, the event will be immediately reviewed.  Continuing reviews will 
be submitted in accordance with the IRB.  
 
b. Safety monitoring (e.g., Data Safety Monitoring Board)  
 
Protection of subject privacy:  Forms containing personally identifying information (history 
forms and data collected during cognitive-linguistic assessments) will be kept in a locked filing 
cabinet at the MGH-IHP to which only the PI and approved study staff have access.  
 
Deidentified assessment and treatment data will be transferred to a secure network maintained 
by Partners, which can only be accessed by the PI and approved study staff via electronic ID. 
These digital files will be coded with identification codes and will not contain personally identifiable 
information. A single subject file kept on the secure network, under additional password protection 
will be the only location that stores the link between study codes and subject identifying 
information.  Deidentified standardized assessment scores collected on paper will be transferred 
from paper forms to digital forms and entered into RedCap, a HIPAA compliant, web-based 
software application hosted by Partners. Data will also be stored on Lab Archives and Partners 
Dropbox.  
 
Video data will be kept on a secure network maintained by Partners and accessed only by 
approved researchers. Deidentified video clips will be kept for education purposes within MGB. If 
we do utilize videos, participant faces will be blurred/obscured as to remain de-identified. De-
identified data are kept for possible future analyses, which will be submitted for approval. If we 
re-analyze data in the future, we will notify and submit an application for approval from the IRB.  
 
Sending data to outside collaborators: Accuracy and response data from assessments and 
treatment tasks may be sent to research collaborators outside of Partners. We plan to contribute 
de-identified assessment results and spontaneous speech responses to the AphasiaBank by 
TalkBank (https://aphasia.talkbank.org/), which is a shared database of multimedia interactions 
for the study of communication in aphasia. Access to the data in AphasiaBank is password 
protected and restricted to members of the AphasiaBank consortium group. All data will be coded 
with study codes only and will not contain identifiers. 
 
Receiving data from outside collaborators: No data will be received from outside of Partners.   
 
d. Adverse event reporting guidelines: Since the risks associated with participation in this study 
are low, we do not anticipate serious adverse events.  In the case of an adverse event, the event 
will immediately be assessed and the IRB office will be contacted. Participant confidentiality will 
be maintained unless otherwise directed and approved by the IRB.   
 
 
X. 
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