Adaptive Trial Scheduling in Naming Treatment for Aphasia

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653466
Collaborator
University of Massachusetts, Amherst (Other), National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
32
1
6
56
0.6

Study Details

Study Description

Brief Summary

Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life.

This study is one of two that are part of a larger grant. This record is for sub-study 2, which will evaluate the benefits of adaptive trial spacing.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adaptive Spacing Condition
  • Behavioral: High-Item Non-Adaptive Spacing Condition
  • Behavioral: Low-Item Non-Adaptive Spacing Condition
N/A

Detailed Description

Study 2: Evaluate the benefits of adaptive trial scheduling.

Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling condition to two non-adaptive conditions. Conditions will be matched for total treatment hours in a synchronous/asynchronous telehealth format designed to approximate real-world clinical practice. Participants will receive 10 weeks of computer-based training per condition, with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment. Condition order will be randomly assigned and counter-balanced across participants. In total, Study 2 will include two initial assessment sessions, 30 one-on-one treatment sessions, 96 independent practice sessions, and 24 baseline and follow-up probe sessions per participant over a 1-year period. All assessment, treatment, and probe sessions will take place via telehealth.

Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. The treatment phase will consist of two weeks of one-on-one treatment twice per week in which the treating clinician will ensure participants know how to use the treatment web app and complete each step of flashcard practice with complete independence, followed by 8 weeks of combined synchronous/asynchronous telepractice, in which the participant will work with the treating clinician once per week and practice an additional 4 days a week for 30 minutes a day between sessions. To carefully control dosage between treatment conditions, all independent practice sessions will be logged and proctored by a student research assistant. In-person treatment sessions will each last 45 minutes to approximate realistic treatment dosage in outpatient or home health practice settings. Treatment will consist of effortful retrieval practice: on each trial, participants will see a picture of the target and attempt to name it, then press "show answer" to see and hear the target in verbal and written form. They will then rate their naming accuracy by button press. If they are unable to name the word correctly, they will be trained to replay the answer and repeat it 3 times prior to moving on to the next trial, per Conroy et al.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Research assistants responsible for coding data will be masked to treatment condition.
Primary Purpose:
Treatment
Official Title:
Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adaptive spacing, then high-item non-adaptive spacing, then low-item non-adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Experimental: Adaptive spacing, then low-item non-adaptive spacing, then high-item non-adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Experimental: High-item non-adaptive spacing, then adaptive spacing, then low-item non-adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Experimental: High-item non-adaptive spacing, then low-item non-adaptive spacing, then adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Experimental: Low-item non-adaptive spacing, then high-item non-adaptive spacing, then adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Experimental: Low-item non-adaptive spacing, then adaptive spacing, then high-item non-adaptive spacing

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Behavioral: Adaptive Spacing Condition
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.

Behavioral: High-Item Non-Adaptive Spacing Condition
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Behavioral: Low-Item Non-Adaptive Spacing Condition
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.

Outcome Measures

Primary Outcome Measures

  1. Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects [Initial assessment (pre-treatment), 3 months post-treatment]

    Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.

  2. Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects [Initial assessment (pre-treatment), 3 months post-treatment]

    Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a primary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.

Secondary Outcome Measures

  1. Mean score on the Comprehensive Aphasia Test (CAT) [Initial assessment (pre-treatment)]

    The Comprehensive Aphasia Test (CAT) is a comprehensive aphasia test battery that assesses language function in the following modalities: Comprehension of Spoken Language, Comprehension of Written Language, Repetition, Naming, Reading, and Writing. The CAT will be used for initial eligibility criteria at baseline. Raw scores for each subtest are converted to T-scores (M = 50; SD = 10) based upon 266 administrations to a normative sample of 113 person with aphasia. A modality mean T-score derived from the eight modalities in the language battery is used to estimate the overall severity of aphasic language impairment. The CAT will be used to confirm a diagnosis of aphasia and determine initial eligibility criteria: participants with CAT mean modality T scores <40 will be excluded from this trial due to the severity of their deficits, as we have found this to be an appropriate cutoff for very severe aphasia in previous trials.

  2. S-weight and P-weight scores on the Philadelphia Naming Test (PNT) [Initial assessment (pre-treatment)]

    The PNT is a confrontation naming test composed of 175 high, middle, and low frequency nouns ranging from 1-4 syllables in length. Items are presented in a random order on a computer monitor and participants are asked to respond with a single word. Responses are recorded and scored offline using standardized procedures for determining accuracy of the first complete attempt and coding of errors. S-weight and P-weight are calculated based on PNT scoring. S-weight can be interpreted as a measure of semantic ability including conceptual access and control and lexical semantics. P-weight is a measure of phonological ability including both lexical and post-lexical phonological access.

  3. Score on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) [Initial assessment (pre-treatment)]

    The TALSA is a diagnostic test battery that assesses the relationship between language and memory in people with aphasia through 16 subtests in three main areas (phonological processing, semantic processing, short-term memory). Raw scores on subtests are converted to T-scores which are used to estimate the overall severity of impairment.

  4. Mean score on the Cactus and Camels Test (CCT) [Initial assessment (pre-treatment)]

    The Cactus and Camel Test is a sub-test of the Cambridge Semantic Battery that consists of 64 items scored for accuracy of response.

  5. Change in core lexicon analysis on the Aphasia Bank Discourse Protocol [Initial assessment (pre-treatment), multiple timepoints up to 6-months post-treatment.]

    The Aphasia Bank Discourse Protocol is a brief, but thorough set of language tasks which will characterize participants' language at the discourse level. The protocol requires participants to generate discourse samples within the contexts of free speech, a picture description, a story narrative, and procedural discourse. Change in performance in core lexicon analysis on discourse samples from initial assessment to each post-treatment follow up timepoint will serve as a secondary outcome measure.

  6. Score on the Adapted Intrinsic Motivation Inventory for Aphasia [Initial assessment (pre-treatment)]

    The adapted intrinsic motivation Inventory for aphasia is a brief instrument comprised of 7 subscales with a total of 45 items intended to characterize intrinsic motivation in people with aphasia. Each item is scored on a scale of 1-7. Higher total score is associated with higher intrinsic motivation.

  7. Change in mean scores on the Aphasia Communication Outcome Measure Short-Form [Initial assessment (pre-treatment), 1 week post-treatment.]

    The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere stroke.

  • Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.

  • Must have access to a high-speed internet connection and be able to participate in telehealth.

Exclusion Criteria:
  • History of other acquired or progressive neurological disease.

  • Significant language comprehension impairments (per performance on the CAT - individuals will be excluded if their spoken language comprehension mean modality T- score on the CAT falls below 40).

  • Unmanaged drug / alcohol dependence.

  • Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh Pittsburgh Pennsylvania United States 15260

Sponsors and Collaborators

  • University of Pittsburgh
  • University of Massachusetts, Amherst
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: William Evans, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
William Evans, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05653466
Other Study ID Numbers:
  • STUDY21120130 (Study 2)
  • 1R01DC019325-01A1
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022