Adaptive Trial Scheduling in Naming Treatment for Aphasia
Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)
2 other identifiers
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedStudy Start
First participant enrolled
December 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
December 11, 2025
December 1, 2025
3.2 years
December 7, 2022
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
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.
Initial assessment (pre-treatment), 3 months post-treatment
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
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.
Initial assessment (pre-treatment), 3 months post-treatment
Secondary Outcomes (3)
Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
Initial assessment (pre-treatment), 3 months post-treatment
Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
Initial assessment (pre-treatment), 1 week post-treatment.
Score on the Adapted Intrinsic Motivation Inventory for Aphasia
1 week post-treatment
Study Arms (6)
Adaptive spacing, then high-item non-adaptive spacing, then low-item non-adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Adaptive spacing, then low-item non-adaptive spacing, then high-item non-adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
High-item non-adaptive spacing, then adaptive spacing, then low-item non-adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
High-item non-adaptive spacing, then low-item non-adaptive spacing, then adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Low-item non-adaptive spacing, then high-item non-adaptive spacing, then adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Low-item non-adaptive spacing, then adaptive spacing, then high-item non-adaptive spacing
EXPERIMENTALAll participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of other acquired or progressive neurological disease.
- Significant language comprehension impairments
- Unmanaged drug / alcohol dependence.
- Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Evans, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research assistants responsible for coding data will be masked to treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 16, 2022
Study Start
December 6, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be shared at the time of study publication without planned end to access.
- Access Criteria
- Anyone who wishes to access the data.
The data sharing plan for this study includes the publication of discourse measures and other study data on Aphasia Bank (R01-DC008524), a large online repository of aphasia behavioral data that supports a great deal of productive aphasia corpora research. De-identified test scores, treatment, and probe data, and audio and/or video recordings of norming, probe, assessment, and treatment data will be shared to this repository for all study participants. Investigators will also make our experimental task files, protocols, and de-identified study data available through Open Science Framework (https://osf.io/) to encourage the replication, collaboration, and expansion of our work by other research groups. Last, investigators plan to publish a modeling and statistical package in open-access software, R, which will include functionality for calculating speed-accuracy tradeoff optimality using our multinomial ex-Gaussian response time model approach.