Balancing Effortful and Errorless Learning in Naming Treatment for Aphasia
NCT ID: NCT05653440
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2023-11-27
2028-01-31
Brief Summary
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This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines.
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Detailed Description
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* Study design: The investigators will enroll 30 people with aphasia in a randomized within-subjects crossover design comparing trained words in three retrieval conditions. Stimuli will be balanced across conditions using an established item-response theory algorithm developed by Dr. Hula (consultant). Participants will receive 8 sessions of treatment per condition (2x/ week for 4 weeks), with probes administered at baseline and 1 week, 3 months, and 6 months post-treatment. Condition treatment order will be randomly assigned and counter- balanced across participants. In total, Sub-study 1 includes typically 3-4 (but up to 6) assessment sessions, 24 treatment sessions, and 24 baseline and follow-up probe assessment sessions per participant over an approximately 10-month period, but up to 18 months. Data collection will take place at the Language Rehabilitation and Cognition Laboratory (LRCL) at the University of Pittsburgh, in participants' homes, or in private rooms in public spaces (e.g. libraries, community centers).
* Participants: The investigators will recruit 30 male and female community-dwelling people with aphasia \>6 months post- onset of aphasia due to left-hemisphere stroke. Aphasia diagnosis will be confirmed by Comprehensive Aphasia Test (CAT) performance and medical history. Investigators will exclude potential participants with a history of other acquired or progressive neurological disease, significant language comprehension impairments, unmanaged drug/alcohol dependence, and severe diagnosed mood or behavioral disorders that require specialized mental health interventions.
* Assessment Procedures: Participants will be tested on a comprehensive initial battery of standardized assessments characterizing their aphasia severity and overall language profile, naming and discourse abilities, semantic processing, verbal short-term and working memory at baseline. Patient-reported measures of treatment motivation and pre-post changes in communication effectiveness will also be measured in response to each treatment condition. These tests will ensure that our participants well-characterized from a behavioral perspective, and measures will be used in secondary analyses and model development exploring predictors of treatment response.
* Treatment description: Each training trial will consist of a fixation cross and picture presentation. A repetition cue (audio recording and written from of the target) will be provided to participants based on the deadlines described above. Participants will be instructed to name the picture and indicate when they have given their final answer via key press, with responses also timed and scored by clinician key press. In the errorless condition, they will be instructed to repeat the target, while in the other conditions they will be asked to try to name the picture independently before they hear the target. Once they have indicated that they have provided their final answer, they will receive accuracy feedback on the computer screen based on clinician scoring. To maximize the clinical relevance of this study, investigators will control total amount of treatment time (8 hours) between conditions, instead of controlling the total number of trials. This is because many more trials can be completed per hour in the errorless or balanced conditions compared to the effort-maximized condition, and investigators want study outcomes to practically inform clinicians on how best to spend limited treatment time.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Effort-maximized, then effort-accuracy balanced, then accuracy-maximized
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Accuracy-maximized, then effort-maximized, then effort-accuracy balanced
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Accuracy-maximized, then effort-accuracy balanced, then effort-maximized
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Effort-accuracy balanced, then effort-maximized, then accuracy maximized
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Effort-accuracy balanced, then accuracy-maximized, then effort-maximized
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Effort-maximized, then accuracy-maximized, then effort-accuracy balanced
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Interventions
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Accuracy-maximized condition
Naming treatment condition in which the target will be immediately provided for repetition at picture onset.
Effort-maximized condition
Naming treatment condition in which participants will have up to 10 seconds to respond before the target is provided for repetition.
Effort-accuracy balanced condition
Naming treatment condition in which naming deadlines will be determined based on the balanced effort-to-accuracy benefit ratio formalized above, calculated on clinician-provided accuracy and response time ratings. Deadlines will be recalculated session-by-session to adjust to participant-specific treatment gains over time.
Eligibility Criteria
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Inclusion Criteria
* Impaired performance on 2/8 sections of the Comprehensive Aphasia Test.
Exclusion Criteria
* Significant language comprehension impairments
* Unmanaged drug / alcohol dependence.
* Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.
18 Years
ALL
No
Sponsors
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University of Massachusetts, Amherst
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University of Pittsburgh
OTHER
Responsible Party
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William Evans
Assistant Professor
Principal Investigators
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William Evans, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY21120130 (Study 1)
Identifier Type: -
Identifier Source: org_study_id
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