Adaptive Trial Scheduling in Naming Treatment for Aphasia

NCT ID: NCT05653466

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-06
• Study Completion Date: 2028-01-31

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.

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. For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. 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 typically 3-4 (but up to 6) assessment sessions, 120 one-on-one treatment sessions, and 24 baseline and follow-up probe sessions per participant over an ~1-year period, or up to 18 months. 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 for each of the three conditions will consist of ten weeks of one-on-one treatment four times per week in which the treating clinician will work alongside participants to complete flashcard practice four days a week. The treatment sessions will each last 30 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 rate their naming accuracy by button press. The experimenter will code their response time and perceived accuracy. Finally, the experimenter will code their accuracy which will reveal the target in verbal and written form. If they are unable to name the word correctly, they will be able to replay the answer and repeat it three times prior to moving on to the next trial, per Conroy et al.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

High-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Low-Item Non-Adaptive Spacing Condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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
• Unmanaged drug / alcohol dependence.
• Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

University of Massachusetts, Amherst

OTHER

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Responsible Party

William Evans

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alyssa Kelly, M.A., CCC-SLP

Role: CONTACT

ank155@pitt.edu

412-648-3274

Facility Contacts

William Evans, PhD

Role: primary

will.evans@pitt.edu

412-383-6943

Other Identifiers

1R01DC019325-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21120130 (Study 2)

Identifier Type: -

Identifier Source: org_study_id