Adaptive Trial Scheduling in Naming Treatment for Aphasia

Official title

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)

Overview

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.

Interventions

• 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-increa
• 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.

Primary outcome measures

• Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]
• Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]

Secondary outcome measures (3)

• Change in core lexicon analysis on the Aphasia Bank Discourse Protocol [Time frame: Initial assessment (pre-treatment), 3 months post-treatment]
• Change in mean scores on the Aphasia Communication Outcome Measure Short-Form [Time frame: Initial assessment (pre-treatment), 1 week post-treatment.]
• Score on the Adapted Intrinsic Motivation Inventory for Aphasia [Time frame: 1 week post-treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, Scho — Pittsburgh

Identifiers

NCT: NCT05653466 · STUDY21120130 (Study 2) · 1R01DC019325-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗