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
NA
152 participants
INTERVENTIONAL
2025-01-22
2029-02-28
Brief Summary
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The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time?
Participants will read words and sentences while they are interacting with their caregivers.
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Detailed Description
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The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice.
Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
Delivery of Intervention: Using tablets and audio recording devices provided to them, participants will complete this task in the comfort of their home. Study protocols will be explained via videoconferencing by experimenters. Produced speech will be recorded using solid-state audio recorders as well as remotely through the video conferencing software.
Adequacy of Sample size. Assuming medium effect sizes (Cohen's f = 0.3) based on our pilot data, for 80% power at an alpha of .05, the investigators will require 76 speakers. The investigators propose n =76 PALS and their caregivers (total 152) in order to account for speech variability that is common for PALS.
Adequacy of Analyses. The proposed statistical analyses (Generalized mixed effects regressions) are standard and will be used to analyze the effect of the intervention on the outcome measures described below. Severity of condition (for PALS) will be included in the analyses and by-subject slopes and intercepts will be used to account for variability across participants.
Conditions
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Study Design
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NA
SINGLE_GROUP
The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice.
Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
BASIC_SCIENCE
NONE
Study Groups
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People with ALS and their caregivers
People with ALS and their caregivers will participate in structured communicative interaction.
Structured Communicative Interaction
Two interlocutors, one with ALS and their caregiver will work together. Each participant in the pair will view the same set of words on their screens. After one second, one of the words will be highlighted on the speaker's screen, they will say the word in the phrase "Click on the \_\_\_\_ this time", and the listener will click on it. After the listener has made their selection, both participants will receive feedback on trial success.
Unstructured communicative interaction
Two interlocutors, one with ALS and their caregiver will work together. The pairs will be presented with two different versions of the same picture with eight differences chosen to elicit the same target segments (e.g., "hid", "ship", "net"). These pictures will be modified from the LUCID corpus. In total, pairs will complete four picture sets per session. Pairs will be given 5 minutes for each picture set.
Interventions
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Structured Communicative Interaction
Two interlocutors, one with ALS and their caregiver will work together. Each participant in the pair will view the same set of words on their screens. After one second, one of the words will be highlighted on the speaker's screen, they will say the word in the phrase "Click on the \_\_\_\_ this time", and the listener will click on it. After the listener has made their selection, both participants will receive feedback on trial success.
Unstructured communicative interaction
Two interlocutors, one with ALS and their caregiver will work together. The pairs will be presented with two different versions of the same picture with eight differences chosen to elicit the same target segments (e.g., "hid", "ship", "net"). These pictures will be modified from the LUCID corpus. In total, pairs will complete four picture sets per session. Pairs will be given 5 minutes for each picture set.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of ALS following the revised EL Escorial criteria
* no history of other neurological conditions (e.g., stroke)
* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
* detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)
* the ability to produce single words
* being a native speaker of American English (AE).
Caregivers
* being a caregiver of a participant with ALS
* being a native speaker of American English (AE).
18 Years
90 Years
ALL
Yes
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Penn State University
OTHER
Responsible Party
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Ji Min Lee, Ph.D.
Associate Professor
Principal Investigators
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Jimin Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Anne Olmstead, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Navin Viswanathan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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Speech Core, Pennsylvania State University
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Olmstead, A. J., Viswanathan, N., Cowan, T., & Yang, K. (2021). Phonetic adaptation in interlocutors with mismatched language backgrounds: A case for a phonetic synergy account. Journal of Phonetics, 87, 101054.
Olmstead AJ, Lee J, Viswanathan N. The Role of the Speaker, the Listener, and Their Joint Contributions During Communicative Interactions: A Tripartite View of Intelligibility in Individuals With Dysarthria. J Speech Lang Hear Res. 2020 Apr 27;63(4):1106-1114. doi: 10.1044/2020_JSLHR-19-00233. Epub 2020 Apr 17.
Other Identifiers
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STUDY00024154-1
Identifier Type: -
Identifier Source: org_study_id
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