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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC021714 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers.
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.
PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with ALS and their caregivers | Experimental | People with ALS and their caregivers will participate in structured communicative interaction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Communicative Interaction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Formant frequencies of speech sounds | Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task. | two 60 minute sessions |
| Intelligibility of recorded speech | Perceptual judgments will be provided by solo, naïve listeners who did not participate in the interactions. Listeners will hear recorded speech of PALS and age-matched speakers recorded across the different tasks and indicate what they heard. The score will be expressed in percent. The possible range is between 0-100%. The higher scores mean a better outcome. | two 60 minute sessions |
| Syntactic properties | Syntactic complexity in the unstructured communication task will be measured through mean length of grammatical units, clausal density, and clause type. Each variable will be assessed at both the dyadic level (e.g., clausal density for both interlocutors together) and at the level of the individual speaker (e.g., clausal density of each speaker). A composite of these measures will provide an index of the syntactic complexity of the conversation. | Two 60 minute sessions |
| Pragmatic Properties | The investigators will count the number and duration of silent portions of speech, filled pauses, linguistic mazes, speaking turns, and interruptions in the unstructured communication task. A composite measure of the individual measures will provide an index of an individual's contribution to the conversation. | Two 60 minute sessions |
| Duration of speech sounds | Durations that characterize speech sounds will be made on speech recorded in the intervention task. | two 60 minute sessions |
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Inclusion Criteria:
Speakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)
Caregivers
Exclusion Criteria:
- None - if volunteer meets the inclusion criteria, then they will be enrolled
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Olmstead, Ph.D. | Contact | 814-867-3373 | ajo150@psu.edu | |
| Navin Viswanathan, Ph.D | Contact | 814-867-2340 | nxv175@psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jimin Lee, Ph.D. | Penn State University | Principal Investigator |
| Anne Olmstead, Ph.D. | Penn State University | Principal Investigator |
| Navin Viswanathan, Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Speech Core, Pennsylvania State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 32302251 | Background | 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. |
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The project will involve the collection of audio samples, perceptual judgments, and questionnaire data. All deidentified data will be shared through the Open Science Framework (osf.io). All scripts, protocols, procedures, and analyses will be shared along with the deidentified data to ensure that other researchers can verify and build on the presented results. All shared data will be made available in a format that is accessible by open-access software (e.g., R, Open Office, pdf reader). In addition, platform-specific scripts (e.g., experimental software LabVanced) will be shared with explanations so that they may be implemented across different software environments.
Data will be shared after publication of the study.
All deidentified data, metadata, and related tools will be freely available via Open Science Framework (OSF). The original audio files will be made available (for participants who consent) by request from researchers in the field to ensure responsible use.
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own.
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.
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| Unstructured communicative interaction | Behavioral | 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. |
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| Penn State University |
| Principal Investigator |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |