Examining Interactions Between PALS and Caregivers
2 other identifiers
interventional
152
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2025
CompletedFirst Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
February 11, 2025
February 1, 2025
4.1 years
February 4, 2025
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
People with ALS and their caregivers
EXPERIMENTALPeople with ALS and their caregivers will participate in structured communicative interaction.
Interventions
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.
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
You may qualify if:
- Speakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Speech Core, Pennsylvania State University
University Park, Pennsylvania, 16802, United States
Related Publications (2)
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.
BACKGROUNDOlmstead 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.
PMID: 32302251BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jimin Lee, Ph.D.
Penn State University
- PRINCIPAL INVESTIGATOR
Anne Olmstead, Ph.D.
Penn State University
- PRINCIPAL INVESTIGATOR
Navin Viswanathan, Ph.D.
Penn State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 11, 2025
Study Start
January 22, 2025
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2029
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after publication of the study.
- Access Criteria
- 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.
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.