Examining Interactions Between PALS and Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured Communicative Interaction, Unstructured communicative interaction.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining Interactions Between Persons With ALS and Caregivers
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Formant frequencies of speech sounds [Time frame: two 60 minute sessions]
- Intelligibility of recorded speech [Time frame: two 60 minute sessions]
- Syntactic properties [Time frame: Two 60 minute sessions]
- Pragmatic Properties [Time frame: Two 60 minute sessions]
- Duration of speech sounds [Time frame: two 60 minute sessions]
Eligibility criteria
Inclusion criteria
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).
Exclusion criteria
\- None - if volunteer meets the inclusion criteria, then they will be enrolled
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Speech Core, Pennsylvania State University — University Park
Publications
- 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. PMID 32302251
Identifiers
NCT: NCT06819124 · STUDY00024154-1 · R01DC021714