Clinical trial NCT06266403: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications
Official title: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS.

Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
Primary purpose: BASIC_SCIENCE

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 age-matched speakers.

The question is, What are the effects of communicative interaction on verbal communication in people with ALS?

Participants will read words and sentences while they are in a solo setting and interactive setting.

Detailed description: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS.

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 = 100 PALS in order to account for speech variability that is common for PALS. The investigators plan to recruit 50 age-matched speakers. The investigators anticipate that this sample size will be sufficient to make appropriate comparison to the PALS group because there will be considerably less variability in these speakers.

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.

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).

Age-matched Speakers

* passing the remote hearing screening
* having no known speech, language, or neurological disorders per self-report
* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
* being a functionally native monolingual speaker of American English.

Unfamiliar Interlocutors

* passing the remote hearing screening
* having no known speech, language or neurological disorders per self-report
* being a native monolingual speaker of American English
* having no experience communicating with people with dysarthria
* being between the ages of 18 and 40.

Exclusion Criteria:

* None - if volunteer meets the inclusion criteria, then they will be enrolled

Primary outcomes:
measure: Formant frequencies of speech sounds
timeFrame: two 60 minute sessions
measure: Intelligibility of recorded speech
timeFrame: two 60 minute sessions
measure: Syntactic properties
timeFrame: One 60 minute session
measure: Pragmatic Properties
timeFrame: One 60 minute session
measure: Duration of speech sounds
timeFrame: two 60 minute sessions
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Speech Core, Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Jimin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Navin Viswanathan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Anne Olmstead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.