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Recruiting NCT06266403

Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

No phase Interventional Amyotrophic Lateral Sclerosis

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, Clear Speech, Unstructured communicative interaction, Clear Speech Structured Communicative Interaction.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis. 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 →

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 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.

Interventions

  • Behavioral Structured Communicative Interaction
    Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, will work together. On each trial, one of the interlocutors will be randomly chosen to be the "speaker" and the other will be the "listener". 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", an
  • Behavioral Clear Speech
    PALS and age-matched speakers will read critical words consisting of target segments (e.g., "hid", "ship", "net") in random order four times. These words will be embedded in the carrier phrase "Click on the \_\_\_ this time." Participations will be instructed to overenunciate the critical words.
  • Behavioral Unstructured communicative interaction
    Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, 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.
  • Behavioral Clear Speech Structured Communicative Interaction
    Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, will work together. On each trial, one of the interlocutors will be randomly chosen to be the "speaker" and the other will be the "listener". 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", an

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: One 60 minute session]
  • Pragmatic Properties [Time frame: One 60 minute session]
  • 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).

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

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 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
  • 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.

Identifiers

NCT: NCT06266403 · STUDY00024154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗