Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Behavioral: Structured Communicative Interaction; Behavioral: Clear Speech; Behavioral: Unstructured communicative interaction; Behavioral: Clear Speech Structured Communicative Interaction

• Registration Number: NCT06266403
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-20
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People with amyotrophic lateral sclerosis, age-matched speakers	Structured Communicative Interaction	People with ALS and age-matched speakers will participate in structured communicative interaction.
People with amyotrophic lateral sclerosis, age-matched speakers	Clear Speech	People with ALS and age-matched speakers will participate in structured communicative interaction.
People with amyotrophic lateral sclerosis, age-matched speakers	Unstructured communicative interaction	People with ALS and age-matched speakers will participate in structured communicative interaction.
People with amyotrophic lateral sclerosis, age-matched speakers	Clear Speech Structured Communicative Interaction	People with ALS and age-matched speakers will participate in structured communicative interaction.

Primary Outcome Measures

Name	Time	Method
Formant frequencies of speech sounds	two 60 minute sessions	Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.
Syntactic properties	One 60 minute session	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.
Pragmatic Properties	One 60 minute session	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.
Duration of speech sounds	two 60 minute sessions	Durations that characterize speech sounds will be made on speech recorded in the intervention task.
Intelligibility of recorded speech	two 60 minute sessions	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.

Trial Locations

Locations (1)

Speech Core, Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States