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NCT Number: NCT06266403

Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Speech Core, Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

Jimin Lee, PhD

CONTACT

[email protected]

814-867-3373

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Communicative Interaction

Behavioral

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", and the listener will click on it. After the listener has made their selection, both participants will receive feedback on trial success.

Clear Speech

Behavioral

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.

Unstructured communicative interaction

Behavioral

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.

Clear Speech Structured Communicative Interaction

Behavioral

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", and the listener will click on it. The speaker will be instructed to overenunciate the critical words. After the listener has made their selection, both participants will receive feedback on trial success.

Primary outcomes

  1. Formant frequencies of speech sounds

    Time frame: two 60 minute sessions

    Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.

  2. Intelligibility of recorded speech

    Time frame: 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.

  3. Syntactic properties

    Time frame: 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.

  4. Pragmatic Properties

    Time frame: 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.

  5. Duration of speech sounds

    Time frame: two 60 minute sessions

    Durations that characterize speech sounds will be made on speech recorded in the intervention task.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Olmstead, Ph.D.

CONTACT

[email protected]

814-867-3373

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 20, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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