Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

NCT ID: NCT06266403

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2029-02-28

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

People with amyotrophic lateral sclerosis, age-matched speakers

People with ALS and age-matched speakers will participate in structured communicative interaction.

Group Type: EXPERIMENTAL

Structured Communicative Interaction

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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", 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Ji Min Lee, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jimin Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Navin Viswanathan, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Anne Olmstead, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

Speech Core, Pennsylvania State University

University Park, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne Olmstead, Ph.D.

Role: CONTACT

ajo150@psu.edu

814-867-3373

Facility Contacts

Jimin Lee, PhD

Role: primary

jxl91@psu.edu

814-867-3373

References

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.

Reference Type: BACKGROUND

PMID: 32302251 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

STUDY00024154

Identifier Type: -

Identifier Source: org_study_id