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Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

NCT06266403 · Penn State University
In plain English

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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.
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
Study design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-05
Estimated completion: 2029-02-28
Last updated: 2025-01-13
Interventions
Behavioral: Structured Communicative InteractionBehavioral: Clear SpeechBehavioral: Unstructured communicative interactionBehavioral: Clear Speech Structured Communicative Interaction
Primary outcomes
  • Formant frequencies of speech sounds (two 60 minute sessions)
  • Intelligibility of recorded speech (two 60 minute sessions)
  • Syntactic properties (One 60 minute session)
Sponsor
Penn State University · other
Contacts & investigators
ContactAnne Olmstead, Ph.D. · contact · ajo150@psu.edu · 814-867-3373
InvestigatorJimin Lee, PhD · principal_investigator, The Pennsylvania State University
InvestigatorNavin Viswanathan, PhD · principal_investigator, The Pennsylvania State University
InvestigatorAnne Olmstead, PhD · principal_investigator, The Pennsylvania State University
All locations (1)
Speech Core, Pennsylvania State UniversityRecruiting
University Park, Pennsylvania, United States
Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications · TrialPath