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Purpose

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 their caregivers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time? Participants will read words and sentences while they are interacting with their caregivers.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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). Caregivers - being a caregiver of a participant with ALS - being a native speaker of American English (AE).

Exclusion Criteria

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own. The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice. Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
People with ALS and their caregivers 		People with ALS and their caregivers will participate in structured communicative interaction.
  • Behavioral: Structured Communicative Interaction
    Two interlocutors, one with ALS and their caregiver will work together. 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.
  • Behavioral: Unstructured communicative interaction
    Two interlocutors, one with ALS and their caregiver 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.

Recruiting Locations

Speech Core, Pennsylvania State University
University Park, Pennsylvania 16802
Contact:
Jimin Lee, Ph.D.
814-867-3373
jxl91@psu.edu

More Details

Status
Recruiting
Sponsor
Penn State University

Study Contact

Anne Olmstead, Ph.D.
814-867-3373
ajo150@psu.edu

Detailed Description

PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own. The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice. 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 =76 PALS and their caregivers (total 152) in order to account for speech variability that is common for PALS. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.