Examining Interactions Between PALS and Caregivers

The Pennsylvania State University (PENNSTATE)

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Behavioral: Unstructured communicative interaction; Behavioral: Structured Communicative Interaction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06819124

R01DC021714 (U.S. NIH Grant/Contract)

STUDY00024154-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

People with ALS and their caregivers

Experimental group

Description:

People with ALS and their caregivers will participate in structured communicative interaction.

Treatment:

Behavioral: Structured Communicative Interaction

Behavioral: Unstructured communicative interaction