Conversation Group Treatment for Aphasia: Does it Work?

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05113160
Collaborator
Temple University (Other), Adler Aphasia Center (Other)
168
Enrollment
3
Locations
3
Arms
51.9
Anticipated Duration (Months)
56
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed research will test the efficacy of group conversation treatment for people with aphasia and explore whether the effects of treatment differ as a result of the following factors:

  1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with aphasia demonstrate different levels of improvement with this treatment?

  2. Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia?

  3. Aphasia severity: Do effects of conversation group treatment differ if the individuals within the group have mild-moderate or moderate-severe profiles of aphasia?

Treatment sessions will occur in groups of 6-8 people with aphasia or with 2 people with aphasia. During treatment sessions, discourse will be facilitated on a focused set of every day topics, such as current events or travel. Linguistic and multi modal cueing hierarchies will be tailored to individual client goals and used to maximize communication success.

The prediction is that conversation treatment is an effective method for improving communication in people with aphasia, but that specific benefits may differ based on variables such as group size, group composition, and aphasia severity. The results will help inform best practices for aphasia treatment and refine a hypothesized model about the mechanisms underlying conversation treatment.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Conversation Treatment for Aphasia
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel groups with delayed treatment control group.Parallel groups with delayed treatment control group.
Masking:
Single (Outcomes Assessor)
Masking Description:
Data coders will be blinded to study condition.
Primary Purpose:
Treatment
Official Title:
Understanding the Mechanisms of Change and Optimal Parameters in Conversation Treatment for Aphasia
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

ArmIntervention/Treatment
No Intervention: Treatment efficacy: Delayed Control Group

Treatment cycle 1 only.

Experimental: Experimental: Group Size x Aphasia Severity

Outcomes will be measured for individuals who participate in large group (6-8 group members) compared to dyads (2 group members), and whether this relationship differs as a function of aphasia severity (severe vs. mild-moderate aphasia).

Behavioral: Conversation Treatment for Aphasia
Conversation treatment is a theoretically motivated approach in which a speech language pathologist facilitates discourse about topics of interest to the client using individualized, multi-modal supports. Treatment occurs either in groups of 6-8 people with aphasia or 2 people with aphasia. Individual communication goals are targeted for each group member within the context of naturalistic conversations.

Experimental: Experimental: Group composition

Outcomes will be measured for individuals who participate in homogeneous compared to heterogeneous groups (6-8 people with aphasia), based on aphasia severity (severe vs. mild-moderate aphasia).

Behavioral: Conversation Treatment for Aphasia
Conversation treatment is a theoretically motivated approach in which a speech language pathologist facilitates discourse about topics of interest to the client using individualized, multi-modal supports. Treatment occurs either in groups of 6-8 people with aphasia or 2 people with aphasia. Individual communication goals are targeted for each group member within the context of naturalistic conversations.

Outcome Measures

Primary Outcome Measures

  1. Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment [Baseline and up to 12 weeks after baseline]

    The Aphasia Communication Outcome Measure (ACOM; Hula et al, 2015) is a patient reported outcome measure that reflects the clinical endpoint of conversation treatment. The ACOM is a psychometrically validated measure of the impact of aphasia on communication in daily life. The ACOM asks questions such as how effectively the person with aphasia talks to family members or clerks in a store. Standardized scores (T-scores) are computed, with higher values indicating better self-reported communication ability.

  2. Change in Scores on Aphasia Communication Outcome Measure from Pre-Treatment to One month Post-Treatment [Baseline and up to 16 weeks after baseline]

    The Aphasia Communication Outcome Measure (ACOM; Hula et al, 2015) is a patient reported outcome measure that reflects the clinical endpoint of conversation treatment. The ACOM is a psychometrically validated measure of the impact of aphasia on communication in daily life. The ACOM asks questions such as how effectively the person with aphasia talks to family members or clerks in a store. Standardized scores (T-scores) are computed, with higher values reflecting better self-reported communication ability.

Secondary Outcome Measures

  1. Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment [Baseline and up to 12 weeks after baseline]

    The Comprehensive Aphasia Test (CAT; Swinburn, Howard, & Porter, 2004) is a standardized test battery that targets expressive and receptive language in the oral and written modalities. Six sections of the language battery will be administered: comprehension of spoken language, comprehension of written language, repetition, naming, oral reading, and spoken picture description. Standardized scores (T-scores) are computed, with higher values reflecting better outcomes.

  2. Change in Scores on Comprehensive Aphasia Test from Pre-Treatment to One month Post-Treatment [Baseline and up to 16 weeks after baseline]

    The Comprehensive Aphasia Test (CAT; Swinburn, Howard, & Porter, 2004) is a standardized test battery that targets expressive and receptive language in the oral and written modalities. Six sections of the language battery will be administered: comprehension of spoken language, comprehension of written language, repetition, naming, oral reading, and spoken picture description. Standardized scores (T-scores) are computed, with higher values reflecting better outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Criteria for All Treatment Cycles:
Inclusion Criteria:
  • Clinical diagnosis of aphasia

  • At least 6 months post-onset of stroke in the language-dominant hemisphere.

  • Native English speakers

  • Demonstrate sufficient auditory comprehension skills to participate in a supported conversation, based on results of standardized aphasia tests

Exclusion

  • No history of neurological disease (other than stroke)

  • No history of developmental speech, language, or learning disabilities

  • No current serious medical illness (e.g., cancer)

  • Participants will be asked to abstain from concurrent speech language treatment.

Separate criteria for Treatment Cycles 1, 2, and 3 based on aphasia severity:
Cycle 1 Severity-based Inclusion Criteria (Planned 2022):

-- All aphasia profiles and severity levels.

Cycle 2 Severity-based Inclusion Criteria (Planned 2023):

-- Participants with severe aphasia

Cycle 3 Severity-based Inclusion Criteria (Planned 2024):

-- Participants with mild-moderate aphasia.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Boston University - Charles River CampusBostonMassachusettsUnited States02215
2Adler Aphasia CenterMaywoodNew JerseyUnited States07607
3Temple UniversityPhiladelphiaPennsylvaniaUnited States01922

Sponsors and Collaborators

  • Boston University Charles River Campus
  • Temple University
  • Adler Aphasia Center

Investigators

  • Principal Investigator: Elizabeth Hoover, PhD, Boston University
  • Principal Investigator: Gayle DeDe, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT05113160
Other Study ID Numbers:
  • 4341E
First Posted:
Nov 9, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston University Charles River Campus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021