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Conversation Group Treatment for Aphasia: Does it Work?

Primary Purpose

Aphasia, Acquired

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversation Treatment for Aphasia
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired focused on measuring aphasia, treatment, functional, communication, conversation group treatment, aphasia group, conversation treatment, communication disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston University - Charles River CampusRecruiting
  • Adler Aphasia CenterRecruiting
  • Temple UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Treatment efficacy: Delayed Control Group

Experimental: Group Size x Aphasia Severity

Experimental: Group composition

Arm Description

Treatment cycle 1 only.

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).

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).

Outcomes

Primary Outcome Measures

Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment
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.
Change in Scores on Aphasia Communication Outcome Measure from Pre-Treatment to One month Post-Treatment
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

Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment
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.
Change in Scores on Comprehensive Aphasia Test from Pre-Treatment to One month Post-Treatment
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.

Full Information

First Posted
September 29, 2021
Last Updated
February 13, 2023
Sponsor
Boston University Charles River Campus
Collaborators
Temple University, Adler Aphasia Center
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1. Study Identification

Unique Protocol Identification Number
NCT05113160
Brief Title
Conversation Group Treatment for Aphasia: Does it Work?
Official Title
Understanding the Mechanisms of Change and Optimal Parameters in Conversation Treatment for Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
Temple University, Adler Aphasia Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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? Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia? 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.
Detailed Description
Aphasia is a language disorder that affects approximately two million Americans. The communication barriers associated with aphasia limit the ability to return to work and hobbies, worsen social relationships, and lead to social isolation. Social isolation is correlated with many negative health outcomes, including mortality. As a result, the consequences of aphasia can be wide reaching and severe. Group treatment has the potential to improve communication and reduce social isolation, while also reducing medical costs. However, this treatment format lacks a strong evidence base. This research uses a hypothesis-driven approach to test the efficacy of conversation treatment and develop and refine a mechanistic pathway of how conversation treatment leads to behavioral changes in communication ability. We will systematically explore whether the effects of treatment differ as a result of number of participants (large group or dyad), group composition (heterogenous versus homogenous profiles of aphasia), and severity of aphasia. The study will enroll a total of 168 participants with aphasia across three sites. In cycle one, 72 participants will be randomly assigned to one of three conditions: dyad treatment, traditional group treatment or delayed control group. In cycles two and three, 48 participants with severe aphasia and 48 participants with mild-moderate aphasia will be randomly assigned to either large group or dyad conditions. In all cycles, treatment will occur for 60 minutes, twice per week for 10 weeks. During treatment sessions, a speech pathologist will facilitate discourse on a focused set of salient topics, such as current events, using individualized, linguistic and multimodal cueing hierarchies. The primary outcome measure is a functional measure of communication (Aphasia Communication Outcome Measure, ACOM; Hula et al., 2015). Secondary outcome measures will include standardized tests and patient reported outcome measures, and examine linguistic and functional communication abilities. All participants will be assessed pre-, post-, 4 weeks post- and 12 weeks post-treatment. The proposed research will address the following specific aims. Specific Aim 1 is to examine efficacy of conversation treatment delivered in dyads and large groups compared to a delayed-treatment control group. Specific Aim 2 is to determine optimal parameters for conversation treatment by testing whether the treatment effects differ as a function of aphasia severity (2A) or group composition (2B). Specific Aim 3 will test a hypothesized model of the pathway by which conversation treatment effects behavioral change. The results will provide further efficacy for conversation treatment and inform about the optimal parameters and outcomes of this intervention. This work takes a vital first step towards elucidating the mechanisms of change in conversation group treatment, with a long-term goal of ensuring access to cost-effective care for people with aphasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired
Keywords
aphasia, treatment, functional, communication, conversation group treatment, aphasia group, conversation treatment, communication disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups with delayed treatment control group.
Masking
Outcomes Assessor
Masking Description
Data coders will be blinded to study condition.
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment efficacy: Delayed Control Group
Arm Type
No Intervention
Arm Description
Treatment cycle 1 only.
Arm Title
Experimental: Group Size x Aphasia Severity
Arm Type
Experimental
Arm Description
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).
Arm Title
Experimental: Group composition
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Conversation Treatment for Aphasia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment
Description
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.
Time Frame
Baseline and up to 12 weeks after baseline
Title
Change in Scores on Aphasia Communication Outcome Measure from Pre-Treatment to One month Post-Treatment
Description
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.
Time Frame
Baseline and up to 16 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment
Description
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.
Time Frame
Baseline and up to 12 weeks after baseline
Title
Change in Scores on Comprehensive Aphasia Test from Pre-Treatment to One month Post-Treatment
Description
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.
Time Frame
Baseline and up to 16 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Hoover, PhD
Phone
(617) 353-8967
Email
ehoover@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gayle DeDe, PhD
Phone
(215) 204-2453
Email
gayle.dede@temple.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoover, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gayle DeDe, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University - Charles River Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoover, PhD
Phone
617-353-8967
Email
ehoover@bu.edu
Facility Name
Adler Aphasia Center
City
Maywood
State/Province
New Jersey
ZIP/Postal Code
07607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Szabo, MA
Phone
201-785-7089
Email
gszabo@adleraphasiacenter.org
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
01922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayle DeDe, PhD
Phone
215-204-2453
Email
gayle.dede@temple.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Conversation Group Treatment for Aphasia: Does it Work?

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