Conversation Group Treatment for Aphasia: Does it Work?

NCT ID: NCT05113160

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2026-04-30

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.

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.

Conditions

Aphasia, Acquired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment efficacy: Delayed Control Group

Treatment cycle 1 only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Conversation Treatment for Aphasia

Intervention Type: BEHAVIORAL

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: 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).

Group Type: EXPERIMENTAL

Conversation Treatment for Aphasia

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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:

-- All aphasia profiles and severity levels.

-- Participants with severe aphasia

-- Participants with mild-moderate aphasia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Adler Aphasia Center

UNKNOWN

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Hoover, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Gayle DeDe, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Boston University - Charles River Campus

Boston, Massachusetts, United States

Adler Aphasia Center

Maywood, New Jersey, United States

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

4341E

Identifier Type: -

Identifier Source: org_study_id