Clinical trial NCT05113160: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Keywords: aphasia
treatment
functional
communication
conversation group treatment
aphasia group
conversation treatment
communication disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Temple University
name: Adler Aphasia Center
First posted: 2021-11-09
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups with delayed treatment control group.
Primary purpose: TREATMENT

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.

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 (Completed 2022):

-- All aphasia profiles and severity levels.

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

-- Participants with severe aphasia

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

-- Participants with mild-moderate aphasia.

Primary outcomes:
measure: Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment
timeFrame: Baseline and up to 12 weeks after baseline
measure: Change in Scores on Aphasia Communication Outcome Measure from Pre-Treatment to One month Post-Treatment
timeFrame: Baseline and up to 16 weeks after baseline
Secondary outcomes:
measure: Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment
timeFrame: Baseline and up to 12 weeks after baseline
measure: Change in Scores on Comprehensive Aphasia Test from Pre-Treatment to One month Post-Treatment
timeFrame: Baseline and up to 16 weeks after baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University - Charles River Campus
state: Massachusetts
city: Maywood
country: United States
facility: Adler Aphasia Center
state: New Jersey
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Boston University
name: Elizabeth Hoover, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Gayle DeDe, PhD
role: PRINCIPAL_INVESTIGATOR
References: