Aphasia, AcquiredNCT05113160
Conversation Group Treatment for Aphasia: Does it Work?
A study testing Conversation Treatment for Aphasia in people with Aphasia, Acquired, run by Boston University Charles River Campus at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- Conversation Treatment for Aphasia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 11Show fewer
- -- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston University - Charles River Campus
Boston, Massachusetts, 02215
Adler Aphasia Center
Maywood, New Jersey, 07607
Temple University
Philadelphia, Pennsylvania, 01922
About this study
Official title: Understanding the Mechanisms of Change and Optimal Parameters in Conversation Treatment for Aphasia
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?
Read more
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.
Read the 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
- Being tested
- Conversation Treatment for Aphasia
- Keywords
- aphasia, treatment, functional, communication, conversation group treatment, aphasia group, conversation treatment, communication disorder
- Medical subject headings
- Aphasia, Communication, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversation Treatment for AphasiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment efficacy: Delayed Control Group | No intervention | Treatment cycle 1 only. |
| Experimental: Group Size x Aphasia Severity | Experimental | 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). Receives: Behavioral: Conversation Treatment for Aphasia |
| Experimental: Group composition | Experimental | 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). Receives: Behavioral: Conversation Treatment for Aphasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 12 weeks after baseline
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.
Measured: Baseline and up to 16 weeks after baseline
Secondary outcomes (2)
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.
Measured: Baseline and up to 12 weeks after baseline
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.
Measured: Baseline and up to 16 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups with delayed treatment control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Adler Aphasia Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth Hoover, PhD, Principal investigator, Boston UniversityGayle DeDe, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113160
- Sponsor's protocol ID
- 4341E
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanisms of Change and Optimal Parameters in Conversation Treatment for Aphasia
- ClinicalTrials.gov ID
- NCT05113160
- Acronym / sponsor ID
- 4341E
- Conditions
- Aphasia, Acquired
- Keywords
- aphasia, treatment, functional, communication, conversation group treatment, aphasia group, conversation treatment, communication disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Temple University, Adler Aphasia Center
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel groups with delayed treatment control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment efficacy: Delayed Control Group | No intervention | –Treatment cycle 1 only. |
| Experimental: Group Size x Aphasia Severity | Experimental | Behavioral: Conversation Treatment for AphasiaOutcomes 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). |
| Experimental: Group composition | Experimental | Behavioral: Conversation Treatment for AphasiaOutcomes 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
- -- All aphasia profiles and severity levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversation Treatment for AphasiaConversation 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. | Behavioural | Experimental: Group Size x Aphasia Severity, Experimental: Group composition |
Primary outcome
Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment
Time frame: 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.
Change in Scores on Aphasia Communication Outcome Measure from Pre-Treatment to One month Post-Treatment
Time frame: 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.
2 secondary outcomes
Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment
Time frame: Baseline and up to 12 weeks after baseline
Change in Scores on Comprehensive Aphasia Test from Pre-Treatment to One month Post-Treatment
Time frame: Baseline and up to 16 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Hoover, PhD principal investigator
Boston University
Gayle DeDe, PhD principal investigator
Temple University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversation Treatment for Aphasia in people with Aphasia, Acquired, run by Boston University Charles River Campus at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores on Aphasia Communication Outcome Measure from Pre- to Post- Treatment (time frame: Baseline and up to 12 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.