Conversation Group Treatment for Aphasia: Does it Work?

NCT05113160 | Active Not Recruiting

• 1 other identifier: 4341E
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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. 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. 2.Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia?
3. 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?

Conditions

Aphasia, Acquired

Keywords

aphasia; treatment; functional; communication; conversation group treatment; aphasia group; conversation treatment; communication disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and up to 16 weeks after baseline

Secondary Outcomes (2)

• Change in Scores on Comprehensive Aphasia Test from Pre- to Post- Treatment

  Baseline and up to 12 weeks after baseline

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

  Baseline and up to 16 weeks after baseline

Study Arms (3)

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).

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).

Behavioral: Conversation Treatment for Aphasia

Interventions

Conversation Treatment for Aphasia 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 Size x Aphasia Severity; Experimental: Group composition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Temple University: collaborator
• Adler Aphasia Center: collaborator

Study Sites (3)

Boston University - Charles River Campus

Boston, Massachusetts, 02215, United States

Location

Adler Aphasia Center

Maywood, New Jersey, 07607, United States

Location

Temple University

Philadelphia, Pennsylvania, 01922, United States

Location

MeSH Terms

Conditions

Aphasia; Communication; Communication Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elizabeth Hoover, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Gayle DeDe, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data coders will be blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel groups with delayed treatment control group.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 9, 2021
• Study Start: April 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)