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Impact of Group Participation on Adults With Aphasia

Primary Purpose

Aphasia, Acquired, Stroke, Rehabilitation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Language intervention with group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older
  • Pre-morbid proficient speaker of English
  • Diagnosis of adult-onset aphasia
  • Vision and hearing sufficient to complete assessments

Exclusion Criteria:

  • No history of childhood speech or language difficulties
  • No history of major psychiatric illness, cognitive impairment, or neurological disorders such as seizures

Sites / Locations

  • UAM CHP Speech-Language and Hearing Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reading Group

Arm Description

All participants in this group will receive language intervention within weekly group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia.

Outcomes

Primary Outcome Measures

Reading Comprehension Battery for Aphasia-2 (RCBA-2; LaPointe & Horner, 1998) Scores
To determine if group participation improves intervention-specific language skills in reading comprehension by comparing baseline score to 1-week post-intervention score

Secondary Outcome Measures

Communication Confidence Rating Scale for Aphasia (CCRSA; Babbitt & Cherney, 2010)
To determine participant's feelings related to their communication. Participants rate their confidence on a scale from 0 to 100 for different communication-related activities. Baseline score will be compared to 1-week post-intervention score
Discourse Production Task
Discourse analysis of participants producing monologic narratives (e.g., story retell, procedural explanation, picture sequence description, etc.). Baseline score will be compared to 1-week post-intervention score
Patient Reported Outcomes Measurement Information System (PROMIS)
Selected PROMIS instruments (from cognitive, emotional, and social domains) will be used to measure satisfaction with and quality of life. Baseline score will be compared to 1-week post-intervention score.
Gray Oral Reading Test (GORT; Wiederholt & Bryant, 2012)
To determine changes in oral reading and reading comprehension, baseline score will be compared to 1-week post-intervention score
Writing of Untrained Control Words (non-standardized).
Writing untrained words that will be matched for frequency, length, and complexity with the CART trained words to measure generalization. Baseline score will be compared to 1-week post-intervention score

Full Information

First Posted
August 19, 2022
Last Updated
August 14, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT05520528
Brief Title
Impact of Group Participation on Adults With Aphasia
Official Title
Impact of Group Participation on Adults With Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

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 purpose of the study is to examine the impact of group participation on adults with aphasia. Participants will complete a standard pre-and post-assessment of language abilities (speech, comprehension, reading, and/or writing). Then participants will attend 90-minute weekly reading group sessions during an academic semester.
Detailed Description
The objective of this research is to determine if attendance in groups positively impacts language skills, activity/participation, and/or quality of life in persons with aphasia. This study will employ a university-clinic based outpatient group to administer language intervention. The specific aims of this study are to determine if group participation improves (1) life participation as measured by self-report questionnaires, (2) intervention-specific language skills as measured by treatment-related measures (e.g., reading comprehension and written expression), and (3) performance on non-treated language test scores as measured by a language assessment battery. Participants will complete 4-5 individual testing sessions (e.g., initial assessment and pre-/post-testing), 7-12 group sessions (90-minute weekly reading group session), and 7-12 independent sessions at home (e.g., completion of weekly reading assignments). The participants will read through a designated book incrementally across multiple weeks. The activities completed during the group sessions will focus on improving reading comprehension and written expression skills. Participants will read assigned passages at home and during the group sessions. Participants will complete a Copy and Recall Treatment (CART) worksheet independently to facilitate improvements in writing keywords related to the reading materials. CART involves copying target words and progresses to writing words from recall (Beeson, et al.). Participants will complete a reading comprehension worksheet and engage in discussion regarding the assigned book chapter. Reading comprehension and written expression data will be collected and analyzed to compare the pre-treatment baseline performance from the first treatment session to the post-treatment performance from the last treatment session. Pre-and post-testing scores will be analyzed to investigate the change in scores across the 2-time points to determine the relative effectiveness of book club participation for improving reading comprehension, written expression, and life participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired, Stroke, Rehabilitation, Language Disorder, Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reading Group
Arm Type
Experimental
Arm Description
All participants in this group will receive language intervention within weekly group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia.
Intervention Type
Behavioral
Intervention Name(s)
Language intervention with group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia
Intervention Description
The participants will read through a designated book incrementally across multiple weeks at home and complete reading, writing, and discussion related to weekly readings in a group setting.
Primary Outcome Measure Information:
Title
Reading Comprehension Battery for Aphasia-2 (RCBA-2; LaPointe & Horner, 1998) Scores
Description
To determine if group participation improves intervention-specific language skills in reading comprehension by comparing baseline score to 1-week post-intervention score
Time Frame
1-week after intervention
Secondary Outcome Measure Information:
Title
Communication Confidence Rating Scale for Aphasia (CCRSA; Babbitt & Cherney, 2010)
Description
To determine participant's feelings related to their communication. Participants rate their confidence on a scale from 0 to 100 for different communication-related activities. Baseline score will be compared to 1-week post-intervention score
Time Frame
1-week post-intervention
Title
Discourse Production Task
Description
Discourse analysis of participants producing monologic narratives (e.g., story retell, procedural explanation, picture sequence description, etc.). Baseline score will be compared to 1-week post-intervention score
Time Frame
1-week post-intervention
Title
Patient Reported Outcomes Measurement Information System (PROMIS)
Description
Selected PROMIS instruments (from cognitive, emotional, and social domains) will be used to measure satisfaction with and quality of life. Baseline score will be compared to 1-week post-intervention score.
Time Frame
1-week post-intervention
Title
Gray Oral Reading Test (GORT; Wiederholt & Bryant, 2012)
Description
To determine changes in oral reading and reading comprehension, baseline score will be compared to 1-week post-intervention score
Time Frame
1-week post-intervention
Title
Writing of Untrained Control Words (non-standardized).
Description
Writing untrained words that will be matched for frequency, length, and complexity with the CART trained words to measure generalization. Baseline score will be compared to 1-week post-intervention score
Time Frame
1-week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Pre-morbid proficient speaker of English Diagnosis of adult-onset aphasia Vision and hearing sufficient to complete assessments Exclusion Criteria: No history of childhood speech or language difficulties No history of major psychiatric illness, cognitive impairment, or neurological disorders such as seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Moser, Ph.D
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAM CHP Speech-Language and Hearing Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Group Participation on Adults With Aphasia

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