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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05520528
Other study ID # 274500
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 6, 2022
Est. completion date September 15, 2024

Study information

Verified date August 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date September 15, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Language intervention with group sessions and independent tasks with emphasis on improving reading and writing skills among persons with aphasia
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.

Locations

Country Name City State
United States UAM CHP Speech-Language and Hearing Clinic Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1-week after intervention
Secondary 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 1-week post-intervention
Secondary 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 1-week post-intervention
Secondary 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. 1-week post-intervention
Secondary 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 1-week post-intervention
Secondary 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 1-week post-intervention
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