Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia

Educational Support Group Program for Carepartners of Bilingual and Spanish-speaking Persons With Progressive Forms of Aphasia and for Persons With Progressive Forms of Aphasia

The current study aims to examine the benefits of an education/support group program for individuals with progressive aphasia (caused by various etiologies, diagnoses) and their carepartners. The current study utilizes pre-, post-treatment, and follow-up assessments to measure effects of a psychoeducational support group and an implementation/communication skills training phase on measures of psychosocial function, communicative effectiveness and speech/language function. Analysis of study-specific surveys and semi-structured interviews will provide qualitative data regarding outcomes. Before beginning the education and support group, focus groups will be run in order to set priorities for the themes to be included in the education program. Participants will join via tele-based means if preferred and these participants may reside in the United States, or internationally including Mexico and Spain.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Primary Progressive Aphasia; Aphasia; Progressive Aphasia; Progressive Aphasia in Alzheimer's Disease
• Intervention / Treatment: Behavioral: Psychosocial educational, support group and implementation of strategies

Detailed Description

Two educational/support group routes will be offered:

1. Progressive aphasia (PA) educational/support group or
2. Caregiver educational support group with an implementation phase (including their partner with PA).

The caregiver educational support group path will be delivered in two phases, whereas the PA educational support group path will only consist of the first phase. The first phase of the caregiver educational support group will focus on the educational support group and the second phase will consist of implementation and practice of strategies with feedback provided by the clinician.

The educational/support groups (Routes 1 and 2) will include opportunities for discussion of issues related to language-led dementia or progressive aphasia (e.g., coping with changes in cognition and language, use of strategies for effective communication) and education regarding the disorder provided by relevant experts (e.g., speech-language pathologists, licensed professional counselors), separately for carepartners and individuals with progressive aphasia.

The implementation phase (Route 2, only) will allow for practice of strategies and skills learned in the first phase.

The total amount of time participants will be involved in the study will be 9 months, inclusive of follow-up.

Phase 1. Timeline for the support group portion of the study: Participants will complete pre-treatment measures during a period of 1-2 weeks prior to their first meeting. After four months of twice monthly meetings, post-treatment measures will be completed within 1-2 weeks of treatment completion. Follow-up evaluation will take place at 3-months post-treatment.

Phase 2. Timeline for the implementation/dyad training portion of the study: Post-treatment assessment from Phase 1 will serve as pre-treatment assessment for Phase 2. Treatment sessions will be held once weekly for 4 weeks, and post-treatment assessment will be completed within 1-2 weeks of phase 2 treatment completion. Follow-up evaluation will take place at 3-months post-treatment.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Stephanie M Grasso, PhD; Phone Number: 6268648957; Email: smgrasso@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78702
      • Recruiting
      • University of Texas at Austin
      • Contact: Diana F Cruz; Phone Number: 512-471-3420; Email: diana.cruz@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

All participants must:

• speak Spanish and/or English (although participants may speak other languages in addition to Spanish and/or English)
• identify as Hispanic and/or Latinx,
• or their spouse/family member with PA identifies as Hispanic and/or Latinx
• see and hear well enough to participate
• have access to a computer or mobile device with video capability
• have an internet connection

Additional inclusion criteria for PA/ language-led dementia support group participants:

• Individuals with PA:
• Has a diagnosis of PA, or language-led dementia, and aphasia is one of the primary causes of difficulty with activities of daily living
• Aware of language difficulties and willing to discuss them
• Able to actively engage in group discussion and complete activities with minimal support
• Able to regularly attend meetings
• Willing to follow the rules of the support group for interacting with others respectfully

Additional inclusion criteria for care partner support group plus implementation phase participants:

• Individuals with PA:
• Diagnosis of aphasia or dementia that is progressive in nature, and aphasia is one of the primary causes of difficulty with activities of daily living
• Have some ability to communicate and understand communication in order to participate in training sessions
• Are functionally able to engage in training sessions (e.g., able to maintain some attention, minimal challenging behavior that would cause disruption)
• Have a care partner who also consents to participating in the project
• Care partners:
• Self-identification as a caregiver of an individual with a diagnosis of PA or language-led dementia
• Willing to discuss caregiving for individuals with PA/ language-led dementia
• Able to regularly attend meetings
• Willing to follow the rules of the support group for interacting with others respectfully

Exclusion Criteria:

• Beyond the inclusion criteria included above, no additional exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Condition; Support group meetings and strategy practice	Behavioral: Psychosocial educational, support group and implementation of strategies; Psychosocial educational, support group and implementation of strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment/Acceptability Survey	In-house Acceptability and Perception of Change Survey	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Measure	Acceptability scale for healthcare interventions (the Theoretical Framework of Acceptability based questionnaire; Sekhon et al., 2022)	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% participants who complete intervention, % sessions completed	Adherence/receipt of intervention, 0-100, greater better	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% completion of homework	Engagement, 0-100, greater better	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Retention	Number of dropouts, reasons for dropout (related to intervention or not), and overall, retention rate at final assessment and follow-up; 80% is successful at the final post-treatment assessment and 80% is successful at the 2-month follow-up, 0-100, greater better	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Aphasia Impact Questionnaire	Aphasia impact, Higher score indicates poorer quality of life (worse) Range of scores for each question: 0-4 Total 0-84	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Mini-Mental State Exam	Cognitive screener, 0-30, greater better	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quick Aphasia Battery	Aphasia severity, 0-10, greater better	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Stroke and Aphasia Quality of Life Scale- 39	Quality of life, greater score is better, 0-195	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Progressive Aphasia Severity Scale (PASS)	Aphasia severity, higher score = worse, 0-3	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Neuropsychiatric Inventory	Neuropsychiatric status, higher score = worse, 0-36	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Clinical Dementia Rating Scale (CDR)	Dementia Rating, higher score = worse, 0-3	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quality of the Caregiver Patient Relationship (QCPR)	Quality of life, higher scores is better,14-70	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Quality of Life	Quality of life, higher score is better, 28-112	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Geriatric Depression Scale	Depression, higher score is worse, 0-15	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Knowledge Assessment Scale	Dementia Knowledge, higher score is better, 0-60	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Center for Epidemiologic Studies Depression Scale	Depression, higher score is worse, 0- 60	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Cuestionario de Salud 36-Item Short Form Survey Instrument	General health, higher score is better, 0-100	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
General Anxiety Disorder-7	Anxiety, higher score is worse, 0-21	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Duke University Religion Index	Religion Index	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Familism Scale	Familism Scale, higher score= greater religiosity, 1-15 considering all subscales	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Acculturation Rating Scale for Mexican Americans	Acculturation, higher score is better, 20-124	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Adult Carer Quality of Life Questionnaire	Quality of Life, higher score is better, 0 -105	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief COPE	Coping strategies, higher score is better, 0-6	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief Assessment Scale for Caregivers	Coping strategies, higher score = worse, -28-28	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Zarit Burden Interview	Burden, higher score = worse, 0-88	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Perceived Stress Scale	Stress level, higher = worse, 0-40	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Devereux Adult Resilience Scale	Resilience	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Management Strategies Scale (Tan et al., 2013)	Dementia management, higher score= higher frequency of action, subscales 8-55	Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: The Association for Frontotemporal Degeneration

Publications and helpful links

Helpful Links

• Multilingual Lab Website

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Spanish; bilingual; Castellano; multicultural; multilingual
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Communication Disorders; Language Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Alzheimer Disease; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: STUDY00005541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No