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

NCT ID: NCT06511752

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Dementia Primary Progressive Aphasia Aphasia Progressive Aphasia Progressive Aphasia in Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Behavioral intervention- support group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Condition

Support group meetings and strategy practice

Group Type EXPERIMENTAL

Psychosocial educational, support group and implementation of strategies

Intervention Type BEHAVIORAL

Psychosocial educational, support group and implementation of strategies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychosocial educational, support group and implementation of strategies

Psychosocial educational, support group and implementation of strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Association for Frontotemporal Degeneration

UNKNOWN

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephanie Grasso

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephanie M Grasso, PhD

Role: CONTACT

6268648957

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Diana F Cruz

Role: primary

512-471-3420

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00005541

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rhythm-based Intervention in Aphasia
NCT04581564 TERMINATED NA
Singing for People With Aphasia
NCT03076736 COMPLETED NA
Web-Based Treatment for Aphasia
NCT04413136 COMPLETED NA