Support Group Program for Progressive Aphasia

Overseen By Stephanie M Grasso, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Texas at Austin

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an educational support group can assist people with progressive aphasia—a condition that makes talking and understanding speech difficult—and their caregivers. The goal is to determine if these group sessions enhance communication skills, social interaction, and overall well-being. Participants will engage in group discussions and activity sessions, either in person or online. This trial suits Hispanic or Latinx individuals, or their family members, who have progressive aphasia or a similar language-related condition and wish to improve daily communication skills. Participants must be able to see and hear well, have internet access, and be willing to engage in discussions. As an Early Phase 1 trial, this research focuses on understanding how the educational support group functions in people, offering participants a chance to be among the first to explore this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational support group program is safe?

Research has shown that joining an educational support group for progressive aphasia is generally safe. Studies have found that participants in these groups often improve their communication skills and management of their condition. The program includes activities such as learning new communication methods and receiving counseling, which pose no physical risks. No reports of serious side effects have emerged from participating in such a group. Although this might be an early study, support groups and similar programs are usually well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Support Group Program for Progressive Aphasia because it offers a unique approach compared to current treatments, which often focus on medication or speech therapy. This program emphasizes interactive support group meetings where participants can practice communication strategies in a social setting. By fostering a community environment, it aims to enhance social engagement and communication skills in a way that traditional one-on-one therapy might not fully address. This innovative method could provide a more holistic benefit, helping people not only improve their language skills but also feel more connected and supported.

What evidence suggests that this educational support group program is effective for progressive aphasia?

Research has shown that educational support group programs, like the one tested in this trial, can help people with progressive aphasia. Participants in these programs have demonstrated noticeable improvements in communication and problem-solving. Studies have also found that activities such as these support groups enhance language and communication skills. Personalized support can positively affect those facing communication difficulties due to progressive aphasia. Overall, these programs offer a promising way to improve daily interactions and quality of life for those affected. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for bilingual and Spanish-speaking individuals with progressive aphasia or related conditions, such as Frontotemporal Dementia, and their carepartners. Participants can join from the U.S., Mexico, Spain, and may participate through tele-based means if preferred.

Inclusion Criteria

Participants must identify as Hispanic and/or Latinx, or have a spouse/family member with PA who identifies as Hispanic and/or Latinx

Participants must have access to a computer or mobile device with video capability and an internet connection

I can see and hear well enough to take part in activities.

Exclusion Criteria

No additional exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Educational/Support Group

Participants engage in educational and support group sessions focusing on coping with changes in cognition and language, and effective communication strategies.

4 months

Twice monthly meetings

Implementation/Dyad Training

Caregivers practice strategies and skills learned in the educational support group with feedback from clinicians.

4 weeks

Once weekly sessions

Follow-up

Participants are monitored for psychosocial function, communicative effectiveness, and speech/language function after treatment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Support Group Program

Trial Overview The study tests an educational support group program that includes psychoeducational support and communication skills training. It measures changes in psychosocial function, communicative effectiveness, and speech/language function before, after treatment, and at follow-up.

How Is the Trial Designed?

Group I: Treatment Condition Experimental Treatment 1 Intervention

Support group meetings and strategy practice

Educational Support Group Program is already approved in United States for the following indications:

Approved in United States as Educational Support Group Program for:

• Progressive Aphasia

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

The Association for Frontotemporal Degeneration

Collaborator

Trials

2

Recruited

180+

Published Research Related to This Trial

A short educational program about aphasia (SEPA) was developed for family caregivers, but the study with only four participants showed no significant group differences in burden or quality of life after the intervention.

Despite the lack of significant results, individual trends indicated that all participants experienced some improvement, suggesting that SEPA may have potential benefits that warrant further investigation with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a short educational program about aphasia (SEPA) on the burden and quality of life of family caregivers of people with aphasia. Magnus, BH., Dias, RF., Beber, BC.[2019]

The study developed a comprehensive training program called 'Better Conversations with primary progressive aphasia' for speech and language therapists, which includes seven online modules and a manual for communication partner training, based on extensive stakeholder consultation and co-production.

Key components of the training were identified, such as the use of video feedback and understanding the timing of interventions, which were informed by focus groups with individuals affected by primary progressive aphasia and their families, ensuring the program is tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Medical Research Council framework and public involvement in the development of a communication partner training intervention for people with primary progressive aphasia (PPA): Better Conversations with PPA. Volkmer, A., Spector, A., Swinburn, K., et al.[2021]

A study involving 25 participants (12 individuals with primary progressive aphasia and 13 caregivers) showed that attending an education and support session significantly improved caregivers' knowledge about PPA and coping strategies.

Follow-up interviews revealed that caregivers felt less isolated and more supported, highlighting the importance of these sessions as a valuable part of care for individuals with PPA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Progressive Aphasia Education and Support Groups: A Clinical Evaluation. Taylor-Rubin, C., Azizi, L., Croot, K., et al.[2020]

A feasibility study showed that an education program involving people with aphasia as educators significantly improved nursing assistant students' understanding of aphasia and communication strategies.

The program not only enhanced the students' knowledge but also provided psychosocial benefits to participants with aphasia, indicating its potential for broader application in healthcare training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching nursing assistant students about aphasia and communication. Welsh, JD., Szabo, GB.[2018]

The pilot study of the Better Conversations with PPA (BCPPA) program involved 18 participants with primary progressive aphasia (PPA) and their communication partners, showing that the intervention was well-received and had a high treatment fidelity of 87.2%.

Results indicated that BCPPA led to positive changes in conversation behaviors and communication goals, suggesting it is a promising intervention for improving communication in individuals with PPA, paving the way for a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a randomised controlled pilot study of the Better Conversations with Primary Progressive Aphasia (BCPPA) communication partner training program for people with PPA and their communication partners. Volkmer, A., Walton, H., Swinburn, K., et al.[2023]

A pilot study introduced the first structured group intervention program specifically for individuals with primary progressive aphasia (PPA) and their caregivers, consisting of language activities, communication strategies, and counseling over 10 weeks.

Participants showed significant improvements in communication quality and coping skills compared to a control group, highlighting the need for tailored interventions for the PPA population and their support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group intervention for individuals with primary progressive aphasia and their spouses: Who comes first? Jokel, R., Meltzer, J., D R, J., et al.[2018]

A new psycho-educational program was developed to support individuals with primary progressive aphasia and their care-partners, focusing on education, activities, and emotional support.

Thematic analysis revealed key areas of impact, including coping with language decline, increased dependency, resilience, stigma, self-confidence, and a sense of belonging, highlighting the program's potential benefits for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Psycho-Educational Support Program for Individuals with Primary Progressive Aphasia and their Care-Partners. Morhardt, DJ., O'Hara, MC., Zachrich, K., et al.[2021]

A group treatment model for individuals with primary progressive aphasia (PPA) was developed, incorporating strategies from augmentative communication and aphasia rehabilitation, and was delivered over 6 weeks to enhance communication skills.

Participants reported significant improvements in their understanding of PPA, increased use of multimodal communication, and greater confidence in daily activities, indicating that group training is an effective approach for supporting individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Communication Treatment for Individuals with PPA and Their Partners. Mooney, A., Beale, N., Fried-Oken, M.[2019]

Incorporating communication-centered counseling and care partner training into the treatment of primary progressive aphasia (PPA) can help address the negative psychosocial effects experienced by individuals, such as social isolation and depression.

Current research on counseling and care partner training for PPA is limited, but existing evidence suggests these approaches are beneficial and should be further explored to enhance treatment outcomes and support for both patients and their care partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling and Care Partner Training in Primary Progressive Aphasia. Schaffer, KM., Henry, ML.[2022]

Citations

1. withpower.com withpower.com/trial/early-phase-1-aphasia-primary-progressive-4-2024-fd923

Support Group Program for Progressive Aphasia Participants showed significant improvements in communication quality and coping skills compared to a control group, highlighting the need for tailored ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281019/

Comprehensive intervention combining group and ... Increasingly, studies are demonstrating language and communication improvement after behavioral interventions for primary progressive aphasia ( ...

3. trialx.com trialx.com/clinical-trials/listings/315023/educational-support-group-program-for-bilingual-and-spanish-speaking-carepartners-and-people-with-progressive-aphasia/

Educational Support Group Program for Bilingual and Spanish ... The current study aims to examine the benefits of an education/support group program for individuals with progressive aphasia (caused by various etiologies, ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2021_PERSP-20-00296

Counseling and Care Partner Training in Primary ... Individuals with primary progressive aphasia (PPA) experience loss of communication abilities in the context of neurodegenerative disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5696112/

Development of a psycho-educational support program for ... This paper describes the development of a program that offers support, education and activities for persons with primary progressive aphasia and their care- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10691435/

Primary Progressive Aphasia Education and Support Groups The program provided ten 2-hour weekly sessions, which included language activities, learning communication strategies, counseling, and ...

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70132

Comprehensive intervention combining group and ... Implementing a telehealth-delivered psychoeducational support group for care partners of individuals with primary progressive aphasia.

8. researchgate.net researchgate.net/publication/315525899_Development_of_a_Psycho-Educational_Support_Program_for_Individuals_with_Primary_Progressive_Aphasia_and_their_Care-Partners

Development of a Psycho-Educational Support Program for ... This paper describes the development of a program that offers support, education and activities for persons with primary progressive aphasia and ...