Alzheimer DiseaseEarly Phase 1NCT06511752
Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia
A Early Phase 1 study testing Psychosocial educational, support group and implementation of strategies in people with Alzheimer Disease and Dementia, run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Primary Progressive Aphasia
- What is being tested?
- Psychosocial educational, support group and implementation of strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to Dec 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
Who cannot join
- Beyond the inclusion criteria included above, no additional exclusion criteria apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78702
Diana F Cruz, (512) 471-3420, diana.cruz@austin.utexas.edu
About this study
Official title: 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.
Read the detailed description
Two educational/support group routes will be offered:
- Progressive aphasia (PA) educational/support group or
- 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
- Alzheimer Disease, Dementia, Primary Progressive Aphasia, Aphasia, Progressive Aphasia, Progressive Aphasia in Alzheimer's Disease
- Being tested
- Psychosocial educational, support group and implementation of strategies
- Keywords
- bilingual, Spanish, Castellano, multicultural, multilingual
- Medical subject headings
- Alzheimer Disease, Dementia, Aphasia, Primary Progressive, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial educational, support group and implementation of strategiesBehavioural
Psychosocial educational, support group and implementation of strategies
| Study group | Role | What they receive |
|---|---|---|
| Treatment Condition | Experimental | Support group meetings and strategy practice Receives: Behavioral: Psychosocial educational, support group and implementation of strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment/Acceptability Survey
In-house Acceptability and Perception of Change Survey
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Secondary outcomes (28)
Acceptability Measure
Acceptability scale for healthcare interventions (the Theoretical Framework of Acceptability based questionnaire; Sekhon et al., 2022)
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% completion of homework
Engagement, 0-100, greater better
Measured: 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
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Mini-Mental State Exam
Cognitive screener, 0-30, greater better
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quick Aphasia Battery
Aphasia severity, 0-10, greater better
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Progressive Aphasia Severity Scale (PASS)
Aphasia severity, higher score = worse, 0-3
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Neuropsychiatric Inventory
Neuropsychiatric status, higher score = worse, 0-36
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Clinical Dementia Rating Scale (CDR)
Dementia Rating, higher score = worse, 0-3
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Quality of Life
Quality of life, higher score is better, 28-112
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Geriatric Depression Scale
Depression, higher score is worse, 0-15
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Knowledge Assessment Scale
Dementia Knowledge, higher score is better, 0-60
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Center for Epidemiologic Studies Depression Scale
Depression, higher score is worse, 0- 60
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
General Anxiety Disorder-7
Anxiety, higher score is worse, 0-21
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Duke University Religion Index
Religion Index
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Familism Scale
Familism Scale, higher score= greater religiosity, 1-15 considering all subscales
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Acculturation Rating Scale for Mexican Americans
Acculturation, higher score is better, 20-124
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief COPE
Coping strategies, higher score is better, 0-6
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief Assessment Scale for Caregivers
Coping strategies, higher score = worse, -28-28
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Zarit Burden Interview
Burden, higher score = worse, 0-88
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Perceived Stress Scale
Stress level, higher = worse, 0-40
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Devereux Adult Resilience Scale
Resilience
Measured: 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
Measured: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start21 May 2024
- Primary completionMay 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Behavioral intervention- support group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- The Association for Frontotemporal Degeneration
- Responsible party
- Principal investigator, Stephanie Grasso, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511752
- Sponsor's protocol ID
- STUDY00005541
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06511752
- Acronym / sponsor ID
- STUDY00005541
- Conditions
- Alzheimer Disease, Dementia, Primary Progressive Aphasia, Aphasia, Progressive Aphasia, Progressive Aphasia in Alzheimer's Disease
- Keywords
- bilingual, Spanish, Castellano, multicultural, multilingual
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- The Association for Frontotemporal Degeneration
- Study start
- 21 May 2024 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Two educational/support group routes will be offered:
- Progressive aphasia (PA) educational/support group or
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Behavioral intervention- support group
| Arm | Type | Receives |
|---|---|---|
| Treatment Condition | Experimental | Behavioral: Psychosocial educational, support group and implementation of strategiesSupport group meetings and strategy practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (1 listed)
- Beyond the inclusion criteria included above, no additional exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial educational, support group and implementation of strategiesPsychosocial educational, support group and implementation of strategies | Behavioural | Treatment Condition |
Primary outcome
Treatment/Acceptability Survey
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
In-house Acceptability and Perception of Change Survey
28 secondary outcomes
Acceptability Measure
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% participants who complete intervention, % sessions completed
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% completion of homework
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Retention
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Aphasia Impact Questionnaire
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Mini-Mental State Exam
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quick Aphasia Battery
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Stroke and Aphasia Quality of Life Scale- 39
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Progressive Aphasia Severity Scale (PASS)
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Neuropsychiatric Inventory
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Clinical Dementia Rating Scale (CDR)
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quality of the Caregiver Patient Relationship (QCPR)
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Quality of Life
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Geriatric Depression Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Knowledge Assessment Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Cuestionario de Salud 36-Item Short Form Survey Instrument
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
General Anxiety Disorder-7
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Duke University Religion Index
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Familism Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Acculturation Rating Scale for Mexican Americans
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Adult Carer Quality of Life Questionnaire
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief COPE
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief Assessment Scale for Caregivers
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Zarit Burden Interview
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Perceived Stress Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Devereux Adult Resilience Scale
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Management Strategies Scale (Tan et al., 2013)
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Multilingual Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psychosocial educational, support group and implementation of strategies in people with Alzheimer Disease and Dementia, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie M Grasso, PhD (6268648957, smgrasso@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment/Acceptability Survey (time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.