An Early Phase 1 interventional study of Psychosocial educational, support group and implementation of strategies in Alzheimer Disease, Dementia and Primary Progressive Aphasia, sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Texas at Austin · Early Phase 1, Interventional, and Treatment
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.
Two educational/support group routes will be offered:
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants must:
Additional inclusion criteria for PA/ language-led dementia support group participants:
Additional inclusion criteria for care partner support group plus implementation phase participants:
Exclusion Criteria:
Support group meetings and strategy practice
Behavioral: Psychosocial educational, support group and implementation of strategies
Psychosocial educational, support group and implementation of strategies
Treatment/Acceptability Survey
In-house Acceptability and Perception of Change Survey
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Acceptability Measure
Acceptability scale for healthcare interventions (the Theoretical Framework of Acceptability based questionnaire; Sekhon et al., 2022)
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
% completion of homework
Engagement, 0-100, greater better
Time frame: 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
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Mini-Mental State Exam
Cognitive screener, 0-30, greater better
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Quick Aphasia Battery
Aphasia severity, 0-10, greater better
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Progressive Aphasia Severity Scale (PASS)
Aphasia severity, higher score = worse, 0-3
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Neuropsychiatric Inventory
Neuropsychiatric status, higher score = worse, 0-36
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Clinical Dementia Rating Scale (CDR)
Dementia Rating, higher score = worse, 0-3
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Quality of Life
Quality of life, higher score is better, 28-112
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Geriatric Depression Scale
Depression, higher score is worse, 0-15
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Dementia Knowledge Assessment Scale
Dementia Knowledge, higher score is better, 0-60
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Center for Epidemiologic Studies Depression Scale
Depression, higher score is worse, 0- 60
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
General Anxiety Disorder-7
Anxiety, higher score is worse, 0-21
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
The Duke University Religion Index
Religion Index
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Familism Scale
Familism Scale, higher score= greater religiosity, 1-15 considering all subscales
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Acculturation Rating Scale for Mexican Americans
Acculturation, higher score is better, 20-124
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief COPE
Coping strategies, higher score is better, 0-6
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Brief Assessment Scale for Caregivers
Coping strategies, higher score = worse, -28-28
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Zarit Burden Interview
Burden, higher score = worse, 0-88
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Perceived Stress Scale
Stress level, higher = worse, 0-40
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Devereux Adult Resilience Scale
Resilience
Time frame: 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
Time frame: Baseline, Immediately following treatment, Follow-up at 3-months post-treatment
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas at Austin →