NCT06511752

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for early_phase_1 alzheimer-disease

Timeline
56mo left

Started May 2024

Longer than P75 for early_phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
May 2024Dec 2030

Study Start

First participant enrolled

May 21, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

5.9 years

First QC Date

June 6, 2024

Last Update Submit

February 27, 2025

Conditions

Keywords

bilingualSpanishCastellanomulticulturalmultilingual

Outcome Measures

Primary Outcomes (1)

  • Treatment/Acceptability Survey

    In-house Acceptability and Perception of Change Survey

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

Secondary Outcomes (28)

  • Acceptability Measure

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

  • % participants who complete intervention, % sessions completed

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

  • % completion of homework

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

  • Retention

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

  • Aphasia Impact Questionnaire

    Baseline, Immediately following treatment, Follow-up at 3-months post-treatment

  • +23 more secondary outcomes

Study Arms (1)

Treatment Condition

EXPERIMENTAL

Support group meetings and strategy practice

Behavioral: Psychosocial educational, support group and implementation of strategies

Interventions

Psychosocial educational, support group and implementation of strategies

Treatment Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78702, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementiaAphasia, Primary ProgressiveAphasia

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

Stephanie M Grasso, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Behavioral intervention- support group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2024

First Posted

July 22, 2024

Study Start

May 21, 2024

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations