NCT07036406

Brief Summary

The goal of this clinical trial is to compare the effectiveness of traditional Semantic Feature Analysis (SFA) treatment to a modified SFA protocol that includes Metacognitive Strategy Training (SFA+MST) for adults with acquired aphasia. The main questions it aims to answer are:

  • What are the comparative outcomes in picture naming accuracy and strategy use during picture naming following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia?
  • What are the comparative outcomes in percent of informative content and rate of informative content during spontaneous speech production following 2 months of traditional SFA versus SFA + MST in adults with acquired aphasia? Researchers will compare outcomes between these two treatments to see if SFA+MST yields larger effects in picture naming and spontaneous speech outcomes than traditional SFA. Participants will complete:
  • 5-7 pre-treatment assessment sessions where they will be asked to name pictures, tell stories/describe pictures, answer questions, and complete questionnaires,
  • 3 treatment sessions of SFA \*OR\* SFA+MST per week for 8 weeks, for a total of 24 sessions,
  • 7 weekly probes (i.e., short, intermittent assessments throughout the treatment phase),
  • 3 post-treatment assessment sessions immediately after treatment ends, where they will complete the same assessment tasks as they did pre-treatment (e.g., naming pictures, telling stories, etc.),
  • 2 retention assessment sessions, one 30 days and the other 60 days following the final treatment session, where they will be asked to name pictures, tell stories/describe pictures, and describe what they learned during the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
14mo left

Started Jul 2025

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 Progress40%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

June 9, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

June 9, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

AphasiaAnomiaStrokeCommunicationLanguage

Outcome Measures

Primary Outcomes (2)

  • Confrontation naming accuracy

    Participants will complete a 60-item confrontation naming assessment before, during, and after treatment. We will calculate the total number of items that participants name accurately across study phases.

    Change from Baseline through study completion, an average of 6 months

  • Independent word-finding strategy use

    Using the 60-item confrontation naming assessment, we will evaluate instances in which participants independently use a specific word-finding strategy (describing or talking around the word) in instances where they cannot name items successfully, and calculate the proportions of incorrect responses with and without strategy use across study phases.

    Change from Baseline through study completion, an average of 6 months

Secondary Outcomes (2)

  • Discourse informativeness

    Change from Baseline through study completion, an average of 6 months

  • Discourse efficiency

    Change from Baseline through study completion, an average of 6 months

Other Outcomes (1)

  • Explicit strategy knowledge

    Change from Baseline through study completion, an average of 6 months

Study Arms (2)

Traditional Semantic Feature Analysis

ACTIVE COMPARATOR

A portion of the study participants will participate in traditional Semantic Feature Analysis treatment, as described in Gravier, M. L., Dickey, M. W., Hula, W. D., Evans, W. S., Owens, R. L., Winans-Mitrik, R. L., \& Doyle, P. J. (2018). What matters in semantic feature analysis: Practice-related predictors of treatment response in aphasia. American Journal of Speech-Language Pathology, 27(1S), 438-453. https://doi.org/10.1044/2017\_AJSLP-16-0196. Briefly, this treatment involves naming pictures of objects, describing the objects' features (e.g., category membership, physical attributes, etc.), and creating sentences using the objects' names.

Behavioral: Semantic Feature Analysis (traditional)

Semantic Feature Analysis + Metacognitive Strategy Training

EXPERIMENTAL

A portion of the study participants will participate in traditional Semantic Feature Analysis treatment, as described in Tilton-Bolowsky, V. E., Brock, L., Nunn, K., Evans, W. S., \& Vallila-Rohter, S. (2023). Incorporating metacognitive strategy training into semantic treatment promotes restitutive and substitutive gains in naming: A single-subject investigation. American journal of speech-language pathology, 32(5), 1979-2020. https://doi.org/10.1044/2023\_AJSLP-22-00230. Briefly, this treatment involves metacognitive teaching and practice, naming pictures of objects, describing the objects' features (e.g., category membership, physical attributes, etc), creating sentences using the objects' names, debriefing on overall performance, and discussing recent and future opportunities for strategy implementation in real life.

Behavioral: Semantic Feature Analysis + Metacognitive Strategy Training

Interventions

This treatment involves naming pictures of objects, describing the objects' features (e.g., category membership, physical attributes, etc.), and creating sentences using the objects' names. It does not include direct metacognitive strategy training.

Traditional Semantic Feature Analysis

This treatment involves metacognitive teaching and practice, naming pictures of objects, describing the objects' features (e.g., category membership, physical attributes, etc), creating sentences using the objects' names, debriefing on overall performance, and discussing recent and future opportunities for strategy implementation in real life.

Semantic Feature Analysis + Metacognitive Strategy Training

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have aphasia due to a single acute event (e.g., left-hemisphere stroke, traumatic brain injury)
  • Be at least six-months post aphasia-onset,
  • Be a proficient English speaker,
  • Have normal or corrected to normal hearing (i.e., hearing aids) and vision (i.e., eyeglasses),
  • Have no history of neurodegenerative disease (e.g., dementia), severe motor speech disorder, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence their cognitive, language, and memory systems

You may not qualify if:

  • A history of neurodegenerative disease (e.g., dementia), severe motor speech disorder, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence their cognitive, language, and memory systems,
  • Children under the age of 18,
  • Adults over the age of 89,
  • Uncorrected hearing and vision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

RECRUITING

Related Publications (3)

  • Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.

    PMID: 8487525BACKGROUND
  • Gravier ML, Dickey MW, Hula WD, Evans WS, Owens RL, Winans-Mitrik RL, Doyle PJ. What Matters in Semantic Feature Analysis: Practice-Related Predictors of Treatment Response in Aphasia. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):438-453. doi: 10.1044/2017_AJSLP-16-0196.

    PMID: 29497754BACKGROUND
  • Tilton-Bolowsky VE, Brock L, Nunn K, Evans WS, Vallila-Rohter S. Incorporating Metacognitive Strategy Training Into Semantic Treatment Promotes Restitutive and Substitutive Gains in Naming: A Single-Subject Investigation. Am J Speech Lang Pathol. 2023 Sep 11;32(5):1979-2020. doi: 10.1044/2023_AJSLP-22-00230. Epub 2023 Jul 11.

    PMID: 37433115BACKGROUND

MeSH Terms

Conditions

AphasiaAnomiaAphasia, BrocaAphasia, ConductionStrokeCommunicationLanguage

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Central Study Contacts

Victoria Tilton-Bolowsky, Ph.D. CCC-SLP

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. CCC-SLP

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 25, 2025

Study Start

July 28, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations