NCT05307796

Brief Summary

This study incorporates metacognitive strategy training into semantic feature analysis treatment. Semantic feature analysis treatment has a strong evidence base and capacity to improve word retrieval by encouraging circumlocution. Circumlocution facilitates self-cued naming and assists listener comprehension when naming fails. However, semantic feature analysis treatment does not include direct techniques to teach patients with aphasia to generalize the use of semantic feature analysis treatment's circumlocution procedure. Therefore, this study proposes that combining semantic feature analysis treatment and metacognitive strategy training will stimulate the semantic system and increase patients with aphasias' use of circumlocution across divergent contexts. This study aims to measure the treatment's effect on naming accuracy for trained and untrained items. The study also aim to measure the treatment's effect on people with aphasias' knowledge of the strategy components and changes in verbalizations during retrieval attempts. The central hypothesis is that strategy training will increase patients with aphasias' explicit knowledge about circumlocution and enable them to use it to (1) self-facilitate naming, and (2) produce more informative connected speech.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 22, 2022

Last Update Submit

March 11, 2024

Conditions

Keywords

Aphasia; Naming; Circumlocution

Outcome Measures

Primary Outcomes (3)

  • Naming accuracy

    Number of pictures named accurately when looking at a series of 176 object pictures

    Change from baseline at 6 months

  • Strategy Use

    Number of instances of circumlocution in moments of naming difficulty when looking at a series of 176 object pictures

    Change from baseline at 6 months

  • Strategy Knowledge

    Number of strategy components (out of 6) participants identify (verbally or gesturally) independently

    Change from baseline at 6 months

Secondary Outcomes (1)

  • Content Information Units

    Change from baseline at 6 months

Study Arms (1)

Semantic Feature Analysis plus metacognitive strategy training

EXPERIMENTAL

Participants attend three treatment sessions per week for eight weeks. Treatment sessions include: strategy education (participants learn about anomia, circumlocution, and circumlocution's purpose), Semantic Feature Analysis plus strategy application (participants build self-awareness and practice circumlocution), and strategy debriefing (participants reflect and receive feedback on their performance, and generate scenarios in which they could use the strategy in everyday life).

Behavioral: Strategy training

Interventions

The strategy training of focus in this study is metacognitive strategy training intended to build awareness of naming and methods to overcome instances of difficult naming. Strategy training involves (a) teaching the participant to identify instances in which they are unable to name objects, (b) learn a 6-feature framework (e.g. group, use, action) that has been identified to support semantic feature activation in aphasia, (c) learn and practice strategies to utilize the framework in instances of word finding difficulty

Semantic Feature Analysis plus metacognitive strategy training

Eligibility Criteria

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

You may qualify if:

  • Experienced a single left-hemisphere stroke,
  • Have aphasia due to stroke,
  • Be in the chronic stages of their aphasia, at least 6 months post onset of stroke.
  • Be between the ages of 18 and 89 years of age, and
  • Be a proficient English speaker,
  • Have no history of neurodegenerative disease, 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:

  • Experienced multiple strokes;
  • Be in the acute stage of their aphasia, \<6 months post onset of stroke;
  • Have a diagnosis of neurodegenerative disease, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence cognitive, language, and memory systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH-Institute of Health Professions

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sofia Vallila Rohter, PhD

    MGH Institute of Health Professions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 1, 2022

Study Start

August 30, 2021

Primary Completion

May 11, 2022

Study Completion

May 11, 2022

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Investigators will share de-identified data sets, statistical analysis codes and experimental set-ups with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with NIH policies.

Time Frame
Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 24 months
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations