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Incorporating Strategy Training Into Naming Treatment in Aphasia

Primary Purpose

Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strategy training
Sponsored by
MGH Institute of Health Professions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia; Naming; Circumlocution

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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

Sites / Locations

  • MGH-Institute of Health ProfessionsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Semantic Feature Analysis plus metacognitive strategy training

Arm Description

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).

Outcomes

Primary Outcome Measures

Naming accuracy
Number of pictures named accurately when looking at a series of 176 object pictures
Strategy Use
Number of instances of circumlocution in moments of naming difficulty when looking at a series of 176 object pictures
Strategy Knowledge
Number of strategy components (out of 6) participants identify (verbally or gesturally) independently

Secondary Outcome Measures

Content Information Units
Number of content information units (CIUs) in connected speech samples when describing pictures and telling stories.

Full Information

First Posted
March 22, 2022
Last Updated
March 23, 2022
Sponsor
MGH Institute of Health Professions
Collaborators
LSVT Global
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1. Study Identification

Unique Protocol Identification Number
NCT05307796
Brief Title
Incorporating Strategy Training Into Naming Treatment in Aphasia
Official Title
Incorporating Strategy Training Into Naming Treatment to Improve Generalization in Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MGH Institute of Health Professions
Collaborators
LSVT Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Every 40 seconds, someone in the United States suffers from a stroke. Approximately 25% of stroke survivors acquire aphasia, a communication disorder that can result in a partial or total loss of spoken and written language ability, which significantly and negatively impacts quality of life and societal participation. The ability to verbally label objects, referred to as 'naming' in the literature, is impaired in all patients with aphasia. Naming is, therefore, a common focus of treatment. Naming treatments improve people with aphasias' naming ability for items that are directly trained during therapy. However, these same treatments face two critical limitations: (1) inconsistent generalization to untrained items, and (2) little to no generalization to spontaneous, connected speech. As it is impossible to train the entire universe of objects during a patient's course of therapy, generalization of gains beyond what is trained in therapy is crucial. Recent work shows that patients with aphasias' learning success depends on their ability to develop optimal strategies that support learning, but that they do not develop these strategies independently. There is also evidence that through explicit strategy training, patients with aphasia can learn to implement and generalize the use of strategies that are known to support learning, and carry over their use across multiple environments. As such, it is predicted that naming treatment outcomes would be greatly improved by incorporating strategy training into treatment. This study proposes to incorporate strategy training into naming treatment to improve generalization. Circumlocution, a verbal behavior in which patients with aphasia describe an object's features if they are unable to name it, is known to facilitate naming and assist listener comprehension. Semantic Feature Analysis is a well-regarded naming treatment thought to encourage circumlocution. Semantic Feature Analysis treatment does not include direct techniques that teach patients with aphasia how to generalize the use of the treatment's circumlocution procedure. In fact, no studies have explicitly trained patients with aphasia how to use the circumlocution procedure they learn in Semantic Feature Analysis treatment during everyday communication. Rather, it is assumed that patients with aphasia will implicitly learn how to use the procedure, through repeated practice and habituation alone. This study proposes that strategy training is the integral missing piece that will successfully result in people with aphasias' generalized application of the semantic feature analysis procedure. The objective of the proposed research is to determine whether naming treatment that incorporates strategy training results in people with aphasias' increased use of circumlocution. 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. It is predicted that increased use of circumlocution will result in generalization at both the impairment level (naming) and participation level (effective communication).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia; Naming; Circumlocution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semantic Feature Analysis plus metacognitive strategy training
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Strategy training
Intervention Description
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
Primary Outcome Measure Information:
Title
Naming accuracy
Description
Number of pictures named accurately when looking at a series of 176 object pictures
Time Frame
Change from baseline at 6 months
Title
Strategy Use
Description
Number of instances of circumlocution in moments of naming difficulty when looking at a series of 176 object pictures
Time Frame
Change from baseline at 6 months
Title
Strategy Knowledge
Description
Number of strategy components (out of 6) participants identify (verbally or gesturally) independently
Time Frame
Change from baseline at 6 months
Secondary Outcome Measure Information:
Title
Content Information Units
Description
Number of content information units (CIUs) in connected speech samples when describing pictures and telling stories.
Time Frame
Change from baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Vallila Rohter, PhD
Phone
617-724-3824
Email
svallilarohter@mghihp.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie Nicholas, PhD
Phone
617-726-0685
Email
mlnicholas@mghihp.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Vallila Rohter, PhD
Organizational Affiliation
MGH Institute of Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH-Institute of Health Professions
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Vallila Rohter, PhD
Phone
617-724-3824
Email
svallilarohter@mghihp.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 24 months
IPD Sharing 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).

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Incorporating Strategy Training Into Naming Treatment in Aphasia

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