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Optimizing Feedback-based Learning in Children With Developmental Language Disorder

Primary Purpose

Developmental Language Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Declarative learning with immediate feedback
Declarative learning with delayed feedback
Probabilistic learning with immediate feedback
Probabilistic learning with delayed feedback
Word learning task with active feedback
Word learning task with passive feedback
Sponsored by
MGH Institute of Health Professions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Developmental Language Disorder

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English as the primary language Nonverbal intelligence quotient (IQ) score on the Wechsler Intelligence Scale for Children-5th Edition (WISC-V) Standard Score >70 Identification Core score on the Test of Integrated Language & Literacy Skills (TILLS) equal to or less than 34 Exclusion Criteria: Hearing loss or other known neurological deficits, or diagnoses (e.g., Attention deficit disorder, Autism, Traumatic Brain Injury) Evidence of color blindness as measured by the EnChroma computer base color blindness screening test for children

Sites / Locations

  • MGH Institute of Health ProfessionsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with developmental language disorder

Arm Description

Outcomes

Primary Outcome Measures

Accuracy (percent correct) on a two-choice paired associate test immediately after the task
Accuracy on a two-choice paired-associate test following each of the learning conditions. The structure of a test trial will be similar to the structure of a task trial but it will not include feedback. This measure will evaluate learning outcomes.
Accuracy (percent correct) on a two-choice paired associate test 1 week after the task
Accuracy on a two-choice paired-associate test a week after the completion of each learning task. The structure of a test trial will be similar to the structure of a task trial but it will not include feedback. This measure will evaluate learning retention.
FRN amplitude
The amplitude (in microvolts) of the feedback related negativity (FRN) event related potential
N170 amplitude
The amplitude (in microvolts) of the N170 event related potential

Secondary Outcome Measures

Full Information

First Posted
January 3, 2023
Last Updated
October 17, 2023
Sponsor
MGH Institute of Health Professions
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1. Study Identification

Unique Protocol Identification Number
NCT05678634
Brief Title
Optimizing Feedback-based Learning in Children With Developmental Language Disorder
Official Title
Optimizing Feedback-based Learning in Children With Developmental Language Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
February 28, 2028 (Anticipated)
Study Completion Date
February 28, 2028 (Anticipated)

3. Sponsor/Collaborators

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

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 project aims to optimize a critical but understudied ingredient of language intervention provided to children with developmental language disorder (DLD) - feedback. The project will bridge a gap between previous findings in our lab of inefficient feedback processing in DLD and clinical practice by identifying the conditions under which feedback-based learning can be improved in DLD. The investigators hypothesize that the effectiveness of feedback can be significantly enhanced for children with DLD when it is tailored to their unique learning strengths. The rationale for this project is based on evidence that feedback-based learning can be improved by enhancing the dominance of an intact learning system. The project will achieve its aim by manipulating (1) the timing of the feedback (immediate vs. delayed) and (2) the level of the learner's involvement in error correction dictated by feedback (active vs. passive correction). Aim 1 will determine the effect of manipulating feedback timing on learning in 140 school-age children (8-12 years) with DLD. While immediate feedback is processed by the striatum, which is also implicated in implicit learning, delaying the feedback by a few seconds shifts feedback processing to the mediate temporal lobe (MTL)-based declarative learning system. Evidence that delaying feedback improves learning in DLD would support the hypothesis of the implicit deficit theory that intervention should capitalize on declarative learning mechanisms. The project will test a novel alternative feedback-learning parity hypothesis whereby feedback-based learning is optimized when the timing of the feedback is aligned with the dominant learning system at a given time (i.e., immediate feedback during striatal-based probabilistic learning; delayed feedback during MTL-based declarative learning). Within the same group of children, Aim 2 will compare feedback-based learning in children with DLD when feedback (a) prompts active self-correction or (b) passively exposes learners to error corrections (corrective recast). Children will engage in two nonword-object paired-associate learning tasks. In one task, feedback will promote active self-correction, which is in line with declarative learning. In the other task, feedback will passively expose the learner to corrective feedback in a manner consistent with teaching approaches aiming at reducing awareness of errors. The project will determine whether children with DLD learn better when feedback prompts self-correction or when they are exposed to passive corrections. Electrophysiological measures will indicate whether passive corrections (corrective recast) are processed as negative feedback by children with DLD. For both aims, behavioral indicators of response to feedback will be complemented by electrophysiological measures of feedback processing that can determine the involvement of the striatum and MTL brain systems during the learning process. This work is scientifically and clinically significant because elucidating what manipulations optimize feedback-based learning will enhance our understanding of the impaired learning mechanism in DLD and will provide clinical guidance on what type of feedback to use during an intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Children with developmental language disorder
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Declarative learning with immediate feedback
Intervention Description
Children will complete a paired associate learning task on a computer. Each response on half of the blocks will be followed by performance feedback. Feedback will be provided 500 ms following a response (button press)
Intervention Type
Behavioral
Intervention Name(s)
Declarative learning with delayed feedback
Intervention Description
Children will complete a paired associate learning task on a computer. Each response on half of the blocks will be followed by performance feedback. Feedback will be provided 5000 ms following a response (button press)
Intervention Type
Behavioral
Intervention Name(s)
Probabilistic learning with immediate feedback
Intervention Description
Children will complete a probabilistic learning task on a computer. Each response on half of the blocks will be followed by feedback. Feedback will be provided 500 ms following a response (button press)
Intervention Type
Behavioral
Intervention Name(s)
Probabilistic learning with delayed feedback
Intervention Description
Children will complete a probabilistic learning task on a computer. Each response on half of the blocks will be followed by feedback. Feedback will be provided 5000 ms following a response (button press)
Intervention Type
Behavioral
Intervention Name(s)
Word learning task with active feedback
Intervention Description
Children will complete a two-choice nonword learning task in which they will be tasked with learning to associate novel objects with novel nonword names through trial and error guided by feedback. Each response will be followed by feedback either indicating that the response is correct or prompting the child to try again (i.e., to correct an error)
Intervention Type
Behavioral
Intervention Name(s)
Word learning task with passive feedback
Intervention Description
Children will complete a two-choice nonword learning task in which they will be tasked with learning to associate novel objects with novel nonword names. Regardless of response accuracy on each trial, each response will be followed by a visual presentation of the correct response.
Primary Outcome Measure Information:
Title
Accuracy (percent correct) on a two-choice paired associate test immediately after the task
Description
Accuracy on a two-choice paired-associate test following each of the learning conditions. The structure of a test trial will be similar to the structure of a task trial but it will not include feedback. This measure will evaluate learning outcomes.
Time Frame
Immediately after learning task
Title
Accuracy (percent correct) on a two-choice paired associate test 1 week after the task
Description
Accuracy on a two-choice paired-associate test a week after the completion of each learning task. The structure of a test trial will be similar to the structure of a task trial but it will not include feedback. This measure will evaluate learning retention.
Time Frame
1 week after the learning task
Title
FRN amplitude
Description
The amplitude (in microvolts) of the feedback related negativity (FRN) event related potential
Time Frame
During each learning task
Title
N170 amplitude
Description
The amplitude (in microvolts) of the N170 event related potential
Time Frame
During each learning task

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English as the primary language Nonverbal intelligence quotient (IQ) score on the Wechsler Intelligence Scale for Children-5th Edition (WISC-V) Standard Score >70 Identification Core score on the Test of Integrated Language & Literacy Skills (TILLS) equal to or less than 34 Exclusion Criteria: Hearing loss or other known neurological deficits, or diagnoses (e.g., Attention deficit disorder, Autism, Traumatic Brain Injury) Evidence of color blindness as measured by the EnChroma computer base color blindness screening test for children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
research coordinator
Phone
(617) 724-7363
Email
cnglead@mghihp.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Arbel, 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
Research Coordinator
Phone
617-724-7363
Email
cnglead@mghihp.edu
First Name & Middle Initial & Last Name & Degree
Yael Arbel, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Feedback-based Learning in Children With Developmental Language Disorder

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