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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05678634
Other study ID # 2022P003376
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2023
Est. completion date October 1, 2027

Study information

Verified date January 2024
Source MGH Institute of Health Professions
Contact research coordinator
Phone (617) 724-7363
Email cnglead@mghihp.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date October 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Declarative learning with immediate feedback
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)
Declarative learning with delayed feedback
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)
Probabilistic learning with immediate feedback
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)
Probabilistic learning with delayed feedback
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)
Word learning task with active feedback
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)
Word learning task with passive feedback
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.

Locations

Country Name City State
United States MGH Institute of Health Professions Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
MGH Institute of Health Professions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Immediately after learning task
Primary 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. 1 week after the learning task
Primary FRN amplitude The amplitude (in microvolts) of the feedback related negativity (FRN) event related potential During each learning task
Primary N170 amplitude The amplitude (in microvolts) of the N170 event related potential During each learning task
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