NCT05678634

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Jul 2023

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress67%
Jul 2023Oct 2027

First Submitted

Initial submission to the registry

January 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

January 3, 2023

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • FRN amplitude

    The amplitude (in microvolts) of the feedback related negativity (FRN) event related potential

    During each learning task

  • N170 amplitude

    The amplitude (in microvolts) of the N170 event related potential

    During each learning task

Study Arms (1)

Children with developmental language disorder

EXPERIMENTAL
Behavioral: Declarative learning with immediate feedbackBehavioral: Declarative learning with delayed feedbackBehavioral: Probabilistic learning with immediate feedbackBehavioral: Probabilistic learning with delayed feedbackBehavioral: Word learning task with active feedbackBehavioral: Word learning task with passive feedback

Interventions

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)

Children with developmental language disorder

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)

Children with developmental language disorder

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)

Children with developmental language disorder

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)

Children with developmental language disorder

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)

Children with developmental language disorder

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.

Children with developmental language disorder

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Hearing loss or other known neurological deficits, or diagnoses (e.g., Autism, Traumatic Brain Injury)
  • Evidence of color blindness as measured by the EnChroma computer base color blindness screening test for children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yael Arbel, PhD

    MGH Institute of Health Professions

    PRINCIPAL INVESTIGATOR

Central Study Contacts

research coordinator

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 10, 2023

Study Start

July 20, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations