NCT04508699

Brief Summary

School age children with developmental language disorder (DLD) have known semantic learning deficits but what is less well understood is why semantic learning is difficult for these children. This project will combine behavioral and brain methods to investigate the cognitive and linguistic processes underlying semantic learning in children with DLD compared to typically developing peers. The outcomes will have implications for semantic learning intervention approaches in DLD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2024

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

August 6, 2020

Results QC Date

October 25, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

Semantic LearningERPN400ERSP

Outcome Measures

Primary Outcomes (5)

  • Mean Percent Correct Semantic Meaning Identification

    Accuracy on the semantic learning task. Did they correctly identify when there was a meaning or did they say there was no meaning when there should have been one (incorrect response) Higher is better outcome

    immediately following treatment, on the same day as treatment, within 30 minutes

  • N400 Amplitude - Sentence 1

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 1 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    immediately following treatment, on the same day as treatment, within 30 minutes

  • Theta Changes

    Changes in theta band activity (measured in hertz) from sentence 1 to sentence 3, time locked to the final word in the sentence. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    immediately following treatment, on the same day as treatment, within 30 minutes

  • N400 Amplitude - Sentence 2

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 2 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    immediately following treatment, on the same day as treatment, within 30 minutes

  • N400 Amplitude - Sentence 3

    Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 3 collapsed across groups matched for age. Meaning plus condition only. Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

    immediately following treatment, on the same day as treatment, within 30 minutes

Secondary Outcomes (3)

  • General Language Level

    baseline

  • Nonverbal Cognition

    baseline

  • Nonword Repetition Task

    baseline

Study Arms (2)

Developmental language disorder

EXPERIMENTAL

Children with language impairment but in the absence of cognitive deficits

Other: semantic learning

Typical language

ACTIVE COMPARATOR

Children with typical language development and typical cognitive development

Other: semantic learning

Interventions

Experimental semantic learning from linguistic context task

Developmental language disorderTypical language

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • history of typical language development or history of language or literacy difficulties
  • must be willing to wear EEG cap
  • must be able to sit still for 1.5 hours to complete experimental tasks
  • must be literate

You may not qualify if:

  • neurological disorders (i.e., ASD, ADHD)
  • significant neurological history (i.e., head injury, epilepsy)
  • left handedness
  • primary language other than English
  • medication other than over-the-counter allergy medications
  • and/or nonverbal IQ less than 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
AVP for Research Support Services
Organization
San Diego State University

Study Officials

  • Alyson Abel, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Some participants and care providers might not be aware of their child's language impairment
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Compare behavioral and EEG outcomes of semantic learning in children with and without developmental language disorder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 11, 2020

Study Start

October 31, 2022

Primary Completion

May 31, 2023

Study Completion

October 8, 2024

Last Updated

December 13, 2024

Results First Posted

December 13, 2024

Record last verified: 2024-11

Locations