- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508699
Semantic Learning Deficits in School Age Children With Developmental Language Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project will elucidate deficits in learning semantic information in developmental language disorder (DLD, formerly referred to as specific language impairment) by combining behavioral and neural measures to examine differences in the semantic learning process between school-age children with and without DLD. Vocabulary knowledge, particularly semantic knowledge, has a critical influence on reading comprehension and academic success. Despite the strong association between vocabulary knowledge and academic success, vocabulary is an under-recognized area of deficit in school-age children with DLD. Younger children with DLD have well-established deficits in vocabulary and word learning and weaknesses in semantic knowledge. Additionally, the rate of vocabulary growth in children with DLD decreases compared to typically developing peers around age 10 and semantic representations of known vocabulary items are sparse. Even with this knowledge, the field's ability to make progress toward improved semantic learning in school age DLD is hindered by the lack of basic information on the underlying nature of the semantic learning deficits in this population. This project establishes how and why semantic learning differs between school-age children with and without DLD, providing a much-needed theoretical foundation for clinical research.
Storkel, expanding on an adult word learning model by Leach and Samuel, provides a clearly testable account of word learning that has been used with children with DLD. This account involves three processes: 1) triggering, in which a new lexical encounter is compared to existing lexical representations, 2) configuration, which adds information to the expanding lexical representation, and 3) engagement, which examines how the new lexical representation behaves dynamically with existing representations. The configuration process is arguably the most critical for semantic development. Successful configuration requires the simultaneous engagement of cognitive and linguistic processes, such as attention, inhibition, working memory, and semantic and syntactic processing. While it is widely accepted that configuration is the most affected word learning process in DLD, what is unknown is what underlies deficits in configuration and whether these deficits vary across the DLD profile. These questions are further compounded by difficulty measuring configuration and associated processes, given that they are largely internal, and therefore invisible. Electroencephalography (EEG) addresses this invisibility problem by allowing for a real-time examination of unconscious levels of semantic learning and cognitive and linguistic processes. A combined EEG-behavioral methods approach can illustrate how children with DLD are approaching configuration in terms of the relative contribution of these processes. The central hypothesis of this research is that children with DLD engage cognitive and linguistic processes at different points during configuration compared to their typical peers, resulting in poorer semantic learning outcomes.
To test the central hypothesis, the investigators will record behavioral and EEG data from 10-12 year old children with DLD and typical-language peers as they complete a semantic learning task. This age aligns with the point where vocabulary growth rates in DLD further diverge from typical peers [6]. In the semantic learning task, children listen to sets of three sentences that all end with the same nonword: half of the sentence triplets support learning meaning of the nonword, half do not. The investigators will analyze EEG data for event-related potentials (ERPs) as well as changes in neural oscillations (time frequency analysis). The investigators will combine EEG and behavioral measures to examine the following aims:
Aim 1. To investigate the cognitive and linguistic processes underlying configuration in children with DLD and typical language (TL) peers. This aim will include data from the semantic learning task. Based on the assessment of behavioral outcomes, the investigators predict that the TL group will be more accurate in semantic learning than the DLD group. ERP analyses will focus on the N400 component, associated with semantic processing. Time frequency analysis will focus on changes in the theta (4-8 Hz) and alpha (8-12 Hz) frequency bands, typically associated with lexical retrieval and attention/inhibition, respectively. For both neural measures, the investigators predict engagement of the same components (N400, theta, alpha) across groups but different patterns of change in those components during configuration between groups.
Aim 2. To investigate individual differences in configuration in children with DLD and TL peers. This aim will include data from the semantic learning task and a behavioral assessment battery. Assessment of behavioral data will focus the types of errors children make during semantic learning. The investigators expect that children with DLD will provide incorrect meanings for the nonword that best fit with the first sentence in the triplet and that TL children will provide incorrect meanings that best fit with the last sentence. The investigators will also examine individual differences related to semantic learning outcomes and fine-grained differences in N400 learning effects across groups. Here, the investigators expect that individual differences in general language ability and semantic knowledge, measured via the behavioral assessment battery, will be most predictive of both behavioral semantic learning and N400 change during learning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92182
- San Diego State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Developmental language disorder
Children with language impairment but in the absence of cognitive deficits
|
Experimental semantic learning from linguistic context task
|
|
Active Comparator: Typical language
Children with typical language development and typical cognitive development
|
Experimental semantic learning from linguistic context task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Percent Correct Semantic Meaning Identification
Time Frame: immediately following treatment, on the same day as treatment, within 30 minutes
|
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
Time Frame: immediately following treatment, on the same day as treatment, within 30 minutes
|
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
Time Frame: immediately following treatment, on the same day as treatment, within 30 minutes
|
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
Time Frame: immediately following treatment, on the same day as treatment, within 30 minutes
|
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
Time Frame: immediately following treatment, on the same day as treatment, within 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Language Level
Time Frame: baseline
|
Full measure title: Clinical Evaluation of Language Fundamentals - 5th edition Standardized language omnibus measure Raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 80 is considered in the sub-clinical range indicating the presence of a language disorder
|
baseline
|
|
Nonverbal Cognition
Time Frame: baseline
|
Full measure title: Wechsler Intelligence Scale for Children - 5th edition Nonverbal index subtests administered, considered the nonverbal subscale For the nonverbal subscale, raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 70 is considered in the sub-clinical range indicating the presence of intellectual disability
|
baseline
|
|
Nonword Repetition Task
Time Frame: baseline
|
experimental task gauging phonological memory
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alyson Abel, PhD, San Diego State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DC018865 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Developmental Language Disorder
-
University College CorkNational University of Ireland, Galway, IrelandNot yet recruitingDevelopmental Language Disorder and Language Impairment | DeprivationIreland
-
University of IoanninaDOTSOFT SA - GR; TELEGLOBAL LP - GR; Region of Epirus (Regional Operational Programme... and other collaboratorsCompletedDevelopmental Articulation Disorder | Developmental Language Disorders | Speech Disorder | Neurodevelopmental Disorder (Diagnosis)Greece
-
Purdue UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingDevelopmental Language Disorder and Language Impairment | Language Development | Specific Language ImpairmentUnited States
-
Heidelberg UniversityUnknownLanguage Delay | Developmental Language DisordersGermany
-
University of Sao PauloCompletedDevelopmental Language DisordersBrazil
-
Ohio UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingDevelopmental Language DisordersUnited States
-
Russian Academy of Medical SciencesCompletedAutism Spectrum Disorder | Language Delay | Language; Developmental Disorder, Expressive | Language; Developmental Disorder, Receptive | Attention Deficit-Hyperactivity Disorder | Speech Disorders in ChildrenRussian Federation
-
Centre Hospitalier Universitaire de la RéunionCompletedLanguage Disorders in Children | Learning; Developmental DisorderRéunion
-
Vanderbilt UniversityCompletedLanguage Developmental DisordersUnited States
-
Nanyang Technological UniversityCompletedDevelopmental Language Disorder and Language Impairment | Anxiety Disorders and SymptomsSingapore
Clinical Trials on semantic learning
-
University Hospital, ToulouseRecruitingPrimary Progressive AphasiaFrance
-
Penn State UniversityCompleted
-
University Hospital, ToulouseRecruiting
-
Boston University Charles River CampusNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingBilingualism | Vocabulary Acquisition | Late Talkers | Network ScienceUnited States
-
Vanderbilt University Medical CenterCompletedDown Syndrome | Language Development Disorders | Child LanguageUnited States
-
Georgetown UniversityJohns Hopkins University; National Institute on Aging (NIA); National Institute...CompletedAlzheimer Disease | Aphasia, Primary Progressive | AnomiaUnited States
-
Göteborg UniversityThe Swedish Research Council; Swedish Council for Working Life and Social ResearchCompletedStroke | Multiple Sclerosis | Parkinson Disease | Aphasia | AnomiaSweden
-
Istanbul UniversityRecruiting
-
Boston University Charles River CampusNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance