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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04508699
Other study ID # R21DC018865
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 31, 2024
Est. completion date July 31, 2025

Study information

Verified date April 2024
Source San Diego State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility 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 Design


Intervention

Other:
semantic learning
Experimental semantic learning from linguistic context task

Locations

Country Name City State
United States San Diego State University San Diego California

Sponsors (1)

Lead Sponsor Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean percent correct semantic meaning identification accuracy on the semantic learning task (did they identify when there was a meaning and when there was not) immediately following treatment, on the same day as treatment
Primary change in the N400 mean amplitude at the word being learned across presentations of the new word analysis of the N400 erp component related to attaching semantic meaning immediately following treatment, on the same day as treatment
Primary change in the alpha and theta band power at the word being learned across presentations of the new word analysis of the theta and alpha frequency bands related to attaching semantic meaning immediately following treatment, on the same day as treatment
Secondary Clinical Evaluation of Language Fundamentals - 5th edition standardized language omnibus measure baseline
Secondary Test of Integrated Language and Literacy Skills, Vocabulary awareness subtest standardized semantic knowledge measures baseline
Secondary Wechsler Intelligence Scale for Children - 5th edition, nonverbal index standardized nonverbal cognition assessment baseline
Secondary Nonword repetition task experimental task gauging phonological memory, participants are asked to repeat made up words baseline
Secondary Flanker inhibitory control and attention task Experimental measure of inhibition and attention baseline
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