Developmental Language DisorderNCT04508699
Semantic Learning Deficits in School Age Children With Developmental Language Disorder
A study testing semantic learning in people with Developmental Language Disorder, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- semantic learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
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.
Read the 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.
- Conditions
- Developmental Language Disorder
- Being tested
- semantic learning
- Keywords
- Semantic Learning, ERP, N400, ERSP
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semantic learningOther
Experimental semantic learning from linguistic context task
| Study group | Role | What they receive |
|---|---|---|
| Developmental language disorder | Experimental | Children with language impairment but in the absence of cognitive deficits Receives: Other: semantic learning |
| Typical language | Active comparator | Children with typical language development and typical cognitive development Receives: Other: semantic learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately following treatment, on the same day as treatment, within 30 minutes
Secondary outcomes (3)
General Language Level
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
Measured: baseline
Nonverbal Cognition
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
Measured: baseline
Nonword Repetition Task
experimental task gauging phonological memory
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start31 Oct 2022
- Primary completion31 May 2023
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compare behavioral and EEG outcomes of semantic learning in children with and without developmental language disorder
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyson Abel Mills, San Diego State University
- Investigators
- Alyson Abel, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508699
- Sponsor's protocol ID
- R21DC018865
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2020
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semantic Learning Deficits in School Age Children With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT04508699
- Acronym / sponsor ID
- R21DC018865
- Conditions
- Developmental Language Disorder
- Keywords
- Semantic Learning, ERP, N400, ERSP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Compare behavioral and EEG outcomes of semantic learning in children with and without developmental language disorder
| Arm | Type | Receives |
|---|---|---|
| Developmental language disorder | Experimental | Other: semantic learningChildren with language impairment but in the absence of cognitive deficits |
| Typical language | Active comparator | Other: semantic learningChildren with typical language development and typical cognitive development |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semantic learningExperimental semantic learning from linguistic context task | Other | Developmental language disorder, Typical language |
Primary outcome
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
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.
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.
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.
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.
3 secondary outcomes
General Language Level
Time frame: baseline
Nonverbal Cognition
Time frame: baseline
Nonword Repetition Task
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson Abel, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semantic learning in people with Developmental Language Disorder, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Correct Semantic Meaning Identification (time frame: immediately following treatment, on the same day as treatment, within 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.