Developmental Language DisorderNCT06968169
The Short-term Verbal Memory Endophenotype for Developmental Language Disorder Language Disorder
A study testing Supportive learning and Cascades in people with Developmental Language Disorder and Healthy Subjects, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder, Healthy Subjects
- What is being tested?
- Supportive learning and Cascades
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Has DLD or typical language development
Who cannot join
- Has not been exposed to English since birth
- Has other neurodevelopmental or sensory condition that could explain the language problem (e.g., intellectual disability, autism, hearing loss).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boys Town National Research Hospital
Omaha, Nebraska, 68131
About this study
Official title: The Short-term Verbal Memory Endophenotype for Developmental Language Disorder
The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary.
Read the detailed description
The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary.
Aims 1-3 include children with DLD and healthy children with typical language development. The general hypothesis is that the memory and attention challenges that characterize DLD, but not healthy development, affect the robustness of word learning. Aim 4 includes healthy children only to simulate the cascading effects of weak word learning on the broader linguistic system. The main questions this clinical trial aims to answer are:
What is the role of linguistic long-term memory in children's ability to hold new verbal information in short-term memory? What is the role of attention in children 's ability to hold new verbal information in short-term memory? What are the cascading effects of short-term verbal memory problems on the integrity of the language system?
In Aim 1a, researchers will compare syllable repetitions when those syllables do or do not have English-like prosody and do or do not have meaning to see if knowledge of prosody and word meaning supports accurate short-term memory.
In Aim 1b, researchers will compare the repetition of adjectives and nouns when those words do or do not have English-like grammar (i.e., when they are presented as adjective + noun rather than noun + adjective) to see if knowledge of word order supports accurate short-term memory.
In Aim 2, researchers will compare the syllable repetitions when those syllables are presented with or without attention cues and with or without a delay of 500msec between presentation and response to see if attention facilitates accurate short-term memory. The delay condition is intended to increase load on short-term memory.
In Aim 3, all measures are observational. The researchers will assess the child's long-term memory of language, attention skills, and verbal short-term memory to see if children with DLD but good attention skills are able to perform well on short-term memory tasks.
In Aim 4, researchers will compare the ability of children to comprehend newly learned words that are taught via active retrieval or passive study. Active retrieval yields more robust learning, and passive study yields weaker learning. The goal is to compare how well children use those newly learned words to recall semantic category information (e.g., was it a bug or a bird) and comprehend sentences to see if the weak word learning has cascading impacts beyond learning the word itself.
- Conditions
- Developmental Language Disorder, Healthy Subjects
- Being tested
- Supportive learning, Cascades
- Keywords
- nonword repetition, word learning, memory, attention
- 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.
Supportive learningBehavioural
All interventions are manipulations to the stimuli that the child hears with the goal of discovering which manipulations support verbal learning.
CascadesBehavioural
The intervention is a manipulation of word instruction with the goal of discovering whether weaker word learning results in cascading effects on semantic category memory and sentence comprehension.
| Study group | Role | What they receive |
|---|---|---|
| Prosody | Experimental | In Aim 1a, the syllables to be repeated are presented with English-like prosody or list-like prosody. Receives: Behavioral: Supportive learning |
| Meaning | Experimental | In Aim 1a, the syllables to be repeated will have meaning (e.g., neck) or no meaning (e.g., ba). Receives: Behavioral: Supportive learning |
| Grammar | Experimental | In Aim 1b, the syllables to be repeated are English adjectives and nouns. They will be presented to obey English grammar (e.g., happy pencil) or not (e.g., pencil happy). Receives: Behavioral: Supportive learning |
| Attention | Experimental | In Aim 2, the syllables to be repeated will be presented in the 'baseline' condition or an 'attention-grabbing' condition. The attention grabbers are a reduction in the audio signal of 10dB (so that the child must listen carefully) and a visual cue (a cartoon character with large ears to cue listening carefully). Receives: Behavioral: Supportive learning |
| Encoding | Experimental | In Aim 4, new words will be learned from instruction that involves active practice (high encoding condition) or passive study (low encoding condition). Receives: Behavioral: Cascades |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Syllable Repetition
Number of syllables pronounced correctly.
Measured: Day 1
Accuracy of Word Comprehension
Number of correct answers on a 4-alternative-forced-choice word comprehension probe.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start9 Feb 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Aims 1 and 2 are single group interventions. Aim 3 is not an intervention. Aim 4 is a parallel intervention.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Karla McGregor, Ph.D., Principal investigator, Boystown National Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968169
- Sponsor's protocol ID
- 24-18-XP
- Other IDs
- R01DC011742
- Status last verified
- May 2025
- First submitted
- 24 Feb 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share research data generated and metadata and descriptors. The purpose is to make shared data meaningful and usable by other researchers. The data will be behavioral data generated from clinical measures and behavioral experiments. The data will consist of numbers (e.g., accuracy levels, scores), demographic descriptors (e.g., age and sex), and audio files of children's repetitions of word- and nonword syllables. De-identified, individual-level raw data will be shared publicly. Audio files will be shared under a data agreement only.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Verbal Memory Endophenotype for Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT06968169
- Acronym / sponsor ID
- 24-18-XP
- Conditions
- Developmental Language Disorder, Healthy Subjects
- Keywords
- nonword repetition, word learning, memory, attention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Collaborators
- University of Iowa, National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary.
Detailed description
The goal of this clinical trial is to determine how memory and attention affect the ability of children with developmental language disorder (DLD) to learn and use new vocabulary.
Aims 1-3 include children with DLD and healthy children with typical language development. The general hypothesis is that the memory and attention challenges that characterize DLD, but not healthy development, affect the robustness of word learning. Aim 4 includes healthy children only to simulate the cascading effects of weak word learning on the broader linguistic system. The main questions this clinical trial aims to answer are:
What is the role of linguistic long-term memory in children's ability to hold new verbal information in short-term memory? What is the role of attention in children 's ability to hold new verbal information in short-term memory? What are the cascading effects of short-term verbal memory problems on the integrity of the language system?
In Aim 1a, researchers will compare syllable repetitions when those syllables do or do not have English-like prosody and do or do not have meaning to see if knowledge of prosody and word meaning supports accurate short-term memory.
In Aim 1b, researchers will compare the repetition of adjectives and nouns when those words do or do not have English-like grammar (i.e., when they are presented as adjective + noun rather than noun + adjective) to see if knowledge of word order supports accurate short-term memory.
In Aim 2, researchers will compare the syllable repetitions when those syllables are presented with or without attention cues and with or without a delay of 500msec between presentation and response to see if attention facilitates accurate short-term memory. The delay condition is intended to increase load on short-term memory.
In Aim 3, all measures are observational. The researchers will assess the child's long-term memory of language, attention skills, and verbal short-term memory to see if children with DLD but good attention skills are able to perform well on short-term memory tasks.
In Aim 4, researchers will compare the ability of children to comprehend newly learned words that are taught via active retrieval or passive study. Active retrieval yields more robust learning, and passive study yields weaker learning. The goal is to compare how well children use those newly learned words to recall semantic category information (e.g., was it a bug or a bird) and comprehend sentences to see if the weak word learning has cascading impacts beyond learning the word itself.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Aims 1 and 2 are single group interventions. Aim 3 is not an intervention. Aim 4 is a parallel intervention.
| Arm | Type | Receives |
|---|---|---|
| Prosody | Experimental | Behavioral: Supportive learningIn Aim 1a, the syllables to be repeated are presented with English-like prosody or list-like prosody. |
| Meaning | Experimental | Behavioral: Supportive learningIn Aim 1a, the syllables to be repeated will have meaning (e.g., neck) or no meaning (e.g., ba). |
| Grammar | Experimental | Behavioral: Supportive learningIn Aim 1b, the syllables to be repeated are English adjectives and nouns. They will be presented to obey English grammar (e.g., happy pencil) or not (e.g., pencil happy). |
| Attention | Experimental | Behavioral: Supportive learningIn Aim 2, the syllables to be repeated will be presented in the 'baseline' condition or an 'attention-grabbing' condition. The attention grabbers are a reduction in the audio signal of 10dB (so that the child must listen carefully) and a visual cue (a cartoon character with large ears to cue listening carefully). |
| Encoding | Experimental | Behavioral: CascadesIn Aim 4, new words will be learned from instruction that involves active practice (high encoding condition) or passive study (low encoding condition). |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Has DLD or typical language development
Key exclusion criteria (2 listed)
- Has not been exposed to English since birth
- Has other neurodevelopmental or sensory condition that could explain the language problem (e.g., intellectual disability, autism, hearing loss).
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 |
|---|---|---|
| Supportive learningAll interventions are manipulations to the stimuli that the child hears with the goal of discovering which manipulations support verbal learning. | Behavioural | Attention, Grammar, Meaning, Prosody |
| CascadesThe intervention is a manipulation of word instruction with the goal of discovering whether weaker word learning results in cascading effects on semantic category memory and sentence comprehension. | Behavioural | Encoding |
Primary outcome
Accuracy of Syllable Repetition
Time frame: Day 1
Number of syllables pronounced correctly.
Accuracy of Word Comprehension
Time frame: Day 2
Number of correct answers on a 4-alternative-forced-choice word comprehension probe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Yes. The study team will share research data generated and metadata and descriptors. The purpose is to make shared data meaningful and usable by other researchers. The data will be behavioral data generated from clinical measures and behavioral experiments. The data will consist of numbers (e.g., accuracy levels, scores), demographic descriptors (e.g., age and sex), and audio files of children's repetitions of word- and nonword syllables. De-identified, individual-level raw data will be shared publicly. Audio files will be shared under a data agreement only.
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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.
Karla McGregor, Ph.D. principal investigator
Boystown National Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive learning and Cascades in people with Developmental Language Disorder and Healthy Subjects, run by Father Flanagan's Boys' Home 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (531-355-5068, karla.mcgregor@boystown.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Syllable Repetition (time frame: Day 1). The study lists 2 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 May 2025.