The Short-term Verbal Memory Endophenotype for Developmental Language Disorder Language Disorder
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2025
CompletedFirst Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
May 13, 2025
May 1, 2025
4.3 years
February 24, 2025
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Accuracy of Syllable Repetition
Number of syllables pronounced correctly.
Day 1
Accuracy of Word Comprehension
Number of correct answers on a 4-alternative-forced-choice word comprehension probe.
Day 2
Study Arms (5)
Prosody
EXPERIMENTALIn Aim 1a, the syllables to be repeated are presented with English-like prosody or list-like prosody.
Meaning
EXPERIMENTALIn Aim 1a, the syllables to be repeated will have meaning (e.g., neck) or no meaning (e.g., ba).
Grammar
EXPERIMENTALIn 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
EXPERIMENTALIn 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
EXPERIMENTALIn Aim 4, new words will be learned from instruction that involves active practice (high encoding condition) or passive study (low encoding condition).
Interventions
All interventions are manipulations to the stimuli that the child hears with the goal of discovering which manipulations support verbal learning.
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.
Eligibility Criteria
You may qualify if:
- Has DLD or typical language development
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Father Flanagan's Boys' Homelead
- University of Iowacollaborator
- National Institutes of Health (NIH)collaborator
- National Institute on Deafness and Other Communication Disorders (NIDCD)collaborator
Study Sites (1)
Boys Town National Research Hospital
Omaha, Nebraska, 68131, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karla McGregor, Ph.D.
Boystown National Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
May 13, 2025
Study Start
February 9, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The start date is 2-20-2026. The end date is 50 years later.
- Access Criteria
- To maximize the benefits of data sharing, the team will share data as broadly as possible to the extent consistent with applicable laws, regulations, rules, and policies. Anyone, including members of the general public, will have access to all of the de-identified data in the form of numbers (e.g., test scores). No video files will be shared. Audio files will be shared with those who qualify and seek permission via a data-sharing agreement. The data-sharing agreement provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. The publicly available data and the data sharing agreement will be accessible in a public-facing Collection in Open Science Framework (osf.io).
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.