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Developmental Language DisorderNCT05268341

Neuroimaging Reveals Treatment-related Changes in DLD

A study testing My Sentence Builder in people with Developmental Language Disorder, run by University of Cincinnati at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Children with developmental language disorders (DLD, aka specific language impairment), a prevalent pediatric disorder, experience hallmark grammar deficits with life-long impacts on educational and occupational outcomes. Read more about this study

Who is it for?
Ages 48 to 71 monthsHealthy volunteers can take part
Conditions the study is for
Developmental Language Disorder
What is being tested?
My Sentence Builder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesUnited States
Study dates
24 May 2022to 30 Jun 2027
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 48 to 71 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • ages 48-71 months
  • average nonverbal intelligence quotient (IQ)
  • enrolled in participating center
  • typically developing (receptive and expressive language, social, articulation, other)
  • DLD for expressive grammar
  • typical oral motor function
Show all 10Show fewer
  • typical social/pragmatics skills
  • average hearing thresholds
  • monolingual and native Standard English speakers
  • does not have any uncorrected vision challenges

Who cannot join

  • receiving co-occurring speech-language or other intervention for communication
  • not MRI safe
  • special education placement of child based on ability or behavior

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karla N Washington, PhD contact

513-558-8533

washink2@ucmail.uc.edu

Jennifer J Vannest, PhD contact

513-558-8518

vannesjr@ucmail.uc.edu

6 sites in 1 country

United States6 sites, 6 recruiting
  • New Horizon Childcare

    Cincinati, Ohio, 45207

    Sherry Bell, 513-861-5284, sherrybell6489@gmail.com

    Not yet recruiting
  • Empower Learn Create INC

    Cincinnati, Ohio, 45220

    Sandy Paul, 513-961-2825, spaul@empowerlearncreate.org

    Audrey Wilson, 513-961-2825, awilson@empowerlearncreate.org

    Recruiting
  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Claire Miller, PhD, 513-636-8409, clarie.miller@cchmc.org

    Not yet recruiting
  • CWFF CHild Development Center

    Cincinnati, Ohio, 45229

    Robin Brandy, 513-569-5662 ext. 18, cwffchilddevelopment@gmail.com

    Recruiting
  • Wesley Education Center for Children and Families

    Cincinnati, Ohio, 45229

    Carla Butler, 513-845-7990, crbutler0915@yahoo.com

    Recruiting
  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Amber Yusko, MA, 513-558-1416, meadowae@ucmail.uc.edu

    Linda Roedig, 513-558-8503, roedigla@ucmail.uc.edu

    Recruiting

Other trials in United States

About this study

Children with developmental language disorders (DLD, aka specific language impairment), a prevalent pediatric disorder, experience hallmark grammar deficits with life-long impacts on educational and occupational outcomes. While effective and early interventions can mitigate the impact of DLD, not enough is known about the neural basis of DLD in young children, yet is needed to inform the design of more individualized interventions. This project uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie grammar learning and impairment, while also considering their association to treatment-related changes in preschoolers with DLD.

Read the detailed description

Although the impact of developmental language disorder (DLD), a prevalent preschool disorder, can be mitigated through evidence-based and early interventions, little is known about the neural basis of DLD, especially in young children, yet is useful in the design of efficacious treatments. While much of the evidence has been furnished by studies examining domain-specific processes (language network), domain-general processes relating memory and language also offer valuable testing ground and present the opportunity to advance the current knowledge base. The Procedural circuit Deficit Hypothesis (PDH) posits that grammar deficits are explained by an impairment of procedural memory (rule learning, "knowing how"). This impairment is associated with structural abnormalities in connections between frontal brain regions and basal ganglia, with corresponding underactivation and reduced functional connectivity. However, the declarative memory system (semantic, "knowing what"), supported by cortical and subcortical regions in the temporal lobes, including hippocampus, is spared, acting as a compensatory mechanism to offset grammar deficits.

This proposed research will use neuroimaging (functional MRI and diffusion imaging) to describe the neural basis (functional and structural connectivity) of grammar learning and treatment-related change by way of the PDH. The investigators will gather critical data regarding grammar learning in preschoolers with DLD before, after, and following a break in intervention (computer-assisted treatment: DLD treatment; "business as usual": DLD no treatment) as part of a randomized controlled trial. The investigators will also include typically developing (TD) peers to inform development vs disorder. Our central hypothesis is that treatment designed to improve grammar learning will normalize the procedural learning network in association with increases in language function and that the degree of improvement may be associated with the underlying neurobiology of baseline grammar deficits.

Building on a robust history of recruitment and treatment of preschoolers with DLD, the investigators will enroll 184 preschoolers, 100 with DLD (n=50 treatment; n=50 no treatment controls) and 84 TD. Aim 1 will establish the relationship between functional and structural connectivity for preschoolers with DLD and their TD peers between regions in the procedural learning and declarative networks. In Aim 2, the investigators will establish the neurobiological basis of treatment-related changes in DLD only. The investigators examine potential changes in functional and structural connectivity between regions of the procedural learning and declarative memory networks, and investigate whether treatment-related changes occur into the typical range (DLD and TD). To meet our scientific goals, the investigators pair behavioral tools (traditional grammar tools) with neuroimaging to describe co-occurring behavioral performance underlying learning and outcome. This research will contribute novel insights into mechanisms underlying learning and impairment to help advance the evidence-based management of DLD.

Being tested
My Sentence Builder
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.

  • My Sentence BuilderBehavioural

    computer-assisted treatment program for expressive grammar

Study groups in NCT05268341
Study groupRoleWhat they receive
TreatmentExperimentalcomputer assisted intervention targeting expressive grammar for preschoolers with DLD
Receives: Behavioral: My Sentence Builder
No treatmentNo interventionbusiness as usual classroom (educational) services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional connectivity data (time 1) from typical and DLD preschoolers

    Aim 1 (all TD and DLD preschoolers)- Primary: Pre/Time 1 data for functional connectivity (assessed using fMRI from the Sentence Completion Expressive Language Task- Preschool (SCELT-P)) between Regions of Interest (ROI) in the procedural learning network and in the declarative memory network

    Measured: Time 1 (pre)

  2. Functional connectivity data DLD preschoolers only to assess changes with treatment

    Primary: Pre-to-post changes and maintenance of changes post-to-followup in functional connectivity (assessed using fMRI from the SCELT-P) between ROI within the procedural learning network and within the declarative memory network.

    Measured: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)

  3. Functional connectivity data for typically developing and DLD preschoolers to assess changes in development

    Changes in development (pre-to-followup) in functional connectivity (assessed using fMRI from the SCELT-P) between ROI within the procedural learning and declarative memory networks.

    Measured: pre-to-follow-up (up to 28 weeks)

Secondary outcomes (13)
  1. Structural connectivity data for typically developing and DLD preschoolers

    Main Secondary: structural connectivity (assessed using diffusion imaging) between anatomically-selected ROI in the procedural learning and declarative memory networks

    Measured: Pre/Time 1 (up to 3-weeks)

  2. Structural connectivity data for DLD preschoolers only to assess changes with treatment

    Main Secondary Pre-to-post changes and maintenance of changes post-to-followup in structural connectivity (assessed using diffusion imaging) between anatomically-selected ROI in the procedural learning network and declarative memory network

    Measured: pre-to-post (up to 14-weeks) and post-to-follow-up (at 27 to 28 weeks)

  3. Structural connectivity data for typically developing and DLD preschoolers to assess development and disorder over time.

    Main Secondary: Changes in development (pre-to-followup) in structural connectivity (assessed using diffusion imaging) between anatomically-selected ROI in the procedural learning network and in the declarative memory network

    Measured: pre-to-followup (up to 28-weeks)

  4. Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.

    Additional secondary outcomes raw score on the PI-designed 45-item grammar probe (%correct for each of the three target forms, 15-forms per target). Scores are combine to get a total score on the task

    Measured: Pre/Time 1 (up to 3-weeks)

  5. Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development

    Additional secondary outcomes raw score a standard grammar test (SPELT-3)

    Measured: Pre/Time 1 (up to 3-weeks)

  6. Raw score on the DSS for typically developing and DLD preschoolers to assess development

    Additional secondary outcomes raw score a standard play based task (DSS) to assess development and disorder

    Measured: Pre/Time 1 (up to 3-weeks)

  7. Percent correct on a grammar screener for DLD preschoolers only to identify treatment targets

    Additional secondary outcomes: raw change score on the PI-designed grammar probe

    Measured: Pre/Time 1 (up to 3-weeks)

  8. Percent correct on a grammar task for DLD preschoolers only

    Additional secondary outcomes raw score on the PI-designed 45-item grammar probe (%correct for each of the three target forms, 15-forms per target). Scores are combine to get a total score on the task.

    Measured: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)

  9. Raw score on the SPELT-3 for DLD preschoolers only to assess change with treatment

    Additional secondary outcomes raw score a standard grammar test (SPELT-3)

    Measured: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)

  10. Raw score on the DSS for DLD preschoolers only to assess change with treatment

    Additional secondary outcomes raw score a standard play based task (DSS) to assess changes with treatment

    Measured: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)

  11. Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.

    Additional secondary outcomes raw score on the PI-designed 45-item grammar probe (%correct for each of the three target forms, 15-forms per target). Scores are combine to get a total score on the task

    Measured: pre-to-followup (up to 28-weeks)

  12. Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development

    Additional secondary outcomes raw score a standard grammar test (SPELT-3)

    Measured: pre-to-followup (up to 28-weeks)

  13. Raw score on the DSS for typically developing and DLD preschoolers to assess development

    Additional secondary outcomes raw score a standard play based task (DSS) to assess development and disorder

    Measured: pre-to-followup (up to 28-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start24 May 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268341
Sponsor's protocol ID
R01DC019337
Status last verified
May 2026
First submitted
10 Feb 2022
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing My Sentence Builder in people with Developmental Language Disorder, run by University of Cincinnati at 6 sites 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 10 inclusion and 3 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 Karla N Washington, PhD (513-558-8533, washink2@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional connectivity data (time 1) from typical and DLD preschoolers (time frame: Time 1 (pre)). The study lists 3 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 26 May 2026.

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