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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
New Horizon Childcare
Cincinati, Ohio, 45207
Sherry Bell, 513-861-5284, sherrybell6489@gmail.com
- Recruiting
Empower Learn Create INC
Cincinnati, Ohio, 45220
Sandy Paul, 513-961-2825, spaul@empowerlearncreate.org
Audrey Wilson, 513-961-2825, awilson@empowerlearncreate.org
- Not yet recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Claire Miller, PhD, 513-636-8409, clarie.miller@cchmc.org
- 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
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.
- Conditions
- Developmental Language Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | computer assisted intervention targeting expressive grammar for preschoolers with DLD Receives: Behavioral: My Sentence Builder |
| No treatment | No intervention | business as usual classroom (educational) services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted7 Mar 2022
- Study start24 May 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Toronto
- Responsible party
- Principal investigator, Karla Washington, University of Cincinnati
- Investigators
- Karla N Washington, PhD, Principal investigator, University of Cincinnati
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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Reveals Treatment-related Changes in DLD
- ClinicalTrials.gov ID
- NCT05268341
- Acronym / sponsor ID
- R01DC019337
- Conditions
- Developmental Language Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Toronto
- Study start
- 24 May 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Mar 2022 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: My Sentence Buildercomputer assisted intervention targeting expressive grammar for preschoolers with DLD |
| No treatment | No intervention | –business as usual classroom (educational) services |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- receiving co-occurring speech-language or other intervention for communication
- not MRI safe
- special education placement of child based on ability or behavior
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 |
|---|---|---|
| My Sentence Buildercomputer-assisted treatment program for expressive grammar | Behavioural | Treatment |
Primary outcome
Functional connectivity data (time 1) from typical and DLD preschoolers
Time frame: Time 1 (pre)
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
Functional connectivity data DLD preschoolers only to assess changes with treatment
Time frame: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
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.
Functional connectivity data for typically developing and DLD preschoolers to assess changes in development
Time frame: pre-to-follow-up (up to 28 weeks)
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.
13 secondary outcomes
Structural connectivity data for typically developing and DLD preschoolers
Time frame: Pre/Time 1 (up to 3-weeks)
Structural connectivity data for DLD preschoolers only to assess changes with treatment
Time frame: pre-to-post (up to 14-weeks) and post-to-follow-up (at 27 to 28 weeks)
Structural connectivity data for typically developing and DLD preschoolers to assess development and disorder over time.
Time frame: pre-to-followup (up to 28-weeks)
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
Time frame: Pre/Time 1 (up to 3-weeks)
Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development
Time frame: Pre/Time 1 (up to 3-weeks)
Raw score on the DSS for typically developing and DLD preschoolers to assess development
Time frame: Pre/Time 1 (up to 3-weeks)
Percent correct on a grammar screener for DLD preschoolers only to identify treatment targets
Time frame: Pre/Time 1 (up to 3-weeks)
Percent correct on a grammar task for DLD preschoolers only
Time frame: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Raw score on the SPELT-3 for DLD preschoolers only to assess change with treatment
Time frame: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Raw score on the DSS for DLD preschoolers only to assess change with treatment
Time frame: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
Time frame: pre-to-followup (up to 28-weeks)
Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development
Time frame: pre-to-followup (up to 28-weeks)
Raw score on the DSS for typically developing and DLD preschoolers to assess development
Time frame: pre-to-followup (up to 28-weeks)
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 26 May 2026.
- Individual participant dataSharing planned: No
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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 N Washington, PhD principal investigator
University of Cincinnati
6 sites in 1 country: see every site and its status.
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.