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NCT Number: NCT05268341

Neuroimaging Reveals Treatment-related Changes in DLD

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.

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Key information

Age range

48 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Horizon Childcare, Cincinati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • typical social/pragmatics skills
  • average hearing thresholds
  • monolingual and native Standard English speakers
  • does not have any uncorrected vision challenges

Exclusion criteria

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

Treatment and study plan

My Sentence Builder

Behavioral

computer-assisted treatment program for expressive grammar

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Structural connectivity data for typically developing and DLD preschoolers

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

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

  2. 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)

    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

  3. 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)

    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

  4. 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)

    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

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

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

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

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

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

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

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

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

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

  8. 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)

    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.

  9. 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)

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

  10. 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)

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

  11. 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)

    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

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

    Time frame: pre-to-followup (up to 28-weeks)

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

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

    Time frame: pre-to-followup (up to 28-weeks)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer J Vannest, PhD

CONTACT

[email protected]

513-558-8518

Karla N Washington, PhD

CONTACT

[email protected]

513-558-8533

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • University of Toronto

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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