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Recruiting NCT05268341

Neuroimaging Reveals Treatment-related Changes in DLD

No phase Interventional Developmental Language Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: My Sentence Builder.
Who it may be relevant to
Registry conditions: Developmental Language Disorder. Basic parameters: 48 months — 71 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral My Sentence Builder
    computer-assisted treatment program for expressive grammar

Primary outcome measures

  • Functional connectivity data (time 1) from typical and DLD preschoolers [Time frame: Time 1 (pre)]
  • 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)]
  • Functional connectivity data for typically developing and DLD preschoolers to assess changes in development [Time frame: pre-to-follow-up (up to 28 weeks)]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 6 centers
  • New Horizon Childcare — Cincinati
  • Empower Learn Create INC — Cincinnati
  • Cincinnati Children's Hospital — Cincinnati
  • CWFF CHild Development Center — Cincinnati
  • Wesley Education Center for Children and Families — Cincinnati
  • University of Cincinnati — Cincinnati

Identifiers

NCT: NCT05268341 · R01DC019337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗