Neuroimaging Reveals Treatment-related Changes in DLD
ConditionDevelopmental Language Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age48-71
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ages 48-71 months
average nonverbal intelligence quotient (IQ)
enrolled in participating center
typically developing (receptive and expressive language, social, articulation, other)
Disqualifiers
receiving co-occurring speech-language or other intervention for communication
not MRI safe
special education placement of child based on ability or behavior
Trial design
Design model
Parallel
Treatments tested in this trial
My Sentence Builder
Behavioralcomputer-assisted treatment program for expressive grammar
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: No treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
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
Time frame
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.
Time frame
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.
Time frame
pre-to-follow-up (up to 28 weeks)Secondary outcomes
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
Time frame
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
Time frame
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
Time frame
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
Time frame
Pre/Time 1 (up to 3-weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov