Neuroimaging Reveals Treatment-related Changes in DLD
1 other identifier
interventional
184
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 6, 2025
May 1, 2025
5.1 years
February 10, 2022
May 1, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 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.
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.
pre-to-follow-up (up to 28 weeks)
Secondary Outcomes (13)
Structural connectivity data for typically developing and DLD preschoolers
Pre/Time 1 (up to 3-weeks)
Structural connectivity data for DLD preschoolers only to assess changes with treatment
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.
pre-to-followup (up to 28-weeks)
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
Pre/Time 1 (up to 3-weeks)
Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development
Pre/Time 1 (up to 3-weeks)
- +8 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALcomputer assisted intervention targeting expressive grammar for preschoolers with DLD
No treatment
NO INTERVENTIONbusiness as usual classroom (educational) services
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- receiving co-occurring speech-language or other intervention for communication
- not MRI safe
- special education placement of child based on ability or behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- Children's Hospital Medical Center, Cincinnaticollaborator
- University of Torontocollaborator
Study Sites (6)
New Horizon Childcare
Cincinati, Ohio, 45207, United States
Empower Learn Create INC
Cincinnati, Ohio, 45220, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
CWFF CHild Development Center
Cincinnati, Ohio, 45229, United States
Wesley Education Center for Children and Families
Cincinnati, Ohio, 45229, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karla N Washington, PhD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 7, 2022
Study Start
May 24, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share