Neuroimaging Reveals Treatment-related Changes in DLD
Primary Purpose
Developmental Language Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Sentence Builder
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Language Disorder
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
Sites / Locations
- New Horizon Childcare
- Empower Learn Create INCRecruiting
- Cincinnati Children's Hospital
- CWFF CHild Development CenterRecruiting
- Wesley Education Center for Children and FamiliesRecruiting
- University of CincinnatiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
No treatment
Arm Description
computer assisted intervention targeting expressive grammar for preschoolers with DLD
business as usual classroom (educational) services
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
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
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
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
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
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)
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
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
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.
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)
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
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
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)
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
Full Information
NCT ID
NCT05268341
First Posted
February 10, 2022
Last Updated
July 25, 2022
Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05268341
Brief Title
Neuroimaging Reveals Treatment-related Changes in DLD
Official Title
Neuroimaging Reveals Treatment-related Changes in DLD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati, University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
computer assisted intervention targeting expressive grammar for preschoolers with DLD
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
business as usual classroom (educational) services
Intervention Type
Behavioral
Intervention Name(s)
My Sentence Builder
Intervention Description
computer-assisted treatment program for expressive grammar
Primary Outcome Measure Information:
Title
Functional connectivity data (time 1) from typical and DLD preschoolers
Description
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)
Title
Functional connectivity data DLD preschoolers only to assess changes with treatment
Description
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)
Title
Functional connectivity data for typically developing and DLD preschoolers to assess changes in development
Description
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 Outcome Measure Information:
Title
Structural connectivity data for typically developing and DLD preschoolers
Description
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)
Title
Structural connectivity data for DLD preschoolers only to assess changes with treatment
Description
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)
Title
Structural connectivity data for typically developing and DLD preschoolers to assess development and disorder over time.
Description
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)
Title
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
Description
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)
Title
Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development
Description
Additional secondary outcomes raw score a standard grammar test (SPELT-3)
Time Frame
Pre/Time 1 (up to 3-weeks)
Title
Raw score on the DSS for typically developing and DLD preschoolers to assess development
Description
Additional secondary outcomes raw score a standard play based task (DSS) to assess development and disorder
Time Frame
Pre/Time 1 (up to 3-weeks)
Title
Percent correct on a grammar screener for DLD preschoolers only to identify treatment targets
Description
Additional secondary outcomes: raw change score on the PI-designed grammar probe
Time Frame
Pre/Time 1 (up to 3-weeks)
Title
Percent correct on a grammar task for DLD preschoolers only
Description
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-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Title
Raw score on the SPELT-3 for DLD preschoolers only to assess change with treatment
Description
Additional secondary outcomes raw score a standard grammar test (SPELT-3)
Time Frame
Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Title
Raw score on the DSS for DLD preschoolers only to assess change with treatment
Description
Additional secondary outcomes raw score a standard play based task (DSS) to assess changes with treatment
Time Frame
Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Title
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
Description
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-to-followup (up to 28-weeks)
Title
Raw score on the SPELT-3 for typically developing and DLD preschoolers to assess development
Description
Additional secondary outcomes raw score a standard grammar test (SPELT-3)
Time Frame
pre-to-followup (up to 28-weeks)
Title
Raw score on the DSS for typically developing and DLD preschoolers to assess development
Description
Additional secondary outcomes raw score a standard play based task (DSS) to assess development and disorder
Time Frame
pre-to-followup (up to 28-weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karla N Washington, PhD
Phone
513-558-8533
Email
washink2@ucmail.uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer J Vannest, PhD
Phone
513-558-8518
Email
vannesjr@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla N Washington, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Horizon Childcare
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Bell
Phone
513-861-5284
Email
sherrybell6489@gmail.com
Facility Name
Empower Learn Create INC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Paul
Phone
513-961-2825
Email
spaul@empowerlearncreate.org
First Name & Middle Initial & Last Name & Degree
Audrey Wilson
Phone
513-961-2825
Email
awilson@empowerlearncreate.org
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Miller, PhD
Phone
513-636-8409
Email
clarie.miller@cchmc.org
Facility Name
CWFF CHild Development Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Brandy
Phone
513-569-5662
Ext
18
Email
cwffchilddevelopment@gmail.com
Facility Name
Wesley Education Center for Children and Families
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Butler
Phone
513-845-7990
Email
crbutler0915@yahoo.com
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Yusko, MA
Phone
513-558-1416
Email
meadowae@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Linda Roedig
Phone
513-558-8503
Email
roedigla@ucmail.uc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuroimaging Reveals Treatment-related Changes in DLD
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