Clinical trial NCT06156865: Using Neuroimaging and Behavioral Assessments to Understand Late Talking
Official title: Neuroimaging Reveals Treatment-related Changes in DLD: A Randomized Controlled Trial (Supplement)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Language Disorder
Language Delay
Language Development
Keywords: children
late talking
typical development
assessment
intervention
neuroimaging
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Holland Bloorview Kids Rehabilitation Hospital
name: Children's Hospital Medical Center, Cincinnati
name: University of Cincinnati
name: Georgetown University
First posted: 2023-12-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: toddlers who are late talking receive either intervention or are waitlist controls. There is also a group of typically developing children
Primary purpose: TREATMENT

Brief summary: Late talkers (LT), representing 10-20% of children under 3, demonstrate hallmark syntax and vocabulary deficits similar to preschoolers with developmental language disorder. While effective and early interventions can mitigate the impact of late talking, not enough is known about its neural basis, yet is needed to inform the design of more individualized interventions. This proposed effort uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie learning and late talking, while also considering their association to treatment-related changes in LT.

Detailed description: Late talking represents one of the most common reasons children under 3-years of age are referred for speech-language evaluations, impacting about 10%-20% of children in this age-group. Late talkers (LT) also share similarities with children diagnosed with developmental language disorder (DLD) at 4 - 5 years of age, endorsing the notion that shared neurobiological underpinnings might exist between these two clinical groups. However, little is known about the neural basis of late talking, yet is needed to better inform the design of efficacious therapies that address hallmark delays in syntax and vocabulary. For the DLD population, domain-general processes relating memory and language are being investigated in the parent grant, offering valuable testing ground for also advancing the current knowledge base regarding LT. The Procedural circuit Deficit Hypothesis (PDH) posits that relative strengths and weaknesses exist between procedural (impaired) and declarative (less impaired) memory systems. Structural abnormalities in connections between frontal brain regions and basal ganglia, with under activation and reduced connectivity also evident. However, cortical and subcortical regions in the temporal lobes, including hippocampus, might be impaired to a lesser degree.

This proposed research will use diffusion imaging to describe the neural basis (structural connectivity) of late talking and treatment-related change by way of the PDH. The investigators will gather data regarding LT before, after, and following a break in standard intervention for LT (e.g., parent coaching, direct therapy for children who are LT): LT treatment. The investigators will also include a "business as usual": LT no treatment as part of a highly feasible pragmatic design that leverages existing pipelines. The investigators will also include typically developing (TD) peers to inform development vs late talking. The central hypothesis is that treatment designed to improve syntax and vocabulary will change procedural and declarative networks in association with increases in language function and the degree of improvement may be associated with the underlying neurobiology of baseline syntax and vocabulary deficits.

Building on a robust history of recruitment and treatment of toddlers by the investigators' partnering sites, and the investigators' successful imaging partner, this project will enroll 30 LT (n=15 treatment; n=15 controls) and 15 TD peers. Aim 1 will establish the structural connectivity in LT 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 LT only. The investigators examine potential changes in structural connectivity between regions of the procedural learning and declarative memory networks, and investigate whether treatment-related changes occur into the typical range (LT, TD). To meet the scientific goals, the investigators pair behavioral tools (syntax and vocabulary) with neuroimaging to describe co-occurring behavioral performance underlying learning and outcome, while also gathering parental and clinician qualitative data regarding treatment outcomes. This research will contribute novel insights into mechanisms underlying learning and impairment to offer a ground-breaking shift in the understanding of LT.

Eligibility criteria: Inclusion Criteria:

* child and parent are monolingual/native (primarily) English speakers
* child is enrolled at one of the participating facilities
* child is recruited via word of mouth, including social media
* child is between 18 and 30 months of age
* child does not have any contraindications to magnetic resonance imaging (i.e., intracranial metal implants, claustrophobia)
* child does not have any uncorrected vision challenges

Exclusion Criteria:

* Child does not meet criteria for LT or typical development
* Standard magnetic resonance imaging exclusion criteria
* Gestational age less than 37 weeks or greater than 42 weeks
* Special education placement of child based on ability or behavior

Primary outcomes:
measure: Aim 1/Pre - Structural connectivity data using diffusion imaging
timeFrame: Weeks 1 to 2 (Time 1/pre)
measure: Aim 2/Pre - Changes in structural connectivity data using diffusion imaging
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Secondary outcomes:
measure: Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
timeFrame: Weeks 1 to 2 (Time 1/pre - first set)
measure: Aim 1 - Raw score on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - second set)
measure: Aim 1/Pre - Raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - third set)
measure: Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - fourth set)
measure: Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - fifth set)
measure: Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - sixth set)
measure: Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set)
timeFrame: Weeks 1 to 2 - (Time 1/pre - seventh set)
measure: Aim 2 - Changes in structural connectivity data using diffusion imaging for late talkers only
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes on the Intelligibility in Context Scale- (fourth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes on the Communication Function Classification System- CFCS (fifth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw score changes in the Consonant Inventory- (sixth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw change scores calculated using a Play-based language sample- (seventh set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Aim 2 - Raw change scores calculated using the MacArthur Bates Communicative Development Inventories- (eighth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Parent Version- (ninth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
measure: Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Clinician Version- (tenth set)
timeFrame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Other outcomes:
measure: Aim 1/Pre - qualitative data clinician reported
timeFrame: Weeks 1 to 2 (Pre/Time 1)
measure: Aim 1/Pre - qualitative data parent reported
timeFrame: Weeks 1 to 2 (Pre/Time 1)
measure: Aim 2 - Qualitative data parent reported
timeFrame: Weeks 1 or 2 (pre/Time 1); Weeks 9 or 10 (post/Time 2), Weeks 17 or 18 (followup/Time 3)
measure: Aim 2 - qualitative data clinician reported
timeFrame: Weeks 1 or 2 (pre/Time 1); Weeks 9 or 10 (post/Time 2), Weeks 17 or 18 (followup/Time 3)
Locations:
city: Oshawa
country: Canada
facility: Grandview Kids
state: Ontario
city: Toronto
country: Canada
facility: Speech Specialists
state: Ontario
Study officials:
affiliation: University of Toronto
name: Karla N Washington, PhD
role: PRINCIPAL_INVESTIGATOR
References: