Using Neuroimaging and Behavioral Assessments to Understand Late Talking

NCT ID: NCT06156865

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2025-06-30

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.

Conditions

Developmental Language Disorder; Language Delay; Language Development

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention to address late talking

half the participants receive an intervention program addressing late talking. The intervention is comprised of adult learning (to teach parents) and direct support for children who are late talkers. The intervention occurs over 6 to 8 weeks and is designed to improve grammar, vocabulary, and functional communication

Group Type: EXPERIMENTAL

Intervention to address late talking

Intervention Type: BEHAVIORAL

this intervention is designed to support both speech and language development in children who are toddlers. Given the age group of children their parents are part of the intervention program. Importantly the frequency of the intervention can range from once to twice per week, with timing also designed to complement the particular agency

Waitlist controls

half the participants are waitlist controls who receive intervention at a later date, after the study has ended

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention to address late talking

this intervention is designed to support both speech and language development in children who are toddlers. Given the age group of children their parents are part of the intervention program. Importantly the frequency of the intervention can range from once to twice per week, with timing also designed to complement the particular agency

Intervention Type: BEHAVIORAL

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
• Gestational age less than 37 weeks or greater than 42 weeks
• Special education placement of child based on ability or behavior

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Karla Washington

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karla N Washington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Grandview Kids

Oshawa, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Speech Specialists

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Karla N Washington, PhD

Role: CONTACT

karla.washington@utoronto.ca

416-978-6499

Nicole Bazzocchi, MhSc

Role: CONTACT

nicole.bazzocchi@mail.utoronto.ca

647-239-9330

Facility Contacts

Taryn Eickmeier

Role: primary

Taryn.Eickmeier@grandviewkids.ca

1-800-304-6180

Alicia Gibson

Role: backup

Alicia.Gibson@grandviewkids.ca

1-800-304-6180

Maheen Mas

Role: primary

maheen@speechspecialists.ca

416-858-4300

Emily Wood

Role: backup

e.wood@utoronto.ca

Other Identifiers

3R01DC019337-04S1

Identifier Type: NIH

Identifier Source: org_study_id

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