Using Neuroimaging and Behavioral Assessments to Understand Late Talking

NCT06156865 | Recruiting

• 1 other identifier: 3R01DC019337-04S1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Developmental Language Disorder; Language Delay; Language Development

Keywords

children; late talking; typical development; assessment; intervention; neuroimaging

Outcome Measures

Primary Outcomes (2)

• Aim 1/Pre - Structural connectivity data using diffusion imaging

  Connectivity data (density of streamlines connecting regions of the procedural learning and declarative networks) will be measured using tractography, a 3D modeling technique, to visually represent nerve tracts using data that we collect using diffusion MRI from each of the 45 participants at Weeks 1 to 2 as part of a non-sedated sleep scan.

  Weeks 1 to 2 (Time 1/pre)

• Aim 2/Pre - Changes in structural connectivity data using diffusion imaging

  Changes in connectivity data (density of streamlines connecting regions of the procedural learning and declarative networks) calculated using data collected over two time points (pre to post; post to followup) will be measured from each of the 45 participants. Connectivity data measured using tractography collected using diffusion MRI are gathered from these participants at pre, post, and followup to inform these changes over time as part of a non-sedated sleep scan.

  Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)

Secondary Outcomes (18)

• Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)

  Weeks 1 to 2 (Time 1/pre - first set)

• Aim 1 - Raw score on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)

  Weeks 1 to 2 - (Time 1/pre - second set)

• Aim 1/Pre - Raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)

  Weeks 1 to 2 - (Time 1/pre - third set)

• Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set)

  Weeks 1 to 2 - (Time 1/pre - fourth set)

• Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set)

  Weeks 1 to 2 - (Time 1/pre - fifth set)

Other Outcomes (4)

• Aim 1/Pre - qualitative data clinician reported

  Weeks 1 to 2 (Pre/Time 1)

• Aim 1/Pre - qualitative data parent reported

  Weeks 1 to 2 (Pre/Time 1)

• Aim 2 - Qualitative data parent reported

  Weeks 1 or 2 (pre/Time 1); Weeks 9 or 10 (post/Time 2), Weeks 17 or 18 (followup/Time 3)

Study Arms (2)

Intervention to address late talking

EXPERIMENTAL

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

Behavioral: Intervention to address late talking

Waitlist controls

NO INTERVENTION

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

Interventions

Intervention to address late talking 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

Intervention to address late talking

Eligibility Criteria

• Age: 18 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Holland Bloorview Kids Rehabilitation Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Cincinnati: collaborator
• Georgetown University: collaborator

Study Sites (2)

Grandview Kids

Oshawa, Ontario, L1H0C8, Canada

NOT YET RECRUITING

Speech Specialists

Toronto, Ontario, M1X0C3, Canada

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karla N Washington, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla N Washington, PhD

CONTACT

416-978-6499; karla.washington@utoronto.ca

Nicole Bazzocchi, MhSc

CONTACT

647-239-9330; nicole.bazzocchi@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the scorers of the outcomes are not informed of participants' group status
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: toddlers who are late talking receive either intervention or are waitlist controls. There is also a group of typically developing children

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 5, 2023
• Study Start: January 19, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: In keeping with our Resource Sharing Plan with the NIH, we agree to make data available is specific repositories 12 to 24-months after the end of the research project timeline associated with the supplement award mechanism
• Access Criteria: We intend to share data with researchers, clinicians, and government/educational officials, including at academic institutions. These individuals will work with institutions/entities that have necessary Ethics Boards and Federal Wide Assurance. We agree to institute an adjudication process for granting or denying access to data that includes procedures consistent with the NIH data sharing policies. Requesting individuals will be asked to provide a request in writing that adheres to set components. They will be able to access the data for educational (student training) and research (secondary analyses) purposes regarding intervention outcomes and syntax and vocabulary language-learning profiles in LT and TD peers. We agree that the names of individuals and their institutions/entities will be summarized in the annual report regardless of whether or not these persons are granted or denied permission to access the data.

Locations

CA (2)