Recruiting

Observational Study

Sponsor:

University of Toronto

Code:

NCT06156865

Conditions

Developmental Language Disorder

Language Delay

Language Development

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

Interventions

Intervention to address late talking

Study Details

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

Study ID

NCT06156865

Start date

Jan 19, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: Waitlist controls

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

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

Primary outcome measure

  • Aim 1/Pre - Structural connectivity data using diffusion imaging [ Time Frame: Weeks 1 to 2 (Time 1/pre) ]
  • Aim 2/Pre - Changes in structural connectivity data using diffusion imaging [ Time Frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup) ]

Central Contacts and Locations

Central contacts

Karla N Washington, PhD

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

Nicole Bazzocchi, MhSc

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

Locations

Grandview Kids

Recruiting

Oshawa, Ontario, Canada, L1H0C8

Contacts

Taryn Eickmeier

1-800-304-6180Taryn.Eickmeier@grandviewkids.ca

Alicia Gibson

1-800-304-6180Alicia.Gibson@grandviewkids.ca

Speech Specialists

Recruiting

Toronto, Ontario, Canada, M1X0C3

Contacts

Maheen Mas

416-858-4300maheen@speechspecialists.ca

Emily Wood

e.wood@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2026-06-02.