Developmental Language DisorderNCT06156865
Using Neuroimaging and Behavioral Assessments to Understand Late Talking
A study testing Intervention to address late talking in people with Developmental Language Disorder and Language Delay, run by University of Toronto at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder, Language Delay, Language Development
- What is being tested?
- Intervention to address late talking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Jan 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Grandview Kids
Oshawa, Ontario, L1H0C8
Taryn Eickmeier, 1-800-304-6180, Taryn.Eickmeier@grandviewkids.ca
Alicia Gibson, 1-800-304-6180, Alicia.Gibson@grandviewkids.ca
- Recruiting
Speech Specialists
Toronto, Ontario, M1X0C3
Maheen Mas, 416-858-4300, maheen@speechspecialists.ca
Emily Wood, e.wood@utoronto.ca
About this study
Official title: Neuroimaging Reveals Treatment-related Changes in DLD: A Randomized Controlled Trial (Supplement)
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.
Read the 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.
- Being tested
- Intervention to address late talking
- Keywords
- children, late talking, typical development, assessment, intervention, neuroimaging
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to address late talkingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 are collected using diffusion MRI from each of the 45 participants at Weeks 1 to 2 as part of a non-sedated sleep scan.
Measured: 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.
Measured: 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)
Raw score data calculated using the MacArthur Bates Communicative Development Inventories: Words and Sentences. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '680'. These data serve as main secondary outcomes.
Measured: 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)
Raw score data calculated using the Focus on the Outcomes of Communication Under - Parent Version. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '238'. These data will inform main secondary outcomes.
Measured: 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)
Raw score data calculated using the Focus on the Outcomes of Communication Under - Clinician Version. This measure is completed by each of the 45 children's clinicians. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '238'. These data will inform main secondary outcomes.
Measured: Weeks 1 to 2 - (Time 1/pre - third set)
Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set)
Raw score data calculated using the Intelligibility in Context Scale. This measure is completed by each of the 45 children's parents. High scores indicate better performance compared to lower scores. Minimum score is '0' and maximum is '35'. These data will inform additional secondary outcomes.
Measured: Weeks 1 to 2 - (Time 1/pre - fourth set)
Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set)
Raw score data obtained using the Communication Function Classification System. This measure is completed by each of the 45 children's parents. Lower scores indicate better performance compared to higher scores. The minimum score is "1" and the maximum is "5". These data will inform additional secondary outcomes.
Measured: Weeks 1 to 2 - (Time 1/pre - fifth set)
Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set)
Raw score data obtained using a Consonant Inventory collected during a play-based language sample. These data are collected from each of the 45 children during their assessment with the clinician. Higher scores indicate better performance compared to lower scores. The minimum score is "0" and the maximum score is "24". These data will inform additional secondary outcomes.
Measured: Weeks 1 to 2 - (Time 1/pre - sixth set)
Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set)
Raw score data obtained on language complexity (grammar and vocabulary) collected during a play-based language sample timed for 15-minutes. These data are collected from each of the 45 children during their assessment with the clinician. Higher scores indicate better performance compared to lower scores. The minimum score is "0" and the maximum score is variable. There is not a ceiling since this is based on a spontaneous language sample and some children can talk more than others during the 15-minute period. However the team has a metric of performance based on scores less than the 10th percentile and then those greater than the 10th percentile. Performance at or below the 10th percentile is worse than performance greater than the 10th percentile. These data will inform additional secondary outcomes.
Measured: Weeks 1 to 2 - (Time 1/pre - seventh set)
Aim 2 - Changes in structural connectivity data using diffusion imaging for late talkers only
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 only the 30 participants who are late talkers. 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.
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
Raw change score data calculated using the MacArthur Bates Communicative Development Inventories: Words and Sentences that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents whose children are late talkers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "680". These data serve as main secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)
Raw change score data calculated using the Focus on the Outcomes of Communication Under Six that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents whose children are late talkers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "238". These data serve as main secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)
Raw change score data calculated using the Focus on the Outcomes of Communication Under Six that is completed at pre, post, followup. This measure is completed on three occasions by the clinicians of the 30 children who are late talkers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "238". These data serve as main secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Intelligibility in Context Scale- (fourth set)
Raw change score data calculated using the Intelligibility in Context Scale that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents whose children are late talkers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "35". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Communication Function Classification System- CFCS (fifth set)
Raw change score data calculated using the Communication Function Classification System that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents whose children are late talkers. Higher change scores indicate better performance compared to lower change scores. The minimum score is "1" and the maximum score is "5". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes in the Consonant Inventory- (sixth set)
Raw change score data obtained using a Consonant Inventory collected during a play-based language sample that is completed at pre, post, followup. These data are collected on three occasions from the 30 children who are late talkers. Higher change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "24". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw change scores calculated using a Play-based language sample- (seventh set)
Raw change score data obtained on language complexity (grammar and vocabulary). These data are calculated during a play-based language sample that is completed with a clinician at pre, post, followup. These data are collected on three occasions from the 30 children who are late talkers. Higher change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is variable. There is not a ceiling since this is based on a spontaneous language sample and some children can talk more than others during the 15-minute period. However the team has a metric of performance based on scores less than the 10th percentile and then those greater than the 10th percentile. Performance at or below the 10th percentile is worse than performance greater than the 10th percentile. These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw change scores calculated using the MacArthur Bates Communicative Development Inventories- (eighth set)
Raw change score data calculated using the MacArthur Bates Communicative Development Inventories: Words and Sentences that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents of children who are late talkers as well as by the 15 parents of typically developing peers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "680". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Parent Version- (ninth set)
Raw change score data calculated using the Focus on the Outcomes of Communication Under Six Parent Version that is completed at pre, post, followup. This measure is completed on three occasions by the 30 parents of children who are late talkers as well as by the 15 parents of typically developing peers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "238". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Clinician Version- (tenth set)
Raw change score data calculated using the Focus on the Outcomes of Communication Under Six Clinician Version that is completed at pre, post, followup. This measure is completed on three occasions by the clinicians of 30 children who are late talkers as well as by clinicians of 15 typically developing peers. High change scores indicate better performance compared to lower change scores. The minimum score is "0" and the maximum score is "238". These data serve as additional secondary outcomes to inform immediate (pre-post) and maintenance of changes (post-followup).
Measured: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start19 Jan 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- toddlers who are late talking receive either intervention or are waitlist controls. There is also a group of typically developing children
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital Medical Center, Cincinnati, University of Cincinnati, Georgetown University
- Responsible party
- Principal investigator, Karla Washington, University of Toronto
- Investigators
- Karla N Washington, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156865
- Sponsor's protocol ID
- 3R01DC019337-04S1
- Status last verified
- May 2026
- First submitted
- 10 Nov 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include a sample of late talkers (LT), typically developing (TD) peers, and their parents recruited through the community programs in Ontario Canada. The dataset will include paper-based data along with neuroimaging data, in accordance with Research Ethics Board approval, including parent consent regarding the sharing of data. Further, data are expected to be video- and audio-recorded for reliability and data analyses. While the final dataset will be de-identified, the team believes that the possibility of identification remains due to the use of video- and audio- recorded aspects of this research. Thus, the team will only make the paper-based and neuroimaging data available only under a data-sharing agreement, which applies a higher-level of permission (parent-approved), with the provisos in place
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Reveals Treatment-related Changes in DLD: A Randomized Controlled Trial (Supplement)
- ClinicalTrials.gov ID
- NCT06156865
- Acronym / sponsor ID
- 3R01DC019337-04S1
- Keywords
- children, late talking, typical development, assessment, intervention, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital Medical Center, Cincinnati, University of Cincinnati, Georgetown University
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- toddlers who are late talking receive either intervention or are waitlist controls. There is also a group of typically developing children
| Arm | Type | Receives |
|---|---|---|
| Intervention to address late talking | Experimental | Behavioral: Intervention to address late talkinghalf 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 |
| Waitlist controls | No intervention | –half the participants are waitlist controls who receive intervention at a later date, after the study has ended |
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention to address late talkingthis 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 | Behavioural | Intervention to address late talking |
Primary outcome
Aim 1/Pre - Structural connectivity data using diffusion imaging
Time frame: Weeks 1 to 2 (Time 1/pre)
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 are collected using diffusion MRI from each of the 45 participants at Weeks 1 to 2 as part of a non-sedated sleep scan.
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)
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.
18 secondary outcomes
Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
Time frame: 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)
Time frame: 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)
Time frame: Weeks 1 to 2 - (Time 1/pre - third set)
Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set)
Time frame: Weeks 1 to 2 - (Time 1/pre - fourth set)
Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set)
Time frame: Weeks 1 to 2 - (Time 1/pre - fifth set)
Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set)
Time frame: Weeks 1 to 2 - (Time 1/pre - sixth set)
Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set)
Time frame: Weeks 1 to 2 - (Time 1/pre - seventh set)
Aim 2 - Changes in structural connectivity data using diffusion imaging for late talkers only
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Parent Version- (second set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Intelligibility in Context Scale- (fourth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes on the Communication Function Classification System- CFCS (fifth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw score changes in the Consonant Inventory- (sixth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw change scores calculated using a Play-based language sample- (seventh set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Aim 2 - Raw change scores calculated using the MacArthur Bates Communicative Development Inventories- (eighth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Parent Version- (ninth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Raw change scores calculated using the Focus on the Outcomes of Communication Under Six Clinician Version- (tenth set)
Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. The proposed research will include a sample of late talkers (LT), typically developing (TD) peers, and their parents recruited through the community programs in Ontario Canada. The dataset will include paper-based data along with neuroimaging data, in accordance with Research Ethics Board approval, including parent consent regarding the sharing of data. Further, data are expected to be video- and audio-recorded for reliability and data analyses. While the final dataset will be de-identified, the team believes that the possibility of identification remains due to the use of video- and audio- recorded aspects of this research. Thus, the team will only make the paper-based and neuroimaging data available only under a data-sharing agreement, which applies a higher-level of permission (parent-approved), with the provisos in place
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karla N Washington, PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to address late talking in people with Developmental Language Disorder and Language Delay, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla N Washington, PhD (416-978-6499, karla.washington@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1/Pre - Structural connectivity data using diffusion imaging (time frame: Weeks 1 to 2 (Time 1/pre)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.