Using Neuroimaging and Behavioral Assessments to Understand Late Talking (NCT06156865) | Clinical Trial Compass
RecruitingNot Applicable
Using Neuroimaging and Behavioral Assessments to Understand Late Talking
Canada45 participantsStarted 2024-01-19
Plain-language 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.
Who can participate
Age range
18 Months – 30 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aim 1/Pre - Structural connectivity data using diffusion imaging
Timeframe: Weeks 1 to 2 (Time 1/pre)
2
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)