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Behavioural Intervention

Early Intervention for Language Delay

N/A

Recruiting

Led By Karla N Washington, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child is between 18 and 30 months of age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1 or 2 (pre/time 1); weeks 9 or 10 (post/time 2), weeks 17 or 18 (followup/time 3)

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to use neuroscience and behavior to better understand late talking and how to treat it. Early intervention can help mitigate effects.

Who is the study for?

This trial is for children aged 18-30 months who are late talkers and primarily English-speaking without vision issues. They must be enrolled at a participating facility, have no MRI contraindications like metal implants or claustrophobia, and not be in special education due to ability or behavior.

What is being tested?

The study aims to understand the brain and behavioral aspects of late talking in toddlers using neuroimaging techniques and behavioral assessments. It seeks to identify memory-language mechanisms that could inform tailored interventions for language development disorders.

What are the potential side effects?

There are generally no direct side effects from the non-invasive procedures used in this study such as neuroimaging (MRI) scans. However, there might be discomfort or anxiety related to lying still during imaging, but these can typically be managed with breaks and reassurance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 18 and 30 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1 or 2 (pre/time 1); weeks 9 or 10 (post/time 2), weeks 17 or 18 (followup/time 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1 or 2 (pre/time 1); weeks 9 or 10 (post/time 2), weeks 17 or 18 (followup/time 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 or 2 (pre/time 1); weeks 9 or 10 (post/time 2), weeks 17 or 18 (followup/time 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1/Pre - Structural connectivity data using diffusion imaging

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

Secondary study objectives

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

Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set)

Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set)

+15 more

Other study objectives

Aim 1/Pre - qualitative data clinician reported

Aim 1/Pre - qualitative data parent reported

Aim 2 - Qualitative data parent reported

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention to address late talkingExperimental Treatment1 Intervention

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 II: Waitlist controlsActive Control1 Intervention

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

0 / 1Eligibility criteria met