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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1/Pre - Structural connectivity data using diffusion imaging

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

Secondary outcome measures

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 outcome measures

Aim 1/Pre - qualitative data clinician reported

Aim 1/Pre - qualitative data parent reported

Aim 2 - Qualitative data parent reported

+1 more

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

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,598 Total Patients Enrolled

1 Trials studying Language Developmental Disorders

184 Patients Enrolled for Language Developmental Disorders

Holland Bloorview Kids Rehabilitation HospitalOTHER

67 Previous Clinical Trials

14,029 Total Patients Enrolled

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,546 Total Patients Enrolled

1 Trials studying Language Developmental Disorders

184 Patients Enrolled for Language Developmental Disorders

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors excluded from this trial or can they participate?

"As specified in the prerequisites for enrollment, children must fall between 18-30 months of age to be eligible."

Answered by AI

Who can volunteer for this medical experiment?

"Patients suffering from language delay between 18 and 30 months of age can be admitted to this study. 45 participants are required for the trial's completion."

Answered by AI

How many participants are taking part in this research?

"Affirmative. Clinicaltrials.gov data demonstrates that this clinical trial, which was initially published on December 1st 2023, is actively sourcing applicants. 45 participants must be recruited from 2 distinct medical centres."

Answered by AI

Are there any remaining vacancies for volunteers in this experiment?

"Affirmative. The online repository of clinical trials, clinicaltrials.gov, supports the fact that this medical study is actively recruiting participants and has been since December 1st 2023. 45 volunteers are being sought out from two distinct locations."

Answered by AI

What is the primary goal of this investigation?

"The primary objective of this trial, measured between Weeks 1 and 2 (Time 1/pre), is to observe changes in structural connectivity data using diffusion imaging. Secondary goals include assessing the raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set) from 45 clinicians across all participants with a minimum possible score of 0 and maximum 238; gauging the raw score for Intelligibility in Context Scale- (fourth set) collected from each participant's parents, ranging from 0 to 35; as well as monitoring changes in MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Neuroimaging and Behavioral Assessments to Understand Late Talking

Karla Washington 2023. "Using Neuroimaging and Behavioral Assessments to Understand Late Talking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06156865.

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