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My Sentence Builder for Language Disorder
N/A
Recruiting
Led By Karla N Washington, PhD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 48-71 months
Monolingual and native Standard English speakers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Awards & highlights
Study Summary
This trial uses neuroimaging and behavioral methods to study the memory-language mechanisms that underlie grammar learning and impairment in children with developmental language disorders, in order to informing the design of more individualized interventions.
Who is the study for?
This trial is for preschoolers aged 4 to almost 6 with developmental language disorders affecting their grammar. They must speak only English, have normal hearing and vision (with correction), average nonverbal IQ, and no other interventions or special education for communication issues. Kids who can't safely undergo an MRI are excluded.Check my eligibility
What is being tested?
'My Sentence Builder' is being tested in this study to see if it helps improve grammar in children with developmental language disorders. The research includes brain scans (neuroimaging) and behavior tests to understand how the treatment might cause changes in the brain related to language learning.See study design
What are the potential side effects?
Since 'My Sentence Builder' is a non-medical intervention focusing on language skills, there are no direct medical side effects expected from this treatment as typically associated with drug trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 6 years old.
Select...
I speak only English and it's my first language.
Select...
I have been diagnosed with DLD affecting my ability to use grammar.
Select...
My child is between 4 and 6 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional connectivity data (time 1) from typical and DLD preschoolers
Functional connectivity data DLD preschoolers only to assess changes with treatment
Functional connectivity data for typically developing and DLD preschoolers to assess changes in development
Secondary outcome measures
Percent correct on a grammar screener for DLD preschoolers only to identify treatment targets
Percent correct on a grammar task for DLD preschoolers only
Percent correct on a grammar task for typically developing and DLD preschoolers to assess development and disorder.
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
computer assisted intervention targeting expressive grammar for preschoolers with DLD
Group II: No treatmentActive Control1 Intervention
business as usual classroom (educational) services
Find a Location
Who is running the clinical trial?
University of TorontoOTHER
689 Previous Clinical Trials
1,018,459 Total Patients Enrolled
1 Trials studying Language Developmental Disorders
45 Patients Enrolled for Language Developmental Disorders
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,202 Total Patients Enrolled
1 Trials studying Language Developmental Disorders
45 Patients Enrolled for Language Developmental Disorders
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,412 Total Patients Enrolled
1 Trials studying Language Developmental Disorders
45 Patients Enrolled for Language Developmental Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who have normal language and social skills.I am between 4 and 6 years old.You have normal ability to move your mouth and tongue for eating and speaking.I speak only English and it's my first language.I am currently getting help for my communication skills.You cannot undergo an MRI scan safely.You have normal social and communication skills.I have been diagnosed with DLD affecting my ability to use grammar.Your ability to interact and communicate in social situations is normal.I'm sorry, but the given criterion is not clear. It seems to be incomplete. Can you provide more context or details so that I can assist you properly?Normal ability to move the mouth and swallow.You have normal language and social skills.Criterion: Difficulty with using correct grammar when speaking or writing.You are enrolled in a participating center.My child is between 4 and 6 years old.The average level of hearing ability
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: No treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an open call for volunteers to join this trial?
"According to clinicaltrials.gov, this study is actively recruiting patients with the posting of the trial beginning on May 24th 2022 and concluding July 25th 2022."
Answered by AI
What is the intent of this experiment?
"This trial, to be assessed over a 28-week period, aims to analyze functional connectivity data from both typical and DLD preschoolers. Secondary goals include assessing percent correct on PI's 45-item grammar probe for DLD patients only as well as raw scores on the play based task (DSS) for those with DLD in order to measure treatment efficacy."
Answered by AI
How many individuals have enlisted for participation in this experiment?
"Affirmative. The information uploaded on clinicaltrials.gov confirms that this research, which was initially advertised on May 24th 2022, is actively recruiting participants from 6 sites with a total of 184 required volunteers."
Answered by AI
Is the age range for this trial beyond two decades?
"This clinical research project requires that participants meet certain age requirements; the lower cap is 48 Months and upper limit of 71 months."
Answered by AI
Am I eligible to enroll in this medical experiment?
"Patients between 4 and 5.9 years of age who demonstrate a speech delay may be accepted into this trial, which is estimated to accept 184 participants in total."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Cincinnati
Cincinnati Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Cincinnati Children's Hospital: < 24 hours
Average response time
- < 1 Day
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