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Behavioral Intervention
Technology-Assisted Language Intervention for Hearing Loss-related Language Delay (TALI Trial)
N/A
Recruiting
Led By Jareen Meinzen-Derr
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently receiving speech-language therapy
Age 3-10 years
Must not have
Mild hearing loss and unilateral hearing loss
Significant motor impairments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a technology intervention can help improve language development for deaf or hard of hearing children.
Who is the study for?
This trial is for children aged 3-10 with moderate to profound bilateral hearing loss and a language deficit. They must be receiving speech-language therapy, have an IQ within the normal range, and speak English as their primary language. Children with mild or unilateral hearing loss, severe communication disorders like autism, nonverbal IQ below 80, or significant motor impairments cannot participate.
What is being tested?
The study compares two approaches: one uses technology-assisted language intervention tools designed for deaf or hard of hearing children; the other follows standard treatment without these tools. Kids are randomly assigned to either group to see which method better improves their language skills.
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional side effects are not expected. However, there may be differences in individual experiences based on interaction with the technology.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently undergoing speech-language therapy.
Select...
I am between 3 and 10 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have slight hearing loss in one ear.
Select...
I have major difficulties with movement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Evaluation of Language Fundamentals-5th edition
Mean Length of Utterance in morphemes
Mean Turn Length
+1 moreSecondary study objectives
Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
Expressive Vocabulary Test 2nd edition
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Technology Assisted Language Intervention (TALI)Active Control1 Intervention
Augmentative and alternative communication software incorporated into active speech-language therapy
Group II: Treatment as UsualActive Control1 Intervention
Speech language therapy child is typically receiving (no change to current care)
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,875 Total Patients Enrolled
4 Trials studying Language Development
390 Patients Enrolled for Language Development
Jareen Meinzen-DerrPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have slight hearing loss in one ear.You have permanent hearing loss in both ears that is moderate to severe.I am currently undergoing speech-language therapy.I have major difficulties with movement.I am between 3 and 10 years old.You have trouble understanding or using language, as shown by specific test scores.My child has a severe communication disorder, such as autism.Your nonverbal IQ score is less than 80.
Research Study Groups:
This trial has the following groups:- Group 1: Technology Assisted Language Intervention (TALI)
- Group 2: Treatment as Usual
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.
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