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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 below
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I am currently undergoing speech-language therapy.
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I am between 3 and 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have slight hearing loss in one ear.
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I have major difficulties with movement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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 more
Secondary 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
839 Previous Clinical Trials
6,565,489 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

Technology-assisted Language Intervention (TALI) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04857255 — N/A
Language Development Research Study Groups: Technology Assisted Language Intervention (TALI), Treatment as Usual
Language Development Clinical Trial 2023: Technology-assisted Language Intervention (TALI) Highlights & Side Effects. Trial Name: NCT04857255 — N/A
Technology-assisted Language Intervention (TALI) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857255 — N/A
~0 spots leftby Dec 2024