Technology-assisted Language Intervention (TALI)

Study Overview
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Brief Summary
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This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual

Official Title
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Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)

Conditions
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Hearing Loss, Bilateral, Language Development

Intervention / Treatment
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* Behavioral: Technology assisted language intervention
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3-10 years Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound). Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient <.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive. Currently receiving speech-language therapy. Exclusion Criteria: Mild hearing loss and unilateral hearing loss primary language other than English significant motor impairments nonverbal IQ <80 children with severe communication disorders (i.e. autism spectrum disorders).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Technology Assisted Language Intervention (TALI)<br>Augmentative and alternative communication software incorporated into active speech-language therapy | Behavioral: Technology assisted language intervention<br>* speech language therapy that has integrated technology delivered through specific software on an iPad<br>|
| Active Comparator: Treatment as Usual<br>Speech language therapy child is typically receiving (no change to current care) | Behavioral: Treatment as usual<br>* No change will occur to the current ongoing speech-language therapy being delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Length of Utterance in morphemes | Measurement of syntax | 24 weeks | 
| Mean Turn Length | Measurement of discourse | 24 weeks | 
| Number of different vocabulary words spoken | measure of semantics | 24 weeks | 
| Clinical Evaluation of Language Fundamentals-5th edition | Provides receptive and expressive standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher language skills | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expressive Vocabulary Test 2nd edition | Provides expressive vocabulary standard scores on a scale with a mean of 100 +/- 15standard deviations; higher scores indicate better/higher vocabulary skills | 24 weeks | 
| Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile | Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing loss, randomized clinical trial, intervention, language development