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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology Assisted Language Intervention (TALI) | Active Comparator | Augmentative and alternative communication software incorporated into active speech-language therapy |
|
| Treatment as Usual | Active Comparator | Speech language therapy child is typically receiving (no change to current care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology assisted language intervention | Behavioral | speech language therapy that has integrated technology delivered through specific software on an iPad |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Mild hearing loss and unilateral hearing loss
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| Name | Affiliation | Role |
|---|---|---|
| Jareen Meinzen-Derr | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States | ||
| Cincinnati Children's Hospital Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2021 | Mar 18, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Behavioral | No change will occur to the current ongoing speech-language therapy being delivered. |
|
Provides pragmatic language scores as scaled scores (ranging from 1 to 15), age equivalents and percentile ranks |
| 24 weeks |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |