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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DC015642-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.
Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative Treatment Including Augmentative and Alternative Communication | Experimental | Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word. |
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| Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment | Active Comparator | Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAULT Phase 6 | Behavioral | VAULT is an input-based word learning intervention based on principles of statistical learning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect Size | The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d). | Change from baseline through treatment, which will average an 8-week time frame. |
| Number/Rate of words learned | The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment. | Change from Initial Evaluation through Follow-up, which will average a 6-month time frame. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Treatment Retention | We will use probe data or specific words and parental report to determine how many of the words the child retained from treatment. | Change from end of treatment to follow up, which will average 4-6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Alt, PhD | Contact | 520-626-6180 | malt@arizona.edu | |
| Nora Evans-Reitz, m | Contact | 520-626-6885 | nevansreitz@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Alt, PhD | University of Arizona | Principal Investigator |
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| ID | Term |
|---|---|
| D007805 | Language Development Disorders |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.
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The children and their caregivers will not be told which condition they are assigned to. However, the Augmentative and Alternative Communication device is quite obvious, so although caregivers will not be explicitly told, it is likely they will be aware their child is in that arm.
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |