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Preliminary Clinical Trials in Language Intervention: An Interactive Book Reading Example |
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Holly Storkel - University of Kansas
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Rouzana Komesidou - University of Kansas
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Krista Voelmle - University of Kansas
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| SRCLD Year: |
2015 |
| Presentation Type: |
Special Session |
| Presentation Time: |
(na) |
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Preliminary Clinical Trials address core design and clinical issues necessary to establish the feasibility of a Phase III/IV Definitive Clinical Trial that, in turn, tests the efficacy and effectiveness of the intervention. Phase I trials that address issues of treatment intensity are virtually standard in the drug treatment literature but surprisingly rare in the language intervention literature. We illustrate design issues via a preliminary clinical trial of interactive book reading with children with Specific Language Impairment (SLI). An escalation strategy that hones in a ‘promising’ intensity for the treatment using the fewest number of participants is illustrated. Preliminary results from 21 children show that the adequate intensity for children with SLI is 3- to 4-times the intensity shown to be effective for same-age typically developing children (i.e., 36-48 exposures for children with SLI compared to 12 exposures for peers). This intensity appears sufficient to support learning from input as well as retention. [Funded by DC012824] |
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