- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586479
Kindergarten Children Acquiring Words Through Storybook Reading (KAWStory)
Interactive Book Reading to Accelerate Word Learning by Children With SLI
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Lawrence, Kansas, United States, 66045
- University of Kansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Eligible for kindergarten enrollment Age 5-6 years Normal hearing Normal nonverbal IQ -- Nonverbal IQ of 85 or higher Language impairment as documented by language score </= 94 on SPELT-3 or </=91 on TNL-2 Vocabulary impairment as documented by a vocabulary score </= 6 on DELV, </= 6 on CELF-4 Word Classes, </= 6 on CCC-2
Exclusion Criteria:
Speaks more than one language Health history indicating neurologic or other disorder that would exclude a diagnosis of SLI (e.g., autism, developmental disability)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Testing
Children will receive 0 testing (talking) exposures and 6 listening exposures for a total of 6 exposures to each word.
This is a listening only condition with minimal testing.
|
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
|
|
Experimental: Mid Testing
Children will receive 2 testing (talking) exposures and 4 listening exposures for a total of 6 exposures to each word.
This is a listening and talking condition with mostly listening.
|
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
|
|
Experimental: High Testing
Children will receive 4 testing (talking) exposures and 2 listening exposures for a total of 6 exposures to each word.
This is a listening and talking condition with mostly talking.
|
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Definition Scores From Pre- to 12-weeks Post-treatment
Time Frame: 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
|
This outcome measure indicates the total number of words children responded to correctly at post-test after subtracting the total number of words correct at pre-test. For the definition scores, this includes the total number of words that the child provided correct definitions for at post-test minus the number of words that the child provided correct definition scores at pre-test. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score. |
20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Naming Scores From Pre- to 12-weeks Post-treatment
Time Frame: 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
|
This outcome measure indicates the total number of words children responded to correctly at post-test after subtracting the total number of words correct at pre-test.
For the naming scores, this included the total number of words that the child provided the correct name for (target word) when given a picture and sentence prompt at post-test, minus the total number of words that the child provided the correct name for at pre-test.
For each child, there was a total of 30 taught words and 30 untaught words.
Thus, for all word learning outcomes the range is 0-30.
For all assessments of word learning, higher values represent a better outcome.
In this study, the subscales are not combined into a total score.
|
20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Untaught Vocabulary
Time Frame: 10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment
|
Pre-treatment general vocabulary measures will be re-administered post-treatment. We report the change in number of words defined at pretest and immediate post test. Each child was tested on taught words (words trained during the intervention) and untaught words (words assessed but not trained). Thus, there are four primary outcome scores for word learning: assessments of 1. form and 2. meaning for taught words, and assessments of 3. form and 4. meaning for untaught words. For each child, there was a total of 30 taught words and 30 untaught words. Thus, for all word learning outcomes the range is 0-30. For all assessments of word learning, higher values represent a better outcome. In this study, the subscales are not combined into a total score. |
10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca E Swinburne Romine, PhD, University of Kansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20482
- 2R01DC012824 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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