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Kindergarten Children Acquiring Words Through Storybook Reading (KAWStory)

Primary Purpose

Language Development Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive storybook reading
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Language Development Disorders focused on measuring Vocabulary

Eligibility Criteria

5 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of KansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Testing

Mid Testing

High Testing

Arm Description

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 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 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.

Outcomes

Primary Outcome Measures

Change in definition scores from pre- to 12-weeks post-treatment
All new words will be presented. The child will be asked to provide a definition. Definitions will be scored as 0, 1, 2,or 3 points

Secondary Outcome Measures

Change in naming scores from pre- to 12-weeks post-treatment
A picture and a prompt will be provided for each word and the child will be asked to name the word. Naming responses will be scored as 0 or 1 point

Full Information

First Posted
July 2, 2018
Last Updated
April 1, 2022
Sponsor
University of Kansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03586479
Brief Title
Kindergarten Children Acquiring Words Through Storybook Reading
Acronym
KAWStory
Official Title
Interactive Book Reading to Accelerate Word Learning by Children With SLI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Children with Specific Language Impairment (SLI) are slower to learn new words than their peers, placing them at risk for academic failure. In this study, we are improving a storybook reading treatment to help Kindergarten children with SLI learn new words. In this study, we compare three versions of book reading that vary in how often children are tested on, meaning asked to talk about, the words they are learning in the book: low vs. mid vs. high testing. We then examine which version of the treatment leads to better learning of the words during treatment and remembering of the words after treatment. We also seek to understand individual differences in treatment outcomes by examining pre-treatment predictors as well as progress during and after treatment.
Detailed Description
Children with Specific Language Impairment (SLI) are slower to learn new words than their peers, placing them at risk for academic failure. Our long-term goal is to develop an effective word learning treatment for kindergarten children with SLI, thereby improving their academic and vocational outcomes. During the prior funding period, we successfully taught new words to children with SLI via interactive book reading, a treatment involving an adult reading a storybook to a child and deviating from the text to teach new words. We identified the adequate intensity of the treatment and showed that children with SLI learn an appropriate number of words by the end of 8-weeks of treatment, approximating the number of words learned by typically developing children in prior studies. However, this successful support of short-term word learning revealed new challenges that must be overcome in this renewal to continue to understand and improve long-term word learning by children with SLI. Thus, a second preliminary clinical trial involving 60 kindergarten children with SLI is proposed. Aim 1 addresses the challenge that newly learned words were forgotten once treatment was withdrawn. We attempt to buffer forgetting by comparing different amounts of testing during interactive book reading (low vs. mid vs high testing). Incorporating testing into training is a well-established and highly replicated means of reducing forgetting by adults and typically developing children. Aim 1 will determine whether testing can be harnessed to buffer forgetting by children with SLI under real world conditions. Aims 2 and 3 address the challenge that not all children benefitted equally from interactive book reading. In Aim 2, we identify pre-treatment characteristics of children with SLI that are associated with the slope of learning during treatment or the slope of forgetting post-treatment. Moreover, we select a pre-treatment battery that samples a wide array of skills likely to be associated with learning (language processing, working memory, and episodic memory) or forgetting (overall learning during treatment, decay rate). Aim 2 will provide a foundation for predicting which children will benefit from interactive book reading and will identify which skills are major barriers to long-term word learning by children with SLI. In Aim 3, we classify each child's response at the end of treatment (learner vs. non-learner) and at the end of post-treatment monitoring (rememberer vs. forgetter). Then, we examine earlier performance to determine when treatment and post-treatment outcomes can be predicted. This yields empirically based benchmarks for progress that can be used to tailor the treatment to individual children and establishes the stability of learning and forgetting over time. Overall, this research advances a promising treatment to effectively overcome the significant word learning challenges faced by children with SLI and reveals the contribution of learning and forgetting to language normalization by children with SLI. The results will have impact beyond word learning and SLI because all treatments require boosting learning and buffering forgetting. Thus, the knowledge gained will further catalyze clinical research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders
Keywords
Vocabulary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children will be randomly assigned to one of three treatment arms
Masking
Outcomes Assessor
Masking Description
Pre- and post-outcome assessments will be performed by an individual blind to arm assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Testing
Arm Type
Experimental
Arm Description
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.
Arm Title
Mid Testing
Arm Type
Experimental
Arm Description
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.
Arm Title
High Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive storybook reading
Other Intervention Name(s)
interactive book reading, dialogic reading
Intervention Description
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Primary Outcome Measure Information:
Title
Change in definition scores from pre- to 12-weeks post-treatment
Description
All new words will be presented. The child will be asked to provide a definition. Definitions will be scored as 0, 1, 2,or 3 points
Time Frame
20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
Secondary Outcome Measure Information:
Title
Change in naming scores from pre- to 12-weeks post-treatment
Description
A picture and a prompt will be provided for each word and the child will be asked to name the word. Naming responses will be scored as 0 or 1 point
Time Frame
20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Change in untaught vocabulary
Description
Pre-treatment general vocabulary measures will be re-administered post-treatment
Time Frame
10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Storkel
Phone
785-864-4873
Email
hstorkel@ku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Storkel
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Storkel
Phone
785-864-4873
Email
hstorkel@ku.edu
First Name & Middle Initial & Last Name & Degree
Holly Storkel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified pre-treatment test scores and pre-, during, and post-treatment outcome measures will be included as supplemental material to publications. All study information will be shared as supplemental material to publication or upon request.
IPD Sharing Time Frame
Data will become available as findings are published (in conjunction with publication)
IPD Sharing Access Criteria
Data will be open access

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Kindergarten Children Acquiring Words Through Storybook Reading

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