Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 34 for:    Specific Language Impairment 1

Kindergarten Children Acquiring Words Through Storybook Reading (KAWStory)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03586479
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Kansas

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.

Condition or disease Intervention/treatment Phase
Language Development Disorders Behavioral: Interactive storybook reading Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children will be randomly assigned to one of three treatment arms
Masking: Single (Outcomes Assessor)
Masking Description: Pre- and post-outcome assessments will be performed by an individual blind to arm assignment.
Primary Purpose: Treatment
Official Title: Interactive Book Reading to Accelerate Word Learning by Children With SLI
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

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.
Behavioral: Interactive storybook reading
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
  • interactive book reading
  • dialogic reading

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.
Behavioral: Interactive storybook reading
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
  • interactive book reading
  • dialogic reading

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.
Behavioral: Interactive storybook reading
Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
Other Names:
  • interactive book reading
  • dialogic reading




Primary Outcome Measures :
  1. 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 ]

    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 :
  1. 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 ]
    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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586479


Contacts
Layout table for location contacts
Contact: Holly Storkel 785-864-4873 hstorkel@ku.edu

Locations
Layout table for location information
United States, Kansas
University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Holly Storkel    785-864-4873    hstorkel@ku.edu   
Principal Investigator: Holly Storkel         
Sponsors and Collaborators
University of Kansas
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Layout table for investigator information
Principal Investigator: Holly Storkel University of Kansas

Layout table for additonal information
Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT03586479     History of Changes
Other Study ID Numbers: 20482
2R01DC012824 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available as findings are published (in conjunction with publication)
Access Criteria: Data will be open access

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas:
Vocabulary

Additional relevant MeSH terms:
Layout table for MeSH terms
Language Development Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms