Accelerating Word Learning in Children With Language Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Kansas Medical Center
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01829360
First received: March 12, 2013
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
This research attempts to adapt and optimize a word learning treatment, specifically interactive book reading, for use with Kindergarten children with Specific Language Impairment (SLI). Children with SLI have difficulty learning language without any obvious cause for this difficulty. Two treatment studies will be conducted to determine (1) the number of times children with SLI need to hear new words during book reading to learn the new words; (2) the best way to provide the target number of exposures to new words during book reading. For example, is it better to hear the new words many times within the book and to read the book few times, or is it better to hear the new words a few times within the book and to read the book many times. The investigators hypothesize that children with SLI will need to hear new words 2 to 3 times as often as children with normal language to learn the words and that reading the books many times will be more effective than repeating the words many times within a book.

Condition Intervention Phase
Specific Language Impairment
Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Book Reading to Accelerate Word Learning by Children With SLI

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in definition score from pre- to post-treatment [ Time Frame: Pre- and Post-treatment with treatment lasting 10 to 38 sessions (approximately 5 to 19 weeks) ] [ Designated as safety issue: No ]
    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 from pre- to post-treatment [ Time Frame: Pre- and Post-treatment with treatment lasting 10 to 38 sessions (approximately 5 to 19 weeks) ] [ Designated as safety issue: No ]
    A definition will be presented for each new word and the child will be asked to name the word that matches the definition. Naming responses will be scored as 0 or 1 point.


Other Outcome Measures:
  • Change in standardized vocabulary tests from pre- to post-treatment [ Time Frame: Pre- and Post-treatment with treatment lasting 10 to 38 sessions (approximately 5 to 19 weeks) ] [ Designated as safety issue: No ]
    Vocabulary tests commonly used by educators and clinicians will be administered to assess broader gains in vocabulary beyond just the taught words.


Estimated Enrollment: 104
Study Start Date: March 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
In Study 1, words will be randomized to the treatment or comparison arm but all children will receive treatment on half the words and no treatment on half the words. Children will hear new words during storybook reading. Children will hear the word in the text of the book but also will be told additional information about the word including a synonym, a definition, and a supportive context.
Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)
In Study 1, children are randomized to one of four treatment conditions, determining whether they will hear the treated words either 12, 24, 36, or 48 times during treatment. In Study 2, one of the intensities from Study 1 will be tested more extensively by examining how best to achieve the adequate intensity. Specifically, is it better to hear the word more often in the book or to read the book more times? In the treatment condition, words are randomized to more repetitions in the book or to more repetitions of reading the same book to address this question.
Other Names:
  • Interactive book reading
  • Dialogic reading
  • Shared book reading
Experimental: Comparison1
In Study 2, children will be randomized to two treatment versions. In Study 2, children will receive a treatment that is balanced between the number of times a word is read in the book and the number of times that the book is read. Children will also be randomized a second version that is more heavily weighted towards word repetitions .
Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)
In Study 1, children are randomized to one of four treatment conditions, determining whether they will hear the treated words either 12, 24, 36, or 48 times during treatment. In Study 2, one of the intensities from Study 1 will be tested more extensively by examining how best to achieve the adequate intensity. Specifically, is it better to hear the word more often in the book or to read the book more times? In the treatment condition, words are randomized to more repetitions in the book or to more repetitions of reading the same book to address this question.
Other Names:
  • Interactive book reading
  • Dialogic reading
  • Shared book reading
Experimental: Comparison2
In Study 2, children will be randomized to two treatment versions. In Study 2, children will receive a treatment that is balanced between the number of times a word is read in the book and the number of times that the book is read. Children will also be randomized a second version that is more heavily weighted to number of times the book is read.
Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)
In Study 1, children are randomized to one of four treatment conditions, determining whether they will hear the treated words either 12, 24, 36, or 48 times during treatment. In Study 2, one of the intensities from Study 1 will be tested more extensively by examining how best to achieve the adequate intensity. Specifically, is it better to hear the word more often in the book or to read the book more times? In the treatment condition, words are randomized to more repetitions in the book or to more repetitions of reading the same book to address this question.
Other Names:
  • Interactive book reading
  • Dialogic reading
  • Shared book reading

Detailed Description:

Specific Language Impairment (SLI) affects approximately 7.4% of Kindergarten children. Children with SLI are known to have difficulty learning new words, which places them at greater risk for future reading impairments and academic failure. Surprisingly, there are few interventions for word learning by children with SLI that have undergone rigorous efficacy and/or effectiveness testing. The goal of this research is to optimize an interactive book reading intervention that has proven to be successful in teaching vocabulary to other groups of Kindergarten children.

This preliminary clinical trial consists of two studies. The first study attempts to identify an adequate intensity of the interactive book reading treatment for children with SLI. Here, words are randomized to a treatment or no treatment (i.e., test only) condition and children are randomized to different intensities of the treatment. Specifically, children will hear the treated words either 12, 24, 36, or 48 times during treatment. The second study further tests the adequate intensity by comparing two versions of the treatment within the adequate intensity. Each child will receive two treatments at the identified adequate intensity. Children will be randomized to two treatments. One treatment will be balanced between the amount of times the new word is heard within the book and the amount of times the book is read. The second treatment will be more heavily weighted for either repetitions within the book or the amount of times the book is read. This study will examine how much children with different language skills benefit from the adequate intensity. In addition, this study will examine how best to achieve the adequate intensity. Specifically, is it better to hear the word more often in the session or to read the book more times or to have a balance of both? In the treatment condition, words are randomized to more repetitions in the session or to more repetitions of reading the same book.

At the conclusion of this research, an adequate intensity and manner of achieving this intensity of interactive book reading will have been identified for children with SLI. Moreover, a better understanding of the types of outcomes that can be attained through changing intensity and changing the manner of achieving intensity will be gained for this treatment and this group of children. This will inform future research on this treatment by determining whether a larger study can be initiated or whether the treatment needs further refinement to be effective for children with SLI.

  Eligibility

Ages Eligible for Study:   5 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for Kindergarten enrollment
  • Age 5 to 6 years
  • Normal hearing
  • Nonverbal Intelligence Quotient (IQ) of 85 or higher on the Reynolds Intellectual Assessment Scale
  • Score below 82 on the Clinical Evaluation of Language Fundamentals
  • Score at or below the 10% percentile on one of the approved standardized vocabulary assessments.

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, seizure disorder)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829360

Contacts
Contact: Holly Storkel 785-864-0497 hstorkel@ku.edu
Contact: Word & Sound Learning Lab 785-864-4873 wrdlrng@mail.ku.edu

Locations
United States, Kansas
University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Holly Storkel    785-864-0497    hstorkel@ku.edu   
Principal Investigator: Holly Storkel         
Sponsors and Collaborators
University of Kansas Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Holly Storkel University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01829360     History of Changes
Other Study ID Numbers: R01DC012824 
Study First Received: March 12, 2013
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2016