Clinical trial NCT01829360: Accelerating Word Learning in Children With Language Impairment
Official title: Interactive Book Reading to Accelerate Word Learning by Children With SLI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Language Impairment
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-04-11
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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. This study will examine the best way to achieve the appropriate intensity of 36 exposures. For example, is it better to hear the new words many times within the book (high dose) and to read the book few times (low dose frequency), or is it better to hear the new words a few times within the book (low dose) and to read the book many times (high dose frequency). The investigators hypothesize that reading the books many times will be more effective than repeating the words many times within a book.

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. A secondary goal was to examine whether pre-treatment characteristics predicted how many words children would learn.

This study further tests the adequate intensity of 36 exposures. Each child will receive two treatments at the identified adequate intensity. Children were randomized to two treatments: the standard treatment and 1 of 2 alternative treatments. The standard treatment used in prior research was balanced between the amount of times the new word is heard within the book (dose 6) and the amount of times the book is read (dose frequency 6). The alternative treatments were more heavily weighted for either repetitions within the book (high dose/low dose frequency, i.e., dose 9 x dose frequency 4) or the amount of times the book is read (low dose/high dose frequency, i.e., dose 4 x dose frequency 9). Ultimately, this study determines how best to achieve the adequate intensity of 36 exposures.

A secondary goal was to further examine the pre-treatment factors associated with the number of words learned by children with SLI during interactive book reading. We once again explore a variety of potential predictors including those that were significant in a prior study (i.e., phonological awareness, nonword repetition, and semantics) as well as those that were not significant in a prior study but that had the potential to be related to a child's ability to learn during interactive book reading. That is, a child's general language abilities (as measured by the Clinical Evaluation of Language Fundamentals-4, CELF-4, Core Language score) and their ability to understand verbally presented stories (as measured by the CELF-4 Understanding Spoken Paragraphs score) could impact their success in encoding new words during interactive book reading.

Eligibility 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)

Primary outcomes:
measure: Change in Words Known From Pre- to Post-treatment
timeFrame: Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)
Secondary outcomes:
measure: Interim Definition
timeFrame: Treatment lasted 5-12 weeks. Data was taken during this time.
measure: Interim Naming
timeFrame: Administered during treatment, which lasted 5-12 weeks
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Holly Storkel
role: PRINCIPAL_INVESTIGATOR
References: