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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DC012824 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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 Aim 1 addresses the challenge that newly learned words were forgotten once treatment was withdrawn.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Testing | Experimental | 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. |
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| Mid Testing | Experimental | 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. |
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| High Testing | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive storybook reading | Behavioral | Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Definition Scores From Pre- to 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Naming Scores From Pre- to 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Untaught Vocabulary | 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. |
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 \
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca E Swinburne Romine, PhD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas | Lawrence | Kansas | 66045 | United States |
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.
Data will become available as findings are published (in conjunction with publication)
Data will be open access
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| FG001 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| FG002 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is reported in months |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Definition Scores From Pre- to 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. | Posted | Mean | Standard Deviation | number of words | 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment |
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All participants during the 15 treatment sessions (8 weeks) and during the retention period up to 12 weeks post treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
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We excluded the data from 8 children from analyses whose testing schedules were disrupted due to the 2020 pandemic. These children finished the clinical trial, however, because the primary questions of this study focused on learning rates and forgetting rates, and the schedule for these children differed substantially from the other children, we elected to exclude their data as their treatment schedules would not capture learning and retention rates on the same schedule as other children.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Swinburne Romine | University of Kansas | 7857668612 | swin0024@ku.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 | Nov 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2023 | Nov 3, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007805 | Language Development Disorders |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Children will be randomly assigned to one of three treatment arms
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Pre- and post-outcome assessments will be performed by an individual blind to arm assignment.
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| 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment |
| 10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment |
| Lost to Follow-up |
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| Behavioral Issues |
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| BG001 |
| 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| BG002 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Test of Narrative Language, Second Edition | The Test of Narrative Language-Second Edition "is a comprehensive measure of children's ability to understand and tell stories" (Gillam & Pearson, 2017, page 1). Each child's Narrative Language Ability Index score is reported. To obtain the index, each child's subtest scaled scores are summed and converted to the narrative language ability index . The subtest scaled scores include comprehension and production. The Language Ability Index Score ranges from 50 (less that 1st percentile) to 155 (greater than 99th percentile). Higher values represent a better outcome. | Mean | Standard Deviation | TNL score |
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| OG001 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
| OG002 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. |
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| Secondary | Change in Naming Scores From Pre- to 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. | Posted | Mean | Standard Deviation | number of words | 20 weeks: pre-treatment, treatment (7.5 weeks), 12-weeks post-treatment |
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| Other Pre-specified | Change in Untaught Vocabulary | 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. | One child in High Testing Group did not complete immediate post test. | Posted | Mean | Standard Deviation | number of words | 10 weeks: pre-treatment, treatment (7.5 weeks), immediate post-treatment |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | 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. Interactive storybook reading: Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |