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This study is designed to evaluate whether children with Down syndrome and children with typical development exhibit different levels of accuracy demonstrating novel verbs taught under three conditions: semantic cues (perform action), syntactic cues (sentence frame), and combined (syntactic and semantic cues). The participants complete an eligibility evaluation and then one verb learning session (approximately 60 minutes in length). During that verb learning session they are taught sets of words under each condition (i.e., within-subjects design) and then asked to identify and label those target words immediately after instruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verb strategies | Experimental | The examiner labels each target word and performs the corresponding action six times in each condition. She elicits the target word from the participant two times per word per condition and provides feedback on accuracy each time. In the semantic cues condition, the examiner prompts the child to perform the target action twice. In the syntactic cues condition, instead of only saying the target word with the present progressive verb marker, the examiner uses two forms of complete sentences while performing the action (i.e., "I am X-ing," and "See. I X."). In the combined condition, the examiner prompts the child to perform the target action and consistently uses complete sentences. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues | Behavioral | Verb Learning Session Teaching phase. The examiner labels each target word and performs the action 6 times in each condition. She elicits the target word from the participant 2 times per word per condition and provides feedback on accuracy. Testing phase. Receptive probes are administered after every 2 words are taught. Expressive probes are at the end of the condition. For receptive probes, the examiner asks the participant to identify novel verbs and for expressive probes, the examiner asks the child to label the novel action. Testing after 2 items is designed to decrease memory load. Participants have a brief break between conditions. Data are collected on: a) child responses on standardized assessments, (b) responses to verb learning probes, (c) parent responses to intake form, and (d) relevant medical history from electronic medical record. None of the above procedures present more than minimal risk to participants or research staff. Vanderbilt IRB approved all procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy Identifying Taught Words - Syntactic Condition | Participants are asked to receptively identify novel verbs taught in syntactic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | From date of initial evaluation to focused intervention session, up to 1 month |
| Accuracy Identifying Taught Words - Semantic Condition | Participants are asked to receptively identify novel verbs taught in semantic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | From date of initial evaluation to focused intervention session, up to 1 month |
| Accuracy Identifying Taught Words - Combined Condition | Participants are asked to receptively identify novel verbs taught in combined condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | From date of initial evaluation to focused intervention session, up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy Labeling Taught Words - Syntactic Condition | After the teaching episodes for the syntactic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome. | From date of initial evaluation to focused intervention session, up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Bill Wilkerson Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Typical Development | Children with typical development |
| FG001 | Down Syndrome | Children with Down syndrome |
| FG002 | Developmental Language Disorder | Children with developmental language disorder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Typical Development | Children with typical development |
| BG001 | Down Syndrome | Children with Down syndrome |
| 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, Categorical | Count of Participants |
| 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 | Accuracy Identifying Taught Words - Syntactic Condition | Participants are asked to receptively identify novel verbs taught in syntactic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
|
Baseline to 30 days
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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 | Typical Development | Children with typical development | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. C. Melanie Schuele | Vanderbilt University Medical Center | 615-936-5256 | melanie.schuele@vanderbilt.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 | Nov 23, 2020 | Dec 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007805 | Language Development Disorders |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
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Participants' completion of study tasks requires knowledge of intervention condition. Participants are blinded to study hypotheses.
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|
| Accuracy Labeling Taught Words - Semantic Condition | After the teaching episodes for the semantic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome. | From date of initial evaluation to focused intervention session, up to 1 month |
| Accuracy Labeling Taught Words - Combined Condition | After the teaching episodes for the combined condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome | From date of initial evaluation to focused intervention session, up to 1 month |
| BG002 |
| Developmental Language Disorder |
Children with developmental language disorder |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Children with Down syndrome |
| OG002 | Developmental Language Disorder | Children with developmental language disorder |
|
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| Primary | Accuracy Identifying Taught Words - Semantic Condition | Participants are asked to receptively identify novel verbs taught in semantic condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
|
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|
|
| Primary | Accuracy Identifying Taught Words - Combined Condition | Participants are asked to receptively identify novel verbs taught in combined condition by selecting the video of the named verb from a field of two. Participants were asked to identify each of the 4 taught words per condition 3 times for a total of 12 trials per condition. This "receptive probe" has a minimum score of 0 and maximum of 12. Higher scores indicate a better outcome. | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
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| Secondary | Accuracy Labeling Taught Words - Syntactic Condition | After the teaching episodes for the syntactic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome. | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
|
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|
|
| Secondary | Accuracy Labeling Taught Words - Semantic Condition | After the teaching episodes for the semantic condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome. | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
|
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|
|
| Secondary | Accuracy Labeling Taught Words - Combined Condition | After the teaching episodes for the combined condition participants are asked to label novel verbs expressively. Participants were asked to label each of the 4 taught words per condition one time for a total of 4 trials per condition. This "expressive probe" has a minimum score of 0 and maximum of 4. Higher scores indicate a better outcome | Analyzed eligible participants | Posted | Mean | Standard Deviation | Score on a scale | From date of initial evaluation to focused intervention session, up to 1 month |
|
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|
|
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Down Syndrome | Children with Down syndrome | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Developmental Language Disorder | Children with developmental language disorder | 0 | 7 | 0 | 7 | 0 | 7 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008607 | Intellectual Disability |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| 0.79 |
Asymptotic p-value |
| Other |
Accuracy identifying taught verbs in semantic vs combined condition (receptive) |
| Wilcoxon Signed Ranks Test | 1.00 | Asymptotic p-value | Other | Accuracy identifying taught verbs in semantic vs combined condition (receptive) |
| One-sample Wilcoxon signed rank test | 0.003 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| One-sample Wilcoxon signed rank test | 0.029 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| One-sample Wilcoxon signed rank test | 0.027 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| 0.46 |
Asymptotic p-value |
| Other |
Accuracy identifying taught verbs in syntactic vs combined condition (receptive) |
| Wilcoxon Signed Ranks Test | 0.89 | Asymptotic p-value | Other | Accuracy identifying taught verbs in syntactic vs combined condition (receptive) |
| One-sample Wilcoxon signed rank test | <.001 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| One-sample Wilcoxon signed rank test | 0.018 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| One-sample Wilcoxon signed rank test | 0.027 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 6. |
| 0.16 |
Asymptotic p-value |
| Other |
Accuracy labeling taught verbs in syntactic vs semantic condition (expressive) |
| Wilcoxon Signed Ranks Test | 0.18 | Asymptotic p-value | Other | Accuracy labeling taught verbs in syntactic vs semantic condition (expressive) |
| One-sample Wilcoxon signed rank test | <.001 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.034 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.063 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| 0.18 |
Asymptotic p-value |
| Other |
Accuracy labeling taught verbs in semantic vs combined condition (expressive) |
| Wilcoxon Signed Ranks Test | 0.58 | Other | Accuracy labeling taught verbs in semantic vs combined condition (expressive) |
| One-sample Wilcoxon signed rank test | 0.006 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.02 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.18 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| 0.10 |
Asymptotic p-value |
| Other |
Accuracy labeling taught verbs in syntactic vs combined condition (expressive) |
| Wilcoxon Signed Ranks Test | 0.71 | Asymptotic p-value | Other | Accuracy labeling taught verbs in syntactic vs combined condition (expressive) |
| One-sample Wilcoxon signed rank test | <.001 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.024 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |
| One-sample Wilcoxon signed rank test | 0.10 | Asymptotic p-value | Other | One-sample Wilcoxon signed rank test with comparison value of 0 |