An interventional study of Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues in Language Development Disorders, Down Syndrome and Child Language, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
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.
Time frame: 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
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
| Milestone | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Started | 23 | 8 | 7 |
| Completed | 23 | 8 | 7 |
| Not completed | 0 | 0 | 0 |
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.
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Identifying Taught Words - Syntactic Condition | 8.73 ± 3.26 | 8.75 ± 3.11 | 10.29 ± 2.21 |
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.
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Identifying Taught Words - Semantic Condition | 8.91 ± 3.54 | 9.50 ± 2.93 | 10.14 ± 2.67 |
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.
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Identifying Taught Words - Combined Condition | 9.04 ± 2.75 | 9.38 ± 2.07 | 10.00 ± 2.24 |
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.
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Labeling Taught Words - Syntactic Condition | 0.61 ± 0.58 | 0.75 ± 0.71 | 0.86 ± 0.90 |
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.
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Labeling Taught Words - Semantic Condition | 0.52 ± 0.73 | 1.00 ± 0.93 | 0.43 ± 0.79 |
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
| Score on a scale | Typical Development | Down Syndrome | Developmental Language Disorder |
|---|---|---|---|
| Accuracy Labeling Taught Words - Combined Condition | 0.70 ± 0.63 | 1.38 ± 1.41 | 0.71 ± 1.11 |
Collected over Baseline to 30 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Typical Development | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Down Syndrome | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Developmental Language Disorder | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| <=18 years | 23 | 8 | 7 | 38 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| Female | 13 | 6 | 2 | 21 |
| Male | 10 | 2 | 5 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 3 | 5 |
| Not Hispanic or Latino | 20 | 7 | 4 | 31 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 17 | 8 | 4 | 29 |
| More than one race | 6 | 0 | 0 | 6 |
| Unknown or Not Reported | 0 | 0 | 2 | 2 |
| Region of Enrollment(participants) | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| United States | 23 | 8 | 7 | 38 |
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Vanderbilt University Medical Center