Child Language, Down Syndrome, Language Development Disorders
Conditions
Brief summary
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.
Interventions
BEHAVIORALSemantic 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants' completion of study tasks requires knowledge of intervention condition. Participants are blinded to study hypotheses.
Intervention model description
All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Must use oral communication as their primary means of communication * Must be monolingual English speakers * Behaviorally able to attend for 20 minutes * Children with typical development must demonstrate no more than one standard deviation below the mean on the speech and language measures
Exclusion criteria
* Nonverbal cognitive score less than three standard deviations below the mean (standard score of 54 below) * Identified hearing loss or failed hearing screening * Uncorrected vision impairment * Motor impairment that prevents completion of study activities * Concomitant disorders (e.g., Autism spectrum disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Identifying Taught Words - Syntactic Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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. |
| Accuracy Identifying Taught Words - Semantic Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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. |
| Accuracy Identifying Taught Words - Combined Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Labeling Taught Words - Syntactic Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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. |
| Accuracy Labeling Taught Words - Semantic Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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. |
| Accuracy Labeling Taught Words - Combined Condition | From date of initial evaluation to focused intervention session, up to 1 month | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Typical Development Children with typical development | 23 |
| Down Syndrome Children with Down syndrome | 8 |
| Developmental Language Disorder Children with developmental language disorder | 7 |
| Total | 38 |
Baseline characteristics
| Characteristic | Typical Development | Down Syndrome | Developmental Language Disorder | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 8 Participants | 7 Participants | 38 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 7 Participants | 4 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 8 Participants | 4 Participants | 29 Participants |
| Region of Enrollment United States | 23 participants | 8 participants | 7 participants | 38 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 2 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 2 Participants | 5 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 23 | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 23 | 0 / 8 | 0 / 7 |
Outcome results
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Identifying Taught Words - Combined Condition | 9.04 Score on a scale | Standard Deviation 2.75 |
| Down Syndrome | Accuracy Identifying Taught Words - Combined Condition | 9.38 Score on a scale | Standard Deviation 2.07 |
| Developmental Language Disorder | Accuracy Identifying Taught Words - Combined Condition | 10.00 Score on a scale | Standard Deviation 2.24 |
p-value: 0.72Wilcoxon Signed Ranks Test
p-value: 0.46Wilcoxon Signed Ranks Test
p-value: 0.89Wilcoxon Signed Ranks Test
p-value: <0.001One-sample Wilcoxon signed rank test
p-value: 0.018One-sample Wilcoxon signed rank test
p-value: 0.027One-sample Wilcoxon signed rank test
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Identifying Taught Words - Semantic Condition | 8.91 Score on a scale | Standard Deviation 3.54 |
| Down Syndrome | Accuracy Identifying Taught Words - Semantic Condition | 9.50 Score on a scale | Standard Deviation 2.93 |
| Developmental Language Disorder | Accuracy Identifying Taught Words - Semantic Condition | 10.14 Score on a scale | Standard Deviation 2.67 |
p-value: 0.76Wilcoxon Signed Ranks Test
p-value: 0.79Wilcoxon Signed Ranks Test
p-value: 1Wilcoxon Signed Ranks Test
p-value: 0.003One-sample Wilcoxon signed rank test
p-value: 0.029One-sample Wilcoxon signed rank test
p-value: 0.027One-sample Wilcoxon signed rank test
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Identifying Taught Words - Syntactic Condition | 8.73 Score on a scale | Standard Deviation 3.26 |
| Down Syndrome | Accuracy Identifying Taught Words - Syntactic Condition | 8.75 Score on a scale | Standard Deviation 3.11 |
| Developmental Language Disorder | Accuracy Identifying Taught Words - Syntactic Condition | 10.29 Score on a scale | Standard Deviation 2.21 |
p-value: 0.73Wilcoxon Signed Ranks Test
p-value: 0.69Wilcoxon Signed Ranks Test
p-value: 0.79Wilcoxon Signed Ranks Test
p-value: 0.002One-sample Wilcoxon signed rank test
p-value: 0.049One-sample Wilcoxon signed rank test
p-value: 0.016One-sample Wilcoxon signed rank test
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
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Labeling Taught Words - Combined Condition | 0.70 Score on a scale | Standard Deviation 0.63 |
| Down Syndrome | Accuracy Labeling Taught Words - Combined Condition | 1.38 Score on a scale | Standard Deviation 1.41 |
| Developmental Language Disorder | Accuracy Labeling Taught Words - Combined Condition | 0.71 Score on a scale | Standard Deviation 1.11 |
p-value: 0.56Wilcoxon Signed Ranks Test
p-value: 0.1Wilcoxon Signed Ranks Test
p-value: 0.71Wilcoxon Signed Ranks Test
p-value: <0.001One-sample Wilcoxon signed rank test
p-value: 0.024One-sample Wilcoxon signed rank test
p-value: 0.1One-sample Wilcoxon signed rank test
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Labeling Taught Words - Semantic Condition | 0.52 Score on a scale | Standard Deviation 0.73 |
| Down Syndrome | Accuracy Labeling Taught Words - Semantic Condition | 1.00 Score on a scale | Standard Deviation 0.93 |
| Developmental Language Disorder | Accuracy Labeling Taught Words - Semantic Condition | 0.43 Score on a scale | Standard Deviation 0.79 |
p-value: 0.35Wilcoxon Signed Ranks Test
p-value: 0.18Wilcoxon Signed Ranks Test
p-value: 0.58Wilcoxon Signed Ranks Test
p-value: 0.006One-sample Wilcoxon signed rank test
p-value: 0.02One-sample Wilcoxon signed rank test
p-value: 0.18One-sample Wilcoxon signed rank test
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.
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Population: Analyzed eligible participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Typical Development | Accuracy Labeling Taught Words - Syntactic Condition | 0.61 Score on a scale | Standard Deviation 0.58 |
| Down Syndrome | Accuracy Labeling Taught Words - Syntactic Condition | 0.75 Score on a scale | Standard Deviation 0.71 |
| Developmental Language Disorder | Accuracy Labeling Taught Words - Syntactic Condition | 0.86 Score on a scale | Standard Deviation 0.9 |
p-value: 0.64Wilcoxon Signed Ranks Test
p-value: 0.16Wilcoxon Signed Ranks Test
p-value: 0.18Wilcoxon Signed Ranks Test
p-value: <0.001One-sample Wilcoxon signed rank test
p-value: 0.034One-sample Wilcoxon signed rank test
p-value: 0.063One-sample Wilcoxon signed rank test