NA trial testing Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues in Language Development Disorders in 44 participants. Completed in 2 July 2021.
Timeline
21 March 2018
Primary endpoint 2 July 2021
2 July 2021
Quick facts
Lead sponsor
Vanderbilt University Medical Center
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
na
Design
single group
Masking
none
Primary purpose
treatment
Enrollment
44
Start date
21 March 2018
Primary completion
2 July 2021
Estimated completion
2 July 2021
Sites
1 location across United States
Drugs / interventions tested
Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues
Adults 3 to 17, any sex, with Language Development Disorders or Down Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Accuracy Identifying Taught Words - Syntactic ConditionPrimary· 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.
Group
Value
95% CI
Typical Development
8.73
± 3.26
Down Syndrome
8.75
± 3.11
Developmental Language Disorder
10.29
± 2.21
Accuracy Identifying Taught Words - Semantic ConditionPrimary· 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.
Group
Value
95% CI
Typical Development
8.91
± 3.54
Down Syndrome
9.50
± 2.93
Developmental Language Disorder
10.14
± 2.67
Accuracy Identifying Taught Words - Combined ConditionPrimary· 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.
Group
Value
95% CI
Typical Development
9.04
± 2.75
Down Syndrome
9.38
± 2.07
Developmental Language Disorder
10.00
± 2.24
Accuracy Labeling Taught Words - Syntactic ConditionSecondary· 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.
Group
Value
95% CI
Typical Development
0.61
± 0.58
Down Syndrome
0.75
± 0.71
Developmental Language Disorder
0.86
± 0.90
Accuracy Labeling Taught Words - Semantic ConditionSecondary· 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.
Group
Value
95% CI
Typical Development
0.52
± 0.73
Down Syndrome
1.00
± 0.93
Developmental Language Disorder
0.43
± 0.79
Accuracy Labeling Taught Words - Combined ConditionSecondary· 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
Group
Value
95% CI
Typical Development
0.70
± 0.63
Down Syndrome
1.38
± 1.41
Developmental Language Disorder
0.71
± 1.11
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03441685.