Strategies for Teaching Verbs

Down Syndrome Clinical Trial

Official title:

Strategies for Teaching Verbs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441685
• Other study ID #: 172058
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: July 2, 2021

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Child Language
• Down Syndrome
• Language Development Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt Bill Wilkerson Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From date of initial evaluation to focused intervention session, up to 1 month
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.	From date of initial evaluation to focused intervention session, up to 1 month
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.	From date of initial evaluation to focused intervention session, up to 1 month
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.	From date of initial evaluation to focused intervention session, up to 1 month
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.	From date of initial evaluation to focused intervention session, up to 1 month
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	From date of initial evaluation to focused intervention session, up to 1 month