NCT03441685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

March 21, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

December 1, 2023

Enrollment Period

3.3 years

First QC Date

February 8, 2018

Results QC Date

May 7, 2022

Last Update Submit

December 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Accuracy Labeling Taught Words - Syntactic Condition

    From date of initial evaluation to focused intervention session, up to 1 month

  • Accuracy Labeling Taught Words - Semantic Condition

    From date of initial evaluation to focused intervention session, up to 1 month

  • Accuracy Labeling Taught Words - Combined Condition

    From date of initial evaluation to focused intervention session, up to 1 month

Study Arms (1)

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.

Behavioral: Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues

Interventions

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.

Verb strategies

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Bill Wilkerson Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Language Development DisordersDown Syndrome

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsIntellectual DisabilityAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Results Point of Contact

Title
Dr. C. Melanie Schuele
Organization
Vanderbilt University Medical Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants' completion of study tasks requires knowledge of intervention condition. Participants are blinded to study hypotheses.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 22, 2018

Study Start

March 21, 2018

Primary Completion

July 2, 2021

Study Completion

July 2, 2021

Last Updated

June 7, 2024

Results First Posted

June 7, 2024

Record last verified: 2023-12

Locations