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Strategies for Teaching Verbs

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ClinicalTrials.gov Identifier: NCT03441685
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Melanie Schuele, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Language Development Disorders Down Syndrome Child Language Behavioral: Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
Masking: None (Open Label)
Masking Description: Participants' completion of study tasks requires knowledge of intervention condition. Participants are blinded to study hypotheses.
Primary Purpose: Treatment
Official Title: Strategies for Teaching Verbs
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verb strategies
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.





Primary Outcome Measures :
  1. Percent accuracy identifying taught words [ Time Frame: From date of initial evaluation to focused intervention session, up to 1 month ]
    Participants are asked to receptively identify novel verbs by selecting the video of the named verb from a field of two.


Secondary Outcome Measures :
  1. Percent accuracy labeling taught words [ Time Frame: From date of initial evaluation to focused intervention session, up to 1 month ]
    After the teaching episodes participants are asked to label novel verbs expressively



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441685


Contacts
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Contact: Alison Hessling, M.S. 6159365136 alison.hessling@vanderbilt.edu
Contact: Jena McDaniel, M.S. 6159365136 jena.c.mcdaniel@Vanderbilt.Edu

Locations
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United States, Tennessee
Vanderbilt Bill Wilkerson Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Alison Hessling, MS    615-936-5136    alison.hessling@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center

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Responsible Party: Melanie Schuele, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03441685     History of Changes
Other Study ID Numbers: 172058
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Down Syndrome
Language Development Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Language Disorders
Communication Disorders
Signs and Symptoms