Language Development DisordersNCT03441685
Strategies for Teaching Verbs
A study testing Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues in people with Language Development Disorders and Down Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Development Disorders, Down Syndrome, Child Language
- What is being tested?
- Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Bill Wilkerson Center
Nashville, Tennessee, 37232
About this study
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.
- Being tested
- Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues
- Medical subject headings
- Language Development Disorders, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cuesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From date of initial evaluation to focused intervention session, up to 1 month
Secondary outcomes (3)
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.
Measured: From date of initial evaluation to focused intervention session, up to 1 month
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.
Measured: From date of initial evaluation to focused intervention session, up to 1 month
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
Measured: From date of initial evaluation to focused intervention session, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start21 Mar 2018
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Schuele, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441685
- Sponsor's protocol ID
- 172058
- Status last verified
- Dec 2023
- First submitted
- 8 Feb 2018
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Teaching Verbs
- ClinicalTrials.gov ID
- NCT03441685
- Acronym / sponsor ID
- 172058
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
| Arm | Type | Receives |
|---|---|---|
| Verb strategies | Experimental | Behavioral: Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cuesThe 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cuesVerb 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. | Behavioural | Verb strategies |
Primary outcome
Accuracy Identifying Taught Words - Syntactic Condition
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Accuracy Labeling Taught Words - Syntactic Condition
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Accuracy Labeling Taught Words - Semantic Condition
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Accuracy Labeling Taught Words - Combined Condition
Time frame: From date of initial evaluation to focused intervention session, up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues in people with Language Development Disorders and Down Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Identifying Taught Words - Syntactic Condition (time frame: From date of initial evaluation to focused intervention session, up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.