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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Other trials in United States

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.

Conditions: Language Development Disorders, Down Syndrome, Child Language
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 groups in NCT03441685
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.

21 Mar 20182 Jul 2021

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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
Conditions: Language Development Disorders, Down Syndrome, Child Language
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.

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

Results posted to the registry on 7 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Typical Development	23	23
Down Syndrome	8	8
Developmental Language Disorder	7	7

Primary outcome: Accuracy Identifying Taught Words - Syntactic Condition

Time frame: From date of initial evaluation to focused intervention session, up to 1 month. Mean (Standard Deviation). Unit: Score on a scale

Measure	Typical Development n = 23	Down Syndrome n = 8	Developmental Language Disorder n = 7
Value	8.73 (3.26)	8.75 (3.11)	10.29 (2.21)

Typical Development: p = 0.73, Wilcoxon Signed Ranks Test
Down Syndrome: p = 0.69, Wilcoxon Signed Ranks Test
Developmental Language Disorder: p = 0.79, Wilcoxon Signed Ranks Test

Population analysed: Analyzed eligible participants

Primary outcome: Accuracy Identifying Taught Words - Semantic Condition

Time frame: From date of initial evaluation to focused intervention session, up to 1 month. Mean (Standard Deviation). Unit: Score on a scale

Measure	Typical Development n = 23	Down Syndrome n = 8	Developmental Language Disorder n = 7
Value	8.91 (3.54)	9.50 (2.93)	10.14 (2.67)

Typical Development: p = 0.76, Wilcoxon Signed Ranks Test
Down Syndrome: p = 0.79, Wilcoxon Signed Ranks Test
Developmental Language Disorder: p = 1.00, Wilcoxon Signed Ranks Test

Population analysed: Analyzed eligible participants

Primary outcome: Accuracy Identifying Taught Words - Combined Condition

Time frame: From date of initial evaluation to focused intervention session, up to 1 month. Mean (Standard Deviation). Unit: Score on a scale

Measure	Typical Development n = 23	Down Syndrome n = 8	Developmental Language Disorder n = 7
Value	9.04 (2.75)	9.38 (2.07)	10.00 (2.24)

Typical Development: p = 0.72, Wilcoxon Signed Ranks Test
Down Syndrome: p = 0.46, Wilcoxon Signed Ranks Test
Developmental Language Disorder: p = 0.89, Wilcoxon Signed Ranks Test

Population analysed: Analyzed eligible participants

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 30 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Typical Development	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Down Syndrome	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Developmental Language Disorder	0 of 7 (0%)	0 of 7 (0%)	0 of 7

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?

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?

On the ClinicalTrials.gov record for NCT03441685.

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.