Speech Intelligibility Intervention in Down SyndromeNCT05016037
Predictors of Speech Ability in Down Syndrome
A study testing Lexically based speech recast in people with Speech Intelligibility Intervention in Down Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Speech is a critical aspect of the human experience and usually develops in a "seemingly automatic process that continues from birth through adolescence and underlies many related abilities" (e.g., language and reading, see National Academy of Medicine Report on Speech and Language Disorders, 2016). Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Speech Intelligibility Intervention in Down Syndrome
- What is being tested?
- Lexically based speech recast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 30 Apr 2025
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- previous medical identification of Down Syndrome
- chronological age 4-17 years
- regular use of 3-word utterances (ascertained via parent report during screening and confirmed during assessments)
- pass a hearing screening at the time of enrollment in the project. All will pass a hearing screening (25 dB @1000, 2000, 4000 Hz).
Who cannot join
- A history of or parent report of
- seizures,
- diagnosed ADHD,
- apraxia secondary to a diagnosed neurological disorder
- Autism Spectrum Disorder (Autism Diagnostic Observation Scale-2nd Edition score above the ASD cut-off) or
- severe disruptive behavior that would prevent participation in testing or treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VUMC Bill Wilkerson Center
Nashville, Tennessee, 37232
About this study
Speech is a critical aspect of the human experience and usually develops in a "seemingly automatic process that continues from birth through adolescence and underlies many related abilities" (e.g., language and reading, see National Academy of Medicine Report on Speech and Language Disorders, 2016). Many individuals with Down Syndrome (Trisomy 21, DS) struggle to communicate and participate more fully in human communication and educational learning experiences because their speech is difficult to understand. The purpose of the proposed project was to measure speech-articulation accuracy and speech intelligibility, and their proposed primary predictors at study entry in 16 children with DS age 4;0 to 17;11). A validated treatment, speech recast intervention (see Yoder, Camarata \& Woynaroski, 2016) was used to drive growth in speech intelligibility as a means of evaluating changes in potential sequelae of change. This study included measures of speech-articulation accuracy, and speech-prosody skills as predictors of speech intelligibility growth in DS.
Read the detailed description
In most children, speech development progresses in a "seemingly automatic manner that continues from birth through adolescence"1 and supports related communication and reading abilities. But many individuals with Down Syndrome (DS, about 1 in 700 births in the US) struggle to acquire speech and participate more fully in human communication and gain access to learning experiences, in part, because their speech is often difficult to understand. This persistent speech disorder arises because people with DS must acquire and produce speech using structurally-different articulators and poor speech oral-motor abilities. Moreover, there is considerable variability in the speech intelligibility of people with DS and it is unclear why some people with DS communicate relatively proficiently whereas others are unable to clearly communicate.
The Investigator's recent research provides a unique combination of findings that, when integrated into a prospective project, can potentially provide new insights into how people with DS improve speech intelligibility. This assertion is grounded in the long-standing and replicated finding that speech intelligibility in DS is not strongly correlated with nor solely attributable to measures of phoneme production, so that improvements in intelligibility must rely not only improvements in speech accuracy (phoneme production) but also upon changes in "nonphonemic" factors such as cognitive-linguistic parameters and suprasegmental features such as prosody and speech rate that are currently poorly understood. For example, in a recent paper (Wilson, Abedduto, Camarata \& Shriberg, 2019), the Investigators describe cognitive/linguistic and speech-motor factors that relate to speech intelligibility in DS and provide preliminary data on nonphonemic parameters that are significantly correlated to intelligibility. In the cognitive linguistic domain, the Investigators found that measures of cognitive ability and receptive language abilities were directly related to speech intelligibility in people with DS. The Investigators also found that measures of speech-motor ability related to speech intelligibility. Importantly, in another series of studies, the Investigators demonstrated that individualized lexically based phonological recast intervention resulted in improvements in speech intelligibility in school age children with DS and that these gains were NOT uniquely attributable to changes in speech accuracy (phoneme production). Thus, the Investigators propose to induce growth in speech intelligibility in order to study change in speech and as an important step towards a) developing more effective speech interventions, and b) gaining a better understanding of parameters that drive improved speech intelligibility in DS (e.g.,phoneme production). This latter point is especially important because the Investigator's previous research and the extant literature indicate that traditional measures of speech accuracy (e.g., phoneme articulation) do not completely capture or predict improvements in speech intelligibility in DS. The proposed research would thus test assumptions underlying current models of speech disorder (and intervention) in DS. The Investigator's previous research has indicated that the Investigators can drive change in speech intelligibility without directly targeting speech accuracy, providing an opportunity to study intelligibility while controlling for speech accuracy as an untreated factor. Thus, an important first step in identifying factors that influence variation in speech intelligibility in addition to speech accuracy is to identify predictors of these speech abilities following intervention induced gains. Therefore, in keeping with the goals of an exploratory/developmental research project proposal (R21), the Investigators propose a pre-post design that measures speech intelligibility, and it's posited sequelae within the context of a controlled pre-post speech recast intervention study. Participants were 16 school-age children (4 to 17 years) with DS with varied cognitive ability levels (minimum of 60 with no ceiling). The following specific aims were pursued:
Aim 1: Test whether there were changes in baseline to post intervention measures of speech.
Aim 2: Examine the associations among measures of speech accuracy and prosody and overall speech intelligibility.
Impact: The results of this study within the context of a pre-post intervention design will provide important preliminary information on factors that contribute to intelligible speech in DS; thereby informing models of speech intelligibility and speech accuracy and future larger scale clinical trials. The proposed project will provide preliminary data to guide future longitudinal studies of value-added predictors of speech outcomes, and ultimately, improve assessment and intervention for speech deficits in individuals with DS.
- Being tested
- Lexically based speech recast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lexically based speech recastBehavioural
Also called Phonological Recast
A child's spontaneous or elicited word production containing phonological errors is immediately followed with a clinician verbal model that corrects the error(s) at the word level rather than the isolated phoneme level. As an example, a speech recast of child's production of the word "bake" as [be] would be the whole lexeme bake [bek] rather than production drill on [k] in isolation.
| Study group | Role | What they receive |
|---|---|---|
| Lexically Based Speech Intelligibility Recast | Other | Speech recasts are likely to improve speech intelligibility in Down Syndrome. The goal of this study is to induce change in speech intelligibility in order to study speech accuracy and prosody as predictors of change in speech intelligibility. Receives: Behavioral: Lexically based speech recast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility
Speech intelligibility is a 5 point Likert scale based on the language sample obtained (e.g., based on the number of words spoken in the sample). The scale range is 1 to 5, 1 being very low intelligibility and 5 being high intelligibility.
Measured: six months
Speech Accuracy
Percentage of correct phonemes on standardized speech tests and in a semi structured speech sample. This is the number of correct phonemes divided by the number of total phonemes in the sample (or test) divided by 100.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start14 Feb 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2025
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Speech Intelligibility Intervention in Down SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Stephen Camarata, Vanderbilt University Medical Center
- Investigators
- Stephen Camarata, PhD, Principal investigator, VUMC Dept of Hearing & Speech Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016037
- Sponsor's protocol ID
- Vanderbilt_UniversityMC
- Other IDs
- R21DC019280-01A1
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2021
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoder PJ, Camarata S, Woynaroski T. Treating Speech Comprehensibility in Students With Down Syndrome. J Speech Lang Hear Res. 2016 Jun 1;59(3):446-59. doi: 10.1044/2015_JSLHR-S-15-0148.
PubMed 27300156Yoder PJ, Woynaroski T, Camarata S. Measuring Speech Comprehensibility in Students with Down Syndrome. J Speech Lang Hear Res. 2016 Jun 1;59(3):460-7. doi: 10.1044/2015_JSLHR-S-15-0149.
PubMed 27299989Wilson EM, Abbeduto L, Camarata SM, Shriberg LD. Speech and motor speech disorders and intelligibility in adolescents with Down syndrome. Clin Linguist Phon. 2019;33(8):790-814. doi: 10.1080/02699206.2019.1595736.
PubMed 31221010
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Speech Ability in Down Syndrome
- ClinicalTrials.gov ID
- NCT05016037
- Acronym / sponsor ID
- Vanderbilt_UniversityMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Speech is a critical aspect of the human experience and usually develops in a "seemingly automatic process that continues from birth through adolescence and underlies many related abilities" (e.g., language and reading, see National Academy of Medicine Report on Speech and Language Disorders, 2016). Many individuals with Down Syndrome (Trisomy 21, DS) struggle to communicate and participate more fully in human communication and educational learning experiences because their speech is difficult to understand. The purpose of the proposed project was to measure speech-articulation accuracy and speech intelligibility, and their proposed primary predictors at study entry in 16 children with DS age 4;0 to 17;11). A validated treatment, speech recast intervention (see Yoder, Camarata \& Woynaroski, 2016) was used to drive growth in speech intelligibility as a means of evaluating changes in potential sequelae of change. This study included measures of speech-articulation accuracy, and speech-prosody skills as predictors of speech intelligibility growth in DS.
Detailed description
In most children, speech development progresses in a "seemingly automatic manner that continues from birth through adolescence"1 and supports related communication and reading abilities. But many individuals with Down Syndrome (DS, about 1 in 700 births in the US) struggle to acquire speech and participate more fully in human communication and gain access to learning experiences, in part, because their speech is often difficult to understand. This persistent speech disorder arises because people with DS must acquire and produce speech using structurally-different articulators and poor speech oral-motor abilities. Moreover, there is considerable variability in the speech intelligibility of people with DS and it is unclear why some people with DS communicate relatively proficiently whereas others are unable to clearly communicate.
The Investigator's recent research provides a unique combination of findings that, when integrated into a prospective project, can potentially provide new insights into how people with DS improve speech intelligibility. This assertion is grounded in the long-standing and replicated finding that speech intelligibility in DS is not strongly correlated with nor solely attributable to measures of phoneme production, so that improvements in intelligibility must rely not only improvements in speech accuracy (phoneme production) but also upon changes in "nonphonemic" factors such as cognitive-linguistic parameters and suprasegmental features such as prosody and speech rate that are currently poorly understood. For example, in a recent paper (Wilson, Abedduto, Camarata \& Shriberg, 2019), the Investigators describe cognitive/linguistic and speech-motor factors that relate to speech intelligibility in DS and provide preliminary data on nonphonemic parameters that are significantly correlated to intelligibility. In the cognitive linguistic domain, the Investigators found that measures of cognitive ability and receptive language abilities were directly related to speech intelligibility in people with DS. The Investigators also found that measures of speech-motor ability related to speech intelligibility. Importantly, in another series of studies, the Investigators demonstrated that individualized lexically based phonological recast intervention resulted in improvements in speech intelligibility in school age children with DS and that these gains were NOT uniquely attributable to changes in speech accuracy (phoneme production). Thus, the Investigators propose to induce growth in speech intelligibility in order to study change in speech and as an important step towards a) developing more effective speech interventions, and b) gaining a better understanding of parameters that drive improved speech intelligibility in DS (e.g.,phoneme production). This latter point is especially important because the Investigator's previous research and the extant literature indicate that traditional measures of speech accuracy (e.g., phoneme articulation) do not completely capture or predict improvements in speech intelligibility in DS. The proposed research would thus test assumptions underlying current models of speech disorder (and intervention) in DS. The Investigator's previous research has indicated that the Investigators can drive change in speech intelligibility without directly targeting speech accuracy, providing an opportunity to study intelligibility while controlling for speech accuracy as an untreated factor. Thus, an important first step in identifying factors that influence variation in speech intelligibility in addition to speech accuracy is to identify predictors of these speech abilities following intervention induced gains. Therefore, in keeping with the goals of an exploratory/developmental research project proposal (R21), the Investigators propose a pre-post design that measures speech intelligibility, and it's posited sequelae within the context of a controlled pre-post speech recast intervention study. Participants were 16 school-age children (4 to 17 years) with DS with varied cognitive ability levels (minimum of 60 with no ceiling). The following specific aims were pursued:
Aim 1: Test whether there were changes in baseline to post intervention measures of speech.
Aim 2: Examine the associations among measures of speech accuracy and prosody and overall speech intelligibility.
Impact: The results of this study within the context of a pre-post intervention design will provide important preliminary information on factors that contribute to intelligible speech in DS; thereby informing models of speech intelligibility and speech accuracy and future larger scale clinical trials. The proposed project will provide preliminary data to guide future longitudinal studies of value-added predictors of speech outcomes, and ultimately, improve assessment and intervention for speech deficits in individuals with DS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lexically Based Speech Intelligibility Recast | Other | Behavioral: Lexically based speech recastSpeech recasts are likely to improve speech intelligibility in Down Syndrome. The goal of this study is to induce change in speech intelligibility in order to study speech accuracy and prosody as predictors of change in speech intelligibility. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- previous medical identification of Down Syndrome
- chronological age 4-17 years
- regular use of 3-word utterances (ascertained via parent report during screening and confirmed during assessments)
- pass a hearing screening at the time of enrollment in the project. All will pass a hearing screening (25 dB @1000, 2000, 4000 Hz).
Key exclusion criteria (6 listed)
- A history of or parent report of
- seizures,
- diagnosed ADHD,
- apraxia secondary to a diagnosed neurological disorder
- Autism Spectrum Disorder (Autism Diagnostic Observation Scale-2nd Edition score above the ASD cut-off) or
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 |
|---|---|---|
| Lexically based speech recastAlso: Phonological RecastA child's spontaneous or elicited word production containing phonological errors is immediately followed with a clinician verbal model that corrects the error(s) at the word level rather than the isolated phoneme level. As an example, a speech recast of child's production of the word "bake" as [be] would be the whole lexeme bake [bek] rather than production drill on [k] in isolation. | Behavioural | Lexically Based Speech Intelligibility Recast |
Primary outcome
Speech Intelligibility
Time frame: six months
Speech intelligibility is a 5 point Likert scale based on the language sample obtained (e.g., based on the number of words spoken in the sample). The scale range is 1 to 5, 1 being very low intelligibility and 5 being high intelligibility.
Speech Accuracy
Time frame: six months
Percentage of correct phonemes on standardized speech tests and in a semi structured speech sample. This is the number of correct phonemes divided by the number of total phonemes in the sample (or test) divided by 100.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27300156Yoder PJ, Camarata S, Woynaroski T. Treating Speech Comprehensibility in Students With Down Syndrome. J Speech Lang Hear Res. 2016 Jun 1;59(3):446-59. doi: 10.1044/2015_JSLHR-S-15-0148.
- Background: PubMed 27299989Yoder PJ, Woynaroski T, Camarata S. Measuring Speech Comprehensibility in Students with Down Syndrome. J Speech Lang Hear Res. 2016 Jun 1;59(3):460-7. doi: 10.1044/2015_JSLHR-S-15-0149.
- Background: PubMed 31221010Wilson EM, Abbeduto L, Camarata SM, Shriberg LD. Speech and motor speech disorders and intelligibility in adolescents with Down syndrome. Clin Linguist Phon. 2019;33(8):790-814. doi: 10.1080/02699206.2019.1595736.
- Individual participant dataSharing planned: No
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.
Stephen Camarata, PhD principal investigator
VUMC Dept of Hearing & Speech Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lexically based speech recast in people with Speech Intelligibility Intervention in 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 6 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 3 Aug 2025. 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 3 Aug 2025). 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?
Speech Intelligibility (time frame: six months). The study lists 2 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 NCT05016037, which also lists 3 linked publications.
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 3 Aug 2025.