CClinicalTrials.gg
CompletedNCT05016037Updated Aug 3, 2025Results posted

Predictors of Speech Ability in Down Syndrome

An interventional study of Lexically based speech recast in Speech Intelligibility Intervention in Down Syndrome, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
4 Years to 17 Years
Sex
All
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Study 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). 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.

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Conditions studied

  • Speech Intelligibility Intervention in Down Syndrome
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In context

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Other
    Lexically Based Speech Intelligibility Recast

    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.

    Behavioral: Lexically based speech recast

Interventions

  • BehavioralLexically based speech 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.

    Also known as: Phonological Recast

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: six months

  2. 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.

    Time frame: six months

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Results

Posted Aug 3, 2025
Limitations and caveats
Limitations include that there is no control group, therefore results are not evidence of the efficacy/efficiency of lexical recast intervention on speech production in children with Down syndrome (DS). A caveat is the small sample size.

Participant flow

Participant flow — Overall Study
MilestoneLexically Based Speech Intelligibility Recast
Started18
Completed16
Not completed2
Withdrew: Lost to follow-up2

Outcome measures

PrimarySpeech 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.

Time frame:
six months
Reported as:
Mean · score on a scale
Speech Intelligibility
score on a scaleLexically Based Speech Intelligibility Recast
Speech Intelligibility3.59 ± 0.97
PrimarySpeech 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.

Time frame:
six months
Reported as:
Mean · percentage of correct phonemes
Speech Accuracy
percentage of correct phonemesLexically Based Speech Intelligibility Recast
Percent Consonants Correct61.55 ± 17.97
Percent Vowels Correct89.57 ± 9.05

Adverse events

Collected over Participants were enrolled in the study for ~ 6 months long (from Baseline assessments to Post assessments). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lexically Based Speech Intelligibility Recast0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

18 participants signed informed consent. One person did not complete the baseline assessment and withdrew from the study.

Age, Categorical
Age, Categorical(Participants)Baseline Measures
<=18 years17
Between 18 and 65 years0
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Baseline Measures
Female7
Male10
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Baseline Measures
Hispanic or Latino1
Not Hispanic or Latino15
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Baseline Measures
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White11
More than one race2
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Baseline Measures
United States17
Leiter International Performance Scale, Third Edition
Leiter International Performance Scale, Third Edition(Nonverbal IQ)Baseline Measures
Mean71.69 ± 13.26
Receptive One Word Picture Vocabulary Test (ROWPVT-4)
Receptive One Word Picture Vocabulary Test (ROWPVT-4)(Standard Score)Baseline Measures
Mean74.75 ± 13.42
Expressive One Word Picture Vocabulary Test (EOWPVT-4)
Expressive One Word Picture Vocabulary Test (EOWPVT-4)(standard score)Baseline Measures
Mean73.7 ± 10.5

7 further baseline measures are reported on the registry.

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Study locations

1 site
  • VUMC Bill Wilkerson Center
    Nashville, Tennessee 37232, United States
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References and documents

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 27300156 ↗
  • Yoder 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 27299989 ↗
  • Wilson 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 documents

  • Study protocol · Jun 20, 2025
  • Statistical analysis plan · Apr 24, 2025
  • Informed consent form · Jan 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05016037
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Stephen Camarata (Professor, Hearing and Speech Sciences, Vanderbilt University Medical Center) — Principal investigator
First posted
Aug 23, 2021
Start date
Feb 14, 2022
Primary completion
Apr 30, 2024
Completion
Apr 30, 2025
Results posted
Aug 3, 2025
Last update
Aug 3, 2025

Study contacts

Stephen Camarata, PhD
principal investigator · VUMC Dept of Hearing & Speech Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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