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Predictors of Speech Ability in Down Syndrome

Primary Purpose

Speech Intelligibility Intervention in Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lexically based speech recast
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Speech Intelligibility Intervention in Down Syndrome

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • previous medical identification of Down Syndrome
  • chronological age 6-14 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:

A history of or parent report of

  • seizures,
  • diagnosed ADHD,
  • apraxia secondary to a diagnosed neurological disorder
  • stuttering,
  • 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.

Sites / Locations

  • VUMC Bill Wilkerson CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lexically Based Speech Intelligibility Recast

Arm Description

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 phonological, acoustic and suprasegmental sequelae of improvements in speech.

Outcomes

Primary Outcome Measures

Speech Intelligibility
Percentage of intelligible words in a semi structured speech sample
Speech Accuracy
Number of correct phonemes on standardized speech tests and in a semi structured speech sample

Secondary Outcome Measures

Speech Rate
Number of Phonemes and Number of syllables produced in a repeated rote phrase

Full Information

First Posted
August 17, 2021
Last Updated
July 5, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05016037
Brief Title
Predictors of Speech Ability in Down Syndrome
Official Title
Predictors of Speech Ability in Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 is to measure speech-articulation accuracy and speech intelligibility, and their proposed primary predictors at study entry in 20 children with DS age 6;0 to 13;11). A validated treatment, speech recast intervention (see Yoder, Camarata & Woynaroski, 2016) will be used to drive growth in speech intelligibility as a means of evaluating changes in potential sequelae of change. This integrated study will include measures of speech-articulation accuracy, speech-prosody, general cognitive ability, receptive vocabulary skills, and clinical assay of oral-motor ability as potential predictors of speech intelligibility growth in DS. The Investigators will also be measuring suprasegmental and rhythmic factors associated with growth.
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).6,65 Thus, the Investigators propose to induce growth in speech intelligibility in order to study cognitive-linguistic, suprasegmental and speech motor sequelae of change 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 in addition to 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 adequately 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. It is noteworthy that the Investigator's past work supports the hypothesis that nonphonemic factors such as general cognitive level and vocabulary comprehension level are predictors of later speech intelligibility in school age students with 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 mixed effects regression predictor design that measures speech intelligibility, and it's posited sequelae within the context of a controlled pre-post speech recast intervention study. Participants will be 20 school-age children (6 to 14 years) with DS with varied cognitive ability levels (minimum of 60 with no ceiling). The following specific aims will be pursued: Aim 1: Estimate the relative contribution of (a) general cognitive level and (b) vocabulary comprehension level, controlling for speech accuracy in accounting for variance in pre-post levels of speech intelligibility growth. Aim 2: Estimate the relative contribution of oral-motor skills in accounting for variance in speech intelligibility growth while controlling for speech accuracy. Aim 3: Estimate the relative contribution of suprasegmental prosodic parameters of (a) acoustic prominence (frequency (F0), duration, and intensity) of pitch accented target words; (b) metrical structure of rhythmic speech (rhythmic variability and accent structure) and (c) speech rate in accounting for change overall pre-post growth in speech intelligibility while controlling for speech accuracy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Intelligibility Intervention in Down Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lexically Based Speech Intelligibility Recast
Arm Type
Other
Arm Description
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 phonological, acoustic and suprasegmental sequelae of improvements in speech.
Intervention Type
Behavioral
Intervention Name(s)
Lexically based speech recast
Other Intervention Name(s)
Phonological Recast
Intervention Description
a child's spontaneous or elicited production containing phonological errors is immediately followed with a clinician 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.
Primary Outcome Measure Information:
Title
Speech Intelligibility
Description
Percentage of intelligible words in a semi structured speech sample
Time Frame
six months
Title
Speech Accuracy
Description
Number of correct phonemes on standardized speech tests and in a semi structured speech sample
Time Frame
six months
Secondary Outcome Measure Information:
Title
Speech Rate
Description
Number of Phonemes and Number of syllables produced in a repeated rote phrase
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: previous medical identification of Down Syndrome chronological age 6-14 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: A history of or parent report of seizures, diagnosed ADHD, apraxia secondary to a diagnosed neurological disorder stuttering, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen M Camarata, PhD
Phone
615-936-5111
Email
stephen.camarata@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Mazzone, MS
Phone
615-936-5000
Email
julie.mazzone@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Camarata, PhD
Organizational Affiliation
VUMC Dept of Hearing & Speech Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
VUMC Bill Wilkerson Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne M Tharpe, PhD
Phone
615-936-5000
Email
anne.m.tharpe@vumc.org
First Name & Middle Initial & Last Name & Degree
Stephen Camarata, PhD
Phone
615936-5111
Email
stephen.camarata@vumc.org
First Name & Middle Initial & Last Name & Degree
Stephen Camarata, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27300156
Citation
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.
Results Reference
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PubMed Identifier
27299989
Citation
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.
Results Reference
background
PubMed Identifier
31221010
Citation
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.
Results Reference
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Predictors of Speech Ability in Down Syndrome

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