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Down Syndrome Speech Intelligibility Diagnostic Treatment Study

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech therapy addressing phonology and motor learning
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Speech intelligibility

Eligibility Criteria

7 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Males with a diagnosis of Down syndrome between the ages of 7 and 16 years
  • Primary language is English
  • Interested in improving their speech intelligibility.
  • All participants must consent/assent to participate. As this is a multiple single subject design, services are available to all motivated participants who are willing to commit to the time/durations described in the diagnostic treatment.

Exclusion Criteria:

  • Primary language is not American English
  • Do not have a diagnosis of Down syndrome
  • Female
  • Ages birth-6 and 17 years or older
  • Individuals who have a co-occurring diagnosis that affects communication abilities [e.g., diagnosed as deaf with cochlear implants, Autism, only use an alternative/augmentative communication (AAC) device to communicate],
  • Severe hearing loss which will limit their ability to participate in the treatment

    • Individuals with a known mild or moderate hearing loss or current speech- language therapy services will not be excluded, but this information will be requested in the Parent Questionnaire. In addition, access to their current individualized education program (IEP) will be requested.

Sites / Locations

  • Waisman Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Speech therapy

Arm Description

Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.

Outcomes

Primary Outcome Measures

Change in formant frequency for vowels in recorded words/sentences.
The participant's vowels in recorded words/sentences will be subjected to acoustic analysis to assess changes in measures of the fundamental frequency (F0) and formant frequencies F1, F2, F3, and F4 (first four resonant frequencies of the vocal tract). All measurements will be made in Hertz (Hz).
Change in formant bandwidth for vowels in recorded words/sentences.
The participant's vowels in recorded words/sentences will be analyzed acoustically to measure the formant bandwidth (or thickness of the resonant frequencies). Much like formants, the measurement unit for formant bandwidth is in Hertz (Hz) .
Change in time to produce the individual phonemes in recorded words/sentences will be measured.
The participant's duration measurements for phonemes (vowels, consonants) produced and the time taken to produce an entire word will be measured in recorded words . For example, the word "hat" the sounds "h", "a", and "t" would all be measured for their durations, along with the time it takes to produce the sounds in the entire word "hat'.

Secondary Outcome Measures

Change in Hodson Assessment of Phonological Patterns-3 (HAPP-3) score.
The Hodson Assessment of Phonological Patterns-Third Edition (HAPP-3) is a valid, reliable, standardized test that is norm-referenced and also criterion-referenced. The HAPP-3 was designed for children with highly unintelligible speech. The reported score will be a sum of word/syllable omissions score plus the consonant category deficiencies score. Severity scores are a range, score 1-50 is rated mild, 51-100 is moderate, 101-150 is severe, and >150 is profound.
Change in Peabody Picture Vocabulary Test-4 (PPVT-4) score.
Peabody Picture Vocabulary Test-4 (PPVT-4) is an assessment measure of receptive vocabulary for Standard English. Higher scores suggest greater vocabulary knowledge. Standard scores are rated 20-150. 20-69 are Extremely low score, 70-84 Moderately low score, 85-114 Average score, 115-129 Moderately high score, and 130-160 Extremely high score.
Change in the percentage of correct phonemes derived from a language sample
A language sample will be recorded and analyzed at baseline and post- treatments. The percentage of phonemes (a phoneme is any of the perceptually distinct units of sound in a specified language that distinguish one word from another, it will include both vowels and consonants) will be derived from these participant's recordings as a rating of intelligibility.
Percentage of correct consonants in recorded words/sentences rated by perceptual listeners
Adult listeners will listen to and rate the participant's recorded words/sentences by typing what they hear. A percentage of correct consonants is measured by comparing the stimuli and the perceptual raters outcome.
Percentage of correct vowels in recorded words/sentences rated by perceptual listeners
Adult listeners will listen to and rate the participant's recorded words/sentences by typing what they hear. A percentage of correct vowels is measured by comparing the stimuli and the perceptual raters outcome.
Change in scores for the Intelligibility in Context Scale
The Intelligibility in Context Scale is a quick parent reported measure of children's intelligibility. The 7-item questionnaire rates the degree to which children's speech is understood by different communication partners (parents, immediate family, extended family, friends, acquaintances, teachers, and strangers) on a 5-point scale. The score ranges from 7-35, higher scores correlate with higher intelligibility.
Change in number of correct words/sentences produced in the Scripts
The participant's will learn basic Scripts on common communication topics of their choice (ordering in a restaurant, favorite movie, inviting a friend over). The percentage of words correct in the script is measured by counting the correct words produced intelligibly out of the total words.

Full Information

First Posted
August 14, 2019
Last Updated
June 3, 2021
Sponsor
University of Wisconsin, Madison
Collaborators
Office of the Vice Chancellor for Research and Graduate Education, Wisconsin Alumni Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04059354
Brief Title
Down Syndrome Speech Intelligibility Diagnostic Treatment Study
Official Title
Down Syndrome Speech Intelligibility Diagnostic Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Office of the Vice Chancellor for Research and Graduate Education, Wisconsin Alumni Research Foundation

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
This Down Syndrome (DS) speech intelligibility diagnostic treatment study is a pilot clinical intervention study assessing the efficacy of a speech treatment approach for male participants with DS between the ages of 7-16 years.
Detailed Description
This Down Syndrome (DS) speech intelligibility diagnostic treatment study is a pilot clinical intervention study assessing the efficacy of an integrative speech treatment approach for individuals with DS. DS is a common genetic disorder that causes lifelong intellectual disability where speech intelligibility is typically compromised affecting quality of life. The clinical management of communication disorders in individuals with DS is a priority for NIH's National Institute on Deafness and Other Communicative Disorder. The proposed treatment addresses the void in speech intervention and is based on our Vocal Tract Development Laboratory's (VTLab) research findings on anatomic, acoustic and perceptual studies from speakers with DS. Having identified specific difficulties in the production and perception of select vowels, this treatment focuses on accurate vowel production, while combining and adapting two established speech treatment approaches on articulatory accuracy and motor learning. The articulatory treatment uses the cycles phonological approach and the motor learning treatment is script training. Findings from this clinical intervention study are expected to pave the path towards optimal management of speech intelligibility in speakers with DS. The current pilot study is open to males based on findings from our lab's research that males are less intelligible than their female peers. The investigators also expect findings to provide the preliminary data needed to bridge the gap towards an exploratory clinical research proposal on functional anatomy as an intervention strategy for both males and females.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple single subject baseline design
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Speech therapy
Arm Type
Experimental
Arm Description
Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Intervention Type
Behavioral
Intervention Name(s)
Speech therapy addressing phonology and motor learning
Other Intervention Name(s)
Speech motor learning
Intervention Description
Determine the efficacy of a newly devised intensive speech treatment plan (DS-DxTx) focusing on vowels that combines efficacious treatment approaches to use with individuals with Down syndrome. The phonological speech intervention, Phonological Cycles approach, is designed for use with children with highly unintelligible speech and the speech motor learning intervention, Script training is a functional treatment to promote phrase level productions. Both approaches are documented to be efficacious with other speech disorders. The proposed approach takes into account the multiple deficits commonly present in individuals with DS, and based on the acoustic and perceptual finding on vowels from our VTLab. Acoustic and perceptual measures will be used to assess treatment efficacy.
Primary Outcome Measure Information:
Title
Change in formant frequency for vowels in recorded words/sentences.
Description
The participant's vowels in recorded words/sentences will be subjected to acoustic analysis to assess changes in measures of the fundamental frequency (F0) and formant frequencies F1, F2, F3, and F4 (first four resonant frequencies of the vocal tract). All measurements will be made in Hertz (Hz).
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in formant bandwidth for vowels in recorded words/sentences.
Description
The participant's vowels in recorded words/sentences will be analyzed acoustically to measure the formant bandwidth (or thickness of the resonant frequencies). Much like formants, the measurement unit for formant bandwidth is in Hertz (Hz) .
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in time to produce the individual phonemes in recorded words/sentences will be measured.
Description
The participant's duration measurements for phonemes (vowels, consonants) produced and the time taken to produce an entire word will be measured in recorded words . For example, the word "hat" the sounds "h", "a", and "t" would all be measured for their durations, along with the time it takes to produce the sounds in the entire word "hat'.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Secondary Outcome Measure Information:
Title
Change in Hodson Assessment of Phonological Patterns-3 (HAPP-3) score.
Description
The Hodson Assessment of Phonological Patterns-Third Edition (HAPP-3) is a valid, reliable, standardized test that is norm-referenced and also criterion-referenced. The HAPP-3 was designed for children with highly unintelligible speech. The reported score will be a sum of word/syllable omissions score plus the consonant category deficiencies score. Severity scores are a range, score 1-50 is rated mild, 51-100 is moderate, 101-150 is severe, and >150 is profound.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in Peabody Picture Vocabulary Test-4 (PPVT-4) score.
Description
Peabody Picture Vocabulary Test-4 (PPVT-4) is an assessment measure of receptive vocabulary for Standard English. Higher scores suggest greater vocabulary knowledge. Standard scores are rated 20-150. 20-69 are Extremely low score, 70-84 Moderately low score, 85-114 Average score, 115-129 Moderately high score, and 130-160 Extremely high score.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in the percentage of correct phonemes derived from a language sample
Description
A language sample will be recorded and analyzed at baseline and post- treatments. The percentage of phonemes (a phoneme is any of the perceptually distinct units of sound in a specified language that distinguish one word from another, it will include both vowels and consonants) will be derived from these participant's recordings as a rating of intelligibility.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Percentage of correct consonants in recorded words/sentences rated by perceptual listeners
Description
Adult listeners will listen to and rate the participant's recorded words/sentences by typing what they hear. A percentage of correct consonants is measured by comparing the stimuli and the perceptual raters outcome.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Percentage of correct vowels in recorded words/sentences rated by perceptual listeners
Description
Adult listeners will listen to and rate the participant's recorded words/sentences by typing what they hear. A percentage of correct vowels is measured by comparing the stimuli and the perceptual raters outcome.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in scores for the Intelligibility in Context Scale
Description
The Intelligibility in Context Scale is a quick parent reported measure of children's intelligibility. The 7-item questionnaire rates the degree to which children's speech is understood by different communication partners (parents, immediate family, extended family, friends, acquaintances, teachers, and strangers) on a 5-point scale. The score ranges from 7-35, higher scores correlate with higher intelligibility.
Time Frame
Baseline, 3 months, 4 months, and 9 months.
Title
Change in number of correct words/sentences produced in the Scripts
Description
The participant's will learn basic Scripts on common communication topics of their choice (ordering in a restaurant, favorite movie, inviting a friend over). The percentage of words correct in the script is measured by counting the correct words produced intelligibly out of the total words.
Time Frame
Baseline, 3 months, 4 months, and 9 months.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
At this time, only males are eligible to participate.
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males with a diagnosis of Down syndrome between the ages of 7 and 16 years Primary language is English Interested in improving their speech intelligibility. All participants must consent/assent to participate. As this is a multiple single subject design, services are available to all motivated participants who are willing to commit to the time/durations described in the diagnostic treatment. Exclusion Criteria: Primary language is not American English Do not have a diagnosis of Down syndrome Female Ages birth-6 and 17 years or older Individuals who have a co-occurring diagnosis that affects communication abilities [e.g., diagnosed as deaf with cochlear implants, Autism, only use an alternative/augmentative communication (AAC) device to communicate], Severe hearing loss which will limit their ability to participate in the treatment Individuals with a known mild or moderate hearing loss or current speech- language therapy services will not be excluded, but this information will be requested in the Parent Questionnaire. In addition, access to their current individualized education program (IEP) will be requested.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houri K Vorperian, PhD
Organizational Affiliation
University of Wisconsin, Madison- Waisman Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Waisman Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Down Syndrome Speech Intelligibility Diagnostic Treatment Study

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