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Down Syndrome Speech Intelligibility Diagnostic Treatment Study

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ClinicalTrials.gov Identifier: NCT04059354
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Office of the Vice Chancellor for Research and Graduate Education
Wisconsin Alumni Research Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Behavioral: Speech therapy addressing phonology and motor learning Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple single subject baseline design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Down Syndrome Speech Intelligibility Diagnostic Treatment Study
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Speech therapy
Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Behavioral: Speech therapy addressing phonology and motor learning
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.
Other Name: Speech motor learning




Primary Outcome Measures :
  1. Change in formant frequency for vowels in recorded words/sentences. [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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).

  2. Change in formant bandwidth for vowels in recorded words/sentences. [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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) .

  3. Change in time to produce the individual phonemes in recorded words/sentences will be measured. [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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 :
  1. Change in Hodson Assessment of Phonological Patterns-3 (HAPP-3) score. [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  2. Change in Peabody Picture Vocabulary Test-4 (PPVT-4) score. [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  3. Change in the percentage of correct phonemes derived from a language sample [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  4. Percentage of correct consonants in recorded words/sentences rated by perceptual listeners [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  5. Percentage of correct vowels in recorded words/sentences rated by perceptual listeners [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  6. Change in scores for the Intelligibility in Context Scale [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.

  7. Change in number of correct words/sentences produced in the Scripts [ Time Frame: Baseline, 3 months, 4 months, and 9 months. ]
    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.



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   At this time, only males are eligible to participate.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059354


Contacts
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Contact: Julie Eichhorn, MS 608-263-5610 jeichhorn@wisc.edu

Locations
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United States, Wisconsin
Waisman Center Recruiting
Madison, Wisconsin, United States, 53705
Contact: Houri K Vorperian, PhD    608-263-5513    vorperian@waisman.wisc.edu   
Contact: Julie Eichhorn, MS    608-263-5610    jeichhorn@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Office of the Vice Chancellor for Research and Graduate Education
Wisconsin Alumni Research Foundation
Investigators
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Principal Investigator: Houri K Vorperian, PhD University of Wisconsin, Madison- Waisman Center

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04059354     History of Changes
Other Study ID Numbers: 2019-0706
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Speech intelligibility
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn