Down Syndrome Speech Intelligibility Diagnostic Treatment Study

Down Syndrome Clinical Trial

Official title:

Down Syndrome Speech Intelligibility Diagnostic Treatment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059354
• Other study ID #: 2019-0706
• Secondary ID: A348700VCRGE/WAI
• Status: Completed
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: June 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Waisman Center	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Office of the Vice Chancellor for Research and Graduate Education, Wisconsin Alumni Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, 3 months, 4 months, and 9 months.
Primary	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) .	Baseline, 3 months, 4 months, and 9 months.
Primary	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'.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.
Secondary	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.	Baseline, 3 months, 4 months, and 9 months.