Down Syndrome Speech Intelligibility Diagnostic Treatment Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04059354|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome||Behavioral: Speech therapy addressing phonology and motor learning||Not Applicable|
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.
|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)|
|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|
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
- 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).
- 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) .
- 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'.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Julie Eichhorn, MSemail@example.com|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Contact: Houri K Vorperian, PhD 608-263-5513 firstname.lastname@example.org|
|Contact: Julie Eichhorn, MS 608-263-5610 email@example.com|
|Principal Investigator:||Houri K Vorperian, PhD||University of Wisconsin, Madison- Waisman Center|