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NCT04059354 · ClinicalTrials.gov registry record · NA
Down Syndrome Speech Intelligibility Diagnostic Treatment Study
A NA study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04059354: Clinical Trial NA study, sponsored by University of Wisconsin, Madison.
NCT04059354 is a NA study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04059354, a NA study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The 'Down syndrome speech intelligibility diagnostic treatment study' is a pilot clinical intervention study assessing the efficacy of an integrative speech treatment approach for individuals with Down syndrome (DS). This study will use a single-subject design with 10 male participants with DS, aged 7 to 16 years. The proposed intervention, combines two treatment approaches that are documented to be efficacious with other speech disorders: 1) The Cycles Phonological Remediation Approach, designed for highly unintelligible speech, as guided by the Hodson Assessment of Phonological Patterns (HAPP-3); and 2) Script training, a functional speech motor intervention that promotes phrase-level productions. During the twelve-week intensive intervention period, both approaches will be adapted to prioritize the production of words with low vowels to incorporate increased practice of the low-front and low-back vowels. This modification is based on the investigator's perceptual, acoustic and anatomic research findings. Outcome measures will include perceptual, intelligibility, and acoustic analyses obtained from acoustic recordings. These measures will be used to assess treatment efficacy, and to gain insight into the motoric versus anatomic limitations in speech production commonly present in individuals with DS.
Primary Outcome
The HAPP-3 test is designed to assess the phonological disorder severity in children, guide intervention and document progress. This 50-word test categorizes phonological deviations into two patterns to guide intervention: 1) Word/Syllable Structure Omissions (129 total instances): including omission of syllables, consonant clusters, and single consonants; 2) Consonant Category Deficiencies (144 instances): including consonant substitutions and assimilations. The range of the combined sum of err
Interventions
- BEHAVIORAL Speech therapy addressing phonology and motor learning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2020-02-28 |
| Phase | NA |
Why NCT04059354 stopped before completion
NCT04059354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Speech therapy addressing phonology and motor learning is the first listed.
NCT04059354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04059354 about?
NCT04059354 is a clinical study titled "Down Syndrome Speech Intelligibility Diagnostic Treatment Study". The 'Down syndrome speech intelligibility diagnostic treatment study' is a pilot clinical intervention study assessing the efficacy of an integrative speech treatment approach for individuals with Down syndrome (DS). This study will use a single-subject design with 10 male participants with DS, aged...
What is the current status of trial NCT04059354?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2019-09-05. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT04059354?
The interventions under investigation include: Speech therapy addressing phonology and motor learning (BEHAVIORAL).
Who is sponsoring clinical trial NCT04059354?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04059354's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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