Predictors of Speech Ability in Down Syndrome (NCT05016037) | Clinical Trial Compass
CompletedNot Applicable
Predictors of Speech Ability in Down Syndrome
United States18 participantsStarted 2022-02-14
Plain-language summary
Speech is a critical aspect of the human experience and usually develops in a "seemingly automatic process that continues from birth through adolescence and underlies many related abilities" (e.g., language and reading, see National Academy of Medicine Report on Speech and Language Disorders, 2016). Many individuals with Down Syndrome (Trisomy 21, DS) struggle to communicate and participate more fully in human communication and educational learning experiences because their speech is difficult to understand. The purpose of the proposed project was to measure speech-articulation accuracy and speech intelligibility, and their proposed primary predictors at study entry in 16 children with DS age 4;0 to 17;11). A validated treatment, speech recast intervention (see Yoder, Camarata \& Woynaroski, 2016) was used to drive growth in speech intelligibility as a means of evaluating changes in potential sequelae of change. This study included measures of speech-articulation accuracy, and speech-prosody skills as predictors of speech intelligibility growth in DS.
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* previous medical identification of Down Syndrome
* chronological age 4-17 years
* regular use of 3-word utterances (ascertained via parent report during screening and confirmed during assessments)
* pass a hearing screening at the time of enrollment in the project. All will pass a hearing screening (25 dB @1000, 2000, 4000 Hz).
Exclusion Criteria:
A history of or parent report of
* seizures,
* diagnosed ADHD,
* apraxia secondary to a diagnosed neurological disorder
* Autism Spectrum Disorder (Autism Diagnostic Observation Scale-2nd Edition score above the ASD cut-off) or
* severe disruptive behavior that would prevent participation in testing or treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.