N/A
N=18
Predictors of Speech Ability in Down Syndrome
Speech Intelligibility Intervention in Down Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05016037 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Speech Intelligibility — 3.59 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lexically based speech recast (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility |
3.59 | — |
| PRIMARY Speech Accuracy |
61.55; 89.57 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05016037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.