Trial Outcomes & Findings for Predictors of Speech Ability in Down Syndrome (NCT NCT05016037)
NCT ID: NCT05016037
Last Updated: 2025-08-03
Results Overview
Speech intelligibility is a 5 point Likert scale based on the language sample obtained (e.g., based on the number of words spoken in the sample). The scale range is 1 to 5, 1 being very low intelligibility and 5 being high intelligibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
six months
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
Lexically Based Speech Intelligibility Recast
Speech recasts are likely to improve speech intelligibility in Down Syndrome. The goal of this study is to induce change in speech intelligibility in order to study phonological, acoustic and suprasegmental sequelae of improvements in speech.
Lexically based speech recast: a child's spontaneous or elicited production containing phonological errors is immediately followed with a clinician model that corrects the error(s) at the word level rather than the isolated phoneme level. As an example, a speech recast of child's production of the word bake as \[be\] would be the whole lexeme bake \[bek\] rather than production drill on \[k\] in isolation.
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|---|---|
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Overall Study
STARTED
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18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lexically Based Speech Intelligibility Recast
Speech recasts are likely to improve speech intelligibility in Down Syndrome. The goal of this study is to induce change in speech intelligibility in order to study phonological, acoustic and suprasegmental sequelae of improvements in speech.
Lexically based speech recast: a child's spontaneous or elicited production containing phonological errors is immediately followed with a clinician model that corrects the error(s) at the word level rather than the isolated phoneme level. As an example, a speech recast of child's production of the word bake as \[be\] would be the whole lexeme bake \[bek\] rather than production drill on \[k\] in isolation.
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Predictors of Speech Ability in Down Syndrome
Baseline characteristics by cohort
| Measure |
Baseline Measures
n=17 Participants
Baseline Measures and Demographic Information
|
|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
|
Leiter International Performance Scale, Third Edition
|
71.69 Nonverbal IQ
STANDARD_DEVIATION 13.26 • n=5 Participants
|
|
Receptive One Word Picture Vocabulary Test (ROWPVT-4)
|
74.75 Standard Score
STANDARD_DEVIATION 13.42 • n=5 Participants
|
|
Expressive One Word Picture Vocabulary Test (EOWPVT-4)
|
73.7 standard score
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Arizona Articulation and Phonology Scale-4th Edition
|
57.5 Standard Score
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Woodcock Camarata Articulation Battery (WCAB)
|
32.56 standard score
STANDARD_DEVIATION 15.43 • n=5 Participants
|
|
Test for Auditory Comprehension of Language - 4th Edition (TACL-4)
Vocabulary Subtest
|
52.06 standard score
STANDARD_DEVIATION 24.74 • n=5 Participants
|
|
Test for Auditory Comprehension of Language - 4th Edition (TACL-4)
Grammatical Morphemes
|
47.12 standard score
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Test for Auditory Comprehension of Language - 4th Edition (TACL-4)
Elaborated Phrases and Sentences
|
46.56 standard score
STANDARD_DEVIATION 15.66 • n=5 Participants
|
|
Percent Consonants Correct
|
61.81 Percent Consonants Correct
STANDARD_DEVIATION 20.45 • n=5 Participants
|
|
Percent Vowels Correct
|
88.82 Percent Vowels Correct
STANDARD_DEVIATION 9.37 • n=5 Participants
|
|
Mean Length of Utterance
|
2.24 morphemes per phrase
STANDARD_DEVIATION 1.17 • n=5 Participants
|
|
Speech Intelligibility
|
3.53 score on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: six monthsSpeech intelligibility is a 5 point Likert scale based on the language sample obtained (e.g., based on the number of words spoken in the sample). The scale range is 1 to 5, 1 being very low intelligibility and 5 being high intelligibility.
Outcome measures
| Measure |
Lexically Based Speech Intelligibility Recast
n=16 Participants
School-age children (4-17 years) with Downs Syndrome with varied cognitive ability levels (minimum of 60 with no ceiling)
|
|---|---|
|
Speech Intelligibility
|
3.59 score on a scale
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: six monthsPopulation: One participant did not complete the final speech accuracy measure. The patient declined (refused) to complete the test. The assent rules require that the study team stop testing if a child indicates they do not want to do a test.
Percentage of correct phonemes on standardized speech tests and in a semi structured speech sample. This is the number of correct phonemes divided by the number of total phonemes in the sample (or test) divided by 100.
Outcome measures
| Measure |
Lexically Based Speech Intelligibility Recast
n=15 Participants
School-age children (4-17 years) with Downs Syndrome with varied cognitive ability levels (minimum of 60 with no ceiling)
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|---|---|
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Speech Accuracy
Percent Consonants Correct
|
61.55 percentage of correct phonemes
Standard Deviation 17.97
|
|
Speech Accuracy
Percent Vowels Correct
|
89.57 percentage of correct phonemes
Standard Deviation 9.05
|
Adverse Events
Lexically Based Speech Intelligibility Recast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephen Camarata
Vanderbilt University Medical Center
Phone: (615) 579-5608
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place