Trial Outcomes & Findings for Down Syndrome Speech Intelligibility Diagnostic Treatment Study (NCT NCT04059354)

Last Updated: 2025-02-07

Results Overview

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 errors from both patterns, or the Total Occurrence of Major Phonological Deviations (TOMPD) score, is 0-273 with a severity of phonological disorder rating of 0-150 (0: No errors; 1-50: Mild; 51-100: Moderate; 101-150: Severe; \>150: Profound). Lower TOMPD scores imply fewer errors and better speech intelligibility, and higher scores indicate more errors and reduced intelligibility. A decrease in TOMPD score post intervention implicates improvement in speech production.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Baseline (pre-treatment), post-treatment (12 weeks), 1-month post-treatment (16weeks), and 6 months post-treatment (36 weeks)

Results posted on

2025-02-07

Participant Flow

Participants were recruited from September 2019 through approximately March 2020.

Participant milestones

Participant milestones
Measure	Speech Therapy Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week (36 sessions per participant) as tolerated and 30 minutes weekly home practice.
Overall Study STARTED	3
Overall Study Completed Treatment	3
Overall Study 1 Month Post-intervention	2
Overall Study 6 Months Post-intervention	0
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Speech Therapy Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week (36 sessions per participant) as tolerated and 30 minutes weekly home practice.
Overall Study COVID-19 pandemic	3

Baseline Characteristics

Down Syndrome Speech Intelligibility Diagnostic Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Speech Therapy n=3 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Age, Continuous	12.42 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants
Race/Ethnicity, Customized White-Asian	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Mean Length of Utterance (MLU)	2.05 morphemes per utterance n=5 Participants
Peabody Picture Vocabulary Test (PPVT)	78.33 score on a scale n=5 Participants
Hearing Screening (Pass / Fail) Pass	3 Participants n=5 Participants
Hearing Screening (Pass / Fail) Fail	0 Participants n=5 Participants
Oral Exam: Mouth Posture at Rest Open	2 Participants n=5 Participants
Oral Exam: Mouth Posture at Rest Approximated	1 Participants n=5 Participants
Oral Exam: Tongue Posture at Rest, In Mouth	3 Participants n=5 Participants
Oral Exam: Palate High and Narrow	2 Participants n=5 Participants
Oral Exam: Palate Refused Exam	1 Participants n=5 Participants
Oral Exam: Dental Malocclusion Class I	2 Participants n=5 Participants
Oral Exam: Dental Malocclusion Class II	0 Participants n=5 Participants
Oral Exam: Dental Malocclusion Class III	1 Participants n=5 Participants
Oral Exam: Orthodontic Treatment Palate Expander	2 Participants n=5 Participants
Oral Exam: Orthodontic Treatment Braces	1 Participants n=5 Participants
Oral Exam: Orthodontic Treatment None	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks), 1-month post-treatment (16weeks), and 6 months post-treatment (36 weeks)

Population: Individual participant data reported. Only 2 participants (Participant 1 and Participant 3) had a 1 month post-treatment follow up, and data was collected from 0 participants at 6 month post-treatment due to COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Pre-Treatment TOMPD	21 sum of errors	34 sum of errors	22 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment TOMPD	6 sum of errors	17 sum of errors	11 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment 1 Month Follow Up TOMPD	8 sum of errors	—	17 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Pre-Treatment Word/Syllable Omissions Sum	5 sum of errors	5 sum of errors	4 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment Word/Syllable Omissions Sum	2 sum of errors	2 sum of errors	3 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment 1 Month Follow Up Word/Syllable Omissions Sum	1 sum of errors	—	3 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Pre-Treatment Consonant Category Deficiencies Sum	16 sum of errors	29 sum of errors	18 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment Consonant Category Deficiencies Sum	4 sum of errors	17 sum of errors	8 sum of errors
Hodson Assessment of Phonological Patterns-3 (HAPP-3) Occurrence Scores Post-Treatment 1 Month Follow Up Consonant Category Deficiencies Sum	7 sum of errors	—	14 sum of errors

PRIMARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks), 1 month post-treatment (16 weeks), and 6 months post-treatment (36 weeks)

Population: Individual participant data reported. Only 2 participants had a 1 month post-treatment follow up, and data was collected from 0 participants at 6 month post-treatment due to COVID-19 pandemic.

The HAPP-3 Comprehensive Phonological Evaluation Record Form specifies, for each phonological deviation pattern, the number of instances the 50-words contain the various deviation types. For example, 1) Word/Syllable Structure Omissions include 39 Consonant Clusters and 16 Syllables; 2) Consonant Category Deficiencies include 19 Liquids /r, l/ and 42 Stridents /s, f/. This enables the calculation of 'Percent of Occurrence' for each error type, allowing personalized intervention where each speaker's deficiencies with higher percentages are targeted first, using the Cycles phonological approach. Here, the top three occurrences of major phonological deviations and deficiencies that were addressed during intervention are reported: Deficiencies of Liquids and Stridents (for all participants), omission of Consonant Clusters for participants 1 and 3, and omission of Syllables for participant 2. Decrease in percent occurrence post-treatment signifies improvement in phonological skills.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Pre-Treatment Liquids total percentage	52.6 percentage of deficient word productions	31.58 percentage of deficient word productions	47.37 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment Liquids total percentage	5.26 percentage of deficient word productions	15.79 percentage of deficient word productions	15.79 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment 1 Month Follow Up Liquids total percentage	10.53 percentage of deficient word productions	—	31.58 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Pre-Treatment Stridents total percentage	14.29 percentage of deficient word productions	26.19 percentage of deficient word productions	16.67 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment Stridents total percentage	4.76 percentage of deficient word productions	16.66 percentage of deficient word productions	11.9 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment 1 Month Follow Up Stridents total percentage	9.52 percentage of deficient word productions	—	7.14 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Pre-Treatment Word/Syllable Structures Omissions percentage	12.8 percentage of deficient word productions	18.75 percentage of deficient word productions	7.69 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment Word/Syllable Structures Omissions percentage	5.13 percentage of deficient word productions	0 percentage of deficient word productions	5.13 percentage of deficient word productions
Percentages of the Top 3 Major Phonological Deviations of HAPP-3 Addressed in Intervention Post-Treatment 1 Month Word/Syllable Structures Omissions percentage	2.56 percentage of deficient word productions	—	7.69 percentage of deficient word productions

PRIMARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks), 1 month post-treatment (16 weeks), and 6 months post-treatment (36 weeks)

Population: Individual participant data reported. Two participants (Participant 1 and Participant 3) had only one of the three baseline recordings; but they had 1 month post-treatment recordings (twice for Participant 1, and once for Participant 3). No participant had 6-month post-treatment recordings due to the COVID-19 pandemic. The overall number of units is unique to the analysis at each time point, as specified in the row title.

Two adult naïve listeners will orthographically transcribe participants' speech recordings of VTLab stimuli to assess word and vowel intelligibility. These stimuli, designed for lifespan studies of vowel acoustics, were chosen due to the lack of standardized speech samples for clinical assessment and the predominant focus of most formal tests on consonants, despite vowels' contribution to intelligibility. VTLab stimuli consist of 25 monosyllabic words, including five words each for four extreme vowels (/i, u, æ, ɑ/) and the central vowel (/ə/) as in 'eat', 'hoot', 'hat', 'hot', and 'hug'. Intelligibility is measured by comparing transcriptions to intended target words and calculating the percentage correct for total words, all aforementioned vowels, and the extreme front-back low vowels (/æ/ and /ɑ/), which are reportedly more difficult to produce in speakers with Down syndrome. An increase in correct percentages indicates improved speech intelligibility.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=840 words/vowels * recordings * listener Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=840 words/vowels * recordings * listener Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=672 words/vowels * recordings * listener Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Pre-Treatment Percentage of Words Correct	92 percentage correct Interval 88.0 to 96.0	77.5 percentage correct Interval 76.0 to 79.0	70 percentage correct Interval 68.0 to 72.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment Percentage of Words Correct	62.5 percentage correct Interval 58.0 to 67.0	82.5 percentage correct Interval 80.0 to 85.0	56.5 percentage correct Interval 50.0 to 63.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment 1 Month Follow Up Percentage of Words Correct	75 percentage correct Interval 74.0 to 76.0	—	46 percentage correct Interval 46.0 to 46.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Pre-Treatment Percentage of all Vowels Correct	98 percentage correct Interval 96.0 to 100.0	88 percentage correct Interval 88.0 to 88.0	80 percentage correct Interval 80.0 to 80.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment Percentage of all Vowels Correct	84 percentage correct Interval 83.0 to 85.0	91 percentage correct Interval 91.0 to 91.0	72 percentage correct Interval 70.0 to 74.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment 1 Month Follow Up Percentage of Vowels Correct	88 percentage correct Interval 88.0 to 88.0	—	69 percentage correct Interval 62.0 to 75.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Pre-Treatment Percentage Vowel /æ/ Correct	90 percentage correct Interval 80.0 to 100.0	84 percentage correct Interval 80.0 to 88.0	60 percentage correct Interval 40.0 to 80.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment Percentage Vowel /æ/ Correct	90 percentage correct Interval 80.0 to 100.0	100 percentage correct Interval 100.0 to 100.0	55 percentage correct Interval 50.0 to 60.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli 1 Month follow-up Post-Treatment Percentage Vowel /æ/ Correct	90 percentage correct Interval 80.0 to 100.0	—	30 percentage correct Interval 0.0 to 60.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Pre-Treatment Percentage Vowel /ɑ/ Correct	100 percentage correct Interval 100.0 to 100.0	75 percentage correct Interval 70.0 to 80.0	70 percentage correct Interval 60.0 to 80.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli Post-Treatment Percentage Vowel /ɑ/ Correct	72.5 percentage correct Interval 70.0 to 75.0	75 percentage correct Interval 70.0 to 80.0	55 percentage correct Interval 50.0 to 60.0
Pre- and Post-Intervention Percentage of Words and Vowels Correctly Identified by Naïve Listeners in Perceptual Ratings of Vocal Tract Development Lab (VTLab) Stimuli 1 Month follow-up Post-Treatment Percentage Vowel /ɑ/ Correct	60 percentage correct Interval 50.0 to 70.0	—	60 percentage correct Interval 40.0 to 80.0

PRIMARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks)

The vowel portion of the VTLab word stimuli was analyzed acoustically. Pre- and post-intervention formant frequencies F1 and F2 of seven words per vowel /æ/ and /ɑ/ are reported here, as the intervention provided practice for their distinct front-back productions. F1 and F2 are critical for determining vowel type and specify acoustic space that is related to speech intelligibility, serving as a proxy for articulatory working space (i.e. reflecting dimensionality of tongue movement/position). See Detailed Description section for additional information. Reported here are formant frequencies averaged across all pre- and post-conditions, a feasible comparison given similarity in the F1 and F2 increase/decrease trend across conditions. The F2-F1 difference correlates with tongue advancement, increasing as the tongue moves forward and decreasing as it retracts.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=140 vowels times recordings Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=140 vowels times recordings Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=112 vowels times recordings Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /æ/ F1 Pre-treatment	1064.50 Hz Standard Deviation 145.73	713.32 Hz Standard Deviation 167.12	758.14 Hz Standard Deviation 45.13
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /æ/ F2 Pre-treatment	2206.13 Hz Standard Deviation 129.42	2290.79 Hz Standard Deviation 239.10	2290.71 Hz Standard Deviation 150.88
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /æ/ F1 Post-treatment	975.75 Hz Standard Deviation 166.89	829.75 Hz Standard Deviation 148.42	707.90 Hz Standard Deviation 56.85
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /æ/ F2 Post-treatment	2289.46 Hz Standard Deviation 150.52	2191.67 Hz Standard Deviation 220.24	2058.10 Hz Standard Deviation 120.61
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /ɑ/ F1 Pre-treatment	1188.14 Hz Standard Deviation 115.94	1049.33 Hz Standard Deviation 100.79	821.14 Hz Standard Deviation 56.56
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /ɑ/ F2 Pre-treatment	1671.29 Hz Standard Deviation 172.57	1458.58 Hz Standard Deviation 148.02	1415.14 Hz Standard Deviation 157.77
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /ɑ/ F1 Post-treatment	1209.64 Hz Standard Deviation 121.80	1013.2 Hz Standard Deviation 81.49	872.06 Hz Standard Deviation 135.75
Pre- and Post-Intervention Vowel Formant Frequencies F1 and F2 for /ɑ/ and /æ/ in Recorded Productions of VTLab Stimuli /ɑ/ F2 Post-treatment	1764.43 Hz Standard Deviation 165.77	1451.93 Hz Standard Deviation 130.13	1480.11 Hz Standard Deviation 181.02

SECONDARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks), 1 month post-treatment (16 weeks), and 6 months post-treatment (36 weeks)

Listeners with linguistic training will use the International Phonetic Alphabet (IPA) to phonetically transcribe participants' productions of the Hodson Assessment of Phonological Patterns-3 (HAPP-3) stimuli. The stimuli consist of the 50 test words for phonological deviations analysis, and 12 multisyllabic screening words. The percentage of correct words is calculated by comparing the listeners' transcriptions of the speakers' productions against the transcriptions of the intended target words, then multiplying the ratio by 100. This process is applied separately for the 50 test words and 12 multisyllabic screening words. Transcriptions were completed by three trained listeners: one highly experienced listener and two listeners in-training. Findings from the experienced listener are reported since the pattern of transcription accuracy were similar across all listeners.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Pre-Treatment percentage total words correct	31 percentage correct	23 percentage correct	24 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment percentage total words correct	53 percentage correct	51 percentage correct	56 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment 1 Month Follow Up percentage total words correct	63 percentage correct	—	48 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Pre-Treatment percentage monosyllabic words correct	35 percentage correct	28 percentage correct	28 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment percentage monosyllabic words correct	60 percentage correct	61 percentage correct	62 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment 1 Month Follow Up percentage monosyllabic words correct	70 percentage correct	—	52 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Pre-Treatment percentage multisyllabic words correct	17 percentage correct	0 percentage correct	8 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment percentage multisyllabic words correct	25 percentage correct	83 percentage correct	33 percentage correct
Percentage of the HAPP-3 50-Word Stimuli With Correct Phonetic Transcriptions by Trained Listeners Using the International Phonetic Alphabet (IPA) Post-Treatment 1 Month Follow Up percentage multisyllabic words correct	33 percentage correct	—	33 percentage correct

SECONDARY outcome

Timeframe: during treatment, up to12 weeks

Population: Individual participant data reported.

The participants will learn basic Scripts using common communication topics of their choice, such as ordering in a restaurant, discussing their favorite movie, or inviting a friend over. Scripts is a guided motor-training protocol used in speech therapy to improve verbal communication skills in everyday situations. Script templates consist of common conversational topics with short, functional, and personally relevant phrases. They are practiced using a cueing hierarchy: 1) Phrase repetition; 2) Phrase repetition in unison using auditory and visual cues; 3) Phrase repetition with prompting, which involves fading unison through a gradual sequential decrease in auditory and visual cues, including the clinician mouthing words; and 4) Independent production without visual cues. Each participant will practice a total of 3-9 scripts with approximately 4-5 words each (e.g. Do you want to play?). Assessment compares three script productions to target scripts for word order and word count.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=3 script phrase Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=3 script phrase Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=3 script phrase Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Number of Scripts Produced Practiced in Unison	3 script phrase	3 script phrase	0 script phrase
Number of Scripts Produced Practiced With Prompting (fading unison)	3 script phrase	3 script phrase	3 script phrase
Number of Scripts Produced Practiced Independently	2 script phrase	2 script phrase	1 script phrase
Number of Scripts Produced Produced Independently	0 script phrase	2 script phrase	0 script phrase

SECONDARY outcome

Timeframe: Baseline (pre-treatment), post-treatment (12 weeks), 1 month post-treatment (16 weeks), and 6 months post-treatment (36 weeks)

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.

Outcome measures

Outcome measures
Measure	Speech Therapy - Participant 1 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 2 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.	Speech Therapy - Participant 3 n=1 Participants Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Scores for the Intelligibility in Context Scale as Rated by Parent Pre-treatment	28 score on a scale	19 score on a scale	26 score on a scale
Scores for the Intelligibility in Context Scale as Rated by Parent Post-treatment	28 score on a scale	24 score on a scale	25 score on a scale
Scores for the Intelligibility in Context Scale as Rated by Parent Post-treatment (1 month follow up)	29 score on a scale	—	25 score on a scale

Adverse Events

Speech Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Speech Therapy n=3 participants at risk Direct speech therapy will be provided for a 12 week period with up to three one-hour sessions per week.
Congenital, familial and genetic disorders Decrease in Speech Intelligibility	33.3% 1/3 • through 12 weeks of intensive therapy and follow up visits (up to 5 months on study)

Additional Information

Houri K. Vorperian, PhD, Senior Scientist Emerita

University of Wisconsin - Madison, Waisman Center

Phone: 608-213-3257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place