CClinicalTrials.gg
CompletedNCT03238677Updated Jun 22, 2023Results posted

Treating Childhood Apraxia of Speech

An interventional study of Speech Motor Chaining without Biofeedback and Biofeedback in Childhood Apraxia of Speech, sponsored by Syracuse University. Completed at 1 site in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Syracuse University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study summary

The study will test two modifications to speech therapy for 40 school-age children with childhood apraxia of speech to determine how to improve treatment outcomes. The study will compare treatment that includes real-time visual feedback of the tongue during speech using ultrasound vs traditional therapy that does not include ultrasound visual feedback. Additionally, some children will be treated with a traditional schedule of 2 sessions per week, whereas others will be provided with treatment that begins with intensive training (10 hours of therapy in one week) and progresses to a more distributed treatment schedule.

Read the detailed description

Childhood apraxia of speech is a developmental speech sound disorder that may lead to persisting speech errors, often despite years of treatment. Such impairments may lead to social, academic, and vocational limitations. Thus, there is a need to explore alternate treatment approaches. This study will explore how to improve speech sound production in school-age children with CAS by modifying a standard speech therapy program. Two adaptations to speech therapy will be tested in a 2 x 2 randomized group design.

In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared against a treatment sequence beginning with an intensive therapy schedule (10 hrs of treatment in one week), which will then transition to a more distributed practice schedule. This treatment modification is intended to minimize erred practice between training sessions in the early stages of learning, then foster generalization through increased time between practice sessions.

In Aim 2, a standard treatment that includes only verbal feedback to the client during speech practice will be compared against a treatment sequence that initially includes real-time ultrasound visual feedback of the tongue during speech, which will be faded over the course of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may enhance children's understanding of the articulatory goals of speech movement patterns by comparing executed tongue movements with intended movements. Prior case reports and single subject experimental designs have shown that speech sound production may be enhanced by including ultrasound visual feedback, although no prior randomized group studies have been conducted.

Beside these modifications, the other aspects of treatment will be held constant. Outcomes will be evaluated by tracking changes in percent consonants correct from a large speech sample, scored by individuals who are blind to treatment status. The four groups will be compared to determine the extent to which speech sound therapy can be enhanced through a treatment sequence that begins with intensive practice and/or with ultrasound visual feedback.

02

Conditions studied

  • Childhood Apraxia of Speech

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Keywords

  • speech sound disorder
03

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Native English speakers who hear English as the dominant language in their home setting.
  • Must pass a hearing screening.
  • Score at or better than -2 standard deviations from the mean on the Matrix Reasoning Task of the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-2; t-score ≥ 30), Peabody Picture Vocabulary Test - 4th Edition (PPVT-4; standard score ≥ 70), and the Following Directions subtest of the Clinical Evaluation of Language Fundamentals - 5th Edition (CELF-5; scaled score ≥ 3).
  • Goldman-Fristoe Test of Articulation - 3rd Edition (GFTA-3) percentile ≤ 5th).
  • A diagnosis of CAS will be verified based on a polysyllable picture naming task, diadochokinetic task (puh-tuh-kuh), and syllable repetition task.

Exclusion criteria

Exclusion Criteria:

  • Parent report or direct evaluation reveals oral-facial structural abnormalities (e.g., cleft palate).
  • Parental report of neurobehavioral disorders (e.g., autism spectrum disorders, ADHD, obsessive-compulsive disorder), or vision problems that are corrected with glasses/contacts.
  • Fail a hearing screening, or failure to meet criteria listed above as Inclusionary
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Biofeedback, Massed->Distributed

    Sequenced biofeedback Mass Practice--\> Distributed Scheduling

    Behavioral: Biofeedback · Behavioral: Massed --> Distributed Practice

  • Active comparator
    No Biofeedback, Distributed

    Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks

    Behavioral: Speech Motor Chaining without Biofeedback · Behavioral: Distributed Practice

  • Experimental
    Biofeedback, Distributed

    Sequenced biofeedback, 2 sessions/wk for 10 weeks

    Behavioral: Biofeedback · Behavioral: Distributed Practice

  • Experimental
    No Biofeedback, Massed-> Distributed

    Speech Motor Chaining with no biofeedback. Mass Practice--\> Distributed Scheduling

    Behavioral: Speech Motor Chaining without Biofeedback · Behavioral: Massed --> Distributed Practice

Interventions

  • BehavioralSpeech Motor Chaining without Biofeedback

    These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html

  • BehavioralBiofeedback

    Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.

  • BehavioralDistributed Practice

    2 sessions per week for 10 weeks

  • BehavioralMassed --> Distributed Practice

    Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment

05

What researchers measure

Primary outcomes

  1. Speech Sound Accuracy

    Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund \& Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.

    Time frame: 10 weeks from the start of treatment

06

Results

Posted Jun 22, 2023
Limitations and caveats
The interruptions due to the COVID-19 pandemic resulted an imbalance in participants in the Ultrasound vs No Ultrasound conditions, which limits statistical power. Participants were not randomized to telepractice vs face-to-face. Also, the treatment emphasizes speech sound accuracy. There is not a direct focus on teaching other features such as lexical stress. Other approaches, such as Rapid Syllable Transition Training would be more appropriate to address other elements of speech production.

Participant flow

Participant flow — Overall Study
MilestoneBiofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, Telepractice
Started99109109
Completed778899
Not completed222110

Outcome measures

PrimarySpeech Sound Accuracy

Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund \& Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.

Time frame:
10 weeks from the start of treatment
Reported as:
Mean · Percent correct
Speech Sound Accuracy
Percent correctBiofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, Telepractice
Speech Sound Accuracy54.1 ± 13.532.5 ± 14.126.8 ± 10.242.1 ± 11.132.50 ± 7.043.0 ± 7.7
Statistical analysis
  • Biofeedback, Massed->Distributed, Face-to-Face vs No Biofeedback, Distributed, Face-to-Face vs Biofeedback, Distributed, Face-to-Face vs No Biofeedback, Massed-> Distributed, Face-to-Face vs No Biofeeedback, Distributed, Telepractice vs No Biofeedback, Massed->Distributed, Telepractice · Mixed Models Analysis · p = .132 · Mean difference (final values): -10.0 · 95% CI -23.2 to 3.1
  • Biofeedback, Massed->Distributed, Face-to-Face vs No Biofeedback, Distributed, Face-to-Face vs Biofeedback, Distributed, Face-to-Face vs No Biofeedback, Massed-> Distributed, Face-to-Face vs No Biofeeedback, Distributed, Telepractice vs No Biofeedback, Massed->Distributed, Telepractice · Mixed Models Analysis · p = .028 · Mean difference (final values): -13.7 · 95% CI -25.9 to -1.5
  • No Biofeedback, Distributed, Face-to-Face vs No Biofeedback, Massed-> Distributed, Face-to-Face vs No Biofeeedback, Distributed, Telepractice vs No Biofeedback, Massed->Distributed, Telepractice · Mixed Models Analysis · p = .187 · Mean difference (final values): -10.0 · 95% CI -24.9 to 5.0
  • Biofeedback, Massed->Distributed, Face-to-Face vs No Biofeedback, Distributed, Face-to-Face vs Biofeedback, Distributed, Face-to-Face vs No Biofeedback, Massed-> Distributed, Face-to-Face vs No Biofeeedback, Distributed, Telepractice vs No Biofeedback, Massed->Distributed, Telepractice · Mixed Models Analysis · p = .125 · Mean difference (final values): 20.22 · 95% CI -5.8 to 46.3

Adverse events

Collected over 5 weeks and 10 weeks after the start of treatment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Biofeedback, Massed->Distributed, Face-to-Face0/9 (0%)0/9 (0%)0/9 (0%)
No Biofeedback, Distributed, Face-to-Face0/9 (0%)0/9 (0%)0/9 (0%)
Biofeedback, Distributed, Face-to-Face0/10 (0%)0/10 (0%)0/10 (0%)
No Biofeedback, Massed-> Distributed, Face-to-Face0/9 (0%)0/9 (0%)0/9 (0%)
No Biofeeedback, Distributed, Telepractice0/10 (0%)0/10 (0%)0/10 (0%)
No Biofeedback, Massed->Distributed, Telepractice0/9 (0%)0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
Mean10.31 ± 1.010.85 ± 1.712.2 ± 2.110.0 ± 1.111.05 ± 2.411.16 ± 2.310.96 ± 1.9
Sex: Female, Male
Sex: Female, Male(Participants)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
Female33234217
Male66866739
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
Hispanic or Latino3120039
Not Hispanic or Latino68899646
Unknown or Not Reported0000101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American0010001
White98876745
More than one race0112329
Unknown or Not Reported0000101
Region of Enrollment
Region of Enrollment(participants)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
United States9910910956
Speech Sound Accuracy
Speech Sound Accuracy(Percent correct)Biofeedback, Massed->Distributed, Face-to-FaceNo Biofeedback, Distributed, Face-to-FaceBiofeedback, Distributed, Face-to-FaceNo Biofeedback, Massed-> Distributed, Face-to-FaceNo Biofeeedback, Distributed, TelepracticeNo Biofeedback, Massed->Distributed, TelepracticeTotal
Mean20.2 ± 7.321.2 ± 12.117.0 ± 4.323.2 ± 7.428.9 ± 8.135.5 ± 7.824.3 ± 7.8
07

Study locations

1 site
  • Syracuse University
    Syracuse, New York 13244, United States
08

References and documents

Publications

  • Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016. PubMed 27625603 ↗
  • Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155. PubMed 28715554 ↗

Study documents

  • Study protocol · Apr 28, 2017
  • Statistical analysis plan · Apr 13, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03238677
Lead sponsor
Syracuse University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Jonathan Preston (Associate Professor, Syracuse University) — Principal investigator
First posted
Aug 3, 2017
Start date
Aug 1, 2017
Primary completion
May 9, 2022
Completion
Jun 7, 2022
Results posted
Jun 22, 2023
Last update
Jun 22, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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