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Treating Childhood Apraxia of Speech

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ClinicalTrials.gov Identifier: NCT03238677
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jonathan Preston, Syracuse University

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Apraxia of Speech Behavioral: Speech Motor Chaining without Biofeedback Behavioral: Biofeedback Behavioral: Distributed Practice Behavioral: Massed --> Distributed Practice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 x 2 design Scheduling: Mass-->Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
Masking: Single (Outcomes Assessor)
Masking Description: Individuals who conduct the phonetic transcriptions that will be used for the primary outcome data will be blinded as to whether the recordings were collected before or after treatment, and also blinded as to the group assignment of the participant.
Primary Purpose: Treatment
Official Title: Treating Childhood Apraxia of Speech: Role of Biofeedback & Practice Distribution
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: Biofeedback, Massed->Distributed
Sequenced biofeedback Mass Practice--> Distributed Scheduling
Behavioral: Biofeedback
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.

Behavioral: Massed --> 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

Active Comparator: No Biofeedback, Distributed
Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks
Behavioral: Speech 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

Behavioral: Distributed Practice
2 sessions per week for 10 weeks

Experimental: Biofeedback, Distributed
Sequenced biofeedback, 2 sessions/wk for 10 weeks
Behavioral: Biofeedback
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.

Behavioral: Distributed Practice
2 sessions per week for 10 weeks

Experimental: No Biofeedback, Massed-> Distributed
Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling
Behavioral: Speech 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

Behavioral: Massed --> 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




Primary Outcome Measures :
  1. Speech sound accuracy [ Time Frame: 10 weeks from the start of treatment (after 20 treatment sessions) ]
    Percent consonants correct


Secondary Outcome Measures :
  1. Speech sound accuracy [ Time Frame: After 15 weeks from the start of treatment ]
    Percent consonants correct



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238677


Contacts
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Contact: Jonathan Preston, PhD 315-443-3143 jopresto@syr.edu
Contact: Megan C Leece, MS 315-443-1351 SpeechProductionLab@syr.edu

Locations
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United States, New York
Syracuse University Recruiting
Syracuse, New York, United States, 13244
Contact: Jonathan Preston, PhD    315-443-3143    jopresto@syr.edu   
Contact: Megan Leece, MC    315-443-1351    SpeechProductionLab@syr.edu   
Principal Investigator: Jonathan Preston, PhD         
Sponsors and Collaborators
Syracuse University
National Institute on Deafness and Other Communication Disorders (NIDCD)

Additional Information:
Publications:
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Responsible Party: Jonathan Preston, Associate Professor, Syracuse University
ClinicalTrials.gov Identifier: NCT03238677     History of Changes
Other Study ID Numbers: 17-177
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jonathan Preston, Syracuse University:
speech sound disorder
Additional relevant MeSH terms:
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Apraxias
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms