Treating Childhood Apraxia of Speech
Primary Purpose
Childhood Apraxia of Speech
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Motor Chaining without Biofeedback
Biofeedback
Distributed Practice
Massed --> Distributed Practice
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Apraxia of Speech focused on measuring speech sound disorder
Eligibility 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
Sites / Locations
- Syracuse University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Arm Label
Biofeedback, Massed->Distributed
No Biofeedback, Distributed
Biofeedback, Distributed
No Biofeedback, Massed-> Distributed
Arm Description
Sequenced biofeedback Mass Practice--> Distributed Scheduling
Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks
Sequenced biofeedback, 2 sessions/wk for 10 weeks
Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03238677
First Posted
August 1, 2017
Last Updated
May 30, 2023
Sponsor
Syracuse University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03238677
Brief Title
Treating Childhood Apraxia of Speech
Official Title
Treating Childhood Apraxia of Speech: Role of Biofeedback & Practice Distribution
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Apraxia of Speech
Keywords
speech sound disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 x 2 design Scheduling: Mass-->Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
Masking
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.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback, Massed->Distributed
Arm Type
Experimental
Arm Description
Sequenced biofeedback Mass Practice--> Distributed Scheduling
Arm Title
No Biofeedback, Distributed
Arm Type
Active Comparator
Arm Description
Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks
Arm Title
Biofeedback, Distributed
Arm Type
Experimental
Arm Description
Sequenced biofeedback, 2 sessions/wk for 10 weeks
Arm Title
No Biofeedback, Massed-> Distributed
Arm Type
Experimental
Arm Description
Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling
Intervention Type
Behavioral
Intervention Name(s)
Speech Motor Chaining without Biofeedback
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Distributed Practice
Intervention Description
2 sessions per week for 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
Massed --> Distributed Practice
Intervention Description
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 Measure Information:
Title
Speech Sound Accuracy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27625603
Citation
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.
Results Reference
background
PubMed Identifier
28715554
Citation
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.
Results Reference
background
Links:
URL
http://speechproductionlab.syr.edu/Resources.html
Description
Speech Motor Chaining Procedural manual
Learn more about this trial
Treating Childhood Apraxia of Speech
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