Back to resultsA Randomized Control Trial of Motor-based Intervention for CAS
Primary Purpose
Childhood Apraxia of Speech
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Temporal and Tactile Cuing
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Apraxia of Speech focused on measuring Pediatric motor speech disorder, Speech motor control
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of childhood apraxia of speech (CAS). Diagnostic classification for CAS will be determined according to the presence of the three core features identified in the ASHA position statement on CAS: 1) inconsistent consonant and vowel errors over productions of repeated trials; 2) difficulties forming accurate movement between sounds and syllables; and 3) prosodic errors (ASHA, 2007). These three characteristics must be present in more than one speaking context (i.e. single words, connected speech, sequencing tasks). In addition to the three core features, children with CAS must demonstrate at least four of the following characteristics: vowel errors, timing errors, phoneme distortions, articulatory groping, impaired volitional oral movement, reduced phonetic inventory and poorer expressive than receptive language skills, which is consistent with the Strand 10-point checklist (Shriberg et al., 2012). We will identify the presence of these factors from the Dynamic Evaluation of Motor Speech Skills (DEMSS, Strand et al., 2013), Verbal Motor Production Assessment for Children (VMPAC, Hayden & Square, 1999), Goldman Fristoe Test of Articulation (GFTA-3, Goldman & Fristoe, 2016), and a connected speech sample. We have used these stringent criteria for diagnosing CAS in our past research (Please see the Diagnostic Framework and Criteria for CAS in Grigos and Case (2017)). The diagnosis will be made independently by two speech language pathologists (one being the PI) with expertise in assessing and treating children with CAS.
- Age between 2.5 and 5 years of age.
- Normal structure of the oral-peripheral mechanism.
- Participants must pass a hearing screening conducted at 20 dB SPL at 500, 1000, 2000 and 4000 Hz.
- No prior DTTC treatment.
Exclusion Criteria:
- Positive history of neurological disorder (e.g. cerebral palsy), developmental disorder (e.g. autism spectrum disorder) or genetic disorder (e.g. Down syndrome).
- Characteristics of dysarthria, even if the child meets criteria for CAS.
- Fluency disorder, even if the child meets criteria for CAS.
- Conductive or sensorineural hearing loss, even if the child meets criteria for CAS.
- History of DTTC treatment.
Sites / Locations
- New York University, Department of Communicative Sciences & DisordesrRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate Treatment
Delayed Treatment
Arm Description
Participants in the Immediate Treatment Group will receive DTTC Treatment four times per week (45-minute sessions each) for 8 weeks. Total duration will be 180 minutes/week over 32 sessions. Treatment will begin between 1-3 weeks following the diagnostic evaluation.
The Delayed Treatment Group serves as a control during the period in which participants are waiting to begin treatment. A delayed treatment onset is employed to control for maturation effects. Participants in the Delayed Treatment Group will receive DTTC Treatment four times per week (45-minute sessions each) for 8 weeks. Total duration will be 180 minutes/week over 32 sessions. Treatment will begin after an 8-week delay following the diagnostic evaluation.
Outcomes
Primary Outcome Measures
Changes in word accuracy
Word accuracy will be quantified for treated and untreated words using a composite score that reflects accuracy of segmental and suprasegmental components of words.
Secondary Outcome Measures
Changes in the percentage of words correctly identified by a listener
Standard procedures (Hustad et al., 2007; 2016) will be used to measure speech intelligibility by computing the percentage of intelligible words (treated and untreated). Five naïve adult listeners will orthographically transcribe randomized word productions from each child.
Changes in the speech motor variability of segments and words
Variability will be measured using acoustic and kinematic methods. Acoustic measures will include coefficient of variation of word and segment duration. Kinematic measures will include lip and jaw movement variability associated with whole word productions (i.e. spatiotemporal index (STI, Smith et al.1995) and coefficient of variation of single movements (i.e. movement from oral closing into oral opening; movement from oral opening into oral closing).
Changes in the duration of segments and words
Word and segment duration will be measured using acoustic and kinematic methods. Acoustic measures will include word and segment duration. Kinematic measures will include word and single movement duration (e.g. oral opening into vowel).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04642053
Brief Title
A Randomized Control Trial of Motor-based Intervention for CAS
Official Title
A Randomized Control Trial of Motor-based Intervention for Childhood Apraxia of Speech
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Childhood apraxia of speech (CAS) is a complex, multivariate speech motor disorder characterized by difficulty planning and programming movements of the speech articulators (ASHA, 2007; Ayres, 1985; Campbell et al., 2007; Davis et al., 1998; Forrest, 2003; Shriberg et al., 1997). Despite the profound impact that CAS can have on a child's ability to communicate, little data are available to direct treatment in this challenging population. Historically, children with CAS have been treated with articulation and phonologically based approaches with limited effectiveness in improving speech, as shown by very slow treatment progress and poor generalization of skills to new contexts. With the emerging data regarding speech motor deficits in CAS, there is a critical need to test treatments that directly refine speech movements using methods that quantify speech motor control.
This research is a Randomized Control Trial designed to examine the outcomes of a non-traditional, motor-based approach, Dynamic Temporal and Tactile Cuing (DTTC), to improve speech production in children with CAS. The overall objectives of this research are (i) to test the efficacy of DTTC in young children with CAS (N=72) by examining the impact of DTTC on treated words, generalization to untreated words and post-treatment maintenance, and (ii) to examine how individual patterns of speech motor variability impact response to DTTC.
Detailed Description
Seventy-two children with CAS, between the ages of 2.5 and 7.11 years of age will be treated with DTTC. This work will employ a delayed treatment control group design across multiple behaviors. Participants will be seen in two groups: an Immediate Treatment group and a Delayed Treatment group. Probe data will be collected during the Pre-Treatment (5 data points), Treatment (12 data points) and Maintenance (minimum 5 data points) phases. The study duration is 28 weeks in total duration for all participants. The study will address the following specific aims:
Aim 1: Quantify the effects of DTTC on improved speech production (perceptual ratings) in treated words that are maintained post-treatment and generalized to untreated words in children with CAS. The working hypothesis is that DTTC will increase accuracy of treated words (primary outcome measure) and this effect will be maintained post-treatment and generalized to untreated words. We also predict that DTTC will increase speech intelligibility pre to post-treatment (secondary outcome measure).
Aim 2: Quantify the effects of DTTC on refined speech motor control (kinematic/acoustic measures) in treated words that are maintained post-treatment and generalized to untreated words in children with CAS. The working hypothesis is that DTTC will be associated with decreases in speech motor variability and duration of treated words (secondary outcome measures) that are maintained pre- to post-treatment and generalized to untreated words.
Aim 3: Characterize the effects of speech motor variability (within-subject) at baseline as a predictor of DTTC efficacy in children with CAS. The working hypothesis is that children with CAS who demonstrate higher levels of speech motor variability at baseline will display greater improvements in speech production accuracy following DTTC than children with lower levels of variability at baseline.
Treatment will be provided four times/week for 45-minute sessions. Principles of motor learning will be incorporated into sessions by controlling the type of practice (blocked vs. randomized), type of feedback (knowledge of results vs. knowledge of performance) and amount of feedback provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Apraxia of Speech
Keywords
Pediatric motor speech disorder, Speech motor control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This work will employ a delayed treatment control group design across multiple behaviors. Participants will be seen in two groups: an Immediate Treatment group and a Delayed Treatment group.
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will be blind to treatment phase/session (i.e. Pre-Treatment, Treatment (including session #) and Maintenance), group (i.e. Immediate vs. Delayed) and word status (i.e. Treated vs. Untreated). They will performed blinded ratings of Word Accuracy and Speech Intelligibility, as well as blinded scoring of Duration and Variability.
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants in the Immediate Treatment Group will receive DTTC Treatment four times per week (45-minute sessions each) for 8 weeks. Total duration will be 180 minutes/week over 32 sessions. Treatment will begin between 1-3 weeks following the diagnostic evaluation.
Arm Title
Delayed Treatment
Arm Type
Experimental
Arm Description
The Delayed Treatment Group serves as a control during the period in which participants are waiting to begin treatment. A delayed treatment onset is employed to control for maturation effects. Participants in the Delayed Treatment Group will receive DTTC Treatment four times per week (45-minute sessions each) for 8 weeks. Total duration will be 180 minutes/week over 32 sessions. Treatment will begin after an 8-week delay following the diagnostic evaluation.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Temporal and Tactile Cuing
Intervention Description
Dynamic Temporal and Tactile Cuing is based on principles of integral stimulation where the client watches, listens to and imitates the clinician (Strand, 2020). Treatment will begin by training the child to imitate and simultaneously produce syllables/words with the clinician. Sessions will focus on establishing accurate movement transitions in treated words. The child will be asked to imitate the clinician's production of the target. If the child's imitation is inaccurate, they will be instructed to simultaneously produce the target with the clinician. Simultaneous productions will continue to provide practice opportunity with maximal cuing. As the child gains greater accuracy, simultaneous productions will be faded and direct imitation will be attempted again. Over the course of treatment, the movement gesture will be shaped with the goal being accurate production with normal rate and naturalness.
Primary Outcome Measure Information:
Title
Changes in word accuracy
Description
Word accuracy will be quantified for treated and untreated words using a composite score that reflects accuracy of segmental and suprasegmental components of words.
Time Frame
Through the treatment phase (32 treatment sessions over 8 weeks)
Secondary Outcome Measure Information:
Title
Changes in the percentage of words correctly identified by a listener
Description
Standard procedures (Hustad et al., 2007; 2016) will be used to measure speech intelligibility by computing the percentage of intelligible words (treated and untreated). Five naïve adult listeners will orthographically transcribe randomized word productions from each child.
Time Frame
Pre to post-treatment (8-weeks from treatment onset)
Title
Changes in the speech motor variability of segments and words
Description
Variability will be measured using acoustic and kinematic methods. Acoustic measures will include coefficient of variation of word and segment duration. Kinematic measures will include lip and jaw movement variability associated with whole word productions (i.e. spatiotemporal index (STI, Smith et al.1995) and coefficient of variation of single movements (i.e. movement from oral closing into oral opening; movement from oral opening into oral closing).
Time Frame
Pre to post-treatment (8-weeks from treatment onset)
Title
Changes in the duration of segments and words
Description
Word and segment duration will be measured using acoustic and kinematic methods. Acoustic measures will include word and segment duration. Kinematic measures will include word and single movement duration (e.g. oral opening into vowel).
Time Frame
Pre to post-treatment (8-weeks from treatment onset)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Months
Maximum Age & Unit of Time
95 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of childhood apraxia of speech (CAS). Diagnostic classification for CAS will be determined according to the presence of the three core features identified in the ASHA position statement on CAS: 1) inconsistent consonant and vowel errors over productions of repeated trials; 2) difficulties forming accurate movement between sounds and syllables; and 3) prosodic errors (ASHA, 2007). These three characteristics must be present in more than one speaking context (i.e. single words, connected speech, sequencing tasks). In addition to the three core features, children with CAS must demonstrate at least four of the following characteristics: vowel errors, timing errors, phoneme distortions, articulatory groping, impaired volitional oral movement, reduced phonetic inventory and poorer expressive than receptive language skills, which is consistent with the Strand 10-point checklist (Shriberg et al., 2012). We will identify the presence of these factors from the Dynamic Evaluation of Motor Speech Skills (DEMSS, Strand et al., 2013), Verbal Motor Production Assessment for Children (VMPAC, Hayden & Square, 1999), Goldman Fristoe Test of Articulation (GFTA-3, Goldman & Fristoe, 2016), and a connected speech sample. We have used these stringent criteria for diagnosing CAS in our past research (Please see the Diagnostic Framework and Criteria for CAS in Grigos and Case (2017)). The diagnosis will be made independently by two speech language pathologists (one being the PI) with expertise in assessing and treating children with CAS.
Age between 2.5 and 7.11 years of age.
Normal structure of the oral-peripheral mechanism.
Participants must pass a hearing screening conducted at 20 dB SPL at 500, 1000, 2000 and 4000 Hz.
No prior DTTC treatment.
Exclusion Criteria:
Positive history of neurological disorder (e.g. cerebral palsy), developmental disorder (e.g. autism spectrum disorder) or genetic disorder (e.g. Down syndrome).
Characteristics of dysarthria, even if the child meets criteria for CAS.
Fluency disorder, even if the child meets criteria for CAS.
Conductive or sensorineural hearing loss, even if the child meets criteria for CAS.
History of DTTC treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria I Grigos, PhD
Phone
212.998.5228
Email
maria.grigos@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria I Grigos, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University, Department of Communicative Sciences & Disordesr
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria I Grigos, PhD
Phone
212-998-5228
Email
maria.grigos@nyu.edu
First Name & Middle Initial & Last Name & Degree
Panagiota Tampakis, MS
Phone
212.998.5232
Email
panagiota.tampakis@nyu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data tied to the primary and secondary outcome measures will be shared after deidentification.
IPD Sharing Time Frame
Beginning 6 months following publication. No end date.
IPD Sharing Access Criteria
Researchers and speech language pathologists who provide a methodologically sound proposal. Proposals should be directed to maria.grigos@nyu.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.
Citations:
Citation
American Speech-Language-Hearing Association (2007). Childhood apraxia of speech: Technical Report. Available online: https://www.asha.org/policy/tr2007-00278/
Results Reference
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Citation
Ayres, A. J. (1985). Developmental dyspraxia and adult-onset apraxia: By A. Jean Ayres. Sensory integration international.
Results Reference
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PubMed Identifier
12705559
Citation
Campbell TF, Dollaghan CA, Rockette HE, Paradise JL, Feldman HM, Shriberg LD, Sabo DL, Kurs-Lasky M. Risk factors for speech delay of unknown origin in 3-year-old children. Child Dev. 2003 Mar-Apr;74(2):346-57. doi: 10.1111/1467-8624.7402002.
Results Reference
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Citation
Davis, B. L., Jakielski, K. J., & Marquardt, T. P. (1998). Developmental apraxia of speech: Determiners of differential diagnosis. Clinical Linguistics & Phonetics, 12(1), 25-45.
Results Reference
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PubMed Identifier
12971826
Citation
Forrest K. Diagnostic criteria of developmental apraxia of speech used by clinical speech-language pathologists. Am J Speech Lang Pathol. 2003 Aug;12(3):376-80. doi: 10.1044/1058-0360(2003/083).
Results Reference
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Citation
Goldman, R. & Fristoe, M. (2016). Goldman Fristoe Test of Articulation - 3. Circle Pines, MN: American Guidance Service
Results Reference
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PubMed Identifier
29281317
Citation
Grigos MI, Case J. Changes in movement transitions across a practice period in childhood apraxia of speech. Clin Linguist Phon. 2018;32(7):661-687. doi: 10.1080/02699206.2017.1419378. Epub 2017 Dec 27.
Results Reference
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Citation
Hayden, D. A., & Square, P. A. (1999). VMPAC: Verbal Motor Production Assessment for Children. San Antonio, TX: Psychological Association.
Results Reference
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PubMed Identifier
27792399
Citation
Hustad KC, Allison KM, Sakash A, McFadd E, Broman AT, Rathouz PJ. Longitudinal development of communication in children with cerebral palsy between 24 and 53 months: Predicting speech outcomes. Dev Neurorehabil. 2017 Aug;20(6):323-330. doi: 10.1080/17518423.2016.1239135. Epub 2016 Oct 28.
Results Reference
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Citation
Hustad, K. C. and Weismer,G. (2007). A continuum of interventions for individuals with dysarthria: Compensatory and Rehabilitative Approaches, in Motor Speech Disorders, Weismer, (Ed.) San Diego, CA: Plural Publishing, 261-303.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Shriberg LD, Lohmeier HL, Strand EA, Jakielski KJ. Encoding, memory, and transcoding deficits in Childhood Apraxia of Speech. Clin Linguist Phon. 2012 May;26(5):445-82. doi: 10.3109/02699206.2012.655841.
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Citation
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Citation
Strand EA. Dynamic Temporal and Tactile Cueing: A Treatment Strategy for Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2020 Feb 7;29(1):30-48. doi: 10.1044/2019_AJSLP-19-0005. Epub 2019 Dec 17.
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Citation
Strand EA, McCauley RJ, Weigand SD, Stoeckel RE, Baas BS. A motor speech assessment for children with severe speech disorders: reliability and validity evidence. J Speech Lang Hear Res. 2013 Apr;56(2):505-20. doi: 10.1044/1092-4388(2012/12-0094). Epub 2012 Dec 28.
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A Randomized Control Trial of Motor-based Intervention for CAS
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