A Randomized Control Trial of Motor-based Intervention for CAS
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| ClinicalTrials.gov Identifier: NCT04642053 |
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Recruitment Status :
Recruiting
First Posted : November 24, 2020
Last Update Posted : February 9, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Childhood Apraxia of Speech | Behavioral: Dynamic Temporal and Tactile Cuing | Not Applicable |
Seventy-two children with CAS, between the ages of 2.5 and 5 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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: | Single (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. |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Control Trial of Motor-based Intervention for Childhood Apraxia of Speech |
| Actual Study Start Date : | September 14, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | March 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Immediate Treatment
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.
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Behavioral: Dynamic Temporal and Tactile Cuing
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. |
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Experimental: Delayed Treatment
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.
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Behavioral: Dynamic Temporal and Tactile Cuing
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. |
- Changes in word accuracy [ Time Frame: Through the treatment phase (32 treatment sessions over 8 weeks) ]Word accuracy will be quantified for treated and untreated words using a composite score that reflects accuracy of segmental and suprasegmental components of words.
- Changes in the percentage of words correctly identified by a listener [ Time Frame: Pre to post-treatment (8-weeks from treatment onset) ]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 [ Time Frame: Pre to post-treatment (8-weeks from treatment onset) ]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 [ Time Frame: Pre to post-treatment (8-weeks from treatment onset) ]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).
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| Ages Eligible for Study: | 30 Months to 60 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT04642053
| Contact: Maria I Grigos, PhD | 212.998.5228 | maria.grigos@nyu.edu |
| United States, New York | |
| New York University, Department of Communicative Sciences & Disordesr | Recruiting |
| New York, New York, United States, 10012 | |
| Contact: Maria I Grigos, PhD 212-998-5228 maria.grigos@nyu.edu | |
| Contact: Panagiota Tampakis, MS 212.998.5232 panagiota.tampakis@nyu.edu | |
| Principal Investigator: | Maria I Grigos, PhD | New York University |
| Responsible Party: | Maria Grigos, Associate Professor, New York University |
| ClinicalTrials.gov Identifier: | NCT04642053 |
| Other Study ID Numbers: |
R01DC018581-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 24, 2020 Key Record Dates |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data tied to the primary and secondary outcome measures will be shared after deidentification. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Beginning 6 months following publication. No end date. |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pediatric motor speech disorder Speech motor control |
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Apraxias Psychomotor Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |