A Randomized Control Trial of Motor-based Intervention for CAS

NCT ID: NCT04642053

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2027-03-31

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.

Conditions

Childhood Apraxia of Speech

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dynamic Temporal and Tactile Cuing

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Dynamic Temporal and Tactile Cuing

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age between 2.5 and 7.11 years of age.

3. Normal structure of the oral-peripheral mechanism.

4. Participants must pass a hearing screening conducted at 20 dB SPL at 500, 1000, 2000 and 4000 Hz.

5. No prior DTTC treatment.

Exclusion Criteria

1. Positive history of neurological disorder (e.g. cerebral palsy), developmental disorder (e.g. autism spectrum disorder) or genetic disorder (e.g. Down syndrome).

2. Characteristics of dysarthria, even if the child meets criteria for CAS.

3. Fluency disorder, even if the child meets criteria for CAS.

4. Conductive or sensorineural hearing loss, even if the child meets criteria for CAS.

5. History of DTTC treatment.

• Minimum Eligible Age: 29 Months
• Maximum Eligible Age: 95 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria I Grigos, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

New York University, Department of Communicative Sciences & Disordesr

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maria I Grigos, PhD

Role: CONTACT

maria.grigos@nyu.edu

212.998.5228

Facility Contacts

Maria I Grigos, PhD

Role: primary

maria.grigos@nyu.edu

212-998-5228

Panagiota Tampakis, MS

Role: backup

panagiota.tampakis@nyu.edu

212.998.5232

References

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Reference Type: BACKGROUND

PMID: 29281317 (View on PubMed)

Hayden, D. A., & Square, P. A. (1999). VMPAC: Verbal Motor Production Assessment for Children. San Antonio, TX: Psychological Association.

Reference Type: BACKGROUND

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).

Reference Type: BACKGROUND

PMID: 12971826 (View on PubMed)

Goldman, R. & Fristoe, M. (2016). Goldman Fristoe Test of Articulation - 3. Circle Pines, MN: American Guidance Service

Reference Type: BACKGROUND

American Speech-Language-Hearing Association (2007). Childhood apraxia of speech: Technical Report. Available online: https://www.asha.org/policy/tr2007-00278/

Reference Type: BACKGROUND

Ayres, A. J. (1985). Developmental dyspraxia and adult-onset apraxia: By A. Jean Ayres. Sensory integration international.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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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Provided Documents

Document Type: Informed Consent Form

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Other Identifiers

R01DC018581-01

Identifier Type: NIH

Identifier Source: org_study_id

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