NCT04642053

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2021Mar 2027

First Submitted

Initial submission to the registry

November 12, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

November 12, 2020

Last Update Submit

January 15, 2026

Conditions

Keywords

Pediatric motor speech disorderSpeech motor control

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through the treatment phase (32 treatment sessions over 8 weeks)

Secondary Outcomes (3)

  • Changes in the percentage of words correctly identified by a listener

    Pre to post-treatment (8-weeks from treatment onset)

  • Changes in the speech motor variability of segments and words

    Pre to post-treatment (8-weeks from treatment onset)

  • Changes in the duration of segments and words

    Pre to post-treatment (8-weeks from treatment onset)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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.

Behavioral: Dynamic Temporal and Tactile Cuing

Delayed Treatment

EXPERIMENTAL

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.

Behavioral: Dynamic Temporal and Tactile Cuing

Interventions

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 TreatmentImmediate Treatment

Eligibility Criteria

Age29 Months - 95 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University, Department of Communicative Sciences & Disordesr

New York, New York, 10012, United States

RECRUITING

Related Publications (15)

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

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

    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.

    PMID: 12705559BACKGROUND
  • 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.

    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).

    PMID: 12971826BACKGROUND
  • Goldman, R. & Fristoe, M. (2016). Goldman Fristoe Test of Articulation - 3. Circle Pines, MN: American Guidance Service

    BACKGROUND
  • 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.

    PMID: 29281317BACKGROUND
  • Hayden, D. A., & Square, P. A. (1999). VMPAC: Verbal Motor Production Assessment for Children. San Antonio, TX: Psychological Association.

    BACKGROUND
  • 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.

    PMID: 27792399BACKGROUND
  • 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.

    BACKGROUND
  • Shriberg LD, Aram DM, Kwiatkowski J. Developmental apraxia of speech: III. A subtype marked by inappropriate stress. J Speech Lang Hear Res. 1997 Apr;40(2):313-37. doi: 10.1044/jslhr.4002.313.

    PMID: 9130201BACKGROUND
  • 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.

    PMID: 22489736BACKGROUND
  • Smith A, Goffman L, Zelaznik HN, Ying G, McGillem C. Spatiotemporal stability and patterning of speech movement sequences. Exp Brain Res. 1995;104(3):493-501. doi: 10.1007/BF00231983.

    PMID: 7589300BACKGROUND
  • 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.

    PMID: 31846588BACKGROUND
  • 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.

    PMID: 23275421BACKGROUND

MeSH Terms

Conditions

Apraxias

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria I Grigos, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria I Grigos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 24, 2020

Study Start

September 14, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data tied to the primary and secondary outcome measures will be shared after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations