Dose Frequency RCT on DTTC in Children With CAS

NCT05675306 | Active Not Recruiting

• 1 other identifier: 75245
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood apraxia of speech (CAS) is a pediatric motor-based speech sound disorder that requires a specialized approach to intervention (Maas et al., 2014). The extant literature on the treatment of CAS commonly recommends intensive treatment using a motor-based approach, with some of the best evidence supporting the use of Dynamic Temporal and Tactile Cueing (DTTC; Strand, 2020). To date, a rigorous and systematic comparison of high and low dose frequency has not been undertaken for DTTC, resulting in a lack of evidence to guide decisions about the optimal treatment schedule for this intervention. The current study aims to fill this gap in knowledge by comparing treatment outcomes when dose frequency is varied. The goal of this clinical trial is to determine whether the number of treatment sessions per week has an effect on intervention outcomes in 60 children with CAS. The main question this research will address is whether whole word accuracy will differ between two groups of children undergoing DTTC treatment when one group of children receives treatment twice a week for 12 weeks and the other group receives treatment 4 times a week for 6 weeks. Community clinicians will administer all treatment sessions.

Conditions

Childhood Apraxia of Speech

Keywords

treatment; dose frequency; speech sound disorders; cumulative dosage; whole word accuracy; Dynamic Temporal and Tactile Cueing; DTTC; Childhood apraxia of speech

Outcome Measures

Primary Outcomes (1)

• Changes to whole word accuracy

  A multi-factor whole word accuracy measure (Multilevel word Accuracy Composite Scale; Case et al., under review) that systematically accounts for segmental and prosodic accuracy, word shape maintenance, and smoothness and fluency of movement transitions will be calculated on treated and similar untreated words in the generalization probe.

  Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)

Secondary Outcomes (3)

• Phoneme accuracy

  Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)

• Speech Intelligibility

  Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)

• Functional communication

  Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)

Study Arms (2)

High Dose Frequency

EXPERIMENTAL

This group will receive treatment 4x/week for 6 weeks

Behavioral: Dynamic Temporal and Tactile Cueing Treatment

Low Dose Frequency

ACTIVE COMPARATOR

This group will receive treatment 2x/week for 12 weeks

Behavioral: Dynamic Temporal and Tactile Cueing Treatment

Interventions

Dynamic Temporal and Tactile Cueing Treatment BEHAVIORAL

DTTC is a dynamic, motor-based treatment approach designed for children with severe CAS. This approach is based on Integral Stimulation (Edeal \& Gildersleeve-Neumann, 2011; Maas \& Farinella, 2012; Maas et al., 2019; Strand \& Debertine, 2000; Strand \& Skinder, 1999), in which the clinician instructs the child to "listen to me, watch me, and do what I do" and systematically taxes and supports the speech motor system to facilitate system-wide change in speech output (Strand, 2020).

Also known as: DTTC

High Dose Frequency; Low Dose Frequency

Eligibility Criteria

• Age: 30 Months - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand \& McCauley, 2019),
• ;6-7;11 years of age at treatment commencement;
• English as the primary language;

You may not qualify if:

• concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
• diagnosis of severe or primary dysarthria as described below;
• palatal or structural orofacial anomalies as described below,
• uncorrected vision impairment
• hearing loss;
• receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication treatment, or similar non-speech treatment, would be permitted
• Receptive Language Index standard score less than 70 on the Receptive-Expressive Emergent Language Test, 4th edition (REEL-4; Brown et al., 2020) for children 2-3 years of age, the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3; Wiig et al., 2020) for children 4-5 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5; Wiig et al., 2013) for children 6-7 years of age,
• Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds \& Kamphaus, 2015), and
• no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.

Sponsors & Collaborators

• Marquette University: lead
• Hofstra University: collaborator
• New York University: collaborator
• University of Vermont: collaborator
• University of Sydney: collaborator
• Remarkable Speech and Movement: collaborator

Study Sites (1)

Marquette U

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (14)

• Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.

  BACKGROUND

• 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: 31846588 RESULT

• Maas E, Gildersleeve-Neumann C, Jakielski KJ, Stoeckel R. Motor-based intervention protocols in treatment of childhood apraxia of speech (CAS). Curr Dev Disord Rep. 2014 Sep;1(3):197-206. doi: 10.1007/s40474-014-0016-4.

  PMID: 25313348 RESULT

• Edeal DM, Gildersleeve-Neumann CE. The importance of production frequency in therapy for childhood apraxia of speech. Am J Speech Lang Pathol. 2011 May;20(2):95-110. doi: 10.1044/1058-0360(2011/09-0005). Epub 2011 Feb 17.

  PMID: 21330650 RESULT

• Maas E, Farinella KA. Random versus blocked practice in treatment for childhood apraxia of speech. J Speech Lang Hear Res. 2012 Apr;55(2):561-78. doi: 10.1044/1092-4388(2011/11-0120). Epub 2011 Dec 29.

  PMID: 22207698 RESULT

• Maas E, Gildersleeve-Neumann C, Jakielski K, Kovacs N, Stoeckel R, Vradelis H, Welsh M. Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech. J Speech Lang Hear Res. 2019 Sep 20;62(9):3160-3182. doi: 10.1044/2019_JSLHR-S-18-0212. Epub 2019 Aug 19.

  PMID: 31425660 RESULT

• Iuzzini-Seigel J, Allison KM, Stoeckel R. A Tool for Differential Diagnosis of Childhood Apraxia of Speech and Dysarthria in Children: A Tutorial. Lang Speech Hear Serv Sch. 2022 Oct 6;53(4):926-946. doi: 10.1044/2022_LSHSS-21-00164. Epub 2022 May 6.

  PMID: 35523425 RESULT

• Shriberg LD, Strand EA, Fourakis M, Jakielski KJ, Hall SD, Karlsson HB, Mabie HL, McSweeny JL, Tilkens CM, Wilson DL. A Diagnostic Marker to Discriminate Childhood Apraxia of Speech From Speech Delay: Introduction. J Speech Lang Hear Res. 2017 Apr 14;60(4):S1094-S1095. doi: 10.1044/2016_JSLHR-S-16-0148.

  PMID: 28384695 RESULT

• Goldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.

  RESULT

• Strand, E. A., & Debertine, P. (2000). The efficacy of integral stimulation intervention with developmental apraxia of speech. Journal of Medical Speech-Language Pathology, 8(4), 295-300.

  RESULT

• Strand, E. A., & McCauley, R. J. (2019). The Dynamic Evaluation of Motor Speech Skill (DEMSS). Brookes.

  RESULT

• Thomas-Stonell, N., Oddson, B., Robertson, B., Walker, J. & Rosenbaum, P. (2015). The FOCUS©-34: Focus on the Outcomes of Communication Under Six. Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON. http://www.focusoutcomemeasurement.ca

  RESULT

• Wiig, E. H., Semel, E. M., & Secord, W. A. (2013). Clinical Evaluation of Language Fundamentals - 5. Pearson.

  RESULT

• Iuzzini-Seigel J, Case J, Grigos MI, Velleman SL, Thomas D, Murray E. Dose frequency randomized controlled trial for Dynamic Temporal and Tactile Cueing (DTTC) treatment for childhood apraxia of speech: protocol paper. BMC Pediatr. 2023 May 25;23(1):263. doi: 10.1186/s12887-023-04066-2.

  PMID: 37226208 DERIVED

MeSH Terms

Conditions

Apraxias; Speech Sound Disorder

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jenya Iuzzini-Seigel, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The proposed work is multisite Phase III parallel-group RCT that aims to investigate the outcomes of DTTC in children with CAS and determine whether dose frequency impacts response to treatment.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: March 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal and evidence of ethical conduct of research and appropriate institutional oversight (e.g., IRB). Proposals should be directed to jenya.iuzzini-seigel@marquette.edu. To gain access, data requestors will need to complete and sign a data sharing agreement.

Locations

US (1)