Dose Frequency RCT on DTTC in Children With CAS

May 16, 2025 updated by: Jenya Iuzzini-Seigel, Marquette University

Dose Frequency Randomized Control Trial for Dynamic Temporal and Tactile Cueing (DTTC) Treatment for Childhood Apraxia of Speech

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Sixty children with childhood apraxia of speech will be treated with DTTC treatment. A Phase III randomized controlled trial with parallel groups will be conducted to compare effects of low versus high dose frequency on DTTC treatment outcomes in children with CAS. Children with CAS between 2;5-7;11 years of age will be recruited to participate in this study. Treatment will be provided in the community setting by speech-language pathologists who have completed specialized training administering DTTC in a research reliable manner.

True randomization with concealed allocation will be used to assign children to either the low or high dose frequency group. Treatment will be administered in 1-hour sessions either 4 times per week over a 6-week period (high dose) or 2 times per week over a 12-week period (low dose) for a total of 24 hours per child. To measure treatment gains, probe data will be collected before treatment, during treatment, and 1 day, 1 week, 4 weeks, and 12 weeks post-treatment. Probe data will consist of customized treated words and a standard set of untreated words to assess generalization of treatment gains. The primary outcome variable will be whole word accuracy, a measure of segmental, phonotactic, and suprasegmental accuracy.

This will be the first randomized controlled trial (RCT) to evaluate dose frequency for DTTC treatment in children with CAS.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Marquette U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. CAS diagnosis confirmed by research team as described below (e.g., Iuzzini-Seigel et al., 2022; Shriberg et al., 2017; Strand & McCauley, 2019),
  2. 2;6-7;11 years of age at treatment commencement;
  3. English as the primary language;

Exclusion Criteria:

  1. concomitant developmental disorders (including autism, global developmental delay, intellectual disability);
  2. diagnosis of severe or primary dysarthria as described below;
  3. palatal or structural orofacial anomalies as described below,
  4. uncorrected vision impairment
  5. hearing loss;
  6. 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
  7. 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,
  8. Nonverbal Index standard score less than 70 on the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (Reynolds & Kamphaus, 2015), and
  9. no evidence of communicative intent, attempts at verbal communication, focused attention to the clinician's face, or demonstrated ability to imitate during the DEMSS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Frequency
This group will receive treatment 4x/week for 6 weeks
Behavioral: Dynamic Temporal and Tactile Cueing Treatment
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).
Other Names:
  • DTTC
Active Comparator: Low Dose Frequency
This group will receive treatment 2x/week for 12 weeks
Behavioral: Dynamic Temporal and Tactile Cueing Treatment
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).
Other Names:
  • DTTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to whole word accuracy
Time Frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phoneme accuracy
Time Frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Percentage of phonemes correct on the generalization probe
Pre to post-treatment follow-up (6-12 weeks of treatment plus 12 weeks post completion of treatment)
Speech Intelligibility
Time Frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure
Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post completion of treatment)
Functional communication
Time Frame: Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)
Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure
Pre to post-treatment follow-up (6-12 weeks of treatment plus 4 weeks post treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Collaborators

New York University
University of Vermont
University of Sydney
Hofstra University
Remarkable Speech and Movement

Investigators

  • Principal Investigator: Jenya Iuzzini-Seigel, PhD, Marquette University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual level data will be shared.

IPD Sharing Time Frame

Beginning 6 months after publication. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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