ClinicalTrials.gg
Active, not recruitingNCT05675306Updated May 21, 2025

Dose Frequency RCT on DTTC in Children With CAS

An interventional study of Dynamic Temporal and Tactile Cueing Treatment in Childhood Apraxia of Speech, sponsored by Marquette University. Active, not recruiting at 1 site in United States. Open to participants aged 30 Months to 95 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Marquette University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Months to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Apraxias

65 studies on the registry are indexed under Apraxias; 21 are open to participants now.

This study's planned enrollment of 60 is above the median of 32 across 50 interventional studies indexed under Apraxias.

Browse Apraxias studies →

Lead sponsor

Marquette University is the lead sponsor of 38 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Months to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    High Dose Frequency

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

    Behavioral: Dynamic Temporal and Tactile Cueing Treatment

  • Active comparator
    Low Dose Frequency

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

    Behavioral: Dynamic Temporal and Tactile Cueing Treatment

Interventions

  • BehavioralDynamic 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).

    Also known as: DTTC

06

What researchers measure

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.

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

Secondary outcomes

  1. Phoneme accuracy

    Percentage of phonemes correct on the generalization probe

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

  2. Speech Intelligibility

    Calculated based on the Intelligibility in Context Scale (McLeod et al., 2012), a parent survey measure

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

  3. Functional communication

    Calculated based on the Functional Outcomes on Communication Under Six (Thomas-Stonell et al., 2015), a parent survey measure

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

07

Study locations

1 site
08

References and documents

Publications

  • Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals - Preschool (3rd ed.). Pearson.
  • 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. PubMed 31846588 ↗
  • 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. PubMed 25313348 ↗
  • 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. PubMed 21330650 ↗
  • 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. PubMed 22207698 ↗
  • 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. PubMed 31425660 ↗
  • 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. PubMed 35523425 ↗
  • 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. PubMed 28384695 ↗
  • Goldman, R., & Fristoe, M. (2015). Goldman-Fristoe Test of Articulation - Third Edition (GFTA-3). Pearson Assessments.
  • 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.
  • Gubiani MB, Pagliarin KC, McCauley RJ, Keske-Soares M. Dynamic Evaluation of Motor Speech Skill: Adaptation for Brazilian Portuguese. J Commun Disord. 2021 Sep-Oct;93:106114. doi: 10.1016/j.jcomdis.2021.106114. Epub 2021 May 24. PubMed 34237603 ↗
  • 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
  • Wiig, E. H., Semel, E. M., & Secord, W. A. (2013). Clinical Evaluation of Language Fundamentals - 5. Pearson.

Individual participant data

Plan to share: Yes — Deidentified individual level data will be shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Nov 2025, 32 months after the start.

Of 30 interventional studies with no phase under Apraxias, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 32 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2022
First posted
Jan 9, 2023
StartActual
Mar 1, 2023
Primary completionEst.
Nov 30, 2025
CompletionEst.
Dec 31, 2025
Last update
May 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05675306
Lead sponsor
Marquette University
Collaborators
Hofstra University, New York University, University of Vermont, University of Sydney, Remarkable Speech and Movement
Responsible party
Jenya Iuzzini-Seigel (Assistant Professor, Marquette University) — Principal investigator
First posted
Jan 9, 2023
Start date
Mar 1, 2023
Primary completion
Nov 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 21, 2025

Study contacts

Jenya Iuzzini-Seigel, PhD
principal investigator · Marquette University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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