AzTrials
AzTrials

Childhood Apraxia of SpeechNCT07526246

Motor-based Intervention for Childhood Apraxia of Speech: DTTC-Connect

A study testing Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect) in people with Childhood Apraxia of Speech, run by New York University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Childhood apraxia of speech (CAS) is a complex motor speech disorder that significantly limits a child's ability to communicate in daily activities, with difficulties often persisting into adolescence and adulthood. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Childhood Apraxia of Speech
What is being tested?
Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesUnited States
Study dates
15 Sep 2026to 31 Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of childhood apraxia of speech (CAS). The diagnosis will be made by two speech language pathologists (SLPs) who have extensive experience in the differential diagnosis of CAS.
  • Age between 3;6 and 12;11 years.
  • Normal structure of the oral-peripheral mechanism as determined by a motor speech examination using established lab protocol.
  • Participants must pass a hearing screening conducted at 20 dB SPL at 500, 1000, 2000 and 4000 Hz.
  • Not receiving speech treatment elsewhere over the course of this study, although language, augmentative and alternative communication (AAC) treatment, or similar non-speech treatment, would be permitted.
  • Language Testing: Receptive Language Index standard score greater than or equal to 70 on the Clinical Evaluation of Language Fundamentals - Preschool 3rd edition (CELF-P3) for children 3;6-5;11 years of age, or the Clinical Evaluation of Language Fundamentals - 5th edition (CELF-5) for children 6;0-12;11 years of age.
Show all 9Show fewer
  • Nonverbal Cognition Testing: Standard score greater than or equal to 70 on the Developmental Assessment of Young Children-2nd edition (DAYC-2) for children 3;6- 5;11 years of age, or the Reynolds Intellectual Assessment Scales- 2nd edition, Remote (RIAS) for children 6;0-12;11 years old.
  • Can imitate 2-3 word phrases.
  • English as the primary language.

Who cannot join

  • Primary dysarthria diagnosis, even if CAS is a secondary diagnosis.
  • Abnormal structure of the oral peripheral mechanism.
  • Fluency disorder, even if the child meets criteria for CAS.
  • Conductive or sensorineural hearing loss, even if the child meets criteria for CAS.
  • Does not imitate 2-3 word phrases.
  • English is not the primary language.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maria I Grigos, PhD contact

212.998.5230

maria.grigos@nyu.edu

Julie Case, PhD contact

julie.case@hofstra.edu

United States2 sites, 2 recruiting
  • Hofstra University

    Hempstead, New York, 11549

    Kelly Sullivan, M.S., 516-463-5508, Kelly.A.Sullivan@hofstra.edu

    Julie Case, PhD

    Recruiting
  • New York

    New York, New York, 10012

    Kelly Sullivan, M.S., 212-998-5228, ks5904@nyu.edu

    maria.grigos@nyu.edu

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Control Trial of Motor-based Intervention for Childhood Apraxia of Speech: Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect)

Childhood apraxia of speech (CAS) is a complex motor speech disorder that significantly limits a child's ability to communicate in daily activities, with difficulties often persisting into adolescence and adulthood. There is solid evidence that motor-based interventions, such as Dynamic Temporal and Tactile Cueing (DTTC), improve word production in children with CAS. Building on this strong foundation, the next critical step is to extend this work to support functional communication in connected speech, where children with CAS often continue to struggle. There is a critical need for a systematic bridge within the context of treatment from word-level practice to connected speech, as robust word-level gains often fail to generalize to other speaking contexts. This work addresses this gap by transitioning children from word- to phrase-level practice using Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect), a novel, structured adaptation of DTTC that targets connected speech production. Our approach builds on established DTTC principles while incorporating progression to more complex utterances, offering a developmentally appropriate, research-informed pathway to functional communication.

This study is a Phase II randomized controlled trial (RCT) designed to examine the efficacy of DTTC-Connect, a motor-based treatment that includes phrase-level practice to refine connected speech and support communicative participation for children with CAS. The overall objectives of this work are to test the efficacy of DTTC-Connect and document changes in speech motor control at the connected speech level in 68 children with CAS (3;6 - 12;11 years of age) who receive treatment twice a week for 8 weeks (16 sessions). The central hypothesis is that DTTC-Connect will lead to lasting improvements in phrase accuracy, speech intelligibility and speech motor control, ultimately enhancing a child's communicative participation.

Read the detailed description

The long-term goal of this research is to provide evidence-based treatment guidelines to enhance speech intelligibility and therefore, communicative participation, for children with childhood apraxia of speech (CAS). The overall objectives are to test the efficacy of Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect) and document changes in speech motor control at the connected speech level, when intervention is provided two times per week for eight weeks. The central hypothesis is that DTTC-Connect will lead to lasting improvements in phrase accuracy, speech intelligibility, and speech motor control, ultimately enhancing a child's communicative participation, as supported by our previous Dynamic Temporal and Tactile Cueing (DTTC) research and pilot data on DTTC-Connect. The following aims are examined:

Aim 1: Quantify the effects of DTTC-Connect on connected speech accuracy and whether previous DTTC modifies response to DTTC-Connect. 68 children with CAS will receive 8 weeks of DTTC-Connect, with a subset of children returning from the prior DTTC randomized controlled trial (RCT). The working hypothesis is that untreated phrase accuracy (primary outcome) and speech intelligibility (secondary outcome) will increase pre-post DTTC-Connect with gains maintained at 8 weeks post-treatment in all children. It is hypothesized that prior DTTC RCT performance (returning participants) will predict untreated phrase accuracy pre-post DTTC-Connect. Linear mixed-effects models will be used to estimate the DTTC-Connect treatment effect and the moderation effect of prior DTTC exposure.

Aim 2: Quantify the effects of DTTC-Connect on speech motor variability and whether previous DTTC modifies response to DTTC-Connect.

Acoustic and kinematic (lip/jaw movement) data will be obtained pre- and post- DTTC-Connect from 68 children with CAS, including a subset of children returning from the prior DTTC RCT. The working hypothesis is that variability (secondary outcome) will be reduced in all children following DTTC-Connect, with changes maintained at 8 weeks post-treatment. Inclusion of returning children will allow the examination of extended treatment on speech motor control. It is hypothesized that the change in variability in the prior DTTC RCT will moderate the treatment effect with DTTC-Connect. Linear mixed-effects models will be used to estimate changes in variability over time as in Aim 1.

Aim 3: Evaluate the effect of DTTC-Connect on communicative participation in children with CAS. Communicative participation (secondary outcome) will be assessed in all children pre- and post- DTTC-Connect. The working hypothesis is that children with CAS who receive DTTC-Connect will show meaningful gains in their attitudes about speaking and in caregiver-reported functional communication. Linear mixed-effects models will be used to estimate changes in communicative participation following DTTC-Connect.

Upon completion of these aims, the expected outcome is to establish the efficacy of DTTC-Connect in a large cohort of children with CAS, while uncovering how previous response to word-level DTTC informs individualized treatment planning. In doing so, it will generate actionable insights to enhance clinical outcomes while also deepening theoretical understanding of speech motor learning in CAS.

Being tested
Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect)
Keywords
Pediatric Motor Speech Disorder, Speech Motor Control, Communicative Participation
Medical subject headings
Apraxias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect)Behavioural

    DTTC-Connect is a motor-based intervention designed to improve speech accuracy in children with CAS by targeting movement transitions within phrases. Treatment begins with selecting a target phrase identified through dynamic assessment as being within the child's optimal challenge point. Using this initial target, four additional phrases are constructed that systematically build in structural, phonetic, and grammatical complexity to support gradual progression in motor skill. Treatment begins with two-word phrases and follows the first three levels of the DTTC temporal hierarchy: Simultaneous Production → Direct Imitation → Delayed Imitation. The final step is Elicited Production where children produce the target at random intervals in the absence of a prior model. Aligned with standard DTTC, children initially receive maximal support during Simultaneous Production. As accuracy improves, support is faded and the child progresses to less supported levels of production.

Study groups in NCT07526246
Study groupRoleWhat they receive
Immediate TreatmentExperimentalParticipants in the Immediate Treatment Group will receive Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect) Treatment two times per week (45-minute sessions each) for 8 weeks. Total duration will be 90 minutes/week over 16 sessions. Treatment will begin following the diagnostic evaluation.
Receives: Behavioral: Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect)
Delayed TreatmentExperimentalThe 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 Dynamic Temporal and Tactile Cueing-Connect (DTTC-Connect) Treatment two times per week (45-minute sessions each) for 8 weeks. Total duration will be 90 minutes/week over 16 sessions. Treatment will begin after an 8-week delay following the diagnostic evaluation.
Receives: Behavioral: Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phrase Accuracy

    The primary outcome measure will be untreated phrase accuracy, quantified using the adapted Multilevel word Accuracy Composite Score (MACS) ratings for phrase-level stimuli. This composite score reflects the accuracy of four key areas: (I) segments (consonant \& vowel accuracy within-word and across-word boundaries); (II) phrase structure (maintenance of structures across the phrase); (III) movement transitions (smoothness and fluency across sounds, syllable, or words); and (IV) prosody (lexical \& phrasal stress). Each component receives a binary rating (0/1). Ratings will consider co-articulatory effects that naturally occur between words within connected speech.

    Measured: Immediate Group: Pre-Treatment Baseline; 1-week Post-Treatment; 8-week Post-Treatment; 16-weeks Post-Treatment; Delayed Group: Pre-Delay Baseline; Pre-Treatment Baseline (8-weeks post Pre-Delay Baseline); 1-week Post-Treatment; 8-weeks Post-Treatment;

Secondary outcomes (3)
  1. Speech Intelligibility

    Speech intelligibility will be assessed to evaluate how well a listener understands a child's connected speech. To elicit naturalistic yet structured speech, children will be audio-recorded while narrating a short story depicting a picture card series using the School-Aged Language Assessment Measures (SLAM). Ten representative utterances per child per time point will be selected, randomized, and presented to five naïve adult listeners for transcription. A mean intelligibility score will be derived from the percentage of words correctly transcribed. This method captures connected speech in a developmentally appropriate and controlled format while supporting consistency and ecological validity.

    Measured: Immediate Group: Pre-Treatment Baseline; 1-week Post-Treatment; 8-week Post-Treatment; 16-weeks Post-Treatment; Delayed Group: Pre-Delay Baseline; Pre-Treatment Baseline (8-weeks post Pre-Delay Baseline); 1-week Post-Treatment; 8-weeks Post-Treatment;

  2. Variability

    Acoustic variability will be quantified using the coefficient of variation from phrase duration. Kinematic variability will be measured using jaw and lip aperture Spatiotemporal Index (STI) values. To ensure reliable estimates, each session must yield a minimum of four analyzable productions per target, with a maximum of eight to balance representation across children with differing levels of speech accuracy.

    Measured: Immediate Group: Pre-Treatment Baseline; 1-week Post-Treatment; 8-week Post-Treatment; 16-weeks Post-Treatment; Delayed Group: Pre-Delay Baseline; Pre-Treatment Baseline (8-weeks post Pre-Delay Baseline); 1-week Post-Treatment; 8-weeks Post-Treatment;

  3. Communicative Participation

    The treating SLP will administer the Focus on the Outcomes of Communication Under Six (FOCUS-34) and the Intelligibility in Context Scale (ICS) to caregivers, who can complete these measures in person while their child receives treatment. If the caregiver is not present, the forms will be sent electronically, and the clinician will schedule a brief Zoom meeting to provide instructions. Completed forms can then be returned electronically.

    To examine children's feelings towards speech, the Communication Attitude Test (CAT) will be administered to children age six years and older and the KiddyCAT Communication Attitude Test for Preschool and Kindergarten Children Who Stutter (KiddyCAT) will be administered to children under 6 years of age.

    Measured: Immediate Group: Pre-Treatment Baseline; 1-week Post-Treatment; 8-week Post-Treatment; 16-weeks Post-Treatment; Delayed Group: Pre-Delay Baseline; Pre-Treatment Baseline (8-weeks post Pre-Delay Baseline); 1-week Post-Treatment; 8-weeks Post-Treatment;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion31 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This work will employ a delayed treatment control group design across multiple behaviors. Participants will be seen in two groups: an Immediate Treatment group (treat first) and a Delayed Treatment group (wait first).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07526246
Sponsor's protocol ID
2R01DC018581
Other IDs
R01DC018581
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data tied to the primary and secondary outcome measures will be shared after de-identification on Open Science Framework (OSF).

Publications

  • Reynolds, C. R., & Kamphaus, R. W. (2015). Reynolds Intellectual Assessment Scales, Second Edition (RIAS-2), and Reynolds Intellectual Screening Test, Second Edition (RIST-2). Lutz, FL: Psychological Assessment Resources.

  • Voress, J. K., & Maddox, T. (2013). Developmental Assessment of Young Children (2nd ed.). Austin, TX: PRO-ED.

  • Vanryckeghem, M. and G.J. Brutten, KiddyCAT: Communication attitude test for preschool and kindergarten children who stutter. 2007: Plural Publishing Incorporated San Diego, CA.

  • Strand, E.A., R. Stoeckel, and B. Baas, Treatment of severe childhood apraxia of speech: A treatment efficacy study. Journal of Medical Speech-Language Pathology, 2006. 14(4): p. 297-308.

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

  • 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, Butalla CE, Farinella KA. Feedback frequency in treatment for childhood apraxia of speech. Am J Speech Lang Pathol. 2012 Aug;21(3):239-57. doi: 10.1044/1058-0360(2012/11-0119). Epub 2012 Mar 21.

    PubMed 22442284
  • Case J, Wang EW, Grigos MI. The Multilevel Word Accuracy Composite Scale: A Novel Measure of Speech Production in Childhood Apraxia of Speech. Am J Speech Lang Pathol. 2023 Aug 17;32(4S):1866-1883. doi: 10.1044/2023_AJSLP-22-00166. Epub 2023 May 17.

    PubMed 37195724
  • 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.

    PubMed 27792399
  • Wiig, E. H., Secord, W. A., & Semel, E. M. (2020). Clinical Evaluation of Language Fundamentals-Preschool 3 (CELF-Preschool 3). Pearson.

  • Wiig, E.H., W.A. Secord, and E. Semel, Clinical evaluation of language fundamentals: CELF-5. 2013: Pearson.

  • Crowley, C., & Baigorri, M. (2014). School-age Language Assessment Measures: SLAM dog comes home cards.

  • Zaretsky E, Velleman SL, Curro K. Through the magnifying glass: Underlying literacy deficits and remediation potential in childhood apraxia of speech. Int J Speech Lang Pathol. 2010 Feb;12(1):58-68. doi: 10.3109/17549500903216720.

    PubMed 20380250
  • Thomas-Stonell NL, Oddson B, Robertson B, Rosenbaum PL. Development of the FOCUS (Focus on the Outcomes of Communication Under Six), a communication outcome measure for preschool children. Dev Med Child Neurol. 2010 Jan;52(1):47-53. doi: 10.1111/j.1469-8749.2009.03410.x. Epub 2009 Aug 26.

    PubMed 19709136
  • Teverovsky EG, Bickel JO, Feldman HM. Functional characteristics of children diagnosed with Childhood Apraxia of Speech. Disabil Rehabil. 2009;31(2):94-102. doi: 10.1080/09638280701795030.

    PubMed 18720114

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Temporal and Tactile Cueing - Connect (DTTC-Connect) in people with Childhood Apraxia of Speech, run by New York University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria I Grigos, PhD (212.998.5230, maria.grigos@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phrase Accuracy (time frame: Immediate Group: Pre-Treatment Baseline; 1-week Post-Treatment; 8-week Post-Treatment; 16-weeks Post-Treatment; Delayed Group: Pre-Delay Baseline; Pre-Treatment Baseline (8-weeks post Pre-Delay Baseline); 1-week Post-Treatment; 8-weeks Post-Treatment;). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07526246, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in