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Uno Studio Controllato Randomizzato di un Intervento Motorio per l'Apraxia Verbale Infantile: DTTC-Connect

9 novembre 2026 aggiornato da: New York University

Uno Studio Randomizzato Controllato sull'Intervento Motorio per l'Apraxia Verbale Infantile: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

68

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • New York
      • Hempstead, New York, Stati Uniti, 11549
        • Reclutamento
        • Hofstra University
        • Contatto:
        • Investigatore principale:
          • Julie Case, PhD
      • New York, New York, Stati Uniti, 10012
        • Reclutamento
        • New York
        • Contatto:
          • Kelly Sullivan, M.S.
          • Numero di telefono: 212-998-5228
          • Email: ks5904@nyu.edu
        • Contatto:
        • Investigatore principale:
          • Maria I Grigos, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 12 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 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.
  2. Age between 3;6 and 12;11 years.
  3. Normal structure of the oral-peripheral mechanism as determined by a motor speech examination using established lab protocol.
  4. Participants must pass a hearing screening conducted at 20 dB SPL at 500, 1000, 2000 and 4000 Hz.
  5. 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.
  6. 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.
  7. 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.
  8. Can imitate 2-3 word phrases.
  9. English as the primary language.

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Immediate Treatment

Participants 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.

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.

Sperimentale: Delayed Treatment

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 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phrase Accuracy
Lasso di tempo: 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;

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.

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;

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Speech Intelligibility
Lasso di tempo: 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;

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.

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;
Variability
Lasso di tempo: 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;

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.

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;
Communicative Participation
Lasso di tempo: 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;

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.

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;

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Maria I. Grigos, PhD, New York University
  • Investigatore principale: Julie Case, PhD, Hofstra University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 settembre 2026

Completamento primario (Stimato)

1 settembre 2030

Completamento dello studio (Stimato)

31 marzo 2031

Date di iscrizione allo studio

Primo inviato

2 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 aprile 2026

Primo Inserito (Effettivo)

13 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2R01DC018581 (Sovvenzione/contratto NIH degli Stati Uniti)
  • R01DC018581 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Individual participant data tied to the primary and secondary outcome measures will be shared after de-identification on Open Science Framework (OSF).

Periodo di condivisione IPD

Beginning 6 months following publication. No end date.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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