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Eine randomisierte kontrollierte Studie zu motorisch basierter Intervention bei kindlicher Sprechapraxie: DTTC-Connect

9. November 2026 aktualisiert von: New York University

Eine randomisierte kontrollierte Studie zu motorisch basierten Interventionen bei kindlicher Sprechapraxie: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • New York
      • Hempstead, New York, Vereinigte Staaten, 11549
        • Rekrutierung
        • Hofstra University
        • Kontakt:
        • Hauptermittler:
          • Julie Case, PhD
      • New York, New York, Vereinigte Staaten, 10012
        • Rekrutierung
        • New York
        • Kontakt:
          • Kelly Sullivan, M.S.
          • Telefonnummer: 212-998-5228
          • E-Mail: ks5904@nyu.edu
        • Kontakt:
        • Hauptermittler:
          • Maria I Grigos, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

3 Jahre bis 12 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phrase Accuracy
Zeitfenster: 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;

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Speech Intelligibility
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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;

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. September 2026

Primärer Abschluss (Geschätzt)

1. September 2030

Studienabschluss (Geschätzt)

31. März 2031

Studienanmeldedaten

Zuerst eingereicht

2. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. April 2026

Zuerst gepostet (Tatsächlich)

13. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

Beginning 6 months following publication. No end date.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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