小児発話失行症に対する運動ベース介入の無作為化比較試験:DTTC-Connect
小児発話失行症に対する運動ベース介入のランダム化比較試験:動的時間的・触覚的キューイング-コネクト(DTTC-コネクト)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Maria I Grigos, PhD
- 電話番号:212.998.5230
- メール:maria.grigos@nyu.edu
研究連絡先のバックアップ
- 名前:Julie Case, PhD
- メール:julie.case@hofstra.edu
研究場所
-
-
New York
-
Hempstead、New York、アメリカ、11549
- 募集
- Hofstra University
-
コンタクト:
- Kelly Sullivan, M.S.
- 電話番号:516-463-5508
- メール:Kelly.A.Sullivan@hofstra.edu
-
主任研究者:
- Julie Case, PhD
-
New York、New York、アメリカ、10012
- 募集
- New York
-
コンタクト:
- Kelly Sullivan, M.S.
- 電話番号:212-998-5228
- メール:ks5904@nyu.edu
-
コンタクト:
-
主任研究者:
- Maria I Grigos, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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. |
|
実験的: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phrase Accuracy
時間枠: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;
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speech Intelligibility
時間枠: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
時間枠: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
時間枠: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;
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Maria I. Grigos, PhD、New York University
- 主任研究者:Julie Case, PhD、Hofstra University
出版物と役立つリンク
一般刊行物
- 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.
- Smith A, Goffman L, Zelaznik HN, Ying G, McGillem C. Spatiotemporal stability and patterning of speech movement sequences. Exp Brain Res. 1995;104(3):493-501. doi: 10.1007/BF00231983.
- 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.
- McLeod S, Harrison LJ, McCormack J. The intelligibility in Context Scale: validity and reliability of a subjective rating measure. J Speech Lang Hear Res. 2012 Apr;55(2):648-56. doi: 10.1044/1092-4388(2011/10-0130). Epub 2012 Jan 3.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lewis BA, Freebairn LA, Hansen AJ, Iyengar SK, Taylor HG. School-age follow-up of children with childhood apraxia of speech. Lang Speech Hear Serv Sch. 2004 Apr;35(2):122-40. doi: 10.1044/0161-1461(2004/014).
- Grigos MI, Moss A, Lu Y. Oral Articulatory Control in Childhood Apraxia of Speech. J Speech Lang Hear Res. 2015 Aug;58(4):1103-18. doi: 10.1044/2015_JSLHR-S-13-0221.
- Grigos MI, Case J, Lu Y, Lyu Z. Dynamic Temporal and Tactile Cueing: Quantifying Speech Motor Changes and Individual Factors That Contribute to Treatment Gains in Childhood Apraxia of Speech. J Speech Lang Hear Res. 2024 Sep 26;67(9S):3359-3376. doi: 10.1044/2023_JSLHR-22-00658. Epub 2023 Jun 28.
- Grigos MI, Case J, Lu Y, Lyu Z. Dynamic Temporal and Tactile Cueing in Young Children With Childhood Apraxia of Speech: A Multiple Single-Case Design. J Speech Lang Hear Res. 2024 Apr 8;67(4):1042-1071. doi: 10.1044/2024_JSLHR-23-00415. Epub 2024 Mar 21.
- Brutten, E. J., & Vanryckeghem, M. (2007). BAB: Behavior Assessment Battery for school-age children who stutter. Plural Publishing.
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研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2R01DC018581 (米国 NIH グラント/契約)
- R01DC018581 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data tied to the primary and secondary outcome measures will be shared after de-identification on Open Science Framework (OSF).
IPD 共有時間枠
Beginning 6 months following publication. No end date.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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