対面および遠隔診療トライアルによるサービス提供における視覚音響介入 (VISIT)
対面および遠隔診療によるサービス提供（VISIT）による視覚音響介入非劣性トライアル
Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice.
The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.
調査の概要
詳細な説明
This study aims to test the working hypothesis that biofeedback treatment delivery via telepractice will not be associated with a reduction in efficacy that exceeds a maximum acceptable value determined a priori. In a prospective randomized controlled non-inferiority trial, children will be randomly assigned to receive a standard course of visual-acoustic biofeedback intervention delivered in-person or via telepractice. Progress will be measured with blinded listeners' ratings of untreated words produced before and after treatment. A survey will also be administered before and after treatment to assess changes in participants' participation and socio-emotional well-being, as well as participants' and caregivers' satisfaction with the therapy experience.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
New Jersey
-
Bloomfield、New Jersey、アメリカ、07003
- 募集
- Montclair State University
-
コンタクト：
- Elaine R Hitchcock, PhD
- 電話番号：973-229-3797
- メール：hitchcocke@montclair.edu
-
コンタクト：
- Laura C Ochs, MS
- 電話番号：(619) 784-4979
- メール：ochsl@montclair.edu
-
-
New York
-
New York、New York、アメリカ、10012
- 積極的、募集していない
- New York University
-
Syracuse、New York、アメリカ、13244
- 募集
- Syracuse University
-
コンタクト：
- Jonathan L Preston, PhD
- 電話番号：315-443-3143
- メール：jopresto@syr.edu
-
コンタクト：
- Megan Leece, MS
- 電話番号：315-443-1351
- メール：mcleece@syr.edu
-
-
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:
- Must be between 9;0 and 17;11 (years;months) old at the time of enrollment.
- Must speak English as the dominant or equally dominant language
- Must have begun learning English by age 3, per parent report.
- Must hear a rhotic dialect of English from at least one speaker in the home if the home language is English.
- Must pass a pure-tone hearing screening.
- Must pass a brief examination of oral structure and function.
- Must exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level.
- Must demonstrate age-appropriate receptive and expressive language abilities on the Clinical Evaluation of Language Fundamentals-5 (CELF-5).
- Must have access to a laptop or desktop computer for study sessions in the event of randomization to the telepractice condition.
- Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition.
Exclusion Criteria:
- Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities.
- Must not currently have orthodontia that crosses the palate and cannot be removed.
- Must not have history of permanent hearing loss.
- Must not have an existing diagnosis of developmental disability such as cerebral palsy or Down Syndrome.
- Must not have history of major brain injury, surgery, or stroke in the past year.
- Must not have epilepsy with active seizure incidents with in the past 6 months.
- Must not show clinically significant signs of apraxia of speech or dysarthria.
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 |
|---|---|
|
実験的：Telepractice delivery
Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room. |
Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. The web-based software staRt will be used for intervention delivery.
他の名前：
|
|
アクティブコンパレータ：In-person delivery
Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites. |
Behavioral: Visual-acoustic biofeedback In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. The web-based software staRt will be used for intervention delivery.
他の名前：
|
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 |
|---|---|---|
|
Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
時間枠：Before the initiation of treatment and again after the end of all treatment (10 weeks later)
|
To assess generalization of treatment gains to untreated words, participants will be assessed with standard probes (30 words [considered the primary target], 20 syllables, and 10 sentences containing /r/ in various phonetic contexts). Stimuli in each probe will be presented individually in randomized order with blocking by stimulus type (word, syllable, sentence). Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/incorrect) by 9 untrained listeners who are blind to treatment condition and time point, but will see the written representation of each target word. The proportion of "correct" ratings for each token will be used as the primary measure of perceptually rated accuracy. |
Before the initiation of treatment and again after the end of all treatment (10 weeks later)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
時間枠：Before the initiation of treatment and again after the end of all treatment (10 weeks later)
|
This survey asks participants to report the impact of speech disorder on their child's social, emotional, and academic well-being. Parents are asked to circle a number from 1 to 5. For all questions, a higher score indicates a greater degree of negative impact of speech disorder on social, emotional, or academic well-being. An impact score will be calculated as described in a previous published study (Hitchcock, Harel, & McAllister Byun, 2015). |
Before the initiation of treatment and again after the end of all treatment (10 weeks later)
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Byun TM, Hitchcock ER. Investigating the use of traditional and spectral biofeedback approaches to intervention for /r/ misarticulation. Am J Speech Lang Pathol. 2012 Aug;21(3):207-21. doi: 10.1044/1058-0360(2012/11-0083). Epub 2012 Mar 21.
- Preston JL, McAllister T, Phillips E, Boyce S, Tiede M, Kim JS, Whalen DH. Treatment for Residual Rhotic Errors With High- and Low-Frequency Ultrasound Visual Feedback: A Single-Case Experimental Design. J Speech Lang Hear Res. 2018 Aug 8;61(8):1875-1892. doi: 10.1044/2018_JSLHR-S-17-0441.
- Preston JL, Holliman-Lopez G, Leece MC. Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Am J Speech Lang Pathol. 2018 May 3;27(2):813-818. doi: 10.1044/2017_AJSLP-17-0121.
- Preston JL, McAllister Byun T, Boyce SE, Hamilton S, Tiede M, Phillips E, Rivera-Campos A, Whalen DH. Ultrasound Images of the Tongue: A Tutorial for Assessment and Remediation of Speech Sound Errors. J Vis Exp. 2017 Jan 3;(119):55123. doi: 10.3791/55123.
- Campbell H, Harel D, Hitchcock E, McAllister Byun T. Selecting an acoustic correlate for automated measurement of American English rhotic production in children. Int J Speech Lang Pathol. 2018 Nov;20(6):635-643. doi: 10.1080/17549507.2017.1359334. Epub 2017 Aug 10.
- Campbell H, McAllister Byun T. Deriving individualised /r/ targets from the acoustics of children's non-rhotic vowels. Clin Linguist Phon. 2018;32(1):70-87. doi: 10.1080/02699206.2017.1330898. Epub 2017 Jul 13.
- McAllister Byun T. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study. J Speech Lang Hear Res. 2017 May 24;60(5):1175-1193. doi: 10.1044/2016_JSLHR-S-16-0038.
- McAllister Byun T, Campbell H. Differential Effects of Visual-Acoustic Biofeedback Intervention for Residual Speech Errors. Front Hum Neurosci. 2016 Nov 11;10:567. doi: 10.3389/fnhum.2016.00567. eCollection 2016.
- McAllister Byun T, Halpin PF, Szeredi D. Online crowdsourcing for efficient rating of speech: a validation study. J Commun Disord. 2015 Jan-Feb;53:70-83. doi: 10.1016/j.jcomdis.2014.11.003. Epub 2014 Dec 15.
- Harel D, Hitchcock ER, Szeredi D, Ortiz J, McAllister Byun T. Finding the experts in the crowd: Validity and reliability of crowdsourced measures of children's gradient speech contrasts. Clin Linguist Phon. 2017;31(1):104-117. doi: 10.3109/02699206.2016.1174306. Epub 2016 Jun 7.
- Hitchcock ER, Harel D, Byun TM. Social, Emotional, and Academic Impact of Residual Speech Errors in School-Aged Children: A Survey Study. Semin Speech Lang. 2015 Nov;36(4):283-94. doi: 10.1055/s-0035-1562911. Epub 2015 Oct 12.
- Hitchcock ER, Byun TM. Enhancing generalisation in biofeedback intervention using the challenge point framework: a case study. Clin Linguist Phon. 2015 Jan;29(1):59-75. doi: 10.3109/02699206.2014.956232. Epub 2014 Sep 12.
- Byun TM, Hitchcock ER, Swartz MT. Retroflex versus bunched in treatment for rhotic misarticulation: evidence from ultrasound biofeedback intervention. J Speech Lang Hear Res. 2014 Dec;57(6):2116-30. doi: 10.1044/2014_JSLHR-S-14-0034.
- Ayala SA, Eads A, Kabakoff H, Swartz MT, Shiller DM, Hill J, Hitchcock ER, Preston JL, McAllister T. Auditory and Somatosensory Development for Speech in Later Childhood. J Speech Lang Hear Res. 2023 Apr 12;66(4):1252-1273. doi: 10.1044/2022_JSLHR-22-00496. Epub 2023 Mar 17.
- Benway NR, Preston JL, Hitchcock E, Rose Y, Salekin A, Liang W, McAllister T. Reproducible Speech Research With the Artificial Intelligence-Ready PERCEPT Corpora. J Speech Lang Hear Res. 2023 Jun 20;66(6):1986-2009. doi: 10.1044/2023_JSLHR-22-00343. Epub 2023 Jun 15.
- Hitchcock ER, Ochs LC, Swartz MT, Leece MC, Preston JL, McAllister T. Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Am J Speech Lang Pathol. 2023 Jan 11;32(1):18-36. doi: 10.1044/2022_AJSLP-22-00142. Epub 2023 Jan 9.
- Peterson L, Savarese C, Campbell T, Ma Z, Simpson KO, McAllister T. Telepractice Treatment of Residual Rhotic Errors Using App-Based Biofeedback: A Pilot Study. Lang Speech Hear Serv Sch. 2022 Apr 11;53(2):256-274. doi: 10.1044/2021_LSHSS-21-00084. Epub 2022 Jan 20.
- McAllister T, Preston JL, Hitchcock ER, Benway NR, Hill J. Protocol for visual-acoustic intervention with service delivery in-person and via telepractice (VISIT) non-inferiority trial for residual speech sound disorder. BMC Pediatr. 2025 Jan 27;25(1):65. doi: 10.1186/s12887-024-05364-z.
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
- VISIT non-inferiority
- 2R01DC017476 (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
A manual of procedures and materials for treatment and clinician training will be released through the Open Science Framework (OSF). Complete de-identified data and analysis scripts on OSF will also be released when the study is completed.
OSF as projects are completed
IPD 共有時間枠
Data will be shared within 6 months of the study end date (7/31/28) and will be made available indefinitely.
IPD 共有アクセス基準
Publicly accessible
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。