Intervenção viso-acústica com prestação de serviço presencial e via teste de teleprática (VISIT)
Intervenção viso-acústica com prestação de serviços presencial e via teleprática (VISIT) Teste de não inferioridade
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
New Jersey
-
Bloomfield, New Jersey, Estados Unidos, 07003
- Recrutamento
- Montclair State University
-
Contato:
- Elaine R Hitchcock, PhD
- Número de telefone: 973-229-3797
- E-mail: hitchcocke@montclair.edu
-
Contato:
- Laura C Ochs, MS
- Número de telefone: (619) 784-4979
- E-mail: ochsl@montclair.edu
-
-
New York
-
New York, New York, Estados Unidos, 10012
- Ativo, não recrutando
- New York University
-
Syracuse, New York, Estados Unidos, 13244
- Recrutamento
- Syracuse University
-
Contato:
- Jonathan L Preston, PhD
- Número de telefone: 315-443-3143
- E-mail: jopresto@syr.edu
-
Contato:
- Megan Leece, MS
- Número de telefone: 315-443-1351
- E-mail: mcleece@syr.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
|
|
Comparador Ativo: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of "Correct" Ratings by Blinded Untrained Listeners for /r/ Sounds Produced in Word Probes
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
1. Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.
Prazo: 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)
|
Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VISIT non-inferiority
- 2R01DC017476 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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
Prazo de Compartilhamento de IPD
Data will be shared within 6 months of the study end date (7/31/28) and will be made available indefinitely.
Critérios de acesso de compartilhamento IPD
Publicly accessible
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .