Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics

Официальное название

Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics

Обзор

The goal of this clinical trial is to determine whether perceptual training enhances speech perception and production outcomes in children with Residual Speech Sound Disorders (RSSD). The main questions it aims to answer are: Does pre-treatment speech production accuracy predict treatment response? Does perceptual acuity influence the effectiveness of perception-first versus production-first interventions? Researchers will compare TAU+Perception-first and TAU-first treatment conditions to see if the order of intervention affects speech improvement outcomes, particularly based on participants' initial perception and production accuracy. Participants will: Complete pre-treatment evaluations to assess /r/ production and speech perception. Be grouped into high or low production and perception accuracy categories based on established thresholds. Be randomly assigned (using a blocked randomization procedure) to one of two treatment arms via telepractice. Participate in the assigned treatment condition designed to target speech sound accuracy. Randomization is stratified to ensure treatment groups are balanced based on pre-treatment severity in both the perception and production domains.

Подробное описание

Children with RSSD may vary in pre-treatment speech production severity, and the extent to which they can approximate /r/ may be an important indicator of subsequent treatment response. In addition, perceptual acuity may influence how participants respond to perception and/or production treatment. Therefore, a blocked randomization procedure will be used to protect against a situation where treatment groups are unbalanced with respect to pre-treatment severity in either the perception or production domain. Based on the treating clinicians' perceptual ratings of participants' performance in /r/ word probes administered in the pre-treatment evaluation phase, participants will be categorized as High Accuracy (\>10% accuracy) or Low Accuracy (\<=10% accuracy), a cutoff determined from pre-treatment baseline data aggregated over 11 studies previously conducted by our team. The investigators will henceforth refer to these groups as "production accuracy groups." In addition, the investigators will use the criteria adopted in the previous funding cycle to classify participants into high or low perception groups (henceforth, "perception accuracy groups"). Participants will be randomized to the TAU(Treatment as Usual) +Perception-first or TAU-first condition via telepractice with stratification on both perception and production accuracy group. Randomization will be supervised by statistician J. Hill at the NYU site. The investigators will use the following approach, adopted successfully for the RCT in the previous funding cycle: (1) Participants will be randomized after providing informed consent, meeting eligibility requirements, and completing the tasks and clinician-rated baselines that determine response group (High, Low). (2) For each perception accuracy group, the statistician will develop 2 batches of 10 concealed envelopes for assignment, one for high production accuracy participants and one for low production accuracy participants. Each will contain 10 participant assignments in random order: 5 TAU+ Perception-first, 5 TAU-first. (3) The investigators cannot fully predict the exact proportion of participants with high versus low production accuracy in each category of perceptual accuracy, so it is possible that the investigators will encounter significantly more in one group than the other. Thus, once the investigators have recruited the first 10 participants for one subgroup (e.g., Low Perceptual Accuracy, Low Production Accuracy), another batch of 10 envelopes will be generated to allocate the next 10 children recruited in that subgroup.

Вмешательства

• Поведенческое Visual acoustic biofeedback: ORDER
  In visual-acoustic biofeedback treatment, elements of traditional articulation treatment are used, including auditory models, verbal descriptions of correct articulator placement, cues for repetitive motor practice via images and diagrams of the vocal tract as visual aids. These strategies are supplemented with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum (Sona-Match module of PENTAX Sona- Speech software). Because correct vs incorre
• Поведенческое Perception Training: ORDER
  Description: Perceptual training involves self-paced presentation of auditory stimuli via a computerized software program (Gorilla). Stimuli are organized into three separate tasks. In tasks 1 and 3, which train category goodness judgment, participants will hear 75 naturally produced speech tokens containing /r/ from various speakers, with a balance of correct and incorrect productions. They will classify each /r/ as correct or incorrect and receive feedback on the accuracy of their classificati

Первичные конечные точки

• Change in perceptually rated accuracy of /r/ [Срок оценки: The timepoints for comparison will be from baseline to after both groups have completed 4 weeks of VAB and when both groups have completed the target 12 weeks of treatment (all types interventions: VAB, Perception training and no treatment).]

Вторичные конечные точки (3)

• Socio-emotional well-being [Срок оценки: Baseline and after all interventions are completed (target time frame: 12 weeks)]
• Percent accuracy pooled across Identification Perception task [Срок оценки: The timepoints for comparison will be from baseline to after both groups have completed 4 weeks of VAB and when both groups have completed the target 12 weeks of treatment (all types interventions: VAB, Perception training and no treatment).]
• Percent accuracy pooled across Category Goodness Perception task [Срок оценки: The timepoints for comparison will be from baseline to after both groups have completed 4 weeks of VAB and when both groups have completed the target 12 weeks of treatment (all types interventions: VAB, Perception training and no treatment).]

Критерии участия

Критерии включения

Must be between 8;0 and 17;11 years of age at the time of enrollment. Must speak English as the dominant language (i.e., must have begun learning English by age 2, per parent report).

Must speak a rhotic dialect of English. Must pass a pure-tone hearing screening at 20dB hearing level. Must pass a brief examination of oral structure and function. Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level.

Must exhibit no more than 3 sounds other than /r/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3).

Критерии исключения

Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5).

Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Montclair State University — Montclair

Идентификаторы

NCT: NCT06969521 · 20-21-2137-Study 4 · 2R15DC019775-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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