Online Assessment and Enhancement of Auditory Perception for Speech Sound Errors: Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in perceptually rated accuracy of /r/
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All perceptual ratings will be obtained from blinded, skilled clinician listeners recruited and trained in previous studies. Following protocols refined in previous published research, binary rating responses (1=correct; 0=incorrect) will be aggregated over at least 4 unique listeners per token.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
ORDER: Visual acoustic biofeedback training
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. 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.
干预措施: Visual acoustic biofeedback: ORDER (Behavioral)
ORDER: Perceptual training
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. Thus, once we 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.
干预措施: Perception Training: ORDER (Behavioral)
ORDER: No treatment
No treatment, 4-week period of no treatment
结局指标
主要结局
Change in perceptually rated accuracy of /r/
时间窗: 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).
To assess generalization of treatment gains to untreated words, participants will be assessed with standard probes containing 45 syllables, 50 words and 5 sentences with rhotic targets in various phonetic contexts. Stimuli in each probe will be presented individually in randomized order with blocking by stimulus type (word, syllable, sentence). No auditory models will be provided; for children with reading difficulty, semantic cues will be provided to elicit the intended word. Individual words will be isolated from the audio record of each word probe and presented in randomized order for binary rating (correct/ incorrect) by 4 trained listeners who are blind to treatment condition and time point (but will see the written representation of each target word). We will use the proportion of "correct" ratings for each token as our primary measure of perceptually rated accuracy from which we will fit a multilevel model as the primary outcome variable.
次要结局
- Socio-emotional well-being(Baseline and after all interventions are completed (target time frame: 12 weeks))
- Percent accuracy pooled across Identification Perception task(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(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).)