Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Change in word-level speech intelligibility
研究概览
简要总结
The purpose of this study is to carry out a high-level treatment efficacy study on children with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled Randomized Controlled Trial design.
The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) approach, which has been effective in treating motor speech disorders in adults and in children with autism and cerebral palsy.
详细描述
The results of this study will allow us to determine if there is a causal relationship between PROMPT treatment and outcome measures and predict how much improvement can be expected from this therapy. This study is being conducted as a part of a multicenter clinical trial in the province of Ontario, Canada with three sites: The John McGivney Children's Centre in Windsor, The ErinoakKids Centre for Treatment and Development in Mississauga, and The Speech and Stuttering Institute in Toronto.
The study integrity will be monitored by an arms-length, external agency, The Applied Health Research Centre (AHRC) at St. Michael's Hospital in Toronto. The study is coordinated by the Department of Speech-Language Pathology at the University of Toronto and funded by the PROMPT Institute in Santa Fe, New Mexico.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child is between 3 and 10 Years.
- •English is the primary language spoken by the primary caregiver at home.
- •Hearing/Vision (corrected is acceptable- e.g., spectacles) is within normal limits.
- •Readiness for direct speech therapy.
- •Age appropriate social interaction and play skills.
- •Age appropriate or mildly delayed receptive language skills.
- •Normal to any amount of delay in expressive language development.
- •Moderate to severe speech sound disorder.
- •Age appropriate or slight delay non-verbal intelligence.
- •4 red flags for motor speech involvement.
排除标准
- •Signs and symptoms suggesting global motor involvement (Cerebral Palsy).
- •Signs and symptoms suggesting Autism Spectrum Disorders.
- •Oral structural deficits.
- •Feeding impairments.
- •Signs of Dysarthric speech or significant drooling.
- •Prosodic and / or resonance disorders.
- •Diagnosis of Childhood Apraxia of Speech features
研究组 & 干预措施
Intervention Group - PROMPT therapy
Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)
干预措施: PROMPT (Behavioral)
Waitlist or Delay Group
Participants in this group are on the waitlist for 10 weeks
结局指标
主要结局
Change in word-level speech intelligibility
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure.
Change in speech articulation
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Change in speech motor control
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Formal assessment of the neuromotor integrity of the motor speech system will be carried out using the verbal motor production assessment for children (VMPAC).
Change in Functional Communication:
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Focus on the Outcomes of Communication Under Six (FOCUS), is a parent questionnaire that captures preschool children's communication abilities as they participate in real-world situations.
Change in phonological processes
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Change in sentence-level speech intelligibility
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test.
Change in criterion-referenced measure of speech motor control.
时间窗: At baseline and following 10 weeks of intervention or waitlist delay
Criterion-referenced assessment of the motor speech system will be carried out using a set of probe words. The audio-video recordings of the probe words will be analyzed by three qualified and blinded speech language pathologists.
次要结局
未报告次要终点