Treatment Efficacy for Developmental Motor Speech Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial

Conditions
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Randomized Controlled Trial for Speech Disorders in Children

Intervention / Treatment
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* Behavioral: PROMPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group - PROMPT therapy<br>Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) | Behavioral: PROMPT<br>* The PROMPT approach utilizes a motor-speech hierarchy (MSH) to guide speech language pathologists (SLP) in selecting speech movement goals for treatment. PROMPT treatment generally proceeds systematically in a bottom-up fashion starting with the lowest subsystem in the hierarchy where a child has control issues. Furthermore, in the PROMPT approach specific techniques are used to stimulate sensory input that are assumed to facilitate the formation of sensory-motor pathways required for the acquisition and accurate production of speech movement patterns. As the speech motor behaviors are established, the clinician reduces the number of cues and the frequency and immediacy of feedback and practices transfer and generalization activities.<br>* Other names: PROMPT therapy;|
| No Intervention: Waitlist or Delay Group<br>Participants in this group are on the waitlist for 10 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speech motor control | Formal assessment of the neuromotor integrity of the motor speech system will be carried out using the verbal motor production assessment for children (VMPAC). | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in speech articulation | Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test. | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in word-level speech intelligibility | Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure. | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in Functional Communication: | 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. | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in criterion-referenced measure of speech motor control. | 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. | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in phonological processes | Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test. | At baseline and following 10 weeks of intervention or waitlist delay | 
| Change in sentence-level speech intelligibility | Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test. | At baseline and following 10 weeks of intervention or waitlist delay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional outcomes, Speech sound disorders, Randomized Controlled Trial, Speech intelligibility, PROMPT treatment, Developmental motor speech disorders, Children, Treatment efficacy