Treatment Efficacy for Developmental Motor Speech Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02105402|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : September 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Randomized Controlled Trial for Speech Disorders in Children||Behavioral: PROMPT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Intervention Group - PROMPT therapy
Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)
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.
Other Name: PROMPT therapy
No Intervention: Waitlist or Delay Group
Participants in this group are on the waitlist for 10 weeks
- Change in speech motor control [ Time Frame: 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 speech articulation [ Time Frame: 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 word-level speech intelligibility [ Time Frame: 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 Functional Communication: [ Time Frame: 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 criterion-referenced measure of speech motor control. [ Time Frame: 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.
- Change in phonological processes [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105402
|ErinoakKids Centre for Treatment and Development|
|Mississauga, Ontario, Canada, L5K 2N6|
|The Speech and Stuttering Institute|
|Toronto, Ontario, Canada, M3B 3J5|
|The John McGivney Children's Centre of Essex County|
|Windsor, Ontario, Canada, N9C 4C2|
|Principal Investigator:||Aravind Namasivayam, Ph.D.||University of Toronto|
|Study Director:||Deborah Hayden, M.A.||The PROMPT Institute, Santa Fe, NM, 87505 USA|
|Study Chair:||Pascal van Lieshout, Ph.D.||University of Toronto|