Treatment Efficacy for Developmental Motor Speech Disorders

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

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.

Study Overview

• Status: Completed
• Conditions: Randomized Controlled Trial for Speech Disorders in Children
• Intervention / Treatment: Behavioral: PROMPT

Detailed Description

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
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5K 2N6
      • ErinoakKids Centre for Treatment and Development
    • Toronto, Ontario, Canada, M3B 3J5
      • The Speech and Stuttering Institute
    • Windsor, Ontario, Canada, N9C 4C2
      • The John McGivney Children's Centre of Essex County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - PROMPT therapy; Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)	Behavioral: 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 Names: PROMPT therapy
No Intervention: Waitlist or Delay Group; Participants in this group are on the waitlist for 10 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Prompt Institute
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 7, 2014

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Children; Randomized Controlled Trial; Treatment efficacy; Functional outcomes; Speech sound disorders; Speech intelligibility; PROMPT treatment; Developmental motor speech disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Disease; Speech Disorders
• Other Study ID Numbers: PROMPT-29142