Treatment Efficacy for Developmental Motor Speech Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Prompt Institute
Sponsor:
Information provided by (Responsible Party):
The Prompt Institute
ClinicalTrials.gov Identifier:
NCT02105402
First received: April 1, 2014
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention
Randomized Controlled Trial for Speech Disorders in Children
Behavioral: PROMPT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by The Prompt Institute:

Primary Outcome Measures:
  • Change in speech motor control [ Time Frame: At baseline and following 10 weeks of intervention or waitlist delay ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test.


Estimated Enrollment: 44
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PROMPT therapy
No Intervention: Waitlist or Delay Group
Participants in this group are on the waitlist for 10 weeks

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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02105402

Contacts
Contact: Aravind Namasivayam, Ph.D. 416-946-8552 a.namasivayam@utoronto.ca
Contact: Pascal van Lieshout, Ph.D. 416-978-8334 p.vanlieshout@utoronto.ca

Locations
Canada, Ontario
ErinoakKids Centre for Treatment and Development Recruiting
Mississauga, Ontario, Canada, L5K 2N6
Contact: Jan Pepper, M.H.Sc    905.855.2690 ext 4394    jpepper@erinoakkids.ca   
Principal Investigator: Jan Pepper, M.H.Sc.         
The Speech and Stuttering Institute Recruiting
Toronto, Ontario, Canada, M3B 3J5
Contact: Margit Pukonen, MH.S.c    416-491-7771 ext 238    margitp@speechandstuttering.com   
Contact: Robert Kroll, Ph.D.    416-491-7771    margitp@speechandstuttering.com   
Principal Investigator: Margit Pukonen, M.H.Sc.         
The John McGivney Children's Centre of Essex County Recruiting
Windsor, Ontario, Canada, N9C 4C2
Contact: Laurie Lessard, M.H.Sc.    519-252-7281    laurie.lessard@jmccentre.ca   
Principal Investigator: Mileva Vuletic, M.H.Sc.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: The Prompt Institute
ClinicalTrials.gov Identifier: NCT02105402     History of Changes
Other Study ID Numbers: PROMPT-29142
Study First Received: April 1, 2014
Last Updated: April 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Prompt Institute:
Speech sound disorders
Randomized Controlled Trial
Speech intelligibility
PROMPT treatment
Developmental motor speech disorders
Children
Functional outcomes
Treatment efficacy

Additional relevant MeSH terms:
Disease
Speech Disorders
Pathologic Processes
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014