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Completed

NCT Number: NCT02105402

Treatment Efficacy for Developmental Motor Speech Disorders

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.

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Key information

Conditions

Randomized Controlled Trial for Speech Disorders in Children Behavior Communication Communication Disorders Mental Disorders Neurodevelopmental Disorders Speech Speech Intelligibility Speech Sound Disorder Verbal Behavior

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ErinoakKids Centre for Treatment and Development, Mississauga, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMPT

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

The Prompt Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2014
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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