Treatment Efficacy for Developmental Motor Speech Disorders

NCT02105402 | Completed DMC

• 1 other identifier: PROMPT-29142
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Randomized Controlled Trial for Speech Disorders in Children

Keywords

Speech sound disorders; Randomized Controlled Trial; Speech intelligibility; PROMPT treatment; Developmental motor speech disorders; Children; Functional outcomes; Treatment efficacy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Intervention Group - PROMPT therapy

EXPERIMENTAL

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)

Behavioral: PROMPT

Waitlist or Delay Group

NO INTERVENTION

Participants in this group are on the waitlist for 10 weeks

Interventions

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.

Also known as: PROMPT therapy

Intervention Group - PROMPT therapy

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• red flags for motor speech involvement.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Prompt Institute: lead

Study Sites (3)

ErinoakKids Centre for Treatment and Development

Mississauga, Ontario, L5K 2N6, Canada

Location

The Speech and Stuttering Institute

Toronto, Ontario, M3B 3J5, Canada

Location

The John McGivney Children's Centre of Essex County

Windsor, Ontario, N9C 4C2, Canada

Location

MeSH Terms

Conditions

Speech Sound Disorder; Speech Intelligibility

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Speech; Verbal Behavior; Communication; Behavior

Study Officials

• Aravind Namasivayam, Ph.D.

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Deborah Hayden, M.A.

  The PROMPT Institute, Santa Fe, NM, 87505 USA

  STUDY DIRECTOR

• Pascal van Lieshout, Ph.D.

  University of Toronto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 7, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

CA (3)