Treatment Efficacy for Developmental Motor Speech Disorders

Randomized Controlled Trial for Speech Disorders in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105402
• Other study ID #: PROMPT-29142
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: September 28, 2017
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: The Prompt Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Dysphonia
• Randomized Controlled Trial for Speech Disorders in Children
• Speech Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	ErinoakKids Centre for Treatment and Development	Mississauga	Ontario
Canada	The Speech and Stuttering Institute	Toronto	Ontario
Canada	The John McGivney Children's Centre of Essex County	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Prompt Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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