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Treatment Efficacy for Developmental Motor Speech Disorders

Primary Purpose

Randomized Controlled Trial for Speech Disorders in Children

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

PROMPT

About this trial

This is an interventional treatment trial for Randomized Controlled Trial for Speech Disorders in Children focused on measuring Speech sound disorders, Randomized Controlled Trial, Speech intelligibility, PROMPT treatment, Developmental motor speech disorders, Children, Functional outcomes, Treatment efficacy

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ErinoakKids Centre for Treatment and Development
The Speech and Stuttering Institute
The John McGivney Children's Centre of Essex County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group - PROMPT therapy

Waitlist or Delay Group

Arm Description

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)

Participants in this group are on the waitlist for 10 weeks

Outcomes

Primary Outcome Measures

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).

Change in speech articulation

Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.

Change in word-level speech intelligibility

Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure.

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.

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.

Change in phonological processes

Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.

Change in sentence-level speech intelligibility

Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test.

Secondary Outcome Measures

Full Information

NCT ID

NCT02105402

First Posted

April 1, 2014

Last Updated

September 28, 2017

Sponsor

The Prompt Institute

1. Study Identification

Unique Protocol Identification Number

NCT02105402

Brief Title

Treatment Efficacy for Developmental Motor Speech Disorders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Prompt Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group - PROMPT therapy

Arm Type

Experimental

Arm Description

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)

Arm Title

Waitlist or Delay Group

Arm Type

No Intervention

Arm Description

Participants in this group are on the waitlist for 10 weeks

Intervention Type

Behavioral

Intervention Name(s)

PROMPT

Other Intervention Name(s)

PROMPT therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in speech motor control

Description

Formal assessment of the neuromotor integrity of the motor speech system will be carried out using the verbal motor production assessment for children (VMPAC).

Time Frame