Treatment Efficacy for Developmental Motor Speech Disorders

NCT ID: NCT02105402

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Randomized Controlled Trial for Speech Disorders in Children

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Group - PROMPT therapy

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)

Group Type EXPERIMENTAL

PROMPT

Intervention Type 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.

Waitlist or Delay Group

Participants in this group are on the waitlist for 10 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PROMPT therapy

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Prompt Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aravind Namasivayam, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Deborah Hayden, M.A.

Role: STUDY_DIRECTOR

The PROMPT Institute, Santa Fe, NM, 87505 USA

Pascal van Lieshout, Ph.D.

Role: STUDY_CHAIR

University of Toronto

Locations

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ErinoakKids Centre for Treatment and Development

Mississauga, Ontario, Canada

Site Status

The Speech and Stuttering Institute

Toronto, Ontario, Canada

Site Status

The John McGivney Children's Centre of Essex County

Windsor, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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PROMPT-29142

Identifier Type: -

Identifier Source: org_study_id