Treatment Efficacy for Developmental Motor Speech Disorders

The Prompt Institute

Status: Completed

Conditions: Randomized Controlled Trial for Speech Disorders in Children

Treatments: Behavioral: PROMPT

Study type: Interventional

Funder types: Other

Identifiers

NCT02105402

PROMPT-29142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Intervention Group - PROMPT therapy

Experimental group

Description:

Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)

Treatment:

Behavioral: PROMPT

Waitlist or Delay Group

No Intervention group

Description:

Participants in this group are on the waitlist for 10 weeks