Clinical trial NCT02105402: Treatment Efficacy for Developmental Motor Speech Disorders
Official title: Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: The Prompt Institute
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in speech motor control
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in speech articulation
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in word-level speech intelligibility
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in Functional Communication:
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in criterion-referenced measure of speech motor control.
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in phonological processes
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
measure: Change in sentence-level speech intelligibility
timeFrame: At baseline and following 10 weeks of intervention or waitlist delay
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: ErinoakKids Centre for Treatment and Development
state: Ontario
city: Toronto
country: Canada
facility: The Speech and Stuttering Institute
state: Ontario
city: Windsor
country: Canada
facility: The John McGivney Children's Centre of Essex County
state: Ontario
Study officials:
affiliation: University of Toronto
name: Aravind Namasivayam, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The PROMPT Institute, Santa Fe, NM, 87505 USA
name: Deborah Hayden, M.A.
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Pascal van Lieshout, Ph.D.
role: STUDY_CHAIR
References: