Randomized Controlled Trial for Speech Disorders in ChildrenNCT02105402
Treatment Efficacy for Developmental Motor Speech Disorders
A study testing PROMPT in people with Randomized Controlled Trial for Speech Disorders in Children, run by The Prompt Institute at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized Controlled Trial for Speech Disorders in Children
- What is being tested?
- PROMPT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Canada3 sites
ErinoakKids Centre for Treatment and Development
Mississauga, Ontario, L5K 2N6
The Speech and Stuttering Institute
Toronto, Ontario, M3B 3J5
The John McGivney Children's Centre of Essex County
Windsor, Ontario, N9C 4C2
About this study
Official title: Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial
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.
Read the 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.
- Being tested
- PROMPT
- Keywords
- Speech sound disorders, Randomized Controlled Trial, Speech intelligibility, PROMPT treatment, Developmental motor speech disorders, Children, Functional outcomes, Treatment efficacy
- Medical subject headings
- Speech Sound Disorder, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMPTBehavioural
Also called PROMPT therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - PROMPT therapy | Experimental | Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) Receives: Behavioral: PROMPT |
| Waitlist or Delay Group | No intervention | Participants in this group are on the waitlist for 10 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and following 10 weeks of intervention or waitlist delay
Change in speech articulation
Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
Change in word-level speech intelligibility
Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
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.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
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.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
Change in phonological processes
Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
Change in sentence-level speech intelligibility
Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test.
Measured: At baseline and following 10 weeks of intervention or waitlist delay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled Trial for Speech Disorders in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Prompt Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aravind Namasivayam, Ph.D., Principal investigator, University of TorontoDeborah Hayden, M.A., Study director, The PROMPT Institute, Santa Fe, NM, 87505 USAPascal van Lieshout, Ph.D., Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105402
- Sponsor's protocol ID
- PROMPT-29142
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2014
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02105402
- Acronym / sponsor ID
- PROMPT-29142
- Keywords
- Speech sound disorders, Randomized Controlled Trial, Speech intelligibility, PROMPT treatment, Developmental motor speech disorders, Children, Functional outcomes, Treatment efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Prompt InstituteUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - PROMPT therapy | Experimental | Behavioral: PROMPTPrompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) |
| Waitlist or Delay Group | No intervention | –Participants in this group are on the waitlist for 10 weeks |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMPTAlso: PROMPT therapyThe 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. | Behavioural | Intervention Group - PROMPT therapy |
Primary outcome
Change in speech motor control
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
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
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Change in word-level speech intelligibility
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure.
Change in Functional Communication:
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
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.
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
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
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.
Change in sentence-level speech intelligibility
Time frame: At baseline and following 10 weeks of intervention or waitlist delay
Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aravind Namasivayam, Ph.D. principal investigator
University of Toronto
Deborah Hayden, M.A. study director
The PROMPT Institute, Santa Fe, NM, 87505 USA
Pascal van Lieshout, Ph.D. study chair
University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMPT in people with Randomized Controlled Trial for Speech Disorders in Children, run by The Prompt Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speech motor control (time frame: At baseline and following 10 weeks of intervention or waitlist delay). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.