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Groundbreaking PROMPT RCT Study yields statistically and clinically significant positive change!

Monday, July 13, 2020   (0 Comments)
Posted by: Lisa Bakosi
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PROMPT INTERVENTION FOR CHILDREN WITH SEVERE SPEECH MOTOR DELAY: A RANDOMIZED CONTROL TRIAL

 

The Department of Speech-Language Pathology at the University of Toronto successfully completed a Randomized Controlled Trial (RCT) of PROMPT intervention for children with moderate-to-severe speech sound disorders this year yielding ground breaking results regarding the  efficacy of the Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) approach. Please note that you can scroll down for key takeaways and frequently asked questions for Clinicians and for Families.

  

Evidence-Informed Practice (previously known as Evidence-Based Practice) is an important concept in Speech-Language Pathology (S-LP). Speech-Language Pathologists and incoming students are strongly encouraged to critically examine research literature to inform their practice. Amongst the vast literature and study designs available, a Randomized Controlled Trial Design (RCT) is considered the “GOLD STANDARD” to establish cause-and-effect between treatment (independent variable) and observed changes in behavior or therapy effects (dependent variable). However, the current state of research literature in the field of S-LP with this level of evidence is limited, in particular with respect to treatment for pediatric speech disorders.

This year, Dr. Aravind Namasivayam (Principal Investigator) and his co-investigator Dr. Pascal van Lieshout at the Department of Speech-Language Pathology (University of Toronto) successfully completed a large-scale, high-level treatment efficacy study on children with speech sound disorders (Subtype Speech Motor Delay) using a well-controlled RCT design. The study is the first of its kind to examine the treatment efficacy of the PROMPT approach for this population. In the RCT design, 49 children with moderate-to-severe speech difficulties were first assessed at baseline (pre-treatment) and were then randomly allocated either to (1) an immediate intervention group (to receive 10 weeks of PROMPT intervention 45-min sessions 2x per week) or (2) a control group that was waitlisted for the same period and received routine home training instructions. Assessments were carried out following the 10-week intervention or waitlist/home training period. 

 

Data collection for this five-year project spanned across three clinical sites in Ontario, namely the ErinoakKids Centre for Treatment and Development in Mississauga, The Speech and Stuttering Institute in Toronto, and The John McGivney Children's Centre of Essex County in Windsor. The project involved more than 40 research assistants, 14 Speech-Language Pathologists and assessors, and 49 participants! Dr. Namasivayam says the results provide critical new information!

 

 

 

The study clearly demonstrated that PROMPT intervention results in statistically and clinically significant, positive changes in: speech motor control skills, articulation, speech severity and word-level speech intelligibility in children with moderate-to-severe speech difficulties. Dr. Namasivayam shares that, “For the first time, the study provides a clear indication of the magnitude of intervention-related change for this population above and beyond developmental changes (i.e. maturation) and home training activities, clearly supporting the need for direct S-LP intervention for this population”.  

 

Dr. Namasivayam has presented the study results with his co-authors at the annual American Speech-Language-Hearing Association’s convention in Boston in November 2018.  The article is currently published in the prestigious Nature.com journal- Pediatric Research (https://www.nature.com/articles/s41390-020-0924-4

 

 

KEY TAKE AWAYS AND FREQUENTLY ASKED QUESTIONS FOR CLINICIANS

 

 

What are the main points an SLP should take away from the RCT? How should their clinical practice change given the study's results?


The findings from this study provide the following key information for S-LPs to apply to their clinical practice:

  • Direct speech therapy is required for children with moderate-to-severe speech difficulties to show meaningful changes. 
  • The use of only at-home activities and strategies is not as effective as direct speech therapy for this population. Home training activities should be used in conjunction with direct speech therapy to ensure effective carry-over and generalization of therapy targets. 
  • This study gives us a clear indication of the amount of change we can expect in the child’s speech following PROMPT speech therapy. For children with moderate-to-severe speech difficulties receiving 10 weeks of PROMPT intervention (2x week; 20 sessions overall), we can expect clinically significant and meaningful improvements in the following:
    • Speech motor control (i.e., more accuracy in their ability to move, control, and coordinate movements required for speech)
    • Sound production (i.e., produce more sounds correctly after therapy)
    • Intelligibility (i.e., they were better understood by unfamiliar listeners)
  • More than 10-weeks of PROMPT is required to show meaningful changes with longer units of speech (i.e., sentences), and to make positive changes in how they function at home/in the community.

  • Following the above findings, clinical practice should change with respect to how S-LPs identify and treat children with moderate-to-severe speech difficulties.

  • Overall, clinicians can be assured that the services they deliver as a PROMPT certified clinician are backed by the most recent and high-quality research evidence available.


As a Clinician, how should I interpret the RCT Study findings?

 

Researchers must show how their study provided clinical benefits to the study population (not only report statistical significance). Overall, 10-weeks of PROMPT intervention demonstrated statistically and clinically significant as well as meaningful improvements in children with severe speech motor disorders (Subtype Speech Motor Delay). The table below explains how the measurements and statistics in the study can be clinically interpreted. 

 

Table describes clinical interpretation of changes in outcome measures following 10-weeks of PROMPT intervention relative to waitlist/home training control group. (Note: All the changes in the table are statistically significant p ≤ 0.05; PROMPT RCT study; Namasivayam et al., 2020 published in Pediatric Research - https://www.nature.com/articles/s41390-020-0924-4).

Measurements

Effect size

Interpretation of Results

Clinical Significance


Verbal Motor Production Assessment for Children - Focal Oromotor Control


Standardized assessment of speech motor skills, i.e., movement /coordination of lips, tongue, jaw.


6% increase


3-year-old child: 6% increase in speech motor skills = approaching the average skills for normal / typically developing children after PROMPT treatment.


> 3-year-old child: 6% increase in speech motor skills = change from a severe to a mild deficit after PROMPT treatment




Clinically significant and meaningful improvement.


Implies PROMPT intervention facilitates the normalization of speech motor skills (Hayden & Square, 1999)

Probe Word scores


Criterion-referenced; 40 item word list to assess speech motor skills

28-point increase

Indicates 9% improvement in speech motor skills

Clinically significant and meaningful improvement.


Change is similar to VMPAC and those reported in literature (Namasivayam et al., 2013; Square et al., 2014)


Speech Articulation


Standardized assessment: DEAP test

5 standard score increase

Indicates clinical improvement from 0.4 to 2nd percentile rank

Clinically significant improvement: Therapy services are offered to children < 7th percentile (Washington Speech and Hearing Association, 2019)

Percentage of Consonants Correct (PCC)

10% increase

Indicates clinical improvement of one level decrease in speech severity from severe to moderate-severe.

Clinically significant and meaningful improvement (Issac & Michael, 1997; Shriberg et al., 1997)

Word-level Speech Intelligibility


i.e., measures if words are understandable to unfamiliar listeners. Assessed using standardized Children’s Speech Intelligibility measure(CSIM)

8.5% increase

Indicates clinical improvement outside of maturation (i.e., natural development) and measurement error

Clinically significant and meaningful improvement

(Namasivayam et al., 2013; Namasivayam et al., 2015; Wilcox & Morris, 1999)



KEY TAKE AWAYS AND FREQUENTLY ASKED QUESTIONS FOR FAMILIES 

 


WHY IS IT IMPORTANT TO DO THIS STUDY?


Evidence-Informed Practice (previously known as Evidence-Based Practice) is an important concept in Speech-Language Pathology (S-LP). Speech-Language Pathologists and incoming students are strongly encouraged to critically examine research literature to inform their clinical practice. Amongst the vast literature and study designs available, a Randomized Controlled Trial Design (RCT) is considered the “GOLD STANDARD” to establish cause-and-effect between treatment and observed changes in behavior or therapy effects. 

 

 

However, the current state of research literature in the field of S-LP with this level of evidence is limited with respect to the treatment for pediatric motor speech disorders. Children with motor speech disorders struggle to appropriately move their tongue, jaw, and lips to produce correct speech sounds and string words together. These children represent a difficult to treat population and are at-risk for future social, emotional, and academic issues because of their speech problems. Despite the severity of the potential impact motor speech disorders on these children, there is not a lot of information available on if/how speech therapy helps children with such speech disorders. The current study is a major step forward in identifying effective therapy solutions to help children with such severe speech difficulties. 

 


WHY IS THIS STUDY IMPORTANT FOR CLIENTS AND PARENTS? WHAT IMPACT SHOULD IT HAVE ON THE SERVICES THEY RECEIVE FROM AN SLP? 


 

This study answers several key questions that parents/clients often have before deciding to invest time/money into their child’s speech therapy:

 

  • For a child diagnosed with moderate-to-severe speech difficulties, should parents “wait-and-see” if children will improve on their own or can they rely on only home-training to improve speech abilities of their child? The results of this key study clearly indicate that for this population a “wait-and-see” approach or simple home training activities (such as following your child’s lead, using simpler language, shared book reading, etc.) are not sufficient to show progress. 

 

  • Specifically, the study shows that a therapy called as PROMPT that focuses on the control of speech movements when provided by a trained specialist results in positive and meaningful improvements in the child’s speech. This high-level research study shows that direct speech-language therapy provided by a PROMPT trained clinician is needed for this population. 

 

  • The study also gives us a clear indication of the amount of change we can expect in the child’s speech following PROMPT speech therapy. The children with these speech difficulties can be expected to be 10% easier to understand at the end of a 10-week PROMPT treatment program.

 

  • Since these children have moderate to severe speech difficulties, they will need more than one 10-week block of therapy to show changes related to how they function at home and in the community (i.e., they may still be easily frustrated by their speech problems, strangers may still ask them to repeat themselves or their speech may not be understood by teachers at school, etc.).

 

  • As other speech therapies were not tested in this study, we do not know if they would work as effectively for this population. 

 

  • Overall, parents/clients can be assured that the services they receive from a PROMPT certified clinician are backed by the most recent and high-quality research evidence available.

 


WHAT MAKES THIS STUDY DIFFERENT FROM OTHER STUDIES THAT HAVE TAKEN PLACE IN THE FIELD? WHY IS IT "GROUND-BREAKING"?


 

  • Speech-language pathology is a growing field, which is often criticized for having weaker evidence on whether their therapies work. This study is ground-breaking because it provides the highest standard/quality of research evidence (using the Gold Standard Randomized Controlled Trial design) that speech therapy is effective. Importantly, it demonstrates that even children with the most difficult to understand and hard-to-treat speech could make noticeable improvements with PROMPT therapy.

  • This study also represents the largest group of children with moderate-to-severe speech difficulties assessed and treated with a motor speech intervention.  

 

  • For the first time, this study provides a clear indication of the extent of therapy-related change for this population above and beyond developmental changes and caregiver home training activities. This study without doubt supports the need for direct and specialized speech therapy for this population.  


  • This study has pioneered new benchmarks or standards for reporting therapy changes (or therapy outcomes) in clinical trials for children with speech difficulties. This is the first published clinical trial to comprehensively report therapy-related changes using ecologically valid measures (i.e. measures that capture meaningful, “real-life” changes in the child) in line with the World Health Organization’s ICF-CY framework recommendations. It reports changes across multiple levels including body structures (speech movement and articulation abilities), body functions (speech intelligibility), and activities and participation (functional communication). This is a paradigm shift in reporting therapy outcomes in clinical trials for children with speech sound disorders.


  • This study meets and/or exceeds industry benchmarking standards for reporting quality of randomized clinical trials. Specifically, the study had several procedures in place to control for the risk of bias including double-blind testing, concealed group allocations, and monitored study integrity by hiring an arm’s-length external agency (Applied Health Research Center at St. Michael’s Hospital in Toronto, Canada). The external agency ensured participants met study inclusion/exclusion criteria; conducted on-site data monitoring visits; centrally administered participant randomization; verified source data and data entry; as well as conducted a priori and interim power analysis and all other statistical analysis on outcome measures. The researchers involved in the study did not perform any of the data/statistical analysis. Finally, the results are not only discussed in terms of statistical significance but reported in clinically meaningful terms to explain the precision and magnitude of effects.



  1. Note. The study was funded via a competitive clinical trials research grant from The PROMPT Institute in Santa Fe (New Mexico, USA) awarded to Dr. Namasivayam in 2013. To avoid any potential for bias and conflict of interest, the study integrity was monitored by an arms-length, external agency, The Applied Health Research Centre (AHRC) at St. Michael's Hospital in Toronto and was pre-registered prior to start of study in U.S. National Institutes of Health Clinical Trials Registry (https://clinicaltrials.gov/; Identifier: NCT02105402).A version of this text appeared in the Dept of S-LP (U of Toronto) Website in 2018. 

  2. Citation: Namasivayam, A. K., Huynh, A., Granata, F., Law, V., & Van Lieshout, P.H.H.M. (2020). PROMPT intervention for children with severe speech motor delay: a randomized control trial. Pediatric Research, 1-10. Doi: https://doi.org/10.1038/s41390-020-0924-4


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