108 Participants Needed

Speech Therapy with Biofeedback for Speech Sound Disorder

(C-RESULTS Trial)

Recruiting at 1 trial location
TC
TM
Overseen ByTara McAllister, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: New York University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late school-age years, between 2-5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood, reflecting about 6 million cases in the US. Both affected children/families and speech-language pathologists (SLPs) have highlighted the critical need for research to identify more effective forms of treatment for children with RSE. In a series of single-case experimental studies, research has found that treatment incorporating technologically enhanced sensory feedback (visual-acoustic biofeedback, ultrasound biofeedback) can improve speech in individuals with RSE who have not responded to previous intervention. A randomized controlled trial (RCT) comparing traditional vs biofeedback-enhanced intervention is the essential next step to inform evidence-based decision-making for this prevalent population. Larger-scale research is also needed to understand heterogeneity across individuals in the magnitude of response to biofeedback treatment. The overall objective of this proposal is to conduct clinical research that will guide the evidence-based management of RSE while also providing novel insights into the sensorimotor underpinnings of speech. The central hypothesis is that biofeedback will yield greater gains in speech accuracy than traditional treatment, and that individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. This study will enroll n = 118 children who misarticulate the /r/ sound, the most common type of RSE. This first component of the study will evaluate the efficacy of biofeedback relative to traditional treatment in a well-powered randomized controlled trial. Ultrasound and visual-acoustic biofeedback, which have similar evidence bases, will be represented equally.

Eligibility Criteria

This trial is for children aged 9 to almost 16 who speak English as their main language, have a specific speech sound disorder with the /r/ sound, and can pass hearing and oral exams. They shouldn't have severe voice or fluency disorders, significant learning disabilities, major neurological conditions, or score too low on certain intelligence and language tests.

Inclusion Criteria

My mouth and its functions have been checked and are okay.
You need to pass a hearing test at a certain level of sound.
You have difficulty pronouncing the "r" sound in different words.
See 2 more

Exclusion Criteria

You must score at least 80 on the language test called CELF-5.
Must not exhibit voice or fluency disorder of a severity judged likely to interfere with the ability to participate in study activities
I do not have a developmental disability or major brain condition.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional articulation treatment or biofeedback-enhanced treatment for speech sound disorder

10 weeks
3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Biofeedback-ultrasound
  • Biofeedback--visual-acoustic
  • Traditional articulation treatment
Trial Overview The study compares traditional speech therapy with two biofeedback methods: visual-acoustic and ultrasound. It aims to see which is more effective in correcting persistent mispronunciation of the /r/ sound in children. Participants are randomly assigned to one of these treatments.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment2 Interventions
Biofeedback-ultrasound
Group II: Group 2Experimental Treatment2 Interventions
Biofeedback--visual-acoustic
Group III: Group 1Experimental Treatment1 Intervention
Traditional articulation treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials
249
Recruited
229,000+

Syracuse University

Collaborator

Trials
54
Recruited
118,000+

Montclair State University

Collaborator

Trials
14
Recruited
1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+
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