Enhanced Treatment for Speech Sound Disorder

(ORDER Trial)

Overseen By Elaine R. Hitchcock, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montclair State University

Disqualifiers: Developmental disability, Neurobehavioral syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine whether perceptual training enhances speech perception and production outcomes in children with Residual Speech Sound Disorders (RSSD). The main questions it aims to answer are: Does pre-treatment speech production accuracy predict treatment response? Does perceptual acuity influence the effectiveness of perception-first versus production-first interventions? Researchers will compare TAU+Perception-first and TAU-first treatment conditions to see if the order of intervention affects speech improvement outcomes, particularly based on participants' initial perception and production accuracy. Participants will: Complete pre-treatment evaluations to assess /r/ production and speech perception. Be grouped into high or low production and perception accuracy categories based on established thresholds. Be randomly assigned (using a blocked randomization procedure) to one of two treatment arms via telepractice. Participate in the assigned treatment condition designed to target speech sound accuracy. Randomization is stratified to ensure treatment groups are balanced based on pre-treatment severity in both the perception and production domains.

Research Team

Elaine Hitchcock, PhD

Principal Investigator

Montclair State University

Eligibility Criteria

This trial is for children with Residual Speech Sound Disorders (RSSD) who have difficulty pronouncing sounds correctly. They must complete evaluations to determine their speech production and perception accuracy, which will decide their group assignment in the study.

Inclusion Criteria

Must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level

I am between 8 and 17 years old.

Must pass a pure-tone hearing screening at 20dB hearing level

Exclusion Criteria

Must not receive a T score more than 1.3 SD below the mean on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2) Matrix Reasoning

Must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, Down Syndrome, or Autism Spectrum Disorder

Must not receive a scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Evaluation

Participants complete pre-treatment evaluations to assess /r/ production and speech perception

1-2 weeks

Treatment

Participants are randomized to TAU+Perception-first or TAU-first treatment conditions via telepractice

12 weeks

No Treatment

A 4-week period of no treatment for control comparison

4 weeks

Follow-up

Participants are monitored for changes in socio-emotional well-being and speech accuracy

4 weeks

Treatment Details

Interventions

• Perception Training
• Visual acoustic biofeedback

Trial Overview The study tests if changing the order of teaching sound perception before production (or vice versa) affects how well children with RSSD improve their speech. It compares two methods: Perception-first and Production-first, delivered online.

Participant Groups

Group I: ORDER: Perceptual training Experimental Treatment 1 Intervention

The investigators will use the following approach, adopted successfully for the RCT in the previous funding cycle: (1) Participants will be randomized after providing informed consent, meeting eligibility requirements, and completing the tasks and clinician-rated baselines that determine response group (High, Low). (2) For each perception accuracy group, the statistician will develop 2 batches of 10 concealed envelopes for assignment, one for high production accuracy participants and one for low production accuracy participants. Each will contain 10 participant assignments in random order: 5 TAU+ Perception-first, 5 TAU-first. Thus, once we have recruited the first 10 participants for one subgroup (e.g., Low Perceptual Accuracy, Low Production Accuracy), another batch of 10 envelopes will be generated to allocate the next 10 children recruited in that subgroup.

Group II: ORDER: Visual acoustic biofeedback training Active Control 1 Intervention

The investigators will use the following approach, adopted successfully for the RCT in the previous funding cycle: (1) Participants will be randomized after providing informed consent, meeting eligibility requirements, and completing the tasks and clinician-rated baselines that determine response group (High, Low). (2) For each perception accuracy group, the statistician will develop 2 batches of 10 concealed envelopes for assignment, one for high production accuracy participants and one for low production accuracy participants. Each will contain 10 participant assignments in random order: 5 TAU+ Perception-first, 5 TAU-first. Thus, once the investigators have recruited the first 10 participants for one subgroup (e.g., Low Perceptual Accuracy, Low Production Accuracy), another batch of 10 envelopes will be generated to allocate the next 10 children recruited in that subgroup.

Group III: ORDER: No treatment Active Control 1 Intervention

No treatment, 4-week period of no treatment

Who Is Running the Clinical Trial?

Montclair State University

Lead Sponsor

Trials

14

Recruited

1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+