NCT05988515

Brief Summary

The goal of this randomized-controlled trial is to determine how artificial intelligence-assisted home practice may enhance speech learning of the "r" sound in school-age children with residual speech sound disorders. All child participants will receive 1 speech lesson per week, via telepractice, for 5 weeks with a human speech-language clinician. Some participants will receive 3 speech sessions per week with an Artificial Intelligence (AI)-clinician during the same 5 weeks as the human clinician sessions (CONCURRENT treatment order group), whereas others will receive 3 speech sessions per week with an AI-clinician after the human clinician sessions end (SEQUENTIAL treatment order group.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Sep 2024Dec 2027

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

August 4, 2023

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in percent correct for the /ɹ/ sound in untreated words, rated by blinded listeners.

    To assess generalization of treatment gains to untreated words, participants will read a word list eliciting /ɹ/. Stimuli in each list will be presented individually in randomized order. Individual words will be isolated from the audio record of each word probe and presented in randomized order for perceptual rating by trained listeners who are blind to treatment condition and time point (but will see the written representation of each target word). We will use the change in percent correct as our primary measure of perceptually rated accuracy.

    Before the initiation of treatment and again 5 weeks later.

Secondary Outcomes (6)

  • Retention of percent correct for the /ɹ/ sound in untreated words, rated by blinded listeners.

    Before the initiation of treatment and again 10 weeks later.

  • Change in percent correct for the /ɹ/ sound in untreated words, rated by blinded listeners.

    After 5 weeks of treatment and again 10 weeks later.

  • Survey evaluating impacts of speech disorder on participants' social, emotional, and academic well-being.

    Before the initiation of treatment and again 5 weeks later.

  • Change in percent correct for the /ɹ/ sound in practiced words, rated by blinded listeners.

    Before the initiation of treatment and again 5 weeks later.

  • Change in percent correct for the /ɹ/ sound in practiced words, rated by blinded listeners.

    Before the initiation of treatment and again 10 weeks later.

  • +1 more secondary outcomes

Study Arms (2)

CONCURRENT treatment order

EXPERIMENTAL

* 5 speech lessons with a human speech-language clinician: 1 time per week for 5 weeks. * 15 speech lessons with an AI clinician (supervised by the caregiver), 3 times per week DURING the same 5 weeks as the human clinician sessions.

Behavioral: Speech-Language Pathologist-led Speech Motor ChainingBehavioral: Artificial Intelligence-led Speech Motor Chaining (CHAINING-AI)

SEQUENTIAL treatment order

EXPERIMENTAL

* 5 speech lessons with a human speech-language clinician: 1 time per week for 5 weeks. * 15 speech lessons with an AI clinician (supervised by the caregiver), 3 times per week for the 5 weeks AFTER the human clinician sessions end.

Behavioral: Speech-Language Pathologist-led Speech Motor ChainingBehavioral: Artificial Intelligence-led Speech Motor Chaining (CHAINING-AI)

Interventions

Sessions include Structured Practice and Randomized Practice using our web-based software with an Artificial Intelligence clinician to address the /r/ sound. Within a practice session, participants speak into a microphone, and the audio file is sent to a server to be analyzed by a classifier, which returns a binary accurate/inaccurate rating of productions in a fashion similar to SLP judgment. Our web-based software manipulates the principles of motor learning, including feedback prompts, the complexity of the utterance, and the variability in the practice trial. The software will analyze the child's accuracy as determined by the classifier to increase the difficulty of practice when the child is more accurate.

CONCURRENT treatment orderSEQUENTIAL treatment order

Sessions begin with Pre-practice to elicit the /r/ sound. During Structured Practice, the same utterance is practiced several times in a row (with systematic increases in difficulty based on performance). Our web-based software manipulates the principles of motor learning, including feedback prompts for the clinician, the complexity of the utterance, and the variability in the practice trial; the software will analyze the clinician's rating to increase the difficulty of practice when the child is more accurate. Randomized Practice will also be guided by the software and includes all linguistic levels that were produced correctly during Structured Practice, with items presented in random order. A trained speech-language pathologist is involved in all practice trials to provide feedback throughout the session.

CONCURRENT treatment orderSEQUENTIAL treatment order

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must speak a rhotic dialect of American English as a dominant language.
  • Must have begun learning English by at least the age of 3 years.
  • Must be between 9;0 to 17;11 years of age.
  • Must have reported difficulty with /ɹ/ production.
  • Must have reported hearing within normal limits.
  • Must receive a Scaled Score of 5 or above on both the Listening Comprehension and Story Retelling subtests from the Test of Integrated Language \& Literacy Skills (TILLS).
  • Must receive a percentile score of 8 or below on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) Sounds in Words subtest.
  • Must have 1 scorable response with 5+ consecutive correct /pataka/ with \> 3.4 syllables per second in the MRR-Tri task of the Maximum Performance Tasks OR must demonstrate no childhood apraxia of speech (CAS-only) features in BOTH articulatory and rate/prosody domains of the ProCAD.
  • Must score \<40% accurate based on word-level items from our /ɹ/ probe list.
  • Must score \>=15% accuracy on /ɹ/ on 45 syllables following Dynamic Assessment.
  • Must express interest in changing their /ɹ/ production.
  • Must have oral structure and function that are appropriate for /ɹ/ production.
  • Must have access to broadband internet with videoconferencing capabilities

You may not qualify if:

  • Must have no known history of autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, epilepsy/antiepileptic medication, or brain injury/neurosurgery/stroke.
  • Must not have diagnosis of attention deficit disorder, attention deficit hyperactivity disorder, Tourette's, or Obsessive-compulsive disorder.
  • Must have no orthodontic appliances that block the roof of the mouth (e.g., palate expanders).
  • Must not have current cleft palate, fluency disorder, or voice disorder.
  • Must not demonstrate childhood apraxia of speech (CAS-only) features in BOTH articulatory and rate/prosody domains of the ProCAD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Speech Sound Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Jonathan Preston, PhD

CONTACT

Nina Benway, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All perceptual ratings will be obtained from trained listeners who are blinded to treatment group and to timepoint. Binary rating of accuracy of the "r" sound (i.e., judgments of correct or incorrect) will be obtained from three listeners per token.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized across two conditions, CONCURRENT and SEQUENTIAL Participants randomized to receive CONCURRENT treatment will receive speech lessons with a human clinician once per week for five weeks, along with 3 sessions per week of parent-supervised Chaining-AI (15 Chaining-AI sessions). Therefore, clinician-led and Chaining-AI are completed concurrently. Participants randomized to receive SEQUENTIAL treatment will receive speech lessons with a human clinician once per week for five weeks, followed by three sessions per week of parent-supervised Chaining-AI for the NEXT five weeks. Therefore, clinician-led and Chaining-AI are completed sequentially.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

September 5, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations