Evaluating the Effectiveness of Hybrid and Traditional Speech Therapy for /ɹ/ and /s/ Sound Production

NCT07061730 | Recruiting

• 2 other identifiers: GENESIS-25-065Privately Funded
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the effectiveness of a hybrid Artificial Intelligence-assisted speech therapy model, which combines the use of an AI speech therapist (Jessica) with traditional speech therapy sessions led by a Speech-Language Pathologist (SLP). This study aims to determine whether the hybrid model improves articulation in children more effectively than traditional SLP-only therapy. Over the course of 8 weeks, participants will receive weekly therapy sessions, and those in the hybrid therapy group will also practice with Jessica between sessions. The study will also gather feedback from parents and speech therapists to assess their experiences and satisfaction with treatment.

Conditions

Speech Sound Disorder

Keywords

Artificial Intelligence; Articulation; Speech Language Pathology; Treatment

Outcome Measures

Primary Outcomes (1)

• Motor Learning - Percent Improvement on Outcome Words/Phrases

  Change scores from baseline to week 8 (i.e., after same amount of clinician treatment). Change scores are calculated from expert listener-averaged perceptual ratings of /ɹ/ or /s/ in pre-defined word lists. These ratings/words are solicited from the Outcome Word List. The ratings are obtained using Perceptual Rating Scale-5 point. Note: The Outcome Word List is not necessarily an untreated word list. Untreated words are ideal; however, it is not possible to ensure that words are untreated in a treatment-as-usual paradigm. At a minimum, this word list will be a measure of "retention and generalization".

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Time to Mastery of Practiced Words

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Traditional Therapy

ACTIVE COMPARATOR

The child will receive standard speech therapy, meeting with the SLP once a week for therapy sessions for 8 weeks. These sessions will focus on articulation practice, where the child will work on speech sounds with direct feedback from the SLP.

Behavioral: Traditional Therapy

Hybrid Therapy

EXPERIMENTAL

The child will receive standard speech therapy, meeting with the SLP once a week for therapy sessions for 8 weeks. These sessions will focus on articulation practice, where the child will work on speech sounds with direct feedback from the SLP. In addition to these weekly sessions, the child will practice using the AI-based speech therapy tool, Jessica, at home between sessions for 60 minutes per week. The tool will provide real-time feedback on the child's articulation and track their progress. The child will be asked to practice specific speech exercises, such as producing target sounds (e.g., /r/, /s/) in words, phrases, or sentences.

Behavioral: Hybrid therapy

Interventions

Traditional Therapy BEHAVIORAL

The child would receive standard speech therapy, meeting with the SLP once a week for therapy sessions for 8 weeks. These sessions will focus on articulation practice, where your child will work on speech sounds with direct feedback from the SLP.

Traditional Therapy

Hybrid therapy BEHAVIORAL

The child would receive standard speech therapy, meeting with the SLP once a week for therapy sessions for 8 weeks. These sessions will focus on articulation practice, where your child will work on speech sounds with direct feedback from the SLP. In addition to these weekly sessions, the child will practice using the AI-based speech therapy tool, Jessica, at home between sessions for 60 minutes per week. The tool will provide real-time feedback on the child's articulation and track their progress. The child will be asked to practice specific speech exercises, such as producing target sounds (e.g., /r/, /s/) in words, phrases, or sentences.

Hybrid Therapy

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Response to be filled out by the Parent after sign up.
• Does the child speak American English as one of their primary languages: Yes
• At what age did the child first begin to learn English? Age 4 or younger
• Child's current age: \> 5 years or \< 17 years 8 months
• Does the child have any known history of any of the following: autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, epilepsy/antiepileptic medication, or brain injury/neurosurgery/stroke: NO
• Does the child have a diagnosis of ADD/ADHD, Tourette's Syndrome, or OCD? NO
• Does the child currently have orthodontic appliances that block the roof of the mouth (e.g., palate expanders)? NO
• Does the child currently have a cleft palate, fluency disorder (e.g., stuttering), or voice disorder? NO
• Is one of your goals for your child to work on saying the "r" or "s" sounds? YES

You may not qualify if:

• Does the child speak American English as one of their primary languages: No
• At what age did the child first begin to learn English? Age 4 or older
• Child's current age: \<5 years or \> 17 years 8 months
• Does the child have any known history of any of the following: autism spectrum disorder, Down Syndrome, cerebral palsy, intellectual disability, permanent hearing loss, epilepsy/antiepileptic medication, or brain injury/neurosurgery/stroke: YES
• Does the child have a diagnosis of ADD/ADHD, Tourette's Syndrome, or OCD? YES
• Does the child currently have orthodontic appliances that block the roof of the mouth (e.g., palate expanders)? YES
• Does the child currently have a cleft palate, fluency disorder (e.g., stuttering), or voice disorder? YES
• Is one of your goals for your child to work on saying the "r" or "s" sounds? NO

Sponsors & Collaborators

• Syracuse University: lead
• Better Speech: collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

MeSH Terms

Conditions

Speech Sound Disorder

Interventions

Hybrid Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• James Nehlig

  Better Speech

  STUDY DIRECTOR

• Ranan Lachman

  Better Speech

  STUDY DIRECTOR

Central Study Contacts

Jonathan Preston

CONTACT

315-443-3013; jopresto@syr.edu

Nina Benway

CONTACT

nrbenway@syr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: July 11, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)