Hybrid + Traditional Speech Therapy for Speech Sound Disorder

(GENESIS Trial)

Overseen By Nina Benway

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Syracuse University

Must not be taking: Antiepileptics

Disqualifiers: Autism, Down Syndrome, Cerebral palsy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help children improve their speech by combining traditional speech therapy with an AI tool named Jessica, which children can use at home. The main goal is to determine if this combined approach, known as hybrid therapy, is more effective at helping kids articulate sounds, especially "r" and "s," than traditional methods alone. Children who speak American English as a primary language, began learning English by age 4, and need help with "r" or "s" sounds might be suitable candidates. The study will also collect feedback from parents and therapists to understand their experiences with the treatments. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative therapy methods and contribute to advancing speech therapy techniques.

Do I need to stop my child's current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on speech therapy, so it's best to ask the trial coordinators for clarification.

What prior data suggests that this hybrid therapy model is safe for children with speech sound disorder?

Research has shown that hybrid therapy, which combines AI assistance with regular speech therapy, is generally manageable for patients. In past studies, patients using similar AI-assisted speech therapy tools improved their speech without major side effects. One study noted better speech sound production without any negative effects, suggesting that the AI component is safe to use alongside regular speech therapy.

Since the therapy primarily involves practicing speech exercises with feedback, it poses fewer risks compared to medication. The AI tool, Jessica, offers guidance between sessions, enabling children to safely practice speaking at home. Overall, this therapy appears to be a safe way to help children improve their speech. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hybrid therapy for Speech Sound Disorder because it integrates an AI-based tool with traditional speech therapy. Unlike standard treatments that rely solely on in-person sessions with a speech-language pathologist, this approach adds a digital component called Jessica. This tool allows kids to practice at home and receive real-time feedback, potentially accelerating their progress. The innovation lies in blending human expertise with technology, offering a more flexible and engaging way to improve speech clarity.

What evidence suggests that this trial's treatments could be effective for speech sound disorder?

This trial will compare Hybrid Therapy, which combines traditional speech therapy with an AI-based tool, to Traditional Therapy alone. Studies have shown that AI in speech therapy can noticeably improve speech sound disorders (SSD). For example, participants in an AI-based program improved their pronunciation of the /ɹ/ sound in words they hadn't specifically practiced. AI tools provide instant feedback and track progress, helping children practice more effectively between sessions. This trial researches whether this combined approach can enhance speech improvement more than traditional methods alone. ^{1 5 6 7 8}

Who Is on the Research Team?

James Nehlig

Principal Investigator

Better Speech

Ranan Lachman

Principal Investigator

Better Speech

Are You a Good Fit for This Trial?

This trial is for children with speech sound disorders, specifically difficulty in producing the /ɹ/ and /s/ sounds. Details on age range, specific diagnostic criteria, or other inclusion factors are not provided. Children who may have conditions that could interfere with therapy effectiveness or those unable to commit to the full duration of the study might be excluded.

Inclusion Criteria

Response to be filled out by the Parent after sign up

Child does not have a diagnosis of ADD/ADHD, Tourette's Syndrome, or OCD

Child does not currently have orthodontic appliances that block the roof of the mouth

Exclusion Criteria

Child has a diagnosis of ADD/ADHD, Tourette's Syndrome, or OCD

Improving 'r' or 's' sounds is not a goal for my child.

EXCLUSIONARY Response to be filled out by the Parent after sign up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly speech therapy sessions for 8 weeks. The hybrid group also practices with the AI tool, Jessica, for 60 minutes per week.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for mastery of practiced words and improvement in speech sound learning.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hybrid therapy
• Traditional Therapy

Trial Overview The study compares a new hybrid speech therapy model using an AI assistant 'Jessica' alongside traditional sessions with a Speech-Language Pathologist (SLP), against standard SLP-only therapy over 8 weeks. It aims to see if adding AI practice improves children's articulation more than just regular therapy.

How Is the Trial Designed?

Group I: Hybrid Therapy Experimental Treatment 1 Intervention

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.

Group II: Traditional Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Syracuse University

Lead Sponsor

Trials

54

Recruited

118,000+

Better Speech

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07061730

NCT07061730 | Evaluating the Effectiveness of Hybrid and ... This study aims to determine whether the hybrid model improves articulation in children more effectively than traditional SLP-only therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8700312/

The Effectiveness of an Integrated Treatment for Functional ... This randomized controlled trial evaluates the effectiveness of the integrated SSD treatment program PhonoSens, which focuses on integrating phonological and ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-23-00448

Artificial Intelligence–Assisted Speech Therapy for /ɹ This study provides evidence of participant improvement for /ɹ/ in untreated words in response to an AI-assisted treatment package.

4. tandfonline.com tandfonline.com/doi/abs/10.1080/2050571X.2024.2359274

AI-based automated speech therapy tools for persons with ... Researchers are developing AI-based automated speech therapy tools for individuals with speech sound disorder (SSD).

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07061730/evaluating-the-effectiveness-of-hybrid-and-traditional-speech-therapy-for-and-s-sound-production?mp=s&id=767&slug=communication-disorders

Evaluating the Effectiveness of Hybrid and Traditional ... This study aims to determine whether the hybrid model improves articulation in children more effectively than traditional SLP-only therapy. Over ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379609/

Artificial Intelligence–Assisted Speech Therapy for /ɹ This feasibility trial describes changes in rhotic production in residual speech sound disorder following ten 40-min sessions including artificial intelligence ...

7. mdpi.com mdpi.com/2227-9067/8/12/1190

The Effectiveness of an Integrated Treatment for Functional ... Results: The treatment group showed more percent correct consonants (PCC) and a greater reduction in phonological processes after 15 therapy ...

8. researchgate.net researchgate.net/publication/396791315_Effect_of_Hybrid_Telepractice_and_In-Person_Speech_Therapy_on_Speech_Outcomes_in_Persian-Speaking_Children_with_Cleft_Palate_A_Preliminary_Investigation

Effect of Hybrid Telepractice and In-Person Speech ... Results: Seventy-five RS and 83 ICP patients underwent CP repair. Velopharyngeal insufficiency (VPI) occurred in 41% of RS versus 17% of ICP ...