Speech Sound DisorderGENESISNCT07061730
Evaluating the Effectiveness of Hybrid and Traditional Speech Therapy for /ɹ/ and /s/ Sound Production
A study testing Traditional Therapy and Hybrid therapy in people with Speech Sound Disorder, run by Syracuse University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Traditional Therapy and Hybrid therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- EXCLUSIONARY Response to be filled out by the Parent after sign up.
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genesis: Clinical Trial of Better Speech's Artificial Intelligence Helper for Speech Therapy
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.
Read the detailed description
The RCT compares two intervention conditions over eight weeks: (1) a hybrid treatment group, where children receive one weekly "treatment as usual" clinician-led tele-practice session PLUS an additional 60 minutes of home practice with Jessica, and (2) a traditional treatment group, where children receive one weekly "treatment as usual" clinician-led tele-practice session.
Children from both groups will be assigned to work on either the /ɹ/ or /s/ sound for the duration of the study, depending on their clinical needs. Children are randomized to conditions and stratified by clinicians. The investigators expect to enroll 100 children, 50 in each condition, aged 5-17 from the following states where study-trained SLPs hold valid clinical licenses: CO, NC, WA, KS, MS, IN, MN, MT, AK, NV, OH, VA, FL, GA, AZ, LA, NY, NJ, MI. Participants must be children aged 5;0 to 17;11 who speak American English as a primary language, have no significant cognitive, neurological, or structural speech impairments, score at or below the 10th percentile on the Goldman-Fristoe Test of Articulation-3 (GFTA 3), have a desire to change their production of /ɹ/ or /s/, and have access to broadband internet for telepractice. Participants with autism, Down syndrome, cerebral palsy, intellectual disabilities, epilepsy, significant hearing loss, ADHD, Tourette's, OCD, or orthodontic appliances that block the roof of the mouth are excluded from this clinical trial phase.
The investigators hypothesize that the hybrid treatment group will show greater improvement in speech sound learning compared to the traditional group, as measured by expert perceptual ratings of unpracticed words. Additionally, it is expected that children in the hybrid group will achieve mastery of targeted speech sounds in fewer sessions, making speech therapy more efficient and cost-effective. If successful, this study could provide strong evidence supporting the integration of AI-driven home practice into standard speech therapy protocols, leading to broader accessibility and improved outcomes for children with SSDs. Furthermore, an analysis of treatment fidelity and participant engagement with Jessica will offer insights into the practical implementation of AI-assisted speech therapy in real-world clinical settings.
- Conditions
- Speech Sound Disorder
- Being tested
- Traditional Therapy, Hybrid therapy
- Keywords
- Artificial Intelligence, Articulation, Speech Language Pathology, Treatment
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional TherapyBehavioural
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.
Hybrid therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hybrid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Time to Mastery of Practiced Words
Group-level percent mastery for in-session clinician ratings of /ɹ/ or /s/ in practiced words from weeks 1-8. The target words are solicited from the in-session practiced words and the percent mastery rating is taken from the SLP session notes. Because SLPs rating of session accuracy could possibly be biased by their knowledge of if the child is working with Jessica or not, it is CRITICAL that SLPs MUST NOT know a participant's group assignment.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 May 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Why it stopped: Funding discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- Better Speech
- Responsible party
- Sponsor
- Investigators
- James Nehlig, Study director, Better SpeechRanan Lachman, Study director, Better Speech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061730
- Sponsor's protocol ID
- GENESIS-25-065
- Other IDs
- Privately Funded
- Acronym
- GENESIS
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The audio recordings will be collected at the end of each study session while your child repeats scripted word lists. Recordings will be used to assess the child's speech clarity and to ensure that researchers are following the treatment procedures correctly and also to train new artificial intelligence systems for children's speech. The recordings will capture specific speech tasks such as reading or imitating words or sentences and are labeled with the child's ID session information and the spoken words. Personal information like your name, your child's name, or date of birth are not stored with the audio files. The recordings will be securely stored on a password protected drive at Syracuse University. Only approved study personnel will have access to these files.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genesis: Clinical Trial of Better Speech's Artificial Intelligence Helper for Speech Therapy
- ClinicalTrials.gov ID
- NCT07061730
- Acronym / sponsor ID
- GENESIS / GENESIS-25-065
- Conditions
- Speech Sound Disorder
- Keywords
- Artificial Intelligence, Articulation, Speech Language Pathology, Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding discontinued
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- Better Speech
- Study start
- 1 May 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The RCT compares two intervention conditions over eight weeks: (1) a hybrid treatment group, where children receive one weekly "treatment as usual" clinician-led tele-practice session PLUS an additional 60 minutes of home practice with Jessica, and (2) a traditional treatment group, where children receive one weekly "treatment as usual" clinician-led tele-practice session.
Children from both groups will be assigned to work on either the /ɹ/ or /s/ sound for the duration of the study, depending on their clinical needs. Children are randomized to conditions and stratified by clinicians. The investigators expect to enroll 100 children, 50 in each condition, aged 5-17 from the following states where study-trained SLPs hold valid clinical licenses: CO, NC, WA, KS, MS, IN, MN, MT, AK, NV, OH, VA, FL, GA, AZ, LA, NY, NJ, MI. Participants must be children aged 5;0 to 17;11 who speak American English as a primary language, have no significant cognitive, neurological, or structural speech impairments, score at or below the 10th percentile on the Goldman-Fristoe Test of Articulation-3 (GFTA 3), have a desire to change their production of /ɹ/ or /s/, and have access to broadband internet for telepractice. Participants with autism, Down syndrome, cerebral palsy, intellectual disabilities, epilepsy, significant hearing loss, ADHD, Tourette's, OCD, or orthodontic appliances that block the roof of the mouth are excluded from this clinical trial phase.
The investigators hypothesize that the hybrid treatment group will show greater improvement in speech sound learning compared to the traditional group, as measured by expert perceptual ratings of unpracticed words. Additionally, it is expected that children in the hybrid group will achieve mastery of targeted speech sounds in fewer sessions, making speech therapy more efficient and cost-effective. If successful, this study could provide strong evidence supporting the integration of AI-driven home practice into standard speech therapy protocols, leading to broader accessibility and improved outcomes for children with SSDs. Furthermore, an analysis of treatment fidelity and participant engagement with Jessica will offer insights into the practical implementation of AI-assisted speech therapy in real-world clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Therapy | Active comparator | Behavioral: Traditional TherapyThe 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. |
| Hybrid Therapy | Experimental | Behavioral: Hybrid therapyThe 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- EXCLUSIONARY Response to be filled out by the Parent after sign up.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional TherapyThe 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. | Behavioural | Traditional Therapy |
| Hybrid therapyThe 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. | Behavioural | Hybrid Therapy |
Primary outcome
Motor Learning - Percent Improvement on Outcome Words/Phrases
Time frame: From enrollment to the end of treatment at 8 weeks
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".
1 secondary outcome
Time to Mastery of Practiced Words
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study was stopped early (reason given: Funding discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. The audio recordings will be collected at the end of each study session while your child repeats scripted word lists. Recordings will be used to assess the child's speech clarity and to ensure that researchers are following the treatment procedures correctly and also to train new artificial intelligence systems for children's speech. The recordings will capture specific speech tasks such as reading or imitating words or sentences and are labeled with the child's ID session information and the spoken words. Personal information like your name, your child's name, or date of birth are not stored with the audio files. The recordings will be securely stored on a password protected drive at Syracuse University. Only approved study personnel will have access to these files.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Nehlig study director
Better Speech
Ranan Lachman study director
Better Speech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Therapy and Hybrid therapy in people with Speech Sound Disorder, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding discontinued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Learning - Percent Improvement on Outcome Words/Phrases (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.