StutteringNCT06578416
The Development of Stuttering in Young Children
An observational study of Stuttering and Stuttering, Childhood, run by Michigan State University at 1 site in United States.
Trial summary
The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering, Stuttering, Childhood, Stuttering, Developmental
- What is being tested?
- Standardized assessments of speech and language abilities
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preschool children who do and do not stutter
Who may be able to join
- English as first/primary language
- No history of neurological disease
- Normal or corrected visual acuity
- No medications expected to affect performance
- No intellectual impairment, autism spectrum disorder, ADHD
- Age-appropriate scores on speech and language assessment battery
Show all 13Show fewer
- Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally
- English as first/primary language
- No history of neurological disease
- Normal or corrected visual acuity
- No medications expected to affect performance
- No intellectual impairment or ASD Scores on speech and language assessments indicating stuttering, phonological (speech sound), or language disorders
- Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Developmental Speech Lab
East Lansing, Michigan, 48824
Bridget Walsh, PhD, 5178842401, msustutteringlab@gmail.com
About this study
Official title: Developmental Trajectories to Stuttering Persistence and Recovery
The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.
Read the detailed description
The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years.
Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, online survey in between visits to the lab (1x each year for up to 5 years). Children will take part in standardized and observational assessments (1x each year for up to 5 years). These may cover aspects of social/emotional development, cognition, and speech, language, and hearing abilities. These tests are used to assess whether a child falls within or outside of the normative range for his/her age.
Children will participate in one or more of the following tasks (1x each year for up to 5 years)
- Listen to sounds or words and view or name pictures presented on a monitor. Brain activity electroencephalography (EEG) will be recorded while children listen to speech sounds and name pictures. This will be done with an elastic cap that holds special sensors (electrodes). Sensors will also be placed behind each ear, beside each eye, and under the left eye.
- Virtual reality (VR). Children wear a VR headset and experience virtual, age-appropriate talking situations (e.g., answering questions in a classroom). While they talk in these scenarios, the headset measures where they are looking (eye tracking), and sensors on their forehead, hand, and finger measure their heart rate and sweat response.
- Children will watch cartoons of animals jumping to a consistent beat (rhythm) and produce a word in time with the animal jumping/beat.
- Children will repeat nonwords, name pictures, or count while wearing a cap with sensors. Half of the sensors emit light through while the other half measures the reflected light. These sensors give us information about brain activity and are not harmful.
- Conditions
- Stuttering, Stuttering, Childhood, Stuttering, Developmental
- Being tested
- Standardized assessments of speech and language abilities
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized assessments of speech and language abilitiesDiagnostic test
Standardized and observational assessment of speech and language abilities
| Study group | Role | What they receive |
|---|---|---|
| Children who stutter | Preschool children who stutter aged 3 to 6-years Receives: Diagnostic Test: Standardized assessments of speech and language abilities | |
| Children who do not stutter | Preschool children who do not stutter aged 4 to 6-years Receives: Diagnostic Test: Standardized assessments of speech and language abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering Severity
Assess speech for the presence of stuttering disfluencies and calculate the severity of stuttering based on parent ratings and calculated as the percentage of disfluent syllables out of the total syllables of speech produced.
Measured: 1 x each year for up to 5 years
Virtual reality speaking scenarios
Record looking events in msec during virtual reality scenarios (classroom of children and kitten)
Measured: 1 x each year for up to 5 years
Virtual reality speaking scenarios
Pulse oximetry measures will be taken with a photoplethysmograph transducer (Biopac TSD200) secured around the distal phalanx of the fourth finger of the child's non-dominant hand with a Velcro strap. Two measures will be analyzed. (1) Blood pulse volume (BPV) amplitude, the average trough-to-peak amplitude (in volts) of pulse cycles across segments where the child is producing speech and (2) Pulse rate (PR in pulses per minute ppm), will be recorded for each speech segment then averaged. These pulse oximetry measures will be taken during the viewing of virtual reality scenarios (classroom of children and kitten)
Measured: 1 x each year for up to 5 years
Virtual reality speaking scenarios
Electrodermal (skin conductance) recordings will be collected from the hands while children are immersed in virtual reality speaking scenarios (classroom of children and kitten). We report skin conductance levels and skin conductance response frequency and amplitude in microSiemens (mS).
Measured: 1 x each year for up to 5 years
EEG recording of event-related brain potentials
Electroencephalographic (EEG) recordings of event-related brain potentials will be conducted during a picture identification task. ERPs will be averaged across conditions and reported in microvolts.
Measured: 1 x each year for up to 5 years
Speech production synchronization
We record productions of a word spoken to the beat under different feedback conditions. We will assess timing measures reflecting the accuracy with which children synchronize their speech to the beat and retain the rhythm.
Measured: 1 x each year for up to 5 years
fNIRS recording of cortical hemodynamic responses
Cerebral hemodynamic responses are recorded during the experiment with a continuous-wave fNIRS system (NIRx, Inc). The system uses LED light source optodes, and avalanche photodiode optode detectors for measuring intensity changes in the diffused light at a 10-Hz sampling rate. The optodes are embedded in a standard EEG cap. The concentrations of oxygenated hemoglobin and deoxygenated hemoglobin in micromols will be calculated across trial intervals as participants describe child-friendly picture scenes. These responses will then be averaged across trials for each child.
Measured: 1 x each year for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jun 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Bridget Walsh, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578416
- Sponsor's protocol ID
- 00001704
- Other IDs
- R01DC018000
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Trajectories to Stuttering Persistence and Recovery
- ClinicalTrials.gov ID
- NCT06578416
- Acronym / sponsor ID
- 00001704
- Conditions
- Stuttering, Stuttering, Childhood, Stuttering, Developmental
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Aug 2024 (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 goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.
Detailed description
The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years.
Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, online survey in between visits to the lab (1x each year for up to 5 years). Children will take part in standardized and observational assessments (1x each year for up to 5 years). These may cover aspects of social/emotional development, cognition, and speech, language, and hearing abilities. These tests are used to assess whether a child falls within or outside of the normative range for his/her age.
Children will participate in one or more of the following tasks (1x each year for up to 5 years)
- Listen to sounds or words and view or name pictures presented on a monitor. Brain activity electroencephalography (EEG) will be recorded while children listen to speech sounds and name pictures. This will be done with an elastic cap that holds special sensors (electrodes). Sensors will also be placed behind each ear, beside each eye, and under the left eye.
- Virtual reality (VR). Children wear a VR headset and experience virtual, age-appropriate talking situations (e.g., answering questions in a classroom). While they talk in these scenarios, the headset measures where they are looking (eye tracking), and sensors on their forehead, hand, and finger measure their heart rate and sweat response.
- Children will watch cartoons of animals jumping to a consistent beat (rhythm) and produce a word in time with the animal jumping/beat.
- Children will repeat nonwords, name pictures, or count while wearing a cap with sensors. Half of the sensors emit light through while the other half measures the reflected light. These sensors give us information about brain activity and are not harmful.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children who stutter | – | Diagnostic Test: Standardized assessments of speech and language abilitiesPreschool children who stutter aged 3 to 6-years |
| Children who do not stutter | – | Diagnostic Test: Standardized assessments of speech and language abilitiesPreschool children who do not stutter aged 4 to 6-years |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preschool children who do and do not stutter
Key inclusion criteria (13 listed)
- English as first/primary language
- No history of neurological disease
- Normal or corrected visual acuity
- No medications expected to affect performance
- No intellectual impairment, autism spectrum disorder, ADHD
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standardized assessments of speech and language abilitiesStandardized and observational assessment of speech and language abilities | Diagnostic test | Children who do not stutter, Children who stutter |
Primary outcome
Stuttering Severity
Time frame: 1 x each year for up to 5 years
Assess speech for the presence of stuttering disfluencies and calculate the severity of stuttering based on parent ratings and calculated as the percentage of disfluent syllables out of the total syllables of speech produced.
Virtual reality speaking scenarios
Time frame: 1 x each year for up to 5 years
Record looking events in msec during virtual reality scenarios (classroom of children and kitten)
Virtual reality speaking scenarios
Time frame: 1 x each year for up to 5 years
Pulse oximetry measures will be taken with a photoplethysmograph transducer (Biopac TSD200) secured around the distal phalanx of the fourth finger of the child's non-dominant hand with a Velcro strap. Two measures will be analyzed. (1) Blood pulse volume (BPV) amplitude, the average trough-to-peak amplitude (in volts) of pulse cycles across segments where the child is producing speech and (2) Pulse rate (PR in pulses per minute ppm), will be recorded for each speech segment then averaged. These pulse oximetry measures will be taken during the viewing of virtual reality scenarios (classroom of children and kitten)
Virtual reality speaking scenarios
Time frame: 1 x each year for up to 5 years
Electrodermal (skin conductance) recordings will be collected from the hands while children are immersed in virtual reality speaking scenarios (classroom of children and kitten). We report skin conductance levels and skin conductance response frequency and amplitude in microSiemens (mS).
EEG recording of event-related brain potentials
Time frame: 1 x each year for up to 5 years
Electroencephalographic (EEG) recordings of event-related brain potentials will be conducted during a picture identification task. ERPs will be averaged across conditions and reported in microvolts.
Speech production synchronization
Time frame: 1 x each year for up to 5 years
We record productions of a word spoken to the beat under different feedback conditions. We will assess timing measures reflecting the accuracy with which children synchronize their speech to the beat and retain the rhythm.
fNIRS recording of cortical hemodynamic responses
Time frame: 1 x each year for up to 5 years
Cerebral hemodynamic responses are recorded during the experiment with a continuous-wave fNIRS system (NIRx, Inc). The system uses LED light source optodes, and avalanche photodiode optode detectors for measuring intensity changes in the diffused light at a 10-Hz sampling rate. The optodes are embedded in a standard EEG cap. The concentrations of oxygenated hemoglobin and deoxygenated hemoglobin in micromols will be calculated across trial intervals as participants describe child-friendly picture scenes. These responses will then be averaged across trials for each child.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stuttering and Stuttering, Childhood, run by Michigan State 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 13 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 16 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katelyn Gerwin, Ph.D. (5173553410, msustutteringlab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stuttering Severity (time frame: 1 x each year for up to 5 years). The study lists 7 primary outcomes in all. 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 16 Apr 2026.