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NCT Number: NCT06578416

The Development of Stuttering in Young Children

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.

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Key information

Conditions

Stuttering Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stuttering, Childhood Stuttering, Developmental

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Developmental Speech Lab

East Lansing, Michigan, 48824, United States

Location status: Recruiting

Location contact

Bridget Walsh, PhD

CONTACT

[email protected]

5178842401

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for controls:

  • 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
  • Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally

Inclusion criteria

for children who stutter:

  • 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

Treatment and study plan

Standardized assessments of speech and language abilities

Diagnostic Test

Standardized and observational assessment of speech and language abilities

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bridget Walsh, Ph.D.

CONTACT

[email protected]

5173553410

Katelyn Gerwin, Ph.D.

CONTACT

[email protected]

5173553410

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Developmental Trajectories to Stuttering Persistence and Recovery

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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