Clinical trial NCT06578416: The Development of Stuttering in Young Children
Official title: Developmental Trajectories to Stuttering Persistence and Recovery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stuttering
Stuttering, Childhood
Stuttering, Developmental
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschool children who do and do not stutter

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stuttering Severity
timeFrame: 1 x each year for up to 5 years
measure: Virtual reality speaking scenarios
timeFrame: 1 x each year for up to 5 years
measure: Virtual reality speaking scenarios
timeFrame: 1 x each year for up to 5 years
measure: Virtual reality speaking scenarios
timeFrame: 1 x each year for up to 5 years
measure: EEG recording of event-related brain potentials
timeFrame: 1 x each year for up to 5 years
measure: Speech production synchronization
timeFrame: 1 x each year for up to 5 years
measure: fNIRS recording of cortical hemodynamic responses
timeFrame: 1 x each year for up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Developmental Speech Lab
state: Michigan
Study officials:
References: