RecruitingNCT06578416ClinicalTrials.gov record

The Development of Stuttering in Young Children

Stuttering · Stuttering, Childhood · Stuttering, Developmental

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Observational
Phase: Not applicable / not listed
Age range: 3 years - 6 years
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 120 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

Preschool children who do and do not stutter

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

Children who stutter

Preschool children who stutter aged 3 to 6-years

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

Diagnostic Test: Standardized assessments of speech and language abilities

Standardized assessments of speech and language abilities DIAGNOSTIC_TEST

Standardized and observational assessment of speech and language abilities

Prepare your questions