NCT06578416

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Jun 2027

Study Start

First participant enrolled

June 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 16, 2026

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 1, 2024

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    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)

    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)

    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).

    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.

    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.

    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.

    1 x each year for up to 5 years

Study Arms (2)

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

Interventions

Standardized and observational assessment of speech and language abilities

Children who do not stutterChildren who stutter

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preschool children who do and do not stutter

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Developmental Speech Lab

East Lansing, Michigan, 48824, United States

RECRUITING

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Katelyn Gerwin, Ph.D.

CONTACT

Bridget Walsh, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Communicative Sciences and Disorders

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 29, 2024

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 16, 2026

Record last verified: 2025-09

Locations