Recruiting

Observational Study

Sponsor:

Michigan State University

Code:

NCT06578416

Conditions

Stuttering

Stuttering, Childhood

Stuttering, Developmental

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Accepted

Interventions

Standardized assessments of speech and language abilities

Study Details

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.

Conditions

Stuttering

Stuttering, Childhood

Stuttering, Developmental

Study ID

NCT06578416

Start date

Jun 1, 2023

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Children who stutter

Preschool children who stutter aged 3 to 6-years

Children who do not stutter

Preschool children who do not stutter aged 4 to 6-years

Interventions

Standardized assessments of speech and language abilities

Standardized and observational assessment of speech and language abilities

Primary outcome measure

  • Stuttering Severity [ Time Frame: 1 x each year for up to 5 years ]
  • Virtual reality speaking scenarios [ Time Frame: 1 x each year for up to 5 years ]
  • Virtual reality speaking scenarios [ Time Frame: 1 x each year for up to 5 years ]
  • Virtual reality speaking scenarios [ Time Frame: 1 x each year for up to 5 years ]
  • EEG recording of event-related brain potentials [ Time Frame: 1 x each year for up to 5 years ]
  • Speech production synchronization [ Time Frame: 1 x each year for up to 5 years ]
  • fNIRS recording of cortical hemodynamic responses [ Time Frame: 1 x each year for up to 5 years ]

Central Contacts and Locations

Central contacts

Locations

Developmental Speech Lab

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

More Information

Sponsor

Michigan State University

Last update posted

Apr 16, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michigan State University on 2026-04-16.