NCT05003583

Brief Summary

This study will compare speech variability between preschool-age children who stutter and typically fluent, age-matched peers. Differences in emotional reactivity, regulation and speech motor control have been implicated in stuttering development in children. This study seeks to understand further how these processes interact. Children will repeat a simple phrase after viewing age-appropriate images of either negative or neutral valence to assess speech motor control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 21, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

July 22, 2021

Last Update Submit

January 28, 2026

Conditions

Keywords

stutteringpreschoolmotor controlmotor learningemotional processesbehavioral inhibition

Outcome Measures

Primary Outcomes (4)

  • The spatiotemporal index (STI) of lip aperture during a negative valence condition on Day 1 (pretest).

    The spatiotemporal index (STI), a measure of speech coordination developed by Smith and colleagues (e.g., Smith, Goffman, Zelaznik, Ying \& McGillem, 1995). It will be employed to quantify speech motor control ability and speech motor learning effects. The STI reflects the degree to which repeated performance of a task produces movement trajectories that converge on a single pattern. Children produce less stable movement trajectories, as reflected in higher values of the STI (e.g. Smith \& Goffman, 1998), while adults produce more stable movement trajectories as reflected in lower STI values. The STI of lip aperture (a relative distance between upper and lower lips) will be calculated.

    through study completion, an average of 3 weeks

  • The spatiotemporal index (STI) of lip aperture during a neutral valence condition on Day 1 (pretest).

    The spatiotemporal index (STI), a measure of speech coordination developed by Smith and colleagues (e.g., Smith, Goffman, Zelaznik, Ying \& McGillem, 1995). It will be employed to quantify speech motor control ability and speech motor learning effects. The STI reflects the degree to which repeated performance of a task produces movement trajectories that converge on a single pattern. Children produce less stable movement trajectories, as reflected in higher values of the STI (e.g. Smith \& Goffman, 1998), while adults produce more stable movement trajectories as reflected in lower STI values. The STI of lip aperture (a relative distance between upper and lower lips) will be calculated.

    through study completion, an average of 3 weeks

  • The spatiotemporal index (STI) of lip aperture during a negative valence condition on Day 2 (retention).

    The spatiotemporal index (STI), a measure of speech coordination developed by Smith and colleagues (e.g., Smith, Goffman, Zelaznik, Ying \& McGillem, 1995). It will be employed to quantify speech motor control ability and speech motor learning effects. The STI reflects the degree to which repeated performance of a task produces movement trajectories that converge on a single pattern. Children produce less stable movement trajectories, as reflected in higher values of the STI (e.g. Smith \& Goffman, 1998), while adults produce more stable movement trajectories as reflected in lower STI values. The STI of lip aperture (a relative distance between upper and lower lips) will be calculated.

    through study completion, an average of 3 weeks

  • The spatiotemporal index (STI) of lip aperture during a neutral valence condition on Day 2 (retention).

    The spatiotemporal index (STI), a measure of speech coordination developed by Smith and colleagues (e.g., Smith, Goffman, Zelaznik, Ying \& McGillem, 1995). It will be employed to quantify speech motor control ability and speech motor learning effects. The STI reflects the degree to which repeated performance of a task produces movement trajectories that converge on a single pattern. Children produce less stable movement trajectories, as reflected in higher values of the STI (e.g. Smith \& Goffman, 1998), while adults produce more stable movement trajectories as reflected in lower STI values. The STI of lip aperture (a relative distance between upper and lower lips) will be calculated.

    through study completion, an average of 3 weeks

Secondary Outcomes (4)

  • Skin conductance level (SCL)

    through study completion, an average of 3 weeks

  • Number of phasic skin conductance responses elicited by picture presentations

    through study completion, an average of 3 weeks

  • Respiratory sinus arrhythmia (RSA)

    through study completion, an average of 3 weeks

  • Executive function (EF) composite score

    through study completion, an average of 3 weeks

Study Arms (1)

Experimental Condition

EXPERIMENTAL

Speaking while viewing images with negative and neutral valence

Behavioral: Speaking after viewing pictures with negative and neutral valence

Interventions

Speaking Condition 1: 10 age-appropriate pictures from the International Affective Picture System (IAPS; Lang, Bradley \& Cuthbert, 2005) will be shown to participants. These pictures are classified as high arousal, negative valence stimuli. Participants will be asked to repeat a simple phrase between picture presentations. Speaking Condition 2: A blank screen will be shown to participants in place of pictures. This condition is classified as low arousal, neutral valence. Participants will be asked to repeat a simple phrase between blank screen picture presentations.

Experimental Condition

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • English as the primary language of communication.
  • No history of neurological diseases or diagnosed speech-language disorders apart from stuttering.
  • Parent report or direct observation of oral-facial structural abnormalities (such as cleft lip and/or cleft palate).
  • Free of any medications that may affect neural functions (e.g., medications of seizures).
  • Normal hearing acuity (must pass a hearing screening).
  • Normal vision per parent report.

You may not qualify if:

  • Parental report of neurodevelopmental disorders (such as autism spectrum disorders)
  • Parental report of vision problems that are not corrected or corrected with glasses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University, Department of Communication Sciences and Disorders

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

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

Study Officials

  • Victoria Tumanova, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 12, 2021

Study Start

May 21, 2021

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations