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Stuttering, ChildhoodNCT05003583

Effects of Emotional Processes on Speech Motor Control in Early Childhood Stuttering.

A study testing Speaking after viewing pictures with negative and neutral valence in people with Stuttering, Childhood, run by Syracuse University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Stuttering, Childhood
What is being tested?
Speaking after viewing pictures with negative and neutral valence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
21 May 2021to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Failure to meet the inclusionary criteria listed above
  • Parental report of neurodevelopmental disorders (such as autism spectrum disorders)
  • Parental report of vision problems that are not corrected or corrected with glasses.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Syracuse University, Department of Communication Sciences and Disorders

    Syracuse, New York, 13244

Other trials in United States

About this study

Official title: The Influence of Contextual and Constitutional Emotional Processes on Speech Motor Control and Speech Motor Learning in Early Childhood Stuttering

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.

Read the detailed description

Stuttering is a developmental disorder that emerges in the preschool years as children are undergoing rapid development of their speech, language, and emotional regulation processes. This study aims to understand how speech motor control and emotional processes interact in young children who do and do not stutter.

In Aim 1, the investigators will be observing how speech motor control and learning are affected by emotional (physiological) arousal. High arousal (e.g., stress) has been shown to disrupt highly skilled performances such as in sports and music performance (Yoshie et al., 2009). Parents of children who stutter often report that that exciting or stressful situations lead to increased stuttering in their children. There is little research, however, on how excitement or stress affects fluency in children.

In Aim 2, the investigators will observe how behavioral inhibition plays a role in speech motor control and motor learning in the context of emotional processes. Behavioral inhibition is one aspect of a child's temperament. Temperament refers to self-regulation as well as emotional, motor, and attentional reactivity that differs among individuals. Children with high behavioral inhibition (BI) are hyper-vigilant and more sensitive to new stimuli and negative emotional states. Therefore, the purpose of Aim 2 is to see if children with high BI are more susceptible to contextual emotional processes, therefore affecting speech motor control and learning.

Outcomes will be measured by calculating the variability in speech motor movements (STI). The two groups, children who stutter and age-matched peers who do not stutter, will be compared to see how speech motor control varies between groups and conditions.

Being tested
Speaking after viewing pictures with negative and neutral valence
Keywords
stuttering, preschool, motor control, motor learning, emotional processes, behavioral inhibition
Medical subject headings
Stuttering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speaking after viewing pictures with negative and neutral valenceBehavioural

    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.

Study groups in NCT05003583
Study groupRoleWhat they receive
Experimental ConditionExperimentalSpeaking while viewing images with negative and neutral valence
Receives: Behavioral: Speaking after viewing pictures with negative and neutral valence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 3 weeks

  2. 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.

    Measured: through study completion, an average of 3 weeks

  3. 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.

    Measured: through study completion, an average of 3 weeks

  4. 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.

    Measured: through study completion, an average of 3 weeks

Secondary outcomes (4)
  1. Skin conductance level (SCL)

    Skin conductance level (SCL) measures the activity of the sympathetic branch of the autonomic nervous system. Higher SCL during experimental conditions as compared to the baseline is associated with higher sympathetic nervous system activity and provides physiologic validation of the emotional reactivity differences between the experimental conditions.

    Measured: through study completion, an average of 3 weeks

  2. Number of phasic skin conductance responses elicited by picture presentations

    Phasic skin conductance responses (SCR) measures the activity of the sympathetic branch of the autonomic nervous system. It is elicited by specific stimuli (in this study, by the pictures presented in the two experimental conditions).Greater number of SCRs elicited by picture presentations during experimental conditions is associated with higher sympathetic nervous system activity and provides physiologic validation of the emotional reactivity differences between the experimental conditions.

    Measured: through study completion, an average of 3 weeks

  3. Respiratory sinus arrhythmia (RSA)

    Respiratory sinus arrhythmia (RSA) (rhythmic fluctuations in heart rate associated with the respiratory cycle) measures the activity of the parasympathetic branch of the autonomic nervous system. Decreased RSA during the experimental conditions as compared to the baseline provides physiologic validation of the emotional reactivity differences between the experimental conditions.

    Measured: through study completion, an average of 3 weeks

  4. Executive function (EF) composite score

    Executive function skills will be assessed through behavioral tasks using the NIH Toolbox Early Childhood Cognition Battery (Gershon et al., 2013; Zelazo et al., 2013). The tasks include the Flanker Inhibitory Control and Attention Test to examine inhibitory control, Picture Sequence Memory Test to examine episodic memory, and Dimensional Change Card Sort Test to examine mental flexibility and attention.

    Measured: through study completion, an average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start21 May 2021
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003583
Sponsor's protocol ID
R21DC018103
Other IDs
R21DC018103-01A1
Status last verified
Jan 2026
First submitted
22 Jul 2021
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Speaking after viewing pictures with negative and neutral valence in people with Stuttering, Childhood, run by Syracuse University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The spatiotemporal index (STI) of lip aperture during a negative valence condition on Day 1 (pretest). (time frame: through study completion, an average of 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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