- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05003583
Effects of Emotional Processes on Speech Motor Control in Early Childhood Stuttering.
The Influence of Contextual and Constitutional Emotional Processes on Speech Motor Control and Speech Motor Learning in Early Childhood Stuttering
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Syracuse, New York, United States, 13244
- Syracuse University, Department of Communication Sciences and Disorders
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Condition
Speaking while viewing images with negative and neutral valence
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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).
Time Frame: through study completion, an average of 3 weeks
|
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).
Time Frame: through study completion, an average of 3 weeks
|
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).
Time Frame: through study completion, an average of 3 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin conductance level (SCL)
Time Frame: through study completion, an average of 3 weeks
|
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.
|
through study completion, an average of 3 weeks
|
|
Number of phasic skin conductance responses elicited by picture presentations
Time Frame: through study completion, an average of 3 weeks
|
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.
|
through study completion, an average of 3 weeks
|
|
Respiratory sinus arrhythmia (RSA)
Time Frame: through study completion, an average of 3 weeks
|
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.
|
through study completion, an average of 3 weeks
|
|
Executive function (EF) composite score
Time Frame: through study completion, an average of 3 weeks
|
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.
|
through study completion, an average of 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Victoria Tumanova, PhD, Syracuse University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DC018103 (U.S. NIH Grant/Contract)
- R21DC018103-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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