Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578416
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
The Development of Stuttering in Young Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developmental Trajectories to Stuttering Persistence and Recovery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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
Detailed Description:
The length of participation in our study depends on the subset of activities completed Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years
Parents and caregivers will complete parent questionnaires 1 x each year for up to 5 years and a 5-minute online survey in between visits to the lab 1x each year for up to 5 years Children will take part in standardized and observational assessments 1x each year for up to 5 years These may cover aspects of socialemotional development cognition and speech language and hearing abilities These tests are used to assess whether a child falls within or outside of the normative range for hisher age
Children will participate in one or more of the following tasks 1x each year for up to 5 years
Listen to sounds or words and view or name pictures presented on a monitor Brain activity electroencephalography EEG will be recorded while children listen to speech sounds and name pictures This will be done with an elastic cap that holds special sensors electrodes Sensors will also be placed behind each ear beside each eye and under the left eye
Virtual reality VR Children wear a VR headset and experience virtual age-appropriate talking situations eg answering questions in a classroom While they talk in these scenarios the headset measures where they are looking eye tracking and sensors on their forehead hand and finger measure their heart rate and sweat response
Children will watch cartoons of animals jumping to a consistent beat rhythm and produce a word in time with the animal jumpingbeat
Children will repeat nonwords name pictures or count while wearing a cap with sensors Half of the sensors emit light through while the other half measures the reflected light These sensors give us information about brain activity and are not harmful
Parents and caregivers will complete parent questionnaires 1 x each year for up to 5 years and a 5-minute online survey in between visits to the lab 1x each year for up to 5 years Children will take part in standardized and observational assessments 1x each year for up to 5 years These may cover aspects of socialemotional development cognition and speech language and hearing abilities These tests are used to assess whether a child falls within or outside of the normative range for hisher age
Children will participate in one or more of the following tasks 1x each year for up to 5 years
Listen to sounds or words and view or name pictures presented on a monitor Brain activity electroencephalography EEG will be recorded while children listen to speech sounds and name pictures This will be done with an elastic cap that holds special sensors electrodes Sensors will also be placed behind each ear beside each eye and under the left eye
Virtual reality VR Children wear a VR headset and experience virtual age-appropriate talking situations eg answering questions in a classroom While they talk in these scenarios the headset measures where they are looking eye tracking and sensors on their forehead hand and finger measure their heart rate and sweat response
Children will watch cartoons of animals jumping to a consistent beat rhythm and produce a word in time with the animal jumpingbeat
Children will repeat nonwords name pictures or count while wearing a cap with sensors Half of the sensors emit light through while the other half measures the reflected light These sensors give us information about brain activity and are not harmful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None