Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04350294
Brief Summary:
CAPRI-Voc examines the differences in how speech and environmental sounds are processed in the infant brain as they grow from 9 to 12 months. The main aim of our research is to see whether serious mental illness or other factors influence this development in children. This means we are looking for new mums and their infants who have not experienced mental illness.
Detailed Description:
A delay in the development of language can make it hard for individuals to socialise and learn. While many children thrive, some children who live with a parent suffering from a mental illness develop difficulties with language and communication. Unfortunately, language delay is often missed until children are at school. By then, treatment options may be more limited and less effective. These children and their families would do better if they had more support early on. There is a lack of research in this area so we are cannot tell whether an individual child is at more risk or whether they have protective qualities. We need to know this to plan treatment and start it early because the earlier the help, the better the results.
Therefore, our study aims to identify children who will be most at risk of difficulties or delays in their language. It will also examine the effects of mental illness and other factors in mothers in the child's language and communication abilities. This will help us to design better treatments for the most at risk children because identifying them when they are infants means we can help their cognitive, development and language skills earlier.
To do this, we use a form of brain imaging called functional Near-Infrared Spectroscopy (fNIRS). It is a safe, non-invasive technique that records brain responses. When nerve cells in our brains are active, the supply of blood increases to those tissues. Our equipment detects these changes in blood flow by shining light onto the scalp. fNIRS has been safely used with thousands of infants worldwide. It is a common tool in neonatal and intensive care units and there are no side effects of fNIRS.
We ask your baby to put a cap on which has light sensors. Whilst baby has the cap on, we get them to watch 2 six-minute videos which have different sounds playing. Here, we will be able to see whether the baby can tell the difference between vocal sounds and environmental sounds (like traffic), as well as the differences in emotional speech (i.e. happy, sad and neutral speech).
As well as measuring baby's brain activity, we also ask mum questions about herself and video a 6-minute play session between mum and baby. Finally, we carry out a play session to measure baby's development. All assessments are done with the utmost care and mum is always present to make sure everyone is comfortable.
Study:
NCT04350294
Study Brief:
Protocol Section:
NCT04350294