Clinical trial NCT04350294: Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness
Official title: Children and Adolescents With Parental Mental Illness: Measuring Vocal Brain Development in Babies of Mothers Who Have Experienced Serious Mental Illness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorders, Severe
Keywords: Psychosis
Schizophrenia
Depression
Bipolar
Anxiety
Obsessive Compulsive Disorder
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2020-04-17
Enrollment: 250
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are interested in recruiting all women who have given birth since February 2021\*

Please contact the our team if you have any questions about your suitability for the study.

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.

Eligibility criteria: \*\*\*If you have given birth in or after February 2021 and are interested in participating, please contact our research team.\*\*\*

Inclusion Criteria:

* Capacity to consent for themselves and their baby
* Proficiency in English

Exclusion Criteria:

* Women whose baby is permanently removed from their care
* Women with a primary diagnosis of substance/alcohol abuse or dependence in the last year
* Women with a primary diagnosis of anorexia/bulimia nervosa
* Women with a primary diagnosis of a personality disorder, psychological development or somatoform disorders
* Infants with congenital malformations, severe chronic illness, and developmental disorders

Primary outcomes:
measure: functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time
timeFrame: When the child is 9 months and 12 months old
Secondary outcomes:
measure: Bayley scale of infant and toddler development III
timeFrame: When the child is 12 months old
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
affiliation: University of Manchester
name: Kathryn M Abel
role: PRINCIPAL_INVESTIGATOR
References: