Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness (CAPRI-Voc)

Children and Adolescents With Parental Mental Illness: Measuring Vocal Brain Development in Babies of Mothers Who Have Experienced Serious Mental Illness

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders, Severe

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Lucy Stibbs-Eaton; Phone Number: (+44) 07771 396 433; Email: capri@manchester.ac.uk
• Study Contact Backup: Name: Jennifer Crowell; Phone Number: (+44) 07771 396 433; Email: capri@manchester.ac.uk

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9PL
      • Recruiting
      • University of Manchester
      • Contact: Lucy Stibbs-Eaton; Phone Number: (+44) 0161 306 7983; Email: capri@manchester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

***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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Serious Mental Illness *RECRUITMENT IN THIS GROUP IS CLOSED; Mothers with a serious mental illness* *received hospitalisation, treatment or intervention from a secondary care (mental health) service in the last 5 years.
Healthy Controls; Mothers with no history of mental illness, who have given birth since February 2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time	Baby will listen to vocal, non vocal, and emotional speech sounds for around 12 minutes. fNIRS uses near infrared light to capture changes in blood oxygenation in response to the sounds which is analogous to brain function. We are only assessing brain responses to the auditory stimuli played, a video is used to keep the baby's attention on the task	When the child is 9 months and 12 months old

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley scale of infant and toddler development III	A research tool involving standard series of measurements (games/tasks) to assess the cognitive and language development of children. This scale is designed to be used on children up to 3-4 years of age, therefore, the more tasks completed by a child the greater their cognitive or language ability.	When the child is 12 months old

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: European Research Council
• Investigators: Principal Investigator: Kathryn M Abel, University of Manchester

Publications and helpful links

Helpful Links

• CAPRI-Voc website

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): April 20, 2022
• Study Completion (ANTICIPATED): October 20, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Schizophrenia; Psychosis; Anxiety; Bipolar; Obsessive Compulsive Disorder
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 212715