Mental Disorders, SevereCAPRI-VocNCT04350294
Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness
An observational study of Mental Disorders, Severe, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Severe
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Capacity to consent for themselves and their baby
- Proficiency in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Manchester
Manchester, Greater Manchester, M13 9PL
Lucy Stibbs-Eaton, (+44) 0161 306 7983, capri@manchester.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders, Severe
- Keywords
- Psychosis, Schizophrenia, Depression, Bipolar, Anxiety, Obsessive Compulsive Disorder
- Medical subject headings
- Mental Disorders, Psychotic Disorders, Schizophrenia, Depression, Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When the child is 9 months and 12 months old
Secondary outcomes (1)
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.
Measured: When the child is 12 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Sep 2017
- Primary completion20 Apr 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Principal investigator, Kathryn Abel, University of Manchester
- Investigators
- Kathryn M Abel, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350294
- Sponsor's protocol ID
- 212715
- Acronym
- CAPRI-Voc
- Status last verified
- Oct 2021
- First submitted
- 6 Apr 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Adolescents With Parental Mental Illness: Measuring Vocal Brain Development in Babies of Mothers Who Have Experienced Serious Mental Illness
- ClinicalTrials.gov ID
- NCT04350294
- Acronym / sponsor ID
- CAPRI-Voc / 212715
- Conditions
- Mental Disorders, Severe
- Keywords
- Psychosis, Schizophrenia, Depression, Bipolar, Anxiety, Obsessive Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Apr 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Capacity to consent for themselves and their baby
- Proficiency in English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time
Time frame: When the child is 9 months and 12 months old
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
1 secondary outcome
Bayley scale of infant and toddler development III
Time frame: When the child is 12 months old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- CAPRI-Voc websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn M Abel principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, Severe, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Stibbs-Eaton ((+44) 07771 396 433, capri@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time (time frame: When the child is 9 months and 12 months old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.