UnknownNot Applicable

Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness

United Kingdom250 participantsStarted 2017-09-01

Plain-language 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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

\*\*\*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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

functional near infrared spectroscopy (fNIRS) to assess changes in neural responses over time

Timeframe: When the child is 9 months and 12 months old

Trial details

NCT IDNCT04350294

SponsorUniversity of Manchester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-20

Contact for this trial

Lucy Stibbs-Eaton

(+44) 07771 396 433 capri@manchester.ac.uk

View on ClinicalTrials.gov More Mental Disorders, Severe trials