RecruitingOBSERVATIONAL

CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

This study, called CONCEPTT Kids International, is looking at children whose mothers took part in an earlier study called CONCEPTT. These mothers all have Type 1 diabetes. We want to understand how these children are developing, particularly in areas like thinking skills, attention, and social interactions. Researchers will ask mothers from Canada, the UK, Spain, and Italy to complete questionnaires about their child's behaviour and development. They will also collect some basic measurements like height and weight. The goal is to see if there are any links between a mother having Type 1 diabetes and her child's brain development, focusing on thinking skills and conditions like ADHD and autism.

At a glance

Status

Recruiting

Sponsor

University of Manitoba

Enrolment target

225

Start

07 Sep 2023

Estimated completion

01 Jan 2027

Neurocognitive Disorders

What is this study about?

This study is called CONCEPTT Kids International. It's a follow-up to an earlier study called CONCEPTT. In the first study, we learned about managing Type 1 diabetes during pregnancy. Now, we want to see how the children of those mothers are doing as they grow up. We are especially interested in their brain development, focusing on things like how well they can focus, solve problems, and interact with others.

Researchers from several countries, including Canada, the UK, Spain, and Italy, are working together on this project. They will be asking mothers who were part of the original CONCEPTT study to join this new study with their children. By collecting information from many families over three years, we hope to get a clearer picture of how these children are developing. This will help us understand more about Type 1 diabetes in mothers and potential impacts on their children's growth and learning.

We know that sometimes there can be connections between a mother's health condition and her child's development. This study aims to explore these connections specifically for Type 1 diabetes, looking at key areas like attention, social understanding, and how children manage their behaviour. The information we gather will help doctors and parents better understand and support children whose mothers have Type 1 diabetes.

Key takeaways

This study looks at the development of children born to mothers with Type 1 diabetes.
It's a follow-up for families who were part of the earlier CONCEPTT study.
Participation involves completing online questionnaires about your child's thinking and behaviour.
The study aims to understand links between maternal Type 1 diabetes and child development.
It could help doctors and parents better support children in the future.
It lasts for about three years and doesn't involve any medical interventions.

Who may be eligible?

You might be able to take part in this study if you are a mother who participated in the original CONCEPTT study. Importantly, your child also needs to be old enough to be involved, between 6 years old and of any older age.

The main thing is that your child's mother must have been a participant in the earlier CONCEPTT trial. If you weren't part of that study, unfortunately, you and your child won't be able to join this follow-up study.

There are no other specific reasons that would stop you or your child from taking part, as long as you meet the main requirement of being a CONCEPTT mother.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My child's mother participated in the original CONCEPTT study.
My child is 6 years old or older.
I am able to complete online forms and questionnaires.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to complete some forms and questionnaires from home. These will ask about your family's background and, most importantly, about your child's behaviour and development. Specifically, we'll ask about their thinking skills, how they interact with others (social skills), and their ability to pay attention.

You'll also be asked to provide your child's and your own height and weight, and for your partner if you wish. There won't be any in-person visits to a clinic or hospital for this study. The study is expected to last for three years, during which you would fill out these questionnaires at different points. There are no new medications or treatments involved in this study. It's all about collecting information through surveys.

Potential risks and benefits

Taking part in this study won't offer a direct health benefit to you or your child, as it's an observational study, meaning no new treatments are given. However, the information you share will be very valuable to researchers, helping them better understand the development of children whose mothers have Type 1 diabetes, which could help future families. The main risk is the time and effort it takes to complete the questionnaires, and potentially some emotional discomfort if questions bring up challenging topics. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alberta Health Services
Verified postcode
Calgary, Canada· Recruiting
IWK Health
Verified postcode
Halifax, Canada· Recruiting
The Ottawa Hospital - Riverside Campus
Verified postcode
Ottawa, Canada· Recruiting
Mt Sinai Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
Hospital de la Santa Creu
Verified postcode
Barcelona, Spain· Recruiting
NHS Lothian Royal Infirmary of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting
Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom· Recruiting
Ipswich Hospital NHS Trust
Verified postcode
Ipswich, United Kingdom· Recruiting
St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust
Verified postcode
Leeds, United Kingdom· Recruiting
Southampton General Hospital
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand how children of mothers with Type 1 diabetes are developing, particularly their thinking, attention, and social skills.

Who can take part in this study?

Only mothers who participated in the original CONCEPTT study, along with their children aged 6 years or older, can take part.

What will I have to do if I join?

You will be asked to complete questionnaires about your family and your child's behaviour and development, as well as provide some height and weight measurements.

How long will the study last?

The study is expected to last for three years, with you completing questionnaires at different times during this period.

Will my child get any new medicine or treatment?

No, this study does not involve any new medicines, treatments, or clinic visits. It’s about collecting information through questionnaires.

How to find out more

Kanthi Kavikondala

concepttkids@sunnybrook.ca 437-240-8273 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.