International Study on Neurodevelopment in Children of Women with Type 1 Diabetes from the CONCEPTT Trial

What this Trial Is About

Researchers are conducting an international, multicenter prospective cohort study called CONCEPTT Kids International to explore neurodevelopmental outcomes in children born to women with Type 1 Diabetes. The study specifically follows child and mother pairs where the mother previously participated in the CONCEPTT randomized control trial. The goal is to understand how maternal diabetes may relate to childrens executive functions, behavior, and related neurodevelopmental conditions such as Autism Spectrum Disorder ASD and Attention Deficit Hyperactivity Disorder ADHD. Mothers from Canada, the UK, Spain, and Italy who took part in the original CONCEPTT trial will be invited to participate. After consenting, mothers will complete questionnaires about family demographics and their childrens executive function and behavior, including assessments of social responsiveness and attention. The study collects self-reported height and weight for both children and parents. The primary outcome is the childs executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition BRIEF2. Secondary outcomes include parent-reported symptoms related to ASD and ADHD using the Social Responsiveness Scale-2 SRS-2 and ADHD Rating Scale-5 ADHD-5. Participants will be involved for an expected duration of three years. During the study, researchers will gather questionnaire data and physical measurements to evaluate childrens neurocognitive development. The main focus is on the childs executive function, with additional attention to behaviors associated with ASD and ADHD. This observational study does not involve treatment but monitors developmental outcomes over time in this specific group of children.

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