Actively Recruiting
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
Led by University of Manitoba · Updated on 2026-03-20
225
Participants Needed
10
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
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 children's 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 children's 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 child's 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 children's neurocognitive development. The main focus is on the child's 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.
CONDITIONS
Brief Title
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children of women who participated in the CONCEPTT trial at selected recruiting sites
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 years
Participants provide information through questionnaires and forms about their child's executive functions, behavior, and other health measures.
Periodic assessments during the study period
Trial Site Locations
Total: 10 locations
1
Alberta Health Services
Calgary, Alberta, Canada, T2T 5C7
Actively Recruiting
2
IWK Health
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
3
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada, K1H 7W9
Actively Recruiting
4
Mt Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9
Not Yet Recruiting
5
Hospital de la Santa Creu
Barcelona, Spain
Actively Recruiting
6
NHS Lothian Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4UX
Actively Recruiting
7
Glasgow Royal Infirmary
Glasgow, United Kingdom, PA2 7DE
Actively Recruiting
8
Ipswich Hospital NHS Trust
Ipswich, United Kingdom, IP4 5PD
Actively Recruiting
9
St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
10
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
K
Kanthi Kavikondala
M
Mariam Saleem
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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