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CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
NCT05754567 · University of Manitoba
In plain English
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Official title
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
About this study
This is a multicentre, international prospective cohort study of child and mother pairs from sites in Canada, UK, Spain and Italy. The expected duration of the study is three years. Women who participated in CONCEPTT will be invited to participate in CONCEPTT Kids International. Once informed consent is obtained, mothers will be asked to complete forms and questionnaires that provide information on family socio-demographics and their children's executive functions and behaviour (i.e. social responsiveness and attention). Self-reported height and weight measures of the child and parent(s) will also be collected.
Our primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF2)
The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes, and ASD and ADHD. We will use two parent-completed questionnaires to assess symptoms associated with these disorders; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD and the ADHD Rating Scale-5 (ADHD-5) for ADHD symptoms.
Eligibility criteria
Inclusion Criteria:
* Children of women who participated in the CONCEPTT trial at selected recruiting sites
Exclusion Criteria:
* NA
Study design
Enrollment target: 225 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2023-09-07
Estimated completion: 2027-01
Last updated: 2026-03-20
Primary outcomes
- • Childhood executive function (15 minutes)
Sponsor
University of Manitoba · other
With: Canadian Institutes of Health Research (CIHR), SRI International
Contacts & investigators
ContactKanthi Kavikondala · contact · concepttkids@sunnybrook.ca · 437-240-8273
ContactMariam Saleem · contact · mariam.saleem@sunnybrook.ca · 416-480-5628
All locations (10)
Alberta Health ServicesRecruiting
Calgary, Alberta, Canada
IWK HealthRecruiting
Halifax, Nova Scotia, Canada
The Ottawa Hospital - Riverside CampusRecruiting
Ottawa, Ontario, Canada
Mt Sinai HospitalNot Yet Recruiting
Toronto, Ontario, Canada
Hospital de la Santa CreuRecruiting
Barcelona, Spain
NHS Lothian Royal Infirmary of EdinburghRecruiting
Edinburgh, Scotland, United Kingdom
Glasgow Royal InfirmaryRecruiting
Glasgow, United Kingdom
Ipswich Hospital NHS TrustRecruiting
Ipswich, United Kingdom
St. James's Hospital, Leeds Teaching Hospitals Trust NHS TrustRecruiting
Leeds, United Kingdom
Southampton General HospitalRecruiting
Southampton, United Kingdom