CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurocognitive Disorders. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International). An international, multicentre prospective cohort study of child and mother pairs. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.
Detailed description
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.
Primary outcome measures
- Childhood executive function [Time frame: 15 minutes]
Secondary outcome measures (2)
- Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder) [Time frame: 15 minutes]
- Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder) [Time frame: 15 minutes]
Eligibility criteria
Inclusion criteria
- Children of women who participated in the CONCEPTT trial at selected recruiting sites
Exclusion criteria
- NA
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 5 centers
- NHS Lothian Royal Infirmary of Edinburgh — Edinburgh
- Glasgow Royal Infirmary — Glasgow
- Ipswich Hospital NHS Trust — Ipswich
- St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust — Leeds
- Southampton General Hospital — Southampton
Canada · 4 centers
- Alberta Health Services — Calgary
- IWK Health — Halifax
- The Ottawa Hospital - Riverside Campus — Ottawa
- Mt Sinai Hospital — Toronto
Spain · 1 center
- Hospital de la Santa Creu — Barcelona
Identifiers
NCT: NCT05754567 · 4178