Clinical trial NCT05754567: CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: SRI International
First posted: 2023-03-06
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Children of women who participated in the CONCEPTT trial at selected recruiting sites

Exclusion Criteria:

* NA

Primary outcomes:
measure: Childhood executive function
timeFrame: 15 minutes
Secondary outcomes:
measure: Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)
timeFrame: 15 minutes
measure: Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)
timeFrame: 15 minutes
Other outcomes:
measure: Maternal CGM (Continuous Glucose Monitor) percentage time in target
timeFrame: through study completion, an average of 2 year
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: Halifax
country: Canada
facility: IWK Health
state: Nova Scotia
city: Toronto
country: Canada
facility: Mt Sinai Hospital
state: Ontario
Study officials:
References: