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NCT Number: NCT05754567

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

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.

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Key information

Conditions

Neurocognitive Disorders Mental Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Health Services, Calgary, Alberta, Canada

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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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

  1. Childhood executive function

    Time frame: 15 minutes

    The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) is a parent-report 63 item questionnaire will be utilized to measure of executive function in school-aged children and adolescents (5-18 years of age). The BRIEF2 (Behaviour Rating Inventory of Executive Function - Second Edition) provides three broad index scores (i.e., Behaviour Regulation, Emotional Regulation, and Cognitive Regulation) and a General Executive Composite score. Results are provided in the form of T scores (mean=50, SD=10) with higher scores indicative of greater executive function difficulties; T scores of 65 are considered clinically elevated and indicative of executive function deficits.

Secondary outcomes

  1. Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)

    Time frame: 15 minutes

    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 (Autism Spectrum Disorder). The investigators will use a parent-completed questionnaire; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD (Autism Spectrum Disorder).

  2. Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)

    Time frame: 15 minutes

    The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder). The investigators will use a parent-completed questionnaire; the ADHD Rating Scale-5 (ADHD-5) for ADHD (Attention Deficit Hyperactivity Disorder) symptoms.

Other outcomes

  1. Maternal CGM (Continuous Glucose Monitor) percentage time in target

    Time frame: through study completion, an average of 2 year

    Primary Exposure: Maternal CGM (Continuous Glucose Monitor) percentage time in target range (3.5-7.8 mmol/L) during pregnancy. CGM (Continuous Glucose Monitor) percentage time in target range was chosen because it is the most accurate measure of fetal exposure to maternal glycemia during pregnancy. Additionally, percentage time in range has been associated with important neonatal outcomes such as neonatal hypoglycemia.

Study contacts

Contact information is provided by the study sponsor or research team.

Kanthi Kavikondala

CONTACT

[email protected]

437-240-8273

Mariam Saleem

CONTACT

[email protected]

416-480-5628

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • SRI International

Registry information

Official study title

CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial

Acronym: CONCEPTTKids

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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