Neurocognitive DisordersCONCEPTTKidsNCT05754567
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
An observational study of Neurocognitive Disorders, run by University of Manitoba at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 225 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 7 Sep 2023to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial
Who may be able to join
- Children of women who participated in the CONCEPTT trial at selected recruiting sites
Who cannot join
- NA
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United Kingdom5 sites, 5 recruiting
- Recruiting
NHS Lothian Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4UX
Dr. Anna Dover
- Recruiting
Glasgow Royal Infirmary
Glasgow, PA2 7DE
Dr. Robert Lindsay
- Recruiting
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD
Dr. Zeenat Banu
- Recruiting
St. James's Hospital, Leeds Teaching Hospitals Trust NHS Trust
Leeds, LS9 7TF
Dr. Eleanor Scott
- Recruiting
Southampton General Hospital
Southampton, SO16 6YD
Dr. Richard Holt
Canada4 sites, 4 recruiting
- Recruiting
Alberta Health Services
Calgary, Alberta, T2T 5C7
Lois Donovan, FRCPC,MD,, 403-955-8352, lois.donovan@ahs.ca
Lois Donovan, FRCPC,MD
- Recruiting
IWK Health
Halifax, Nova Scotia, B3K 6R8
Janet Slaunwhite, 902-470-6464, janet.slaunwhite@iwk.nshealth.ca
Jillian Coolen, MD FRCSC
- Recruiting
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, K1H 7W9
Dr. Erin Keely
Dr. Erin Keely
- Not yet recruiting
Mt Sinai Hospital
Toronto, Ontario, M5T 3L9
Silva Darrouj, Silva.Darrouj@sinaihealth.ca
Denice Feig
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu
Barcelona
Dr. Rosa Corcoy
Dr. Rosa Corcoy
About this study
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
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.
Read the 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.
- Conditions
- Neurocognitive Disorders
- Medical subject headings
- Neurocognitive Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood executive function
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.
Measured: 15 minutes
Secondary outcomes (2)
Significant associations between maternal pre-existing diabetes and ASD (Autism Spectrum Disorder)
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).
Measured: 15 minutes
Significant associations between maternal pre-existing diabetes and ADHD (Attention Deficit Hyperactivity Disorder)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start7 Sep 2023
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), SRI International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754567
- Sponsor's protocol ID
- 4178
- Acronym
- CONCEPTTKids
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05754567
- Acronym / sponsor ID
- CONCEPTTKids / 4178
- Conditions
- Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), SRI International
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, ages 6 and up, of women with T1D who participated in the CONCEPTT trial
Key inclusion criteria (1 listed)
- Children of women who participated in the CONCEPTT trial at selected recruiting sites
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Related trials for Neurocognitive Disorders
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, run by University of Manitoba at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kanthi Kavikondala (437-240-8273, concepttkids@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood executive function (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.