Clinical Trials Logo
  1. Home
  2. Neurocognitive Disorders
  3. NCT05754567

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

Neurocognitive Disorders Clinical Trial

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

Clinical 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. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05754567
Study type Observational
Source University of Manitoba
Contact Sonya Mergler
Phone 416-480-5627
Email concepttkids@sunnybrook.ca
Status Recruiting
Phase
Start date September 7, 2023
Completion date December 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Not yet recruiting NCT03276377 - VItamin K Inhibition and NeurocoGnition (VIKING) N/A
Completed NCT04175223 - Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders N/A
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Recruiting NCT05732285 - A Pilot Randomized Controlled Trial: CoINTEGRATE N/A
Recruiting NCT04095962 - Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia N/A
Not yet recruiting NCT04113577 - COgilus Remediation in Alzheimer Patients (CORA)
Recruiting NCT06320639 - DRIVing Simulator and People With NeuroCognitive Disorders
Recruiting NCT06105320 - COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study N/A
Completed NCT03050385 - Cognitive Rehabilitation During Transcranial Direct Current Stimulation N/A
Active, not recruiting NCT06372002 - Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia N/A
Recruiting NCT05508789 - A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Phase 3
Recruiting NCT03926351 - High Dose Omega 3 in People at Risk for Dementia Phase 2
Recruiting NCT05504681 - Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
Completed NCT04168268 - Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium
Recruiting NCT04825847 - Neurocognitive Disorders After Major Surgery in Elderly N/A
Active, not recruiting NCT02958670 - Imaging Tau Deposition in the Brain of Elderly Subjects N/A
Enrolling by invitation NCT02652598 - Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD Phase 2
Completed NCT02825732 - MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint N/A
Completed NCT04725708 - Cognitive Functions on Coronary Surgery N/A