Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

Study Overview
=================
Brief Summary
-----------------
FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

Detailed Description
-----------------
The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (RCT) design. The primary objective of the FACT 4 Child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the CIHR funded FACT. The effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. Results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Official Title
-----------------
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

Conditions
-----------------
Autism Spectrum Disorder, Asthma, Executive Dysfunction, Emotional Problem, Behavioural Problem, Pre-Eclampsia, Death

Intervention / Treatment
-----------------
* Diagnostic Test: SRS 2, CBCL, BRIEF-P


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capability of participant to comprehend and comply with study requirements Mother participated in FACT Exclusion Criteria: Confirmed spontaneous termination (miscarriage) or elective termination or stillborn Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother and child(ren)<br>FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years. | Diagnostic Test: SRS 2, CBCL, BRIEF-P<br>* This study does not involve an intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive disability | The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint. | From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Morbidity | Secondary outcomes to be assessed in FACT 4 Child include severe morbidity of FACT offspring, captured by the Mother-Child Health Survey at the age of 4 - 6 years, including incidence of: Severe morbidity defined by any illnesses during the previous years that has necessitated hospitalization or medication/treatment for >2 months | From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurological, autism, ASD, behaviour, folic acid, pre-eclampsia, asthma, executive function