N/A
Completed N=630
Maternal Adversity, Vulnerability and Neurodevelopment
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) · Infant Development · Infant Behavior
Source: ClinicalTrials.gov NCT03434457 ↗
Enrolled (actual)
630
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. — 524; 508; 458; 422 Participants
Summary
Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective community-based, pregnancy and birth cohort of Canadian mother-child dyads. The main objective of MAVAN project is to examine the pre- and postnatal influences, and their interaction, in determining individual differences in children development. The MAVAN project is designed to examine the consequences of fetal adversity as a function of the quality of the postnatal environment, focusing on mother-infant interactions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. |
524; 508; 458; 422 | — |
| PRIMARY Child Temperament Evaluated Using the Infant Behaviour Questionnaire. |
387; 475 | — |
| PRIMARY Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire. |
433; 420 | — |
| PRIMARY Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire. |
485; 471 | — |
| PRIMARY Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist. |
366; 310 | — |
| PRIMARY Changes in Child's School Readiness Measured With the School Readiness Test Battery. |
366; 322 | — |
| PRIMARY Evaluation or Child's Cognitive Development Using the Developmental Neuropsychological Assessment. |
358 | — |
| PRIMARY Evaluation of Child's Cognitive Development Using the Weschler Preschool and Primary Scale of Intelligence. |
355 | — |
| PRIMARY Changes in Child's Hyperactivity Problems Measured With the Conner's. |
323; 272 | — |
| PRIMARY Child's Fears Assessed With the Koala Fear Questionnaire. |
353 | — |
| PRIMARY Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire. |
323; 271 | — |
| PRIMARY Child's Behavioural Inhibition and Behavioural Activation Were Measured Using the Behavioural Inhibition System (BIS) and the Behavioural Approach System (BAS) |
303 | — |
| PRIMARY Child's Mental Health Was Evaluated Using the Dominic Questionnaire. |
279 | — |
| PRIMARY The Child's Attributional Style Was Evaluated With the Child Attributional Style Interview. |
275 | — |
| PRIMARY Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire. |
395; 305 | — |
| PRIMARY Child's Executive Functioning Measured With the Behavior Rating of Executive Function. |
307 | — |
| PRIMARY Sensitivity to Punishment & Sensitivity to Reward in Children Will be Evaluated Using the Child Version of the Sensitivity to Punishment & Sensitivity to Reward Questionnaire. |
308 | — |
| SECONDARY Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory. |
318; 261 | — |
| SECONDARY Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. |
533; 554; 518; 471; 437; 391 | — |
| SECONDARY Changes in Mother's Depression Symptoms Were Measured With the Edinburgh Postnatal Depression Scale. |
481 | — |
| SECONDARY Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory. |
410; 471; 338 | — |
| SECONDARY Mother's Retrospective Assessment of Parental Educational Style Using the Parental Bonding Inventory. |
475 | — |
| SECONDARY Changes in Mother's Sensitivity Was Evaluated Using the Maternal Behaviour Q Sort (Short Version) and the Ainsworth Scales. |
99 | — |
| SECONDARY Mother's Early Life Abuse and Neglect Were Evaluated Using the Childhood Trauma Questionnaire. |
429 | — |
| SECONDARY Mother's Eating Behaviours Were Evaluated Using the Dutch Eating Behavior Questionnaire. |
350 | — |
| SECONDARY Mother's Sensitivity to Punishment and Sensitivity to Reward Were Measured Using the Sensitivity to Punishment and Sensitivity to Reward Questionnaire. |
350 | — |
| SECONDARY Parenting Style Assessed Using the Parental Authority Questionnaire. |
323 | — |
| SECONDARY Family Functioning Assessed Using the Family Assessment Device Questionnaire. |
307 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant women recruited when they attending antenatal care clinics at the time of routine ultrasound or through advertisements at hospitals (usually at 13 to 20 weeks' gestation). Women were included in the study if they were 18 years of age or older, and fluent in either English or French. Only babies born at 37 weeks or later and above 2000 g were included in the MAVAN cohort.
Exclusion Criteria
- Exclusion criteria included serious obstetric complications during the pregnancy or delivery of the child, extremely low birth weight, prematurity (less than 37 weeks of gestation), or any congenital diseases.
Data sourced from ClinicalTrials.gov (NCT03434457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.