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Maternal Adversity, Vulnerability and Neurodevelopment (MAVAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434457
Recruitment Status : Completed
First Posted : February 15, 2018
Results First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The JPB Foundation
Ludmer Family Foundation
Norlien Foundation
WOCO Foundation
Blema & Arnold Steinberg Family Foundation
McGill University
Jacobs Foundation
Information provided by (Responsible Party):
Michael J Meaney, Douglas Mental Health University Institute

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Infant Development
Infant Behavior
Enrollment 630
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Period Title: Overall Study
Started 630
Completed 630
Not Completed 0
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Baseline Participants 630
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants
<=18 years
630
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants
Female
288
  45.7%
Male
342
  54.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Number of Participants that Provided Feedback on the Childhood Trauma Questionnaire  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants
429
  68.1%
1.Primary Outcome
Title Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II.
Hide Description Assessment of child development was done using the cognitive, motor and mental scales of the Bayley Scales of Infant Development II.
Time Frame At 6, 12, 18 and 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
6 months
524
  83.2%
12 months
508
  80.6%
18 months
458
  72.7%
36 months
422
  67.0%
2.Primary Outcome
Title Child Temperament Evaluated Using the Infant Behaviour Questionnaire.
Hide Description Child temperament was evaluated using the Infant Behaviour questionnaire (IBQ). The items represent 14 scales but factor analysis reveals three primary factors: a) impulsivity, b) negative affectivity and c) effortful control.
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
3 months
387
  61.4%
6 months
475
  75.4%
3.Primary Outcome
Title Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire.
Hide Description Assessment of child's temperament was done with the Early Childhood Behaviour questionnaire, the toddler version of the IBQ. It is comprised of 201 items grouped in 18 subscales and is based on a 7-point Likert scale ranging from "never" to "always". The questionnaire yields 18 sub-scores: activity level/energy, attentional focusing, attentional shifting, cuddliness, fear, frustration, high-intensity pleasure, impulsivity, inhibitory control, low-intensity pleasure, motor activation, perceptual sensitivity, positive anticipation, sadness, shyness, sociability, and soothability.
Time Frame 18 and 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
18 months
433
  68.7%
36 months
420
  66.7%
4.Primary Outcome
Title Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire.
Hide Description Socio-emotional development was measured using the Infant Toddler Socio-emotional Assessment questionnaire (ITSEA). It consists of 140 items to evaluate four independent behavioral domains: 1) externalizing, (e.g., high-activity, aggression, defiance, and negative emotional reactivity); 2) internalizing, (e.g., mood regulation problems, social withdrawal and extreme inhibition/shyness); 3) dysregulation (e.g., sleep and eating problems, mood regulation); and 4) maladaptation (e.g., repetitive and stereotypic behaviors). Items are rated on a 3-point scale.
Time Frame 18 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
18 months
485
  77.0%
24 months
471
  74.8%
5.Primary Outcome
Title Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist.
Hide Description

Child's behaviour was evaluated using the Child Behaviour Checklist (CBCL). The CBCL is a well-validated screen for childhood psychopathology. This parent-rated questionnaire contains 100 items divided in 2 broad scales :

Internalizing problems includes : Withdrawn, Somatic Complaints, and Anxious/Depressed subscales. Externalizing problems : including Rule-Breaking Behavior and Aggressive subscales. Total problems score : is the sum of the scores of all the problem items.

Time Frame 48 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
48 months 366
60 months 310
6.Primary Outcome
Title Changes in Child's School Readiness Measured With the School Readiness Test Battery.
Hide Description

School and academic readiness were assessed using the School readiness test battery, including the Lollipop test, Number knowledge and Peabody Picture Vocabulary test.

The NKT measures the development of number concepts. This test measures the mastery of a series of concepts required for learning math and comprises 5 levels.

The Lollipop includes 52 questions, divided in 4 knowledge subtests: (1) colours and forms, (2) spatial relationships, (3) numbers and (4) letters. It is a good predictor of reading and math achievement up to 4th grade.

The PPVT is a receptive vocabulary test that measures the extent of vocabulary a child can understand. A child is asked to identify a spoken word on an array of four pictures, only one of which is correct.

Time Frame 48 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
48 months
366
  58.1%
60 months
322
  51.1%
7.Primary Outcome
Title Evaluation or Child's Cognitive Development Using the Developmental Neuropsychological Assessment.
Hide Description Child's cognitive development was assessed using the sensory-motor and visuo-spatial processing subscales of the Developmental Neuropsychological Assessment (NEPSY).
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
358
  56.8%
8.Primary Outcome
Title Evaluation of Child's Cognitive Development Using the Weschler Preschool and Primary Scale of Intelligence.
Hide Description Child's cognitive development was assessed using the vocabulary and the bloc design subscales of the Weschler Preschool Primary Scale of Intelligence (WPPSI).
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
355
  56.3%
9.Primary Outcome
Title Changes in Child's Hyperactivity Problems Measured With the Conner's.
Hide Description The Conner's was designed to be completed by parents and teachers to assist in evaluating children for attention-deficit/hyperactivity disorder (ADHD). The parents' short version contains 27 items and the teachers' short version has 28. The teacher version is similar but lacks the psychosomatic scale contained on the parent version. The Conner's is validated and the standard for informant-administered ADHD assessment both in clinical and research settings. Oppositional, cognitive problems/inattention, hyperactivity subscales.
Time Frame 60 and 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
60 months
323
  51.3%
72 months
272
  43.2%
10.Primary Outcome
Title Child's Fears Assessed With the Koala Fear Questionnaire.
Hide Description The Koala Fear Questionnaire (KFQ) is a standardized self-report scale for assessing fears and fearfulness in children aged between 4 and 12 years. This scale consists of 31 potentially fear-provoking stimuli and situations that are all illustrated with pictures. Children rate the intensity of their fear of these stimuli by using a visual scale depicting Koala bears expressing various degrees of fear ( no fear, some fear, a lot of fear ).
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
353
  56.0%
11.Primary Outcome
Title Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire.
Hide Description

The Strengths and Difficulties Questionnaire (SDQ) is a brief screening for child emotional and behavioural problems.

It is based on 25 items on psychological attributes.

  1. emotional symptoms (5 items)
  2. conduct problems (5 items)
  3. hyperactivity/inattention (5 items)
  4. peer relationship problems (5 items)
  5. prosocial behaviour (5 items) Number 1) to 4) added together to generate a total difficulties score.
Time Frame 60 and 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
60 months
323
  51.3%
72 months
271
  43.0%
12.Primary Outcome
Title Child's Behavioural Inhibition and Behavioural Activation Were Measured Using the Behavioural Inhibition System (BIS) and the Behavioural Approach System (BAS)
Hide Description

The BIS/BAS was designed to assess dispositional sensitivity to the behavioral inhibition system (BIS) and the behavioral activation or behavioral approach system (BAS).

Questions 20 items using 4 point scales (1 = strongly disagree to 4 = strongly agree).

2 subscales: Behavioral Inhibition System (BIS) 7 items about anticipation of punishment Behavioral Action System (BAS), which has 3 subscales of its own: Reward Responsiveness (RR) 5 items about anticipation or occurrence of reward Drive (D) 4 items about pursuit of desired goals. Fun Seeking (FS) 4 items about desire for new rewards and impulsive approach to potential rewards.

Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
303
  48.1%
13.Primary Outcome
Title Child's Mental Health Was Evaluated Using the Dominic Questionnaire.
Hide Description The Dominic questionnaire is a structured pictorial instrument assessing mental disorders in 6- to 11-year-old children. The Dominic assesses a child's perception of her/his own symptoms, which is critical to balance parents' and school professionals' perception. Ninety-nine drawings represent situations corresponding to DSM-III-R based. ADHD, Conduct Disorder, Oppositional Defiant Disorder, Major Depressive Disorder, Separation Anxiety Disorder, Generalized Anxiety Disorder and Specific Phobia.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
279
  44.3%
14.Primary Outcome
Title The Child's Attributional Style Was Evaluated With the Child Attributional Style Interview.
Hide Description The Child Attributional Style Interview (CASI) is a measure of attributional style in children aged five years old and older. The interactive interview consists of sixteen events, which are presented to the child as illustrations, in a storybook format. The events are equally divided on two domains: valence (positive and negative theme), and interpersonal (parents and peers) and achievement. This creates the possibility of four sub-categories for analysis (i.e. positive-achievement, negative-interpersonal etc.). After the presentation of each event, the child is asked three questions for their level of internal, stable and global attributions for each event.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
275
  43.7%
15.Primary Outcome
Title Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire.
Hide Description The Child Eating Behaviour Questionnaire (CEBQ) was designed to assess children's eating scale styles. It is a parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. The instrument is ideal for use in research investigating the early precursors of eating disorders or obesity.
Time Frame 48 and 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
48 months
395
  62.7%
72 months
305
  48.4%
16.Primary Outcome
Title Child's Executive Functioning Measured With the Behavior Rating of Executive Function.
Hide Description The Behavior Rating Inventory of Executive Function (BRIEF) measures executive function behaviors for children and adolescents ages 5-18. Each form of the BRIEF parent- and teacher- rating form contains 86 items in eight non-overlapping clinical scales and two validity scales. These theoretically and statistically derived scales form two indexes: a) Behavioral Regulation (three scales) and b) Metacognition (five scales), as well as a Global Executive Composite score which takes into account all of the clinical scales and represents the child's overall executive function.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
307
  48.7%
17.Primary Outcome
Title Sensitivity to Punishment & Sensitivity to Reward in Children Will be Evaluated Using the Child Version of the Sensitivity to Punishment & Sensitivity to Reward Questionnaire.
Hide Description The Sensitivity to Punishment & Sensitivity to Reward questionnaire (SPSRQ-C) measures parent-rated sensitivity to punishment and reward and contains 33 items, divided in a Punishment Sensitivity scale, and three Reward Sensitivity scales: Reward Responsivity, Impulsivity/Fun-Seeking, and Drive. Each item is scored on a 5-point Likert scale.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
308
  48.9%
18.Secondary Outcome
Title Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory.
Hide Description The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory that is one of the most widely used instruments for measuring the severity of depression. The most current version of the questionnaire is designed for individuals aged 13 and over and is composed of items relating to depression symptoms such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex (15 minutes). BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Time Frame 60 and 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data is currently being analyzed
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
60 months
318
  50.5%
72 months
261
  41.4%
19.Secondary Outcome
Title Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale.
Hide Description The Center for Epidemiological Studies, Depression Scale (CES-D) is a 20-item instrument that has excellent internal consistency (.90) and reasonable test-retest reliability (.54) for a scale that should be sensitive to adverse changes in the respondent's environment. Questions ake to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time Frame Prenatal, 6, 12, 24, 36, 48, 60, 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
prenatal
533
  84.6%
6 months
554
  87.9%
12 months
518
  82.2%
24 months
471
  74.8%
36 months
437
  69.4%
48 months
391
  62.1%
60 months
342
  54.3%
72 months
287
  45.6%
20.Secondary Outcome
Title Changes in Mother's Depression Symptoms Were Measured With the Edinburgh Postnatal Depression Scale.
Hide Description Edinburgh Postnatal Depression Scale (EPDS). The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report scale designed to screen for postpartum depression. The scale consists of 10 short statements with four possible answers corresponding to how the mother has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. A higher total sum score indicates more severe symptoms of depression.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
481
  76.3%
21.Secondary Outcome
Title Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory.
Hide Description The Speilberger State-Trait Anxiety Inventory (STAI) is self-report scale consisting of two forms of 20 items each to measure psychic components of state and trait anxiety. The State-Anxiety scale measures intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. The Trait-Anxiety scale measures the frequency of feelings "in general": 1) almost never, 2) sometimes, 3) often, and 4) almost always.
Time Frame 3, 24 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
3 months
410
  65.1%
24 months
471
  74.8%
60 months
338
  53.7%
22.Secondary Outcome
Title Mother's Retrospective Assessment of Parental Educational Style Using the Parental Bonding Inventory.
Hide Description Parental Bonding Inventory (PBI) is a standard in retrospective assessment of parental educational style (48 items). Two scales termed 'care' and 'overprotection' or 'control', measure fundamental parental styles as perceived by the child. The measure is 'retrospective', meaning that adults (over 16 years) complete the measure for how they remember their parents during their first 16 years. The measure is to be completed for both mothers and fathers separately. There are 25 item questions, including 12 'care' items and 13 'overprotection' items.
Time Frame 6 months
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The data is currently being analyzed
Arm/Group Title Prenatal and 3 to 72 Months
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Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
475
  75.4%
23.Secondary Outcome
Title Changes in Mother's Sensitivity Was Evaluated Using the Maternal Behaviour Q Sort (Short Version) and the Ainsworth Scales.
Hide Description Mother's sensitivity was assessed using the Maternal Behaviour Q sort (short version) and the Ainsworth scales (AINS). MBQS-S and AINS assess maternal sensitivity. Trained raters scored the mother's behavior on the scale for the MBQS and four scales of the AINS scales (Acceptance, Availability, Cooperation and Sensitivity) during a 20 and 30 minutes video-taped home mother-child interaction. The scales range from -1 to 1 for the MBQS and from 1 to 9 for the AINS scales, with higher scores indicating highly sensitive mothers on both instruments.
Time Frame 18 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
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Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
99
  15.7%
24.Secondary Outcome
Title Mother's Early Life Abuse and Neglect Were Evaluated Using the Childhood Trauma Questionnaire.
Hide Description

The Childhood Trauma Questionnaire (CTQ) is a 28-item self-report retrospective inventory intending to measure childhood or adolescent abuse and neglect, on a 5-point Likert scale ranging from Never True to Very Often True. The central constructs underlying the questionnaire are emotional, physical neglect and abuse, and sexual abuse. The CTQ contains five subscales :

3 subscales assessing abuse : Emotional, Physical, and Sexual abuse 2 subscales assessing neglect : Emotional and Physical neglect.

Time Frame 24 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
429
  68.1%
25.Secondary Outcome
Title Mother's Eating Behaviours Were Evaluated Using the Dutch Eating Behavior Questionnaire.
Hide Description The Dutch Eating Behavior Questionnaire is used to assess emotional, external and restrained eating. The 33 items on the DEBQ represent three separate scales: (i) Emotional Eating, with items such as 'Do you have the desire to eat when you are irritated?, contains 13 items; (ii) External Eating, with items such as 'Do you eat more than usual when you see others eating?, includes 10 items; and (iii) Restraint, with items such as 'Do you deliberately eat less in order not to become heavier? ', has 10 items.
Time Frame 60 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
350
  55.6%
26.Secondary Outcome
Title Mother's Sensitivity to Punishment and Sensitivity to Reward Were Measured Using the Sensitivity to Punishment and Sensitivity to Reward Questionnaire.
Hide Description The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ) (Torrubia et al., 2001) is a 48 yes/no questionnaire measuring SP (sensitivity to punishment) and SR (sensitivity to reward) functioning.
Time Frame 60 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
350
  55.6%
27.Secondary Outcome
Title Parenting Style Assessed Using the Parental Authority Questionnaire.
Hide Description The Parental Authority Questionnaire (PAQ) investigates three prototypes of parental behavior: permissive, authoritative and authoritarian. Each prototype is measured on 10 items on a Likert scale from 1 (disagree strongly) to 5 (agree strongly). The questionnaire was developed to be answered by the child, however, it was adapted in order to let the mother rate her own prototype of parenting. Item scores for each scale were averaged to obtain a total prototype score, with high scores indicating that the mother rates herself to engage strongly in a given parenting prototype.
Time Frame 60 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
323
  51.3%
28.Secondary Outcome
Title Family Functioning Assessed Using the Family Assessment Device Questionnaire.
Hide Description The Family Assessment Device (FAD) questionnaire assesses family functioning on each dimension of the McMaster Model of Family Functioning (MMFF) according to individual family member's perception of their family's functioning. In addition to the six subscales of the MMFF (Problem solving, communication, roles, affective responsiveness, affective involvement, behaviour control) the FAD includes a General Functioning scale that measures the overall level of the family's functioning. Sixty statements, geared to an eighth-grade reading level, describe various aspects of family functioning. Each member of the family over the age of 12 completes the pen-and-paper questionnaire by rating how well the statement describes his or her family. There are four choices (strongly agree, agree, disagree, strongly disagree) per item for each dimension. Dimension items are purposely not listed in consecutive order. Each item matches only one dimension and may describe healthy or unhealthy functioning.
Time Frame 72 months
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[Not Specified]
Arm/Group Title Prenatal and 3 to 72 Months
Hide Arm/Group Description:
Our community sample consisted of mothers recruited in Montréal (Québec) and Hamilton (Ontario), Canada, at 13 to 20 weeks' gestation. Participants were part of the Maternal Adversity, Vulnerability, and Neurodevelopment (MAVAN) study, which examines the development of individual differences in phenotypes associated with multiple forms of psychopathology. Mothers were first assessed during their pregnancy (∼26 weeks) and then followed at multiple time points that included home visits and laboratory sessions.
Overall Number of Participants Analyzed 630
Measure Type: Count of Participants
Unit of Measure: Participants
307
  48.7%
Time Frame 6 years
Adverse Event Reporting Description The study is observational and not experimental. No adverse events were unforeseen for data collection tools used in the study.
 
Arm/Group Title Adverse Events
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All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   0/630 (0.00%) 
Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%)
Total   0/630 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%)
Total   0/630 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr Patricia Pelufo Silveira
Organization: Douglas Mental Health University Institute
Phone: 1514-761-6131 ext 3928
EMail: patricia.silveira@mcgill.ca
Publications of Results:
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Responsible Party: Michael J Meaney, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT03434457    
Other Study ID Numbers: DouglasMHU
First Submitted: January 30, 2018
First Posted: February 15, 2018
Results First Submitted: February 28, 2019
Results First Posted: May 27, 2020
Last Update Posted: May 27, 2020