Trial Outcomes & Findings for Maternal Adversity, Vulnerability and Neurodevelopment (NCT NCT03434457)

NCT ID: NCT03434457

Last Updated: 2020-05-27

Results Overview

Assessment of child development was done using the cognitive, motor and mental scales of the Bayley Scales of Infant Development II.

• Recruitment status: COMPLETED
• Target enrollment: 630 participants
• Primary outcome timeframe: At 6, 12, 18 and 36 months
• Results posted on: 2020-05-27

Participant Flow

Participant milestones

Measure	Prenatal and 3 to 72 Months 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 Study STARTED	630
Overall Study COMPLETED	630
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Age, Categorical <=18 years	630 Participants n=630 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=630 Participants
Age, Categorical >=65 years	0 Participants n=630 Participants
Sex: Female, Male Female	288 Participants n=630 Participants
Sex: Female, Male Male	342 Participants n=630 Participants
Number of Participants that Provided Feedback on the Childhood Trauma Questionnaire	429 Participants n=630 Participants

PRIMARY outcome

Timeframe: At 6, 12, 18 and 36 months

Assessment of child development was done using the cognitive, motor and mental scales of the Bayley Scales of Infant Development II.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. 6 months	524 Participants
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. 12 months	508 Participants
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. 18 months	458 Participants
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. 36 months	422 Participants

PRIMARY outcome

Timeframe: 3 and 6 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Child Temperament Evaluated Using the Infant Behaviour Questionnaire. 3 months	387 Participants
Child Temperament Evaluated Using the Infant Behaviour Questionnaire. 6 months	475 Participants

PRIMARY outcome

Timeframe: 18 and 36 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire. 36 months	420 Participants
Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire. 18 months	433 Participants

PRIMARY outcome

Timeframe: 18 and 24 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire. 18 months	485 Participants
Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire. 24 months	471 Participants

PRIMARY outcome

Timeframe: 48 and 60 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist. 48 months	366 Participants
Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist. 60 months	310 Participants

PRIMARY outcome

Timeframe: 48 and 60 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child's School Readiness Measured With the School Readiness Test Battery. 48 months	366 Participants
Changes in Child's School Readiness Measured With the School Readiness Test Battery. 60 months	322 Participants

PRIMARY outcome

Timeframe: 48 months

Child's cognitive development was assessed using the sensory-motor and visuo-spatial processing subscales of the Developmental Neuropsychological Assessment (NEPSY).

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Evaluation or Child's Cognitive Development Using the Developmental Neuropsychological Assessment.

358 Participants

PRIMARY outcome

Timeframe: 48 months

Child's cognitive development was assessed using the vocabulary and the bloc design subscales of the Weschler Preschool Primary Scale of Intelligence (WPPSI).

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Evaluation of Child's Cognitive Development Using the Weschler Preschool and Primary Scale of Intelligence.

355 Participants

PRIMARY outcome

Timeframe: 60 and 72 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child's Hyperactivity Problems Measured With the Conner's. 60 months	323 Participants
Changes in Child's Hyperactivity Problems Measured With the Conner's. 72 months	272 Participants

PRIMARY outcome

Timeframe: 60 months

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 ).

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Child's Fears Assessed With the Koala Fear Questionnaire.

353 Participants

PRIMARY outcome

Timeframe: 60 and 72 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire. 60 months	323 Participants
Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire. 72 months	271 Participants

PRIMARY outcome

Timeframe: 60 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Child's Behavioural Inhibition and Behavioural Activation Were Measured Using the Behavioural Inhibition System (BIS) and the Behavioural Approach System (BAS)

303 Participants

PRIMARY outcome

Timeframe: 72 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Child's Mental Health Was Evaluated Using the Dominic Questionnaire.

279 Participants

PRIMARY outcome

Timeframe: 72 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

The Child's Attributional Style Was Evaluated With the Child Attributional Style Interview.

275 Participants

PRIMARY outcome

Timeframe: 48 and 72 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire. 48 months	395 Participants
Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire. 72 months	305 Participants

PRIMARY outcome

Timeframe: 72 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Child's Executive Functioning Measured With the Behavior Rating of Executive Function.

307 Participants

PRIMARY outcome

Timeframe: 72 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

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 Participants

SECONDARY outcome

Timeframe: 60 and 72 months

Population: The data is currently being analyzed

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory. 60 months	318 Participants
Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory. 72 months	261 Participants

SECONDARY outcome

Timeframe: Prenatal, 6, 12, 24, 36, 48, 60, 72 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. prenatal	533 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 6 months	554 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 12 months	518 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 24 months	471 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 36 months	437 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 48 months	391 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 60 months	342 Participants
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale. 72 months	287 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Changes in Mother's Depression Symptoms Were Measured With the Edinburgh Postnatal Depression Scale.

481 Participants

SECONDARY outcome

Timeframe: 3, 24 and 60 months

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.

Outcome measures

Measure	Prenatal and 3 to 72 Months n=630 Participants 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.
Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory. 3 months	410 Participants
Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory. 24 months	471 Participants
Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory. 60 months	338 Participants

SECONDARY outcome

Timeframe: 6 months

Population: The data is currently being analyzed

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Mother's Retrospective Assessment of Parental Educational Style Using the Parental Bonding Inventory.

475 Participants

SECONDARY outcome

Timeframe: 18 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Changes in Mother's Sensitivity Was Evaluated Using the Maternal Behaviour Q Sort (Short Version) and the Ainsworth Scales.

99 Participants

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Mother's Early Life Abuse and Neglect Were Evaluated Using the Childhood Trauma Questionnaire.

429 Participants

SECONDARY outcome

Timeframe: 60 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Mother's Eating Behaviours Were Evaluated Using the Dutch Eating Behavior Questionnaire.

350 Participants

SECONDARY outcome

Timeframe: 60 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Mother's Sensitivity to Punishment and Sensitivity to Reward Were Measured Using the Sensitivity to Punishment and Sensitivity to Reward Questionnaire.

350 Participants

SECONDARY outcome

Timeframe: 60 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Parenting Style Assessed Using the Parental Authority Questionnaire.

323 Participants

SECONDARY outcome

Timeframe: 72 months

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.

Outcome measures

Measure

Prenatal and 3 to 72 Months n=630 Participants 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.

Family Functioning Assessed Using the Family Assessment Device Questionnaire.

307 Participants

Adverse Events

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Patricia Pelufo Silveira

Douglas Mental Health University Institute

Phone: 1514-761-6131

Email: patricia.silveira@mcgill.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place