Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)MAVANNCT03434457
Maternal Adversity, Vulnerability and Neurodevelopment
An observational study of Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Infant Development, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- How many people
- 630 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2003to 1 Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Verdun, Quebec, H4H 1R3
About this study
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.
Read the detailed description
In 2003 the Canadian Institutes of Health Research (CIHR) funded an ambitious and internationally unique study on the development of individual differences in vulnerability for mental illness. Increasing evidence indicates that many forms of mental illness as well as diabetes and cardiovascular disease are best considered as developmental disorders where vulnerability emerges as a function of genetic and epigenetic events. Frank pathology then develops as a function of the continuous interaction between underlying vulnerability and prevailing environmental triggers. The critical question is that of understanding the mechanisms by which specific forms of gene x environment interactions in perinatal life define the level of vulnerability/resistance to illness.
Maternal adversity during fetal life including maternal stress (as well as depression), low social support, poor maternal nutrition, and tobacco/alcohol consumption predict both preterm labour and intrauterine growth restriction. These birth outcomes, in turn, represent major epidemiological risk factors for heart disease, diabetes, and depression in adulthood, and neurodevelopmental impairments in children. Postnatal maternal adversity compromises maternal care/behaviour and infant development, and predicts increased risk for obesity, heart disease, attentional deficit disorders (ADD), drug abuse, and depression. Despite the enormous potential for the interaction of prenatal and postnatal influences, research has largely been restricted to the effects of events occurring during only one developmental period which, among other things, ignores the potential importance of 'protective' factors operating at later stages in life. Moreover, the underlying mechanisms by which perinatal adversity might directly affect neurocognitive development have been very poorly studied.
The investigators proposed an innovative research program that focuses on child development using a longitudinal, within-subject design examining neural and cognitive/emotional outcomes as a function of genomic and epigenomic factors. These studies focus on 500 mother-infant dyads drawn from two human studies (Montreal \& Hamilton). Assessment of maternal wellbeing and infant development (cognition, socio-emotional development, temperament, and brain structure) trajectories are undertaken from mid-pregnancy until 10 years of age. Genomic and epigenomic approaches were used to assess genetic vulnerability in these populations using a GWAS approach. This represents the first longitudinal study linking neurocognitive/behavioural function with structural neurodevelopment through neuroimaging and genetic vulnerability in humans, in the presence or absence of maternal adversity. The ability to identify postnatal events that serve to reverse a condition of vulnerability has enormous implications for the development of prevention /intervention programs reducing the future rates of a broad spectrum of chronic illnesses.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Keywords
- Fetal growth retardation, Early adversity, Depressive Symptoms
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, Infant Behavior, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prenatal and 3 to 72 months | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II.
Assessment of child development was done using the cognitive, motor and mental scales of the Bayley Scales of Infant Development II.
Measured: At 6, 12, 18 and 36 months
Child Temperament Evaluated Using the Infant Behaviour Questionnaire.
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.
Measured: 3 and 6 months
Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire.
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.
Measured: 18 and 36 months
Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire.
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.
Measured: 18 and 24 months
Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist.
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.
Measured: 48 and 60 months
Changes in Child's School Readiness Measured With the School Readiness Test Battery.
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.
Measured: 48 and 60 months
Evaluation or Child's Cognitive Development Using the Developmental Neuropsychological Assessment.
Child's cognitive development was assessed using the sensory-motor and visuo-spatial processing subscales of the Developmental Neuropsychological Assessment (NEPSY).
Measured: 48 months
Evaluation of Child's Cognitive Development Using the Weschler Preschool and Primary Scale of Intelligence.
Child's cognitive development was assessed using the vocabulary and the bloc design subscales of the Weschler Preschool Primary Scale of Intelligence (WPPSI).
Measured: 48 months
Changes in Child's Hyperactivity Problems Measured With the Conner's.
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.
Measured: 60 and 72 months
Child's Fears Assessed With the Koala Fear Questionnaire.
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 ).
Measured: 60 months
Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire.
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.
- emotional symptoms (5 items)
- conduct problems (5 items)
- hyperactivity/inattention (5 items)
- peer relationship problems (5 items)
- prosocial behaviour (5 items) Number 1) to 4) added together to generate a total difficulties score.
Measured: 60 and 72 months
Child's Behavioural Inhibition and Behavioural Activation Were Measured Using the Behavioural Inhibition System (BIS) and the Behavioural Approach System (BAS)
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.
Measured: 60 months
Child's Mental Health Was Evaluated Using the Dominic Questionnaire.
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.
Measured: 72 months
The Child's Attributional Style Was Evaluated With the Child Attributional Style Interview.
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.
Measured: 72 months
Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire.
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.
Measured: 48 and 72 months
Child's Executive Functioning Measured With the Behavior Rating of Executive Function.
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.
Measured: 72 months
Sensitivity to Punishment & Sensitivity to Reward in Children Will be Evaluated Using the Child Version of the Sensitivity to Punishment & Sensitivity to Reward Questionnaire.
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.
Measured: 72 months
Secondary outcomes (11)
Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory.
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.
Measured: 60 and 72 months
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale.
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.
Measured: Prenatal, 6, 12, 24, 36, 48, 60, 72 months
Changes in Mother's Depression Symptoms Were Measured With the Edinburgh Postnatal Depression Scale.
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.
Measured: 6 months
Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory.
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.
Measured: 3, 24 and 60 months
Mother's Retrospective Assessment of Parental Educational Style Using the Parental Bonding Inventory.
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.
Measured: 6 months
Changes in Mother's Sensitivity Was Evaluated Using the Maternal Behaviour Q Sort (Short Version) and the Ainsworth Scales.
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.
Measured: 18 months
Mother's Early Life Abuse and Neglect Were Evaluated Using the Childhood Trauma Questionnaire.
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.
Measured: 24 months
Mother's Eating Behaviours Were Evaluated Using the Dutch Eating Behavior Questionnaire.
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.
Measured: 60 months
Mother's Sensitivity to Punishment and Sensitivity to Reward Were Measured Using the Sensitivity to Punishment and Sensitivity to Reward Questionnaire.
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.
Measured: 60 months
Parenting Style Assessed Using the Parental Authority Questionnaire.
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.
Measured: 60 months
Family Functioning Assessed Using the Family Assessment Device Questionnaire.
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.
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Oct 2003
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Michael J Meaney, Douglas Mental Health University Institute
- Investigators
- Michael J Meaney, PhD, Study director, James McGill Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434457
- Sponsor's protocol ID
- DouglasMHU
- Acronym
- MAVAN
- Status last verified
- May 2020
- First submitted
- 30 Jan 2018
- Last updated
- 27 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Donnell KA, Gaudreau H, Colalillo S, Steiner M, Atkinson L, Moss E, Goldberg S, Karama S, Matthews SG, Lydon JE, Silveira PP, Wazana AD, Levitan RD, Sokolowski MB, Kennedy JL, Fleming A, Meaney MJ; MAVAN Research Team. The maternal adversity, vulnerability and neurodevelopment project: theory and methodology. Can J Psychiatry. 2014 Sep;59(9):497-508. doi: 10.1177/070674371405900906.
PubMed 25565695Mileva-Seitz V, Kennedy J, Atkinson L, Steiner M, Levitan R, Matthews SG, Meaney MJ, Sokolowski MB, Fleming AS. Serotonin transporter allelic variation in mothers predicts maternal sensitivity, behavior and attitudes toward 6-month-old infants. Genes Brain Behav. 2011 Apr;10(3):325-33. doi: 10.1111/j.1601-183X.2010.00671.x. Epub 2011 Jan 13.
PubMed 21232011Silveira PP, Agranonik M, Faras H, Portella AK, Meaney MJ, Levitan RD; Maternal Adversity, Vulnerability and Neurodevelopment Study Team. Preliminary evidence for an impulsivity-based thrifty eating phenotype. Pediatr Res. 2012 Mar;71(3):293-8. doi: 10.1038/pr.2011.39. Epub 2012 Jan 25.
PubMed 22278183Mileva-Seitz V, Steiner M, Atkinson L, Meaney MJ, Levitan R, Kennedy JL, Sokolowski MB, Fleming AS. Interaction between oxytocin genotypes and early experience predicts quality of mothering and postpartum mood. PLoS One. 2013 Apr 18;8(4):e61443. doi: 10.1371/journal.pone.0061443. Print 2013.
PubMed 23637833Jonas W, Mileva-Seitz V, Girard AW, Bisceglia R, Kennedy JL, Sokolowski M, Meaney MJ, Fleming AS, Steiner M; MAVAN Research Team. Genetic variation in oxytocin rs2740210 and early adversity associated with postpartum depression and breastfeeding duration. Genes Brain Behav. 2013 Oct;12(7):681-94. doi: 10.1111/gbb.12069. Epub 2013 Aug 31.
PubMed 23941164Adedinsewo DA, Fleming AS, Steiner M, Meaney MJ, Girard AW; MAVAN team. Maternal anxiety and breastfeeding: findings from the MAVAN (Maternal Adversity, Vulnerability and Neurodevelopment) Study. J Hum Lact. 2014 Feb;30(1):102-9. doi: 10.1177/0890334413504244. Epub 2013 Sep 24.
PubMed 24065719Silveira PP, Portella AK, Kennedy JL, Gaudreau H, Davis C, Steiner M, Soares CN, Matthews SG, Sokolowski MB, Dube L, Loucks EB, Hamilton J, Meaney MJ, Levitan RD; MAVAN Study Team. Association between the seven-repeat allele of the dopamine-4 receptor gene (DRD4) and spontaneous food intake in pre-school children. Appetite. 2014 Feb;73:15-22. doi: 10.1016/j.appet.2013.10.004. Epub 2013 Oct 20.
PubMed 24153108Neuwald MF, Agranonik M, Portella AK, Fleming A, Wazana A, Steiner M, Levitan RD, Meaney MJ, Silveira PP; MAVAN Study Team. Transgenerational effects of maternal care interact with fetal growth and influence attention skills at 18 months of age. Early Hum Dev. 2014 May;90(5):241-6. doi: 10.1016/j.earlhumdev.2014.01.015. Epub 2014 Mar 3.
PubMed 24602473Escobar RS, O'Donnell KA, Colalillo S, Pawlby S, Steiner M, Meaney MJ, Levitan RD, Silveira PP; MAVAN Study Team. Better quality of mother-child interaction at 4 years of age decreases emotional overeating in IUGR girls. Appetite. 2014 Oct;81:337-42. doi: 10.1016/j.appet.2014.06.107. Epub 2014 Jul 8.
PubMed 25014742Wendland BE, Atkinson L, Steiner M, Fleming AS, Pencharz P, Moss E, Gaudreau H, Silveira PP, Arenovich T, Matthews SG, Meaney MJ, Levitan RD; MAVAN Study Team. Low maternal sensitivity at 6 months of age predicts higher BMI in 48 month old girls but not boys. Appetite. 2014 Nov;82:97-102. doi: 10.1016/j.appet.2014.07.012. Epub 2014 Jul 15.
PubMed 25049136Pennestri MH, Moss E, O'Donnell K, Lecompte V, Bouvette-Turcot AA, Atkinson L, Minde K, Gruber R, Fleming AS, Meaney MJ, Gaudreau H; MAVAN Research Team. Establishment and consolidation of the sleep-wake cycle as a function of attachment pattern. Attach Hum Dev. 2015;17(1):23-42. doi: 10.1080/14616734.2014.953963. Epub 2014 Sep 18.
PubMed 25231054Levitan RD, Rivera J, Silveira PP, Steiner M, Gaudreau H, Hamilton J, Kennedy JL, Davis C, Dube L, Fellows L, Wazana A, Matthews S, Meaney MJ; MAVAN Study Team. Gender differences in the association between stop-signal reaction times, body mass indices and/or spontaneous food intake in pre-school children: an early model of compromised inhibitory control and obesity. Int J Obes (Lond). 2015 Apr;39(4):614-9. doi: 10.1038/ijo.2014.207. Epub 2014 Dec 16.
PubMed 25512364Bouvette-Turcot AA, Fleming AS, Wazana A, Sokolowski MB, Gaudreau H, Gonzalez A, Deslauriers J, Kennedy JL, Steiner M, Meaney MJ; MAVAN Research Team. Maternal childhood adversity and child temperament: an association moderated by child 5-HTTLPR genotype. Genes Brain Behav. 2015 Mar;14(3):229-37. doi: 10.1111/gbb.12205. Epub 2015 Mar 24.
PubMed 25688466Pennestri MH, Gaudreau H, Bouvette-Turcot AA, Moss E, Lecompte V, Atkinson L, Lydon J, Steiner M, Meaney MJ; Mavan Research Team. Attachment disorganization among children in Neonatal Intensive Care Unit: Preliminary results. Early Hum Dev. 2015 Oct;91(10):601-6. doi: 10.1016/j.earlhumdev.2015.07.005. Epub 2015 Aug 8.
PubMed 26261864Bouvette-Turcot AA, Pluess M, Bernier A, Pennestri MH, Levitan R, Sokolowski MB, Kennedy JL, Minde K, Steiner M, Pokhvisneva I, Meaney MJ, Gaudreau H; MAVAN research team. Effects of Genotype and Sleep on Temperament. Pediatrics. 2015 Oct;136(4):e914-21. doi: 10.1542/peds.2015-0080. Epub 2015 Sep 14.
PubMed 26371199
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Adversity, Vulnerability and Neurodevelopment
- ClinicalTrials.gov ID
- NCT03434457
- Acronym / sponsor ID
- MAVAN / DouglasMHU
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Keywords
- Fetal growth retardation, Early adversity, Depressive Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- 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
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 27 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In 2003 the Canadian Institutes of Health Research (CIHR) funded an ambitious and internationally unique study on the development of individual differences in vulnerability for mental illness. Increasing evidence indicates that many forms of mental illness as well as diabetes and cardiovascular disease are best considered as developmental disorders where vulnerability emerges as a function of genetic and epigenetic events. Frank pathology then develops as a function of the continuous interaction between underlying vulnerability and prevailing environmental triggers. The critical question is that of understanding the mechanisms by which specific forms of gene x environment interactions in perinatal life define the level of vulnerability/resistance to illness.
Maternal adversity during fetal life including maternal stress (as well as depression), low social support, poor maternal nutrition, and tobacco/alcohol consumption predict both preterm labour and intrauterine growth restriction. These birth outcomes, in turn, represent major epidemiological risk factors for heart disease, diabetes, and depression in adulthood, and neurodevelopmental impairments in children. Postnatal maternal adversity compromises maternal care/behaviour and infant development, and predicts increased risk for obesity, heart disease, attentional deficit disorders (ADD), drug abuse, and depression. Despite the enormous potential for the interaction of prenatal and postnatal influences, research has largely been restricted to the effects of events occurring during only one developmental period which, among other things, ignores the potential importance of 'protective' factors operating at later stages in life. Moreover, the underlying mechanisms by which perinatal adversity might directly affect neurocognitive development have been very poorly studied.
The investigators proposed an innovative research program that focuses on child development using a longitudinal, within-subject design examining neural and cognitive/emotional outcomes as a function of genomic and epigenomic factors. These studies focus on 500 mother-infant dyads drawn from two human studies (Montreal \& Hamilton). Assessment of maternal wellbeing and infant development (cognition, socio-emotional development, temperament, and brain structure) trajectories are undertaken from mid-pregnancy until 10 years of age. Genomic and epigenomic approaches were used to assess genetic vulnerability in these populations using a GWAS approach. This represents the first longitudinal study linking neurocognitive/behavioural function with structural neurodevelopment through neuroimaging and genetic vulnerability in humans, in the presence or absence of maternal adversity. The ability to identify postnatal events that serve to reverse a condition of vulnerability has enormous implications for the development of prevention /intervention programs reducing the future rates of a broad spectrum of chronic illnesses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prenatal and 3 to 72 months | – | – |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II.
Time frame: 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.
Child Temperament Evaluated Using the Infant Behaviour Questionnaire.
Time frame: 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.
Changes in Child Temperament Evaluated Using the Early Childhood Behaviour Questionnaire.
Time frame: 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.
Changes in Socio-emotional Development Measured Using the Infant Toddler Socio-emotional Assessment Questionnaire.
Time frame: 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.
Changes in Child's Behaviour Problems Measured With the Child Behaviour Checklist.
Time frame: 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.
Changes in Child's School Readiness Measured With the School Readiness Test Battery.
Time frame: 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.
Evaluation or Child's Cognitive Development Using the Developmental Neuropsychological Assessment.
Time frame: 48 months
Child's cognitive development was assessed using the sensory-motor and visuo-spatial processing subscales of the Developmental Neuropsychological Assessment (NEPSY).
Evaluation of Child's Cognitive Development Using the Weschler Preschool and Primary Scale of Intelligence.
Time frame: 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).
Changes in Child's Hyperactivity Problems Measured With the Conner's.
Time frame: 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.
Child's Fears Assessed With the Koala Fear Questionnaire.
Time frame: 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 ).
Changes in Child's Emotional and Behaviour Problems Measured With the Strength and Difficulty Questionnaire.
Time frame: 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.
Child's Behavioural Inhibition and Behavioural Activation Were Measured Using the Behavioural Inhibition System (BIS) and the Behavioural Approach System (BAS)
Time frame: 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.
Child's Mental Health Was Evaluated Using the Dominic Questionnaire.
Time frame: 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.
The Child's Attributional Style Was Evaluated With the Child Attributional Style Interview.
Time frame: 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.
Changes in Child's Feeding Behaviour Was Measured With the Child Eating Behaviour Questionnaire.
Time frame: 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.
Child's Executive Functioning Measured With the Behavior Rating of Executive Function.
Time frame: 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.
Sensitivity to Punishment & Sensitivity to Reward in Children Will be Evaluated Using the Child Version of the Sensitivity to Punishment & Sensitivity to Reward Questionnaire.
Time frame: 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.
11 secondary outcomes
Changes in Mother's Depression Symptoms Measured With the Beck Depression Inventory.
Time frame: 60 and 72 months
Changes in Mother's Depression Symptoms Measured With the Center for Epidemiological Studies, Depression Scale.
Time frame: Prenatal, 6, 12, 24, 36, 48, 60, 72 months
Changes in Mother's Depression Symptoms Were Measured With the Edinburgh Postnatal Depression Scale.
Time frame: 6 months
Changes in Mother's Anxiety Symptoms Were Measured Using the Speilberger State-Trait Anxiety Inventory.
Time frame: 3, 24 and 60 months
Mother's Retrospective Assessment of Parental Educational Style Using the Parental Bonding Inventory.
Time frame: 6 months
Changes in Mother's Sensitivity Was Evaluated Using the Maternal Behaviour Q Sort (Short Version) and the Ainsworth Scales.
Time frame: 18 months
Mother's Early Life Abuse and Neglect Were Evaluated Using the Childhood Trauma Questionnaire.
Time frame: 24 months
Mother's Eating Behaviours Were Evaluated Using the Dutch Eating Behavior Questionnaire.
Time frame: 60 months
Mother's Sensitivity to Punishment and Sensitivity to Reward Were Measured Using the Sensitivity to Punishment and Sensitivity to Reward Questionnaire.
Time frame: 60 months
Parenting Style Assessed Using the Parental Authority Questionnaire.
Time frame: 60 months
Family Functioning Assessed Using the Family Assessment Device Questionnaire.
Time frame: 72 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25565695O'Donnell KA, Gaudreau H, Colalillo S, Steiner M, Atkinson L, Moss E, Goldberg S, Karama S, Matthews SG, Lydon JE, Silveira PP, Wazana AD, Levitan RD, Sokolowski MB, Kennedy JL, Fleming A, Meaney MJ; MAVAN Research Team. The maternal adversity, vulnerability and neurodevelopment project: theory and methodology. Can J Psychiatry. 2014 Sep;59(9):497-508. doi: 10.1177/070674371405900906.
- Results publication: PubMed 21232011Mileva-Seitz V, Kennedy J, Atkinson L, Steiner M, Levitan R, Matthews SG, Meaney MJ, Sokolowski MB, Fleming AS. Serotonin transporter allelic variation in mothers predicts maternal sensitivity, behavior and attitudes toward 6-month-old infants. Genes Brain Behav. 2011 Apr;10(3):325-33. doi: 10.1111/j.1601-183X.2010.00671.x. Epub 2011 Jan 13.
- Results publication: PubMed 22278183Silveira PP, Agranonik M, Faras H, Portella AK, Meaney MJ, Levitan RD; Maternal Adversity, Vulnerability and Neurodevelopment Study Team. Preliminary evidence for an impulsivity-based thrifty eating phenotype. Pediatr Res. 2012 Mar;71(3):293-8. doi: 10.1038/pr.2011.39. Epub 2012 Jan 25.
- Results publication: PubMed 23637833Mileva-Seitz V, Steiner M, Atkinson L, Meaney MJ, Levitan R, Kennedy JL, Sokolowski MB, Fleming AS. Interaction between oxytocin genotypes and early experience predicts quality of mothering and postpartum mood. PLoS One. 2013 Apr 18;8(4):e61443. doi: 10.1371/journal.pone.0061443. Print 2013.
- Results publication: PubMed 23941164Jonas W, Mileva-Seitz V, Girard AW, Bisceglia R, Kennedy JL, Sokolowski M, Meaney MJ, Fleming AS, Steiner M; MAVAN Research Team. Genetic variation in oxytocin rs2740210 and early adversity associated with postpartum depression and breastfeeding duration. Genes Brain Behav. 2013 Oct;12(7):681-94. doi: 10.1111/gbb.12069. Epub 2013 Aug 31.
- Results publication: PubMed 24065719Adedinsewo DA, Fleming AS, Steiner M, Meaney MJ, Girard AW; MAVAN team. Maternal anxiety and breastfeeding: findings from the MAVAN (Maternal Adversity, Vulnerability and Neurodevelopment) Study. J Hum Lact. 2014 Feb;30(1):102-9. doi: 10.1177/0890334413504244. Epub 2013 Sep 24.
- Results publication: PubMed 24153108Silveira PP, Portella AK, Kennedy JL, Gaudreau H, Davis C, Steiner M, Soares CN, Matthews SG, Sokolowski MB, Dube L, Loucks EB, Hamilton J, Meaney MJ, Levitan RD; MAVAN Study Team. Association between the seven-repeat allele of the dopamine-4 receptor gene (DRD4) and spontaneous food intake in pre-school children. Appetite. 2014 Feb;73:15-22. doi: 10.1016/j.appet.2013.10.004. Epub 2013 Oct 20.
- Results publication: PubMed 24602473Neuwald MF, Agranonik M, Portella AK, Fleming A, Wazana A, Steiner M, Levitan RD, Meaney MJ, Silveira PP; MAVAN Study Team. Transgenerational effects of maternal care interact with fetal growth and influence attention skills at 18 months of age. Early Hum Dev. 2014 May;90(5):241-6. doi: 10.1016/j.earlhumdev.2014.01.015. Epub 2014 Mar 3.
- Results publication: PubMed 25014742Escobar RS, O'Donnell KA, Colalillo S, Pawlby S, Steiner M, Meaney MJ, Levitan RD, Silveira PP; MAVAN Study Team. Better quality of mother-child interaction at 4 years of age decreases emotional overeating in IUGR girls. Appetite. 2014 Oct;81:337-42. doi: 10.1016/j.appet.2014.06.107. Epub 2014 Jul 8.
- Results publication: PubMed 25049136Wendland BE, Atkinson L, Steiner M, Fleming AS, Pencharz P, Moss E, Gaudreau H, Silveira PP, Arenovich T, Matthews SG, Meaney MJ, Levitan RD; MAVAN Study Team. Low maternal sensitivity at 6 months of age predicts higher BMI in 48 month old girls but not boys. Appetite. 2014 Nov;82:97-102. doi: 10.1016/j.appet.2014.07.012. Epub 2014 Jul 15.
- Results publication: PubMed 25231054Pennestri MH, Moss E, O'Donnell K, Lecompte V, Bouvette-Turcot AA, Atkinson L, Minde K, Gruber R, Fleming AS, Meaney MJ, Gaudreau H; MAVAN Research Team. Establishment and consolidation of the sleep-wake cycle as a function of attachment pattern. Attach Hum Dev. 2015;17(1):23-42. doi: 10.1080/14616734.2014.953963. Epub 2014 Sep 18.
- Results publication: PubMed 25512364Levitan RD, Rivera J, Silveira PP, Steiner M, Gaudreau H, Hamilton J, Kennedy JL, Davis C, Dube L, Fellows L, Wazana A, Matthews S, Meaney MJ; MAVAN Study Team. Gender differences in the association between stop-signal reaction times, body mass indices and/or spontaneous food intake in pre-school children: an early model of compromised inhibitory control and obesity. Int J Obes (Lond). 2015 Apr;39(4):614-9. doi: 10.1038/ijo.2014.207. Epub 2014 Dec 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Meaney, PhD study director
James McGill Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Infant Development, run by Douglas Mental Health University Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's Cognitive Development Measured Using the Bayley Scales of Infant Development II. (time frame: At 6, 12, 18 and 36 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434457, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.