- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432243
Mapping Antenatal Maternal Stress - Child Outcomes (MAMS-CO)
Mapping Antenatal Maternal Stress - Child Outcomes (MAMS-CO)
Study Overview
Status
Detailed Description
There is considerable evidence that maternal symptoms of depression and anxiety are associated, independent of birth outcomes, with detrimental outcomes in offspring, including cognitive, emotional and social development, as well as increased risk for psychopathology. Prior neuroimaging evidence has revealed effects of prenatal maternal symptoms of depression or anxiety on offspring brain structure and connectivity. In particular, individual differences in the volume and structure of limbic regions (i.e., hippocampus and amygdala) as well as prefrontal cortical regions implicated in psychopathology are associated with the quality of pre- and post-natal maternal mental health. The more recent studies reveal effects on critical connections between cortical and limbic regions, such as those from the amygdala to the insular cortex. There is also increasing evidence that the effects of maternal antenatal mood are of equal or greater importance in predicting child outcomes than maternal symptoms in the postnatal period.
In addition, whilst literature on paternal involvement has largely reflected a positive impact on child outcomes, these studies were done in western populations and may not be generalised in the context of local population, given the differences in ethnic and cultural backgrounds.
As such, the current study builds on the MAMS study's focus on maternal mental health and wellbeing, by undertaking more comprehensive assessments related to child outcomes and parent-child interactions, including paternal factors. The polygenic risk score (PRS) framework used in MAMS can be extended to fathers and children to investigate inter-individual variations in response to adversity.
Data will be collected through questionnaires done online, measurements, and assessments done during lab-based visits.
- Collection of samples such as buccal swabs and saliva
- Sleep actigraphy measures on infants
- Body measurements such as height, weight, and blood pressure
- Child developmental and behavioral assessments, including cognitive and language assessments
- Cognitive, socio-emotional and parenting tasks for mothers
- Mother-child interaction tasks
- Mother and infant EEG measurements
- Child eye-tracking tasks
- MRI measurements from the infant at postnatal 1 and 6 months
- Questionnaires related to depression, anxiety, psychosocial risk factors such as life stressors, social and partner support, socioeconomic factors, medical history, behavior, cognition, lifestyle, health status, parental bonding, childhood adversity experienced, socio-emotional factors, executive function, family dynamics, sleep quality, personality traits
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 117609
- Institute for Human Development and Potential
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Mother:
- Enrolled in MAMS study
- Intends for herself and her child to stay in Singapore for the next 5 years
- Access to a smartphone or standard laptop/ desktop
- Willing to take part in this study and able to provide written consent
- Aged 21-42 years
Father:
- Partner is already enrolled in MAMS study
- Aged 21-75 years
Exclusion Criteria:
Mother:
- Women with pre-existing or a history of psychotic depression, schizophrenia and bipolar disorders
- Women currently on oral/IV steroids and/or thyroids medication
- Women with a history of thyroid disease
- Women currently involved in on-going interventional randomized controlled trials
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determine specific contribution of maternal prenatal mood factor components to specific child developmental outcomes
Time Frame: From pregnancy to postnatal 6 years
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Analyses of maternal prenatal mood factors (e.g: maternal positive health, anxiety, depressive symptoms etc) to determine which components contribute to specific neurocognitive, socio-emotional and developmental outcomes in children
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From pregnancy to postnatal 6 years
|
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Functional and structural neuroimaging during infancy and early childhood
Time Frame: From birth to postnatal 6 years
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To examine functional dynamics and structural patterns of the brain anatomy and connectivity and its relation to child neurocognitive outcomes
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From birth to postnatal 6 years
|
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Contextual variables that moderate association between parental mental health and child outcomes
Time Frame: From pregnancy to postnatal 6 years
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To assess perinatal parental mental health in relation to child developmental outcomes using standardized clinical measures that have predictive validity for cognitive, emotional and social outcomes in young children, including SES, family cohesion, parental attitudes and genetics
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From pregnancy to postnatal 6 years
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Influence of paternal factors on relationship between maternal mental mood and child outcomes
Time Frame: From pregnancy to postnatal 6 years
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To examine examine paternal factors such as genetics, emotional health and parenting perceptions as modulators and mediators of maternal mental mood on child's socio-emotional, cognitive and developmental outcomes
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From pregnancy to postnatal 6 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/00189
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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