Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perinatal Psychiatry. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood
Overview
The goal of this observational study is to examine the relationship between severe perinatal maternal mental illness and stress reactivity and general development of children aged 6 to 8 years. Mothers were previously recruited and assessed during pregnancy and their babies were assessed at 6 days, 8 weeks and 12 months post delivery. This follow-up will assess the occurrence of any psychiatric episodes (e.g., depression, mania, psychosis) in the intervening period. Assessments of the children will include evaluation of their response to a mildly stressful procedure, as well as their physical, cognitive and social-emotional development, and their mental health. Possible factors that may moderate the relationship between the mother's perinatal mental health and the child's stress reactivity and development, including the home environment, adversity, parent-child interaction and maternal and paternal (or co-parent) mental health will also be assessed.
Detailed description
The principle research question is "does maternal stress system in pregnant women at risk of postpartum psychosis modify stress reactivity in children aged 6 to 8"?.
The "stress system" the investigators are studying is the endocrine system known as the hypothalamic-pituitary-adrenal (HPA) axis. The investigators measured levels of hormones from this system in blood and saliva in a sample of women at risk and not at risk of postpartum psychosis during pregnancy and measured cortisol in the saliva of their babies, before and after a stressful experience at 6 days, 8 weeks and 12 months of age.
The investigators found that infants born to women at risk of postpartum psychosis (PP) who relapsed in the first 4 weeks post-delivery had altered HPA axis activity at 6 days post-birth, compared with infants born to women at risk who remained well in the postpartum period.
The investigators now plan to examine whether levels of mothers' stress hormones associated with risk of postpartum psychosis during pregnancy are also associated with longer-lasting children's cortisol stress reactivity and diurnal rhythm of cortisol during middle childhood (ages 6 to 8).
Genetic material will be extracted from the child's specimens to look at genes, epigenetics (DNA methylation) and changes in gene expression, specifically, changes in genes which might be relevant to the development of stress. Assessments of maternal endocrine and maternal and paternal / co-parent mood measures will be undertaken. Children's cortisol response to stress and cortisol diurnal rhythm will be carried out at ages 6 to 8 years, together with assessments of their growth, cognitive development, social-emotional functioning and mental health. The father or co-parent mental health, their relationship with the mother and their interaction/relationship with the child will also be measured to investigate whether these moderate any effects of maternal perinatal mental health on child development.
Prospective participants (n=72) were recruited in pregnancy, to take part in a study entitled "Risk factors of perinatal mental disorders: stress, electrophysiological and neuroimaging markers", also known as the Psychiatry Research and Motherhood - Psychosis (PRAM-P) study. Clinical assessments were undertaken in pregnancy and, following delivery, assessments of the infant and mother were undertaken at 6 days, 8 weeks and 12 months post delivery. At the final visit, 67 participants gave their written consent to be contacted at some time in the future to discuss the possibility of participating in a follow-up study.
Primary outcome measures
- Child Salivary Cortisol [Time frame: 6-8 years]
- Child Salivary Cortisol [Time frame: 6-8 years]
Secondary outcome measures (12)
- Wechsler Intelligence Scale for Children (4th Edition) (WISC-IV) [Time frame: 6-8 years]
- Wechsler Individual Achievement Test Second UK Edition (WIAT-II UK) [Time frame: 6-8 years]
- Dimensional Change Card Sort Test (DCCS) [Time frame: 6-8 years]
- Depression Self-Rating Scale (DSRS) [Time frame: 6-8 years]
- State-Trait Anxiety Inventory for Children (STAIC) [Time frame: 6-8 years]
- Strengths and Difficulties Questionnaire (SDQ) [Time frame: 6-8 years]
- Development and Well-Being Assessment (DAWBA). [Time frame: 6-8 years]
- Juvenile Victimization Questionnaire (JVQ) [Time frame: 6-8 years]
- Traumatic Events Screening Inventory (TESI) [Time frame: 6-8 years]
- Child Rearing Practices Report (CRPR) [Time frame: 6-8 years]
- The Security Scale [Time frame: 6-8 years]
- Anthropometric Measures [Time frame: 6-8 years]
Eligibility criteria
Inclusion criteria
- Women who participated in the previous study (Risk factors of perinatal mental disorders: Stress, electrophysiological, and neuroimaging markers), who gave consent to be contacted again, together with their offspring, and the child's father/co-parent.
Exclusion criteria
- Women who participated in the previous study who refused consent to be contacted again.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- King's College London — London
Identifiers
NCT: NCT06162689 · 24.03.23 v1.0