Clinical trial NCT06162689: Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)
Official title: Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal Psychiatry
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Biomedical Research Centre
First posted: 2023-12-08
Enrollment: 201
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study comprised 2 groups: women at risk of postpartum psychosis during pregnancy (exposed group) and women with no current or past history of psychiatric disorders (unexposed group).

Cases were women at risk of postpartum psychosis because of a DSM-IV diagnosis of bipolar disorder, schizoaffective disorder or previous postpartum psychosis and controls were women who did not have a current or past history of psychiatric disorders. Clinical assessments were undertaken in the second and third trimesters of pregnancy and, following delivery, assessments of mother and infant were undertaken at 6 days, 8 weeks and 12 months post-delivery (n=72). At this stage, participants were asked to provide written consent to be contacted in the future about the possibility of taking part in a follow-up study.

Brief summary: 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.

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.

Primary outcomes:
measure: Child Salivary Cortisol
timeFrame: 6-8 years
measure: Child Salivary Cortisol
timeFrame: 6-8 years
Secondary outcomes:
measure: Wechsler Intelligence Scale for Children (4th Edition) (WISC-IV)
timeFrame: 6-8 years
measure: Wechsler Individual Achievement Test Second UK Edition (WIAT-II UK)
timeFrame: 6-8 years
measure: Dimensional Change Card Sort Test (DCCS)
timeFrame: 6-8 years
measure: Depression Self-Rating Scale (DSRS)
timeFrame: 6-8 years
measure: State-Trait Anxiety Inventory for Children (STAIC)
timeFrame: 6-8 years
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 6-8 years
measure: Development and Well-Being Assessment (DAWBA).
timeFrame: 6-8 years
measure: Juvenile Victimization Questionnaire (JVQ)
timeFrame: 6-8 years
measure: Traumatic Events Screening Inventory (TESI)
timeFrame: 6-8 years
measure: Child Rearing Practices Report (CRPR)
timeFrame: 6-8 years
measure: The Security Scale
timeFrame: 6-8 years
measure: Anthropometric Measures
timeFrame: 6-8 years
measure: Etch-a-Sketch Task
timeFrame: 6-8 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Paola Dazzan, MD MSc PhD FRCPsych
role: PRINCIPAL_INVESTIGATOR
References: