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NCT Number: NCT06162689

Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

King's College London

London, SE5 8AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Child Salivary Cortisol

    Time frame: 6-8 years

    Child stress response - salivary cortisol: saliva samples will be collected before and after a mild stressor test: Cold Pressor Test (CPT) to assess stress reactivity.

  2. Child Salivary Cortisol

    Time frame: 6-8 years

    Child stress response - salivary cortisol: saliva samples will be collected before and after a mild stress test: MacArthur Story Stem battery (MSSB) to asses stress reactivity

Secondary outcomes

  1. Wechsler Intelligence Scale for Children (4th Edition) (WISC-IV)

    Time frame: 6-8 years

    Child Cognitive Development

  2. Wechsler Individual Achievement Test Second UK Edition (WIAT-II UK)

    Time frame: 6-8 years

    Child Cognitive Development

  3. Dimensional Change Card Sort Test (DCCS)

    Time frame: 6-8 years

    Child Cognitive Development

  4. Depression Self-Rating Scale (DSRS)

    Time frame: 6-8 years

    Child Mental Health

  5. State-Trait Anxiety Inventory for Children (STAIC)

    Time frame: 6-8 years

    Child Mental Health

  6. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 6-8 years

    Child emotional/behavioural symptoms and mental health, parent-report.

  7. Development and Well-Being Assessment (DAWBA).

    Time frame: 6-8 years

    Child emotional/behavioural symptoms and mental health, parent-report.

  8. Juvenile Victimization Questionnaire (JVQ)

    Time frame: 6-8 years

    Child social-relational risk factors, parent-report.

  9. Traumatic Events Screening Inventory (TESI)

    Time frame: 6-8 years

    Child social-relational risk factors, parent-report.

  10. Child Rearing Practices Report (CRPR)

    Time frame: 6-8 years

    Child social-relational risk factors, parent-report.

  11. The Security Scale

    Time frame: 6-8 years

    To assess the child's perceptions of attachment security to their mother

  12. Anthropometric Measures

    Time frame: 6-8 years

    weight, height, waist circumference, waist-to-hip ratio, waist-to-height ratio, head circumference and digit ratio (2D-4D).

  13. Etch-a-Sketch Task

    Time frame: 6-8 years

    Parent-child interaction: video-recording of three joint parent-child activities (Etch-a-Sketch, block puzzles and a card game).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Biomedical Research Centre
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood

Acronym: PRAM-P@6to8

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.