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

NCT06162689 | Enrolling By Invitation

• 1 other identifier: 24.03.23 v1.0
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Psychiatry

Outcome Measures

Primary Outcomes (2)

• Child Salivary Cortisol

  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.

  6-8 years

• Child Salivary Cortisol

  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

  6-8 years

Secondary Outcomes (13)

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

  6-8 years

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

  6-8 years

• Dimensional Change Card Sort Test (DCCS)

  6-8 years

• Depression Self-Rating Scale (DSRS)

  6-8 years

• State-Trait Anxiety Inventory for Children (STAIC)

  6-8 years

Study Arms (2)

Exposed Group

Women at risk of postpartum psychosis during pregnancy

Unexposed Group

Women with no current or past history of psychiatric disorders during pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Women who participated in the previous study who refused consent to be contacted again.

Sponsors & Collaborators

• King's College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• Biomedical Research Centre: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples from adult participants and their children to assess salivary cortisol. Blood serum is collected from participants for the assessment of inflammatory markers and transcriptomic analysis.

Study Officials

• Paola Dazzan, MD MSc PhD FRCPsych

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: December 8, 2023
• Study Start: November 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-03

Locations

GB (1)