Perinatal PsychiatryPRAM-P@6to8NCT06162689
Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)
An observational study of Perinatal Psychiatry, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Psychiatry
- How many people
- 201 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Women who participated in the previous study who refused consent to be contacted again.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood
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.
Read the 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.
- Conditions
- Perinatal Psychiatry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group | Women at risk of postpartum psychosis during pregnancy | |
| Unexposed Group | Women with no current or past history of psychiatric disorders during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6-8 years
Secondary outcomes (13)
Wechsler Intelligence Scale for Children (4th Edition) (WISC-IV)
Child Cognitive Development
Measured: 6-8 years
Wechsler Individual Achievement Test Second UK Edition (WIAT-II UK)
Child Cognitive Development
Measured: 6-8 years
Dimensional Change Card Sort Test (DCCS)
Child Cognitive Development
Measured: 6-8 years
Depression Self-Rating Scale (DSRS)
Child Mental Health
Measured: 6-8 years
State-Trait Anxiety Inventory for Children (STAIC)
Child Mental Health
Measured: 6-8 years
Strengths and Difficulties Questionnaire (SDQ)
Child emotional/behavioural symptoms and mental health, parent-report.
Measured: 6-8 years
Development and Well-Being Assessment (DAWBA).
Child emotional/behavioural symptoms and mental health, parent-report.
Measured: 6-8 years
Juvenile Victimization Questionnaire (JVQ)
Child social-relational risk factors, parent-report.
Measured: 6-8 years
Traumatic Events Screening Inventory (TESI)
Child social-relational risk factors, parent-report.
Measured: 6-8 years
Child Rearing Practices Report (CRPR)
Child social-relational risk factors, parent-report.
Measured: 6-8 years
The Security Scale
To assess the child's perceptions of attachment security to their mother
Measured: 6-8 years
Anthropometric Measures
weight, height, waist circumference, waist-to-hip ratio, waist-to-height ratio, head circumference and digit ratio (2D-4D).
Measured: 6-8 years
Etch-a-Sketch Task
Parent-child interaction: video-recording of three joint parent-child activities (Etch-a-Sketch, block puzzles and a card game).
Measured: 6-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal PsychiatryStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Biomedical Research Centre
- Responsible party
- Sponsor
- Investigators
- Paola Dazzan, MD MSc PhD FRCPsych, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162689
- Sponsor's protocol ID
- 24.03.23 v1.0
- Acronym
- PRAM-P@6to8
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study data will be analysed and results will be submitted for publication; participant identity will not be revealed. Study data will be retained and may be used in future studies, if this happens, further Research Ethics Committee approval will be sought. Authorised persons such as researchers, sponsors, regulatory authorities and Research and Development audit will have access to view identifiable data, for monitoring of the quality of the research. Study data will be retained for 20 years after completion of the study; and will be disposed of securely.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Risk Factors for Postpartum Psychosis Alter Offspring Outcomes in Middle Childhood
- ClinicalTrials.gov ID
- NCT06162689
- Acronym / sponsor ID
- PRAM-P@6to8 / 24.03.23 v1.0
- Conditions
- Perinatal Psychiatry
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Biomedical Research Centre
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group | – | –Women at risk of postpartum psychosis during pregnancy |
| Unexposed Group | – | –Women with no current or past history of psychiatric disorders during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who participated in the previous study who refused consent to be contacted again.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
13 secondary outcomes
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
Etch-a-Sketch Task
Time frame: 6-8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided. Study data will be analysed and results will be submitted for publication; participant identity will not be revealed. Study data will be retained and may be used in future studies, if this happens, further Research Ethics Committee approval will be sought. Authorised persons such as researchers, sponsors, regulatory authorities and Research and Development audit will have access to view identifiable data, for monitoring of the quality of the research. Study data will be retained for 20 years after completion of the study; and will be disposed of securely.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola Dazzan, MD MSc PhD FRCPsych principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Psychiatry, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Salivary Cortisol (time frame: 6-8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.