Depression DisorderPREMA-PSYNCT07918365
The Effects of Extreme Prematurity on Parenting
An observational study of Depression Disorder and Post Traumatic Stress Disorder PTSD, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide. Fathers may also experience significant psychological distress during the perinatal period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression Disorder, Post Traumatic Stress Disorder PTSD
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 31 May 2027
- How long will I take part?
- 1 Day
- 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
- All sexes
- Child, Adult, Older adult
Study population: Parent of a baby born at or before 28 weeks' gestation
Who may be able to join
- To have recently become the parent of a baby born at or before 28 weeks' gestation
- To be proficient in French
- To have signed the study consent form
Who cannot join
- - Persons deprived of their liberty by judicial or administrative decision; persons receiving involuntary psychiatric care
- Adults subject to a legal protection measure or unable to express their consent
- Patients who are not proficient in French
- Refusal to participate in the study
About this study
In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide. Fathers may also experience significant psychological distress during the perinatal period. These difficulties can affect parents' well-being, the developing parent-infant relationship, and family life, highlighting the importance of early identification and appropriate support for both parents.
The birth of an infant before 28 completed weeks of gestation can be a traumatic experience for parents. Concerns about the infant's survival and health, together with the unfamiliar environment of a neonatal intensive care unit, can disrupt the transition to parenthood and may be associated with severe depressive symptoms and childbirth-related post-traumatic stress symptoms.
Read more
This single-centre observational study explores the psychological experiences of couples following the birth of an infant before 28 completed weeks of gestation. Its primary objective is to assess childbirth-related post-traumatic stress symptoms using the City Birth Trauma Scale. Secondary objectives are to assess depressive symptoms and explore parental representations, emotional experiences, and psychological functioning.
Couples will be invited to participate during their infant's hospitalisation in the neonatal intensive care unit at Besançon University Hospital, France. Both parents in each couple will participate, with individual assessments taking place at least one month after birth. Each assessment session will last approximately 90 minutes and will include a semi-structured interview using the Clinical Interview for Parents of High-Risk Infants (CLIP), the Rorschach test, and two self-report questionnaires: the Edinburgh Postnatal Depression Scale (EPDS) and the City Birth Trauma Scale, using the appropriate maternal or partner version.
This exploratory study aims to improve understanding of parental psychological vulnerability following extremely preterm birth. In the longer term, its findings may raise healthcare professionals' awareness of maternal and paternal distress and inform approaches to systematic screening for postnatal depression and childbirth-related post-traumatic stress symptoms. Ultimately, this research seeks to support the development of care that addresses both parents' psychological needs and promotes early parent-infant relationships.
- Medical subject headings
- Combat Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth related post-traumatic stress disorder
The City Birth Trauma Scale (City BiTS) is a self-report questionnaire assessing childbirth-related post-traumatic stress symptoms according to DSM-5 criteria. It explores traumatic exposure, re-experiencing, avoidance, negative cognitions and mood, hyperarousal, symptom duration, distress, and functional impairment. Its 20 symptom items are scored from 0 to 3, yielding a total symptom score ranging from 0 to 60, with higher scores indicating greater symptom severity. In this study, the French versions for mothers and partners will be administered following very preterm birth. Total symptom scores will be analysed as a continuous measure. The questionnaire does not independently establish a clinical diagnosis of post-traumatic stress disorder.
Measured: November 2026 to May 2027
Secondary outcomes (1)
Postnatal Depression
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire assessing depressive symptoms over the past seven days. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 30, with higher scores indicating greater symptom severity. It includes an item assessing thoughts of self-harm. In this study, the French version will be administered to mothers and fathers following very preterm birth to assess parental depressive symptoms. Total scores will be analysed as a continuous measure. The EPDS is a screening instrument and does not establish a clinical diagnosis of depression.
Measured: November 2026 to May 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918365
- Sponsor's protocol ID
- 2026/1119
- Acronym
- PREMA-PSY
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extreme Prematurity on Parenting
- ClinicalTrials.gov ID
- NCT07918365
- Acronym / sponsor ID
- PREMA-PSY / 2026/1119
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide. Fathers may also experience significant psychological distress during the perinatal period. These difficulties can affect parents' well-being, the developing parent-infant relationship, and family life, highlighting the importance of early identification and appropriate support for both parents.
The birth of an infant before 28 completed weeks of gestation can be a traumatic experience for parents. Concerns about the infant's survival and health, together with the unfamiliar environment of a neonatal intensive care unit, can disrupt the transition to parenthood and may be associated with severe depressive symptoms and childbirth-related post-traumatic stress symptoms.
This single-centre observational study explores the psychological experiences of couples following the birth of an infant before 28 completed weeks of gestation. Its primary objective is to assess childbirth-related post-traumatic stress symptoms using the City Birth Trauma Scale. Secondary objectives are to assess depressive symptoms and explore parental representations, emotional experiences, and psychological functioning.
Couples will be invited to participate during their infant's hospitalisation in the neonatal intensive care unit at Besançon University Hospital, France. Both parents in each couple will participate, with individual assessments taking place at least one month after birth. Each assessment session will last approximately 90 minutes and will include a semi-structured interview using the Clinical Interview for Parents of High-Risk Infants (CLIP), the Rorschach test, and two self-report questionnaires: the Edinburgh Postnatal Depression Scale (EPDS) and the City Birth Trauma Scale, using the appropriate maternal or partner version.
This exploratory study aims to improve understanding of parental psychological vulnerability following extremely preterm birth. In the longer term, its findings may raise healthcare professionals' awareness of maternal and paternal distress and inform approaches to systematic screening for postnatal depression and childbirth-related post-traumatic stress symptoms. Ultimately, this research seeks to support the development of care that addresses both parents' psychological needs and promotes early parent-infant relationships.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Parent of a baby born at or before 28 weeks' gestation
Key inclusion criteria (3 listed)
- To have recently become the parent of a baby born at or before 28 weeks' gestation
- To be proficient in French
- To have signed the study consent form
Key exclusion criteria (4 listed)
- - Persons deprived of their liberty by judicial or administrative decision; persons receiving involuntary psychiatric care
- Adults subject to a legal protection measure or unable to express their consent
- Patients who are not proficient in French
- Refusal to participate in the study
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
Childbirth related post-traumatic stress disorder
Time frame: November 2026 to May 2027
The City Birth Trauma Scale (City BiTS) is a self-report questionnaire assessing childbirth-related post-traumatic stress symptoms according to DSM-5 criteria. It explores traumatic exposure, re-experiencing, avoidance, negative cognitions and mood, hyperarousal, symptom duration, distress, and functional impairment. Its 20 symptom items are scored from 0 to 3, yielding a total symptom score ranging from 0 to 60, with higher scores indicating greater symptom severity. In this study, the French versions for mothers and partners will be administered following very preterm birth. Total symptom scores will be analysed as a continuous measure. The questionnaire does not independently establish a clinical diagnosis of post-traumatic stress disorder.
1 secondary outcome
Postnatal Depression
Time frame: November 2026 to May 2027
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 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression Disorder and Post Traumatic Stress Disorder PTSD, run by Centre Hospitalier Universitaire de Besancon.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Childbirth related post-traumatic stress disorder (time frame: November 2026 to May 2027). 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 5 Nov 2026.