Clinical trial NCT05487105: Becoming a Parent During the COVID-19 Pandemic in Austria and Germany
Official title: Addendum Elternwerden in Zeiten Der COVID-19-Pandemie Zum Projekt "Pränatales Lernen Und Wiedererkennen Von Auditiven Reizen - Eine Psychophysiologische Perinatal Studie"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parents
COVID-19 Pandemic
Lead sponsor: University of Salzburg
Sponsor class: OTHER
Collaborators: name: Austrian Science Fund (FWF)
First posted: 2022-08-04
Enrollment: 2226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents that had a baby born since the 16th of March 2020 (which corresponds to the beginning of the first lockdown in Austria and in Bavaria, Germany)

Brief summary: This is an online survey in Austria and Germany directed at parents with children born since the start of the first lockdown of the COVID-19 pandemic (birthdate beginning with 16.03.2020). The survey includes questions about:

* current stress levels and depressive symptoms,
* resilience during the pandemic,
* social support,
* retrospective birth risk factors, pregnancy distress and pregnancy experience,
* demographic factors and
* other questions related to parenting and the COVID-19 pandemic.

Detailed description: The study evaluated data collected in the course of an online survey during the COVID-19 pandemic in Austria and Germany. The questions were conceived to reflect aspects of pregnancy, childbirth and early child rearing that could be affected by the pandemic, and included commonly used and previously validated scores for assessing pregnancy distress (Pregnancy Distress Questionnaire, PDQ), birth experiences (Childbirth Experience Questionnaire 2, CEQ2) postnatal depression (Edinburgh Postnatal Depression Scale, EPDS), perceived stress (Perceived Stress Scale, PSS) and pandemic-related experiences (pandemic resilience part, adapted to postnatal period, from the Pandemic Related Stress in Pregnancy Scale, PREPS). In addition, the investigators composed questions and scales that referred to specific pandemic- and parenting-related issues that were not covered otherwise. The investigators also tried to question both the fathers and the mothers, and consequently mothers received more pregnancy-related questions than fathers. Furthermore, biological mothers received childbirth-related questions which were omitted for adoptive mothers.

Eligibility criteria: Inclusion Criteria:

* parents that had a baby born since the 16th of March 2020 (which corresponds to the beginning of the first lockdown in Austria and in Bavaria, Germany)
* living in Austria or Germany

Exclusion Criteria:

* stillborn or neonatal death

Primary outcomes:
measure: Depressive symptoms
timeFrame: Over the previous seven days from the time of answering the questionnaire
measure: Perceived stress
timeFrame: Over the previous month from the time of answering the questionnaire
measure: Childbirth experience
timeFrame: At 0 to up to 15 months after birth (one assessment)
measure: Pregnancy distress
timeFrame: At 0 to up to 15 months after birth (one assessment)
measure: Resilience during the pandemic
timeFrame: One year after the beginning of the COVID-19 pandemic
measure: Social support
timeFrame: At 0 to up to 15 months after birth (one assessment)
measure: Child's Social Contacts
timeFrame: At 0 to up to 15 months after birth (one assessment)
measure: Pandemic Repercussions
timeFrame: One year after the beginning of the COVID-19 pandemic
measure: Pandemic Distress
timeFrame: One year after the beginning of the COVID-19 pandemic
measure: Birth Risk
timeFrame: Retrospectively assessed, at 0 to up to 15 months after birth (one assessment).
Secondary outcomes:
measure: Correlations between the scores from the primary outcome measures
timeFrame: At the time of answering the questionnaire
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paris-Lodron University of Salzburg
Study officials:
affiliation: Paris-Lodron University of Salzburg
name: Manuel Schabus, Prof. Dr.
role: STUDY_CHAIR
affiliation: Paris-Lodron University of Salzburg
name: Monika Angerer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: