Becoming a Parent During the COVID-19 Pandemic in Austria and Germany

COVID-19 Pandemic Clinical Trial

Official title:

Addendum Elternwerden in Zeiten Der COVID-19-Pandemie Zum Projekt "Pränatales Lernen Und Wiedererkennen Von Auditiven Reizen - Eine Psychophysiologische Perinatal Studie"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487105
• Other study ID #: EK-GZ12/2013-Addendum-07/2021
• Status: Completed
• Start date: May 18, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2022
• Source: University of Salzburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2226
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Parents

Locations

Country	Name	City	State
Austria	Paris-Lodron University of Salzburg	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Salzburg	Austrian Science Fund (FWF)

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	Score on the Edinburgh Postnatal Depression Scale, range 0-30. Interpretation: 0-8 (depression not likely), 9-11 (depression possible), 12-13 (fairly high possibility), 14-30 (probable depression).	Over the previous seven days from the time of answering the questionnaire
Primary	Perceived stress	Score on the Perceived Stress Scale, range 0 to 40. Interpretation: 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress).	Over the previous month from the time of answering the questionnaire
Primary	Childbirth experience	Score on the Childbirth Experience Questionnaire 2 - factors "Coping ability", "Participation" and "Emotional experience". Range 13 (negative) to 52 (positive birth experience).	At 0 to up to 15 months after birth (one assessment)
Primary	Pregnancy distress	Score on the Pregnancy Distress Questionnaire, 10 items scored from 0 to 4. The total score is the sum of all items divided by the number of items (10). The score's range is 0 (low distress) to 4 (high distress).	At 0 to up to 15 months after birth (one assessment)
Primary	Resilience during the pandemic	Score on the resilience subscale from the Pandemic Related Pregnancy Stress Scale, adapted to postpartum participants. It contains 7 items, scored from 1 to 5. The total score range is 7 (low resilience) to 35 (high resilience).	One year after the beginning of the COVID-19 pandemic
Primary	Social support	The Social Support score consisted of 3 Items scored on a Likert scale from 0-4, covering the subjective feeling of social support. Its possible range was 0 to 12, with higher scores indicating more social support.	At 0 to up to 15 months after birth (one assessment)
Primary	Child's Social Contacts	The Child's Social Contacts score is the sum of frequencies with which the child has contact with other people, each item representing one person/relationship (mother, father, siblings, grandparents, other adults, other children), which are independent of each other. The possible range for the Child's Social Contacts score was 0-6, 6 points indicating daily contact with parents, sibling(s), grandparent(s), other adults, and other children, and 0 indicating no contact at all.	At 0 to up to 15 months after birth (one assessment)
Primary	Pandemic Repercussions	The Pandemic Repercussions score comprises five items which inquire about the perceived influence of the coronavirus situation on the pregnancy, birth experience, health and development of the child, financial security, and on the partnership. Each item was scored from -2 (for strong positive influence) to 2 (strong negative influence), making the possible range of the score from -10 to +10, where negative values indicate positive repercussions and positive values indicate negative repercussions.	One year after the beginning of the COVID-19 pandemic
Primary	Pandemic Distress	The Pandemic Distress score consisted of 3 Items that inquired about the participant's worries about the virus affecting herself, her relatives and/or her baby. Each item was scored on a Likert scale from 0-4, so that the possible range of the score was 0-12, with higher values indicating that the participant is more worried. This score is computed only for those participants who had not had Covid-19 themselves, since those who had had Covid-19 were not asked whether they worried to catch it again.	One year after the beginning of the COVID-19 pandemic
Primary	Birth Risk	The Birth Risk score consists of 10 items which reflect the medical risk factors for a poor birth outcome: whether singleton or multiples pregnancy, pre/at/post-term birth, newborn weight at birth, type of birth, maternal age, quarantine during birth, history of miscarriage, mother's parity (higher risk if first or fifth/further pregnancy), length of hospitalization for the mother and for the baby. This score had a possible range of 5 to 29, with lower values indicating smaller risk and higher values higher risk.	Retrospectively assessed, at 0 to up to 15 months after birth (one assessment).
Secondary	Correlations between the scores from the primary outcome measures	Spearman correlations between the scores from the primary outcome measures	At the time of answering the questionnaire