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

NCT05487105 | Completed

• 1 other identifier: EK-GZ12/2013-Addendum-07/2021
• Study Type: observational
• Target: 2,226
• Locations: 1 country
• Sites: 1

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.

Conditions

Parents; COVID-19 Pandemic

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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)

• 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)

• 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

• 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)

• 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)

• 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

• 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

• 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 Outcomes (1)

• Correlations between the scores from the primary outcome measures

  At the time of answering the questionnaire

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• stillborn or neonatal death

Sponsors & Collaborators

• University of Salzburg: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Paris-Lodron University of Salzburg

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Manuel Schabus, Prof. Dr.

  Paris-Lodron University of Salzburg

  STUDY CHAIR

• Monika Angerer, Dr.

  Paris-Lodron University of Salzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 4, 2022
• Study Start: May 18, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: The data will be uploaded by December 2022 and will be available for an unlimited time.
• Access Criteria: Researchers from accredited institutions.

Locations

AU (1)