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ParentsNCT05487105

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

An observational study of Parents and COVID-19 Pandemic, run by University of Salzburg at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Parents, COVID-19 Pandemic
How many people
2,226 participants
Where
1 siteAustria
Study dates
18 May 2021to 1 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • stillborn or neonatal death

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Paris-Lodron University of Salzburg

    Salzburg, 5020

Other trials in Austria

About this study

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

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.
Read the 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.

Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Over the previous seven days from the time of answering the questionnaire

  2. 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).

    Measured: Over the previous month from the time of answering the questionnaire

  3. Childbirth experience

    Score on the Childbirth Experience Questionnaire 2 - factors "Coping ability", "Participation" and "Emotional experience". Range 13 (negative) to 52 (positive birth experience).

    Measured: At 0 to up to 15 months after birth (one assessment)

  4. 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).

    Measured: At 0 to up to 15 months after birth (one assessment)

  5. 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).

    Measured: One year after the beginning of the COVID-19 pandemic

  6. 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.

    Measured: At 0 to up to 15 months after birth (one assessment)

  7. 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.

    Measured: At 0 to up to 15 months after birth (one assessment)

  8. 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.

    Measured: One year after the beginning of the COVID-19 pandemic

  9. 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.

    Measured: One year after the beginning of the COVID-19 pandemic

  10. 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.

    Measured: Retrospectively assessed, at 0 to up to 15 months after birth (one assessment).

Secondary outcomes (1)

  1. Correlations between the scores from the primary outcome measures

    Spearman correlations between the scores from the primary outcome measures

    Measured: At the time of answering the questionnaire

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start18 May 2021
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
2,226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487105
Sponsor's protocol ID
EK-GZ12/2013-Addendum-07/2021
Status last verified
Aug 2022
First submitted
29 Jul 2022
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymously collected data including the answers to the questionnaire, the questionnaire itself, and the analytic code shall be shared on an open data platform at the end of the study.

Questions about this trial

What is this clinical trial studying?

An observational study of Parents and COVID-19 Pandemic, run by University of Salzburg at 1 site in Austria.

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 2 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: finished, as of the sponsor's last update on 4 Aug 2022. 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 Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Depressive symptoms (time frame: Over the previous seven days from the time of answering the questionnaire). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05487105.

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 4 Aug 2022.

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