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Parental Stress During the COVID-19 Pandemic and Its Association With Depression and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377074
Recruitment Status : Completed
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
Modum Bad Psychiatric Center
Oslo Metropolitan University
University of Bergen
Information provided by (Responsible Party):
Sverre Urnes Johnson, University of Oslo

Brief Summary:

This study seeks to investigate the levels of parental stress across different demographic subgroups in the general parental population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of parental stress rates related to these non-pharmacological interventions (NPI's). In addition, the research will investigate the association between parental stress associated and psychopathology symptoms (i.e., depression and generalized anxiety).

The aim of the project is to:

  • Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures on parental stress, with special focus on the school and kindergarten lockdowns.
  • Provide a foundation for policymakers and health-care professionals to employ interventions that protect families against possibly increased psychological stressors.
  • Help policymakers and healthcare professionals to better understand the association of demographic variables and other predictors on parental stress and parent-child dysfunction, which information necessary for evaluating the psychological impact of NPIs on parental stress and thus the framework under which decisions about school/kindergarten lockdowns are made.

Condition or disease
Parental Stress Depression Anxiety

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Study Type : Observational
Actual Enrollment : 2880 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Parenting in a Pandemic: Parental Stress During the COVID-19 and Its Association With Depression and Anxiety
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : April 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. Measure of parental stress [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    Three items from the Danish Parental Stress Scale (PSS) was selected, which intends to be a short measure of perceived stress resulting from being a parent (Pontoppidan et al., 2018). The scale consists of nine items measuring parental stress where each is measured on a five-point Likert scale (1-5), with the scores ranging from 3 to 15. Higher scores indicate higher parental stress. The following three were chosen in this large-scale investigation: 1) I feel overwhelmed by the responsibility of being a parent. 2) The major source of stress in my life is my child(ren), and 3) It is difficult to balance different responsibilities because of my child(ren) (Pontoppidan et al., 2018).

  2. Patient Health Questionnaire 9 [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

  3. Generalized Anxiety Disorder 7 [ Time Frame: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway ]
    The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, and scores that are above the cutoff of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both Biological Sex and self-representation of gender are measured. All participants are welcome to partake in the study.
Sampling Method:   Probability Sample
Study Population
The general population of parents (Age >= 18) from all regions (i.e., counties) of Norway, having equal opportunity and the probability of partaking in the study.
Criteria

Inclusion Criteria:

- Eligible participants are all parents (over 18 years) living with one or more child under 18 years, and/or a child over 18 with special needs (i.e. physical disabilities). All participants are currently living in Norway and thus experiencing identical NPIs, and who had provided digital consent to partake in the study.

How the participants were reached:

Given the time-sensitivity of the project and the strict and time-consuming process of getting approval to access registry data, the investigators did not apply for access to registry data (e.g., address, phone or e-mails of the general population), as such data access is highly strict and regulated in Norway and the time-frame of such an application could have encompassed variation in an important variable we wished to hold constant (namely identical NPIs (non-pharmacological interventions) employed over the time-frame of data collection). Thus, the investigators did not apply for registry data, reached out the population through the means elaborated below. The investigators reached out to the general Norwegian population systematically in the following six ways, with the goal of providing the entire adult population an equal opportunity to be exposed to the survey:

  1. Through broadcasting on the main national news channel of Norway which had nearly 1.1 million viewers at the time of broadcast.
  2. Using Facebook Business Advertisement where we exposed all adult Norwegian Facebook users (3.6 million; 85% of the Norwegian adult population) with an equal opportunity of being exposed to the survey in a random manner. Our survey reached a random selection of nearly 180 000 of the adult population.
  3. Broadcasting the survey on national and region radio stations across the country
  4. Broadcasting about the survey on local radio stations across the country
  5. Using national newspaper to reach out to participants about the survey
  6. Using regional and local newspapers to reach out to participants across all regions and counties in Norway.

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377074


Locations
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Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Modum Bad Psychiatric Center
Oslo Metropolitan University
University of Bergen
Investigators
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Principal Investigator: Miriam Sinkerud Johnson, PhD Oslo Metropolitan University
Principal Investigator: Nora Paulsen Skjerdingstad University of Bergen
Principal Investigator: Omid Ebrahimi University of Oslo & Modum Bad
Principal Investigator: Asle Hoffart, PhD Modum Bad & University of Oslo
Principal Investigator: Sverre Urnes Johnson, PhD University of Oslo & Modum Bad
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Responsible Party: Sverre Urnes Johnson, Associate Professor Sverre Urnes Johnson, University of Oslo
ClinicalTrials.gov Identifier: NCT04377074    
Other Study ID Numbers: REK125510(3)
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sverre Urnes Johnson, University of Oslo:
COVID-19
Parental Stress
Social distancing
Quarantine
Isolation
Non-pharmacological interventions
Disease containment strategies
Depression
Anxiety
Worry
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders