NCT04377074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

7 days

First QC Date

May 4, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

COVID-19Parental StressSocial distancingQuarantineIsolationNon-pharmacological interventionsDisease containment strategiesDepressionAnxietyWorry

Outcome Measures

Primary Outcomes (3)

  • Measure of parental stress

    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).

    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

  • Patient Health Questionnaire 9

    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.

    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

  • Generalized Anxiety Disorder 7

    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).

    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

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Biological Sex and self-representation of gender are measured. All participants are welcome to partake in the study.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- 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:
  • Through broadcasting on the main national news channel of Norway which had nearly 1.1 million viewers at the time of broadcast.
  • 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.
  • Broadcasting the survey on national and region radio stations across the country
  • Broadcasting about the survey on local radio stations across the country
  • Using national newspaper to reach out to participants about the survey
  • Using regional and local newspapers to reach out to participants across all regions and counties in Norway.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Sverre Urnes Johnson

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

March 31, 2020

Primary Completion

April 7, 2020

Study Completion

April 7, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations