Clinical trial NCT04442386: Parental Burnout During the COVID-19 Pandemic: Risk Factors and Predictors
Official title: Parental Burnout During the COVID-19 Pandemic: Risk Factors and Predictors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parental Burnout
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Modum Bad
First posted: 2020-06-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All parents above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.

Brief summary: The present study seeks to investigate the levels of parental burnout in the general parental population during the COVID-19 pandemic. Parental burnout is measured three months following (T2) the initiated viral mitigation protocols in Norway, a period where schools and kindergartens were closed, involving a period of home isolation for parents with their children. The burden of parents during this period is thought to have increased, as they were expected to conduct their own work virtually where possible, while at the same time acting as teachers for their children. The study aims to investigate the level of burnout among parents after months of viral mitigation strategies involved in the pandemic, in addition to predictors of parental burnout measured at (T1) are associated with parental burnout after three months (T2).

Hypothesis and research question:

Research Question 1: What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols (i.e., physical distancing) as compared to other similar pre-pandemic samples?

Hypothesis 1: Parental burnout will be higher in the present sample three months into the pandemic as compared to similar pre-pandemic samples in similar populations.

Hypothesis 2: Levels of parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, marital quality and insomnia, all at T2 will significantly predict levels of parental burnout at T2.

Exploratory: Do the predictors parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict parental burnout at T2, beyond and above these same aforementioned predictors at T2 and pre-existing mental health condition, age, gender, and education?

Exploratory: Levels of parental burnout will be explored across subgroups in the sample.

Detailed description: Hypothesis and research question:

Research Question 1: What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols (i.e., physical distancing) as compared to other similar pre-pandemic samples?

Hypothesis 1: Parental burnout will be higher in the present sample three months into the pandemic as compared to similar pre-pandemic samples in similar populations.

Hypothesis 2: Levels of parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, marital quality and insomnia, all at T2 will significantly predict levels of parental burnout at T2.

Exploratory: Do the predictors parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict parental burnout at T2, beyond and above these same aforementioned predictors at T2 and pre-existing mental health condition, age, gender, and education?

Exploratory: Levels of parental burnout will be explored across subgroups in the sample.

Statistical analysis A hierarchical regression analysis will be conducted with Parental burnout (PBI) as the dependent variable. In the first step, stable characteristics (control variables) will be included: gender, education, and age. In the second step, parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, and unhelpful coping strategies, marital quality, and insomnia, all at T2 will be included.. In the final step, parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, and unhelpful coping strategies, all at T1 will be included.

Part correlations will be reported, presenting the effect size of the hypothesized predictors on parental burnout. A part (semi-partial) correlation gives the least biased and easiest interpretable estimate of the strength of a predictive relationship (Dudgeon, 2016). It is the correlation between the outcome and the aspects of the predictor unique from all the other predictors. As a type of correlation, its size can be evaluated according to Cohen's (1988) criteria: small \>=0.10, medium \>=0.30, large \>=0.50.

Multicollinearity and other statistical assumptions will be checked. Multicollinearity will be assessed with common guidelines (VIF \< 5 and Tolerance \> 0.2; Hocking, 2003; O'Brian, 2007).

Descriptive statistics with frequency tables including N, means, SDs and other standard descriptive statistics will examine the research question concerning general levels of mental well-being. Subgroup differences will be examined.

All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.

Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.

Any questions addressed in the forthcoming paper which is not pre-specified in this protocol will be explicitly defined as exploratory.

Inference criteria Given the estimated large sample size which the investigators hope to collect in this study, the investigators pre-define their significance level: p \< 0.01 to determine significance.

Sample size and power calculation:

The present study is part of a larger project with the first part aiming to investigate predictors of parental burnout through regression analyses, and the second part aiming to examine directional relations amongst specific symptoms and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 900 to 3000 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.

Missing data:

The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, the investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.

Eligibility criteria: Inclusion Criteria:

* Eligible participants are all parents
* Currently living in Norway and thus experiencing identical mitigation strategies
* That provide digital consent to partake in the study

Exclusion Criteria:

* Adults not residing in Norway during the measurement period
* Non-parents

Primary outcomes:
measure: The Parental Burnout Inventory (PBI)
timeFrame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Nora Paulsen Skjerdingstad, Cand.psychol. stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo Metropolitan University
name: Miriam Sinkerud Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Sverre Urnes Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Modum Bad
name: Asle Hoffart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Omid V. Ebrahimi, Double PhD Candidate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roskam I, Raes ME, Mikolajczak M. Corrigendum: Exhausted Parents: Development and Preliminary Validation of the Parental Burnout Inventory. Front Psychol. 2018 Jan 30;9:73. doi: 10.3389/fpsyg.2018.00073. eCollection 2018.