Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442386
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-19
Brief Title:
Parental Burnout During the COVID-19 Pandemic Risk Factors and Predictors
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Parental Burnout During the COVID-19 Pandemic Risk Factors and Predictors
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 ie 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 ie 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 Cohens 1988 criteria small 010 medium 030 large 050
Multicollinearity and other statistical assumptions will be checked Multicollinearity will be assessed with common guidelines VIF 5 and Tolerance 02 Hocking 2003 OBrian 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 001 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 ie 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
Research Question 1 What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols ie 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 Cohens 1988 criteria small 010 medium 030 large 050
Multicollinearity and other statistical assumptions will be checked Multicollinearity will be assessed with common guidelines VIF 5 and Tolerance 02 Hocking 2003 OBrian 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 001 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None