Parental BurnoutNCT04442386
Parental Burnout During the COVID-19 Pandemic: Risk Factors and Predictors
An observational study of Parental Burnout, run by University of Oslo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parental Burnout
- What is being tested?
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 13 Jul 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Eligible participants are all parents
- Currently living in Norway and thus experiencing identical mitigation strategies
- That provide digital consent to partake in the study
Who cannot join
- Adults not residing in Norway during the measurement period
- Non-parents
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Parental Burnout
- Being tested
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnoutOther
Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parental Burnout Inventory (PBI)
The Parental Burnout Inventory (PBI) (Roskam et al., 2017) consists of 22 items related to three divisions of parental burnout: Personal Accomplishment, Emotional Exhaustion and Emotional Distancing. The inventory is rated on a seven-point Likert-scale ranging from never (0) to every day (6). Higher scores indicate greater parental burnout severity, and scores above 88 are considered as the cut-off for parental burnout (Roskam et al., 2017).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parental BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Omid V. Ebrahimi, University of Oslo
- Investigators
- Nora Paulsen Skjerdingstad, Cand.psychol. stud, Principal investigator, University of OsloMiriam Sinkerud Johnson, PhD, Principal investigator, Oslo Metropolitan UniversitySverre Urnes Johnson, PhD, Principal investigator, University of OsloAsle Hoffart, PhD, Principal investigator, Modum BadOmid V. Ebrahimi, Double PhD Candidate, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442386
- Sponsor's protocol ID
- REK125510-15
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29403419
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Burnout During the COVID-19 Pandemic: Risk Factors and Predictors
- ClinicalTrials.gov ID
- NCT04442386
- Acronym / sponsor ID
- REK125510-15
- Conditions
- Parental Burnout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jul 2020 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Eligible participants are all parents
- Currently living in Norway and thus experiencing identical mitigation strategies
- That provide digital consent to partake in the study
Key exclusion criteria (2 listed)
- Adults not residing in Norway during the measurement period
- Non-parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnoutProspective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout | Other | – |
Primary outcome
The Parental Burnout Inventory (PBI)
Time frame: 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
The Parental Burnout Inventory (PBI) (Roskam et al., 2017) consists of 22 items related to three divisions of parental burnout: Personal Accomplishment, Emotional Exhaustion and Emotional Distancing. The inventory is rated on a seven-point Likert-scale ranging from never (0) to every day (6). Higher scores indicate greater parental burnout severity, and scores above 88 are considered as the cut-off for parental burnout (Roskam et al., 2017).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Background: PubMed 29403419Roskam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Paulsen Skjerdingstad, Cand.psychol. stud principal investigator
University of Oslo
Miriam Sinkerud Johnson, PhD principal investigator
Oslo Metropolitan University
Sverre Urnes Johnson, PhD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Burnout, run by University of Oslo.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omid V. Ebrahimi, Double PhD Candidate (+47-22845295, omideb@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parental Burnout Inventory (PBI) (time frame: 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). 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 NCT04442386, which also lists 1 linked publication.
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 23 Jun 2020.