ParentingNCT04442308
Parental Stress After the Covid-19 Pandemic
An observational study of Parenting and Anxiety, run by University of Oslo.
Trial summary
The aim of this study is to investigate the levels of parental stress 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Anxiety, Depression
- How many people
- 1,440 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: The participants are parents in the general population.
Who may be able to join
- Eligible participants are all adults with at least one child, including those of 18 years and above
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who had provided digital consent to partake in the study.
Who cannot join
- Children and adolescents (individuals below 18) Adults not residing in Norway during the measurement period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Parental Stress After the Covid-19 Pandemic: Predictors and Outcome
The aim of this study is to investigate the levels of parental stress 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured during the COVID-19 pandemic are associated with parental stress 3 months after when the majority of the protocols are lifted.
Read the detailed description
Hypothesis/Research Questions H1: There will be a significant decrease in parental stress from T1 to T2. Exploratory: Investigate the difference in level of parental stress across different demographic subgroups.
H2: Higher level in angry at child, relationship quality and anxiety/depression and less reduction from T1 to T2 in angry at child and anxiety/depression will be associated with less reduction in parental stress from T1 to T2, above and beyond gender, age and number of children in household.
This study is part of a 'The Norwegian COVID-19, Mental Health and Adherence project".
Statistical analysis:
Repeated surveys like the present one typically have a lot of drop out and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).
In preliminary analyses, and for the dependent variables (parental stress) the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham \& Anderson, 2004). The program SPSS 25.0 will be used (IBM Corp, 2018).
First, H1 about decrease in parental stress will be tested by using parental stress as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of angry at child and anxiety/depression will be added, together with the interactions of these constant covariates with time. Relationship quality during the whole pandemic period, measured at T2, is considered a constant and is thus included as predictor. These interactions represent tests of H2 about the covariates predicting change in parental stress. Finally, the T2 angry at child and anxiety/depression as constant covariates will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in parental stress from T1 to T2s.
Relationship quality were assessed with three items: 1) From the beginning of the pandemic have you been more or less satisfied with your relationship? 2) I have had several problems in the relationship with my spouse, 3) I have developed a closer relationships to my spouse.
The Patient Health Questionnaire (PHQ-9)3. This measure is routinely used to assess symptoms of depression in accordance with the diagnostic criteria for major depression disorder and consists of nine items where each is scored on a four-point Likert scale.
The Generalized Anxiety Disorder 7 (GAD-7) was used to obtain symptoms of anxiety and worry, encompassing seven items scored on a four-point Likert scale.
Angry at child was measured with a single item Demographics include gender, age, psychiatric diagnosis and number of children in household.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods, alternatively the use of non-parametric tests.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size:
The sample size at T1 included 2880 participants. For the present study at T2, all participants will be invited to participate in accordance with the study plan. The data collection period will continue for up to three weeks until as many of the participants at baseline have responded.
Missing data:
Maximum likelihood
Exploratory:
Questions addressed in the future paper which is not pre-specified will be defined as exploratory.
- Conditions
- Parenting, Anxiety, Depression, Anger
- Medical subject headings
- Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress
The Danish Parental Stress Scale is developed as a short measure of parental stress consisting of nine items. Three items from this scale were chosen by a panel of clinical experts, with the aim of avoiding topological overlap: 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).
Measured: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
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.
- Other trials for ParentingStudies 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
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Miriam S Johnson, PhD, Principal investigator, Oslo Metropolitan UniversityNora Paulsen Skjerdingstad, Principal investigator, University of BergenOmid Ebrahimi, Principal investigator, University of Oslo & Modum BadAsle Hoffart, PhD, Principal investigator, University of Oslo & Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442308
- Sponsor's protocol ID
- REK125510 (6)
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Stress After the Covid-19 Pandemic: Predictors and Outcome
- ClinicalTrials.gov ID
- NCT04442308
- Acronym / sponsor ID
- REK125510 (6)
- Conditions
- Parenting, Anxiety, Depression, Anger
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,440 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 aim of this study is to investigate the levels of parental stress 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured during the COVID-19 pandemic are associated with parental stress 3 months after when the majority of the protocols are lifted.
Detailed description
Hypothesis/Research Questions H1: There will be a significant decrease in parental stress from T1 to T2. Exploratory: Investigate the difference in level of parental stress across different demographic subgroups.
H2: Higher level in angry at child, relationship quality and anxiety/depression and less reduction from T1 to T2 in angry at child and anxiety/depression will be associated with less reduction in parental stress from T1 to T2, above and beyond gender, age and number of children in household.
This study is part of a 'The Norwegian COVID-19, Mental Health and Adherence project".
Statistical analysis:
Repeated surveys like the present one typically have a lot of drop out and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer \& Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).
In preliminary analyses, and for the dependent variables (parental stress) the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham \& Anderson, 2004). The program SPSS 25.0 will be used (IBM Corp, 2018).
First, H1 about decrease in parental stress will be tested by using parental stress as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of angry at child and anxiety/depression will be added, together with the interactions of these constant covariates with time. Relationship quality during the whole pandemic period, measured at T2, is considered a constant and is thus included as predictor. These interactions represent tests of H2 about the covariates predicting change in parental stress. Finally, the T2 angry at child and anxiety/depression as constant covariates will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in parental stress from T1 to T2s.
Relationship quality were assessed with three items: 1) From the beginning of the pandemic have you been more or less satisfied with your relationship? 2) I have had several problems in the relationship with my spouse, 3) I have developed a closer relationships to my spouse.
The Patient Health Questionnaire (PHQ-9)3. This measure is routinely used to assess symptoms of depression in accordance with the diagnostic criteria for major depression disorder and consists of nine items where each is scored on a four-point Likert scale.
The Generalized Anxiety Disorder 7 (GAD-7) was used to obtain symptoms of anxiety and worry, encompassing seven items scored on a four-point Likert scale.
Angry at child was measured with a single item Demographics include gender, age, psychiatric diagnosis and number of children in household.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods, alternatively the use of non-parametric tests.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size:
The sample size at T1 included 2880 participants. For the present study at T2, all participants will be invited to participate in accordance with the study plan. The data collection period will continue for up to three weeks until as many of the participants at baseline have responded.
Missing data:
Maximum likelihood
Exploratory:
Questions addressed in the future paper which is not pre-specified will be defined as exploratory.
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
- The participants are parents in the general population.
Key inclusion criteria (3 listed)
- Eligible participants are all adults with at least one child, including those of 18 years and above
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who had provided digital consent to partake in the study.
Key exclusion criteria (1 listed)
- Children and adolescents (individuals below 18) Adults not residing in Norway during the measurement period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental stress
Time frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
The Danish Parental Stress Scale is developed as a short measure of parental stress consisting of nine items. Three items from this scale were chosen by a panel of clinical experts, with the aim of avoiding topological overlap: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Miriam S Johnson, PhD principal investigator
Oslo Metropolitan University
Nora Paulsen Skjerdingstad principal investigator
University of Bergen
Omid Ebrahimi principal investigator
University of Oslo & Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting and Anxiety, 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 1 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 24 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 Sverre Urnes Johnson, PhD (+47-22845295, s.u.johnson@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress (time frame: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2020.