<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04442308</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510 (6)</org_study_id>
    <nct_id>NCT04442308</nct_id>
  </id_info>
  <brief_title>Parental Stress After the Covid-19 Pandemic</brief_title>
  <official_title>Parental Stress After the Covid-19 Pandemic: Predictors and Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Modum Bad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the levels of parental stress 3 months after (T2) the&#xD;
      strict physical distancing government initiated physical distancing protocols related to the&#xD;
      COVID-19 pandemic (T1). The study also aims to investigate how predictors measured during the&#xD;
      COVID-19 pandemic are associated with parental stress 3 months after when the majority of the&#xD;
      protocols are lifted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis/Research Questions H1: There will be a significant decrease in parental stress&#xD;
      from T1 to T2. Exploratory: Investigate the difference in level of parental stress across&#xD;
      different demographic subgroups.&#xD;
&#xD;
      H2: Higher level in angry at child, relationship quality and anxiety/depression and less&#xD;
      reduction from T1 to T2 in angry at child and anxiety/depression will be associated with less&#xD;
      reduction in parental stress from T1 to T2, above and beyond gender, age and number of&#xD;
      children in household.&#xD;
&#xD;
      This study is part of a 'The Norwegian COVID-19, Mental Health and Adherence project&quot;.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Repeated surveys like the present one typically have a lot of drop out and missing data.&#xD;
      Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and&#xD;
      ordinary linear regression to analyze the data. Mixed models use maximum likelihood&#xD;
      estimation, which is the state of the art approach to handle missing data (Schafer &amp; Graham,&#xD;
      2002). Especially if data are missing at random, which is likely in our survey, mixed models&#xD;
      give more unbiased results than the other analytic methods (O'Connel et al., 2017).&#xD;
&#xD;
      In preliminary analyses, and for the dependent variables (parental stress) the combination of&#xD;
      random effects and covariance structure of residuals that gives the best fit for the &quot;empty&quot;&#xD;
      model (the model without fixed predictors except the intercept) will be chosen. Akaike's&#xD;
      Information Criterion (AIC) will used to compare the fit of different models. Models that&#xD;
      give a reduction in AIC greater than 2 will be considered better (Burnham &amp; Anderson, 2004).&#xD;
      The program SPSS 25.0 will be used (IBM Corp, 2018).&#xD;
&#xD;
      First, H1 about decrease in parental stress will be tested by using parental stress as&#xD;
      dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor.&#xD;
      Second, demographic group variables will be added as predictors. Third, the initial (T1)&#xD;
      levels of angry at child and anxiety/depression will be added, together with the interactions&#xD;
      of these constant covariates with time. Relationship quality during the whole pandemic&#xD;
      period, measured at T2, is considered a constant and is thus included as predictor. These&#xD;
      interactions represent tests of H2 about the covariates predicting change in parental stress.&#xD;
      Finally, the T2 angry at child and anxiety/depression as constant covariates will be added,&#xD;
      together with the interactions of these constant covariates with time. These interactions&#xD;
      represent tests of H2 about the change in the covariates from T1 to T2 predicting change in&#xD;
      parental stress from T1 to T2s.&#xD;
&#xD;
      Relationship quality were assessed with three items: 1) From the beginning of the pandemic&#xD;
      have you been more or less satisfied with your relationship? 2) I have had several problems&#xD;
      in the relationship with my spouse, 3) I have developed a closer relationships to my spouse.&#xD;
&#xD;
      The Patient Health Questionnaire (PHQ-9)3. This measure is routinely used to assess symptoms&#xD;
      of depression in accordance with the diagnostic criteria for major depression disorder and&#xD;
      consists of nine items where each is scored on a four-point Likert scale.&#xD;
&#xD;
      The Generalized Anxiety Disorder 7 (GAD-7) was used to obtain symptoms of anxiety and worry,&#xD;
      encompassing seven items scored on a four-point Likert scale.&#xD;
&#xD;
      Angry at child was measured with a single item Demographics include gender, age, psychiatric&#xD;
      diagnosis and number of children in household.&#xD;
&#xD;
      Possible transformations:&#xD;
&#xD;
      All variables will be assessed in their original and validated format as is recommended&#xD;
      practice, as long as this is possible with regards to statistical assumptions underlying the&#xD;
      pre-defined analyses (i.e., multiple regression). However, if this is not possible with&#xD;
      regards to the statistical assumptions behind the analyses, transformation (e.g., square root&#xD;
      or log-transformations) may be needed to apply interval-based methods, alternatively the use&#xD;
      of non-parametric tests.&#xD;
&#xD;
      Inference criteria Given the large sample size in this study, the investigators pre-define&#xD;
      their significance level: p &lt; 0.01 to determine significance.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The sample size at T1 included 2880 participants. For the present study at T2, all&#xD;
      participants will be invited to participate in accordance with the study plan. The data&#xD;
      collection period will continue for up to three weeks until as many of the participants at&#xD;
      baseline have responded.&#xD;
&#xD;
      Missing data:&#xD;
&#xD;
      Maximum likelihood&#xD;
&#xD;
      Exploratory:&#xD;
&#xD;
      Questions addressed in the future paper which is not pre-specified will be defined as&#xD;
      exploratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 22, 2020</start_date>
  <completion_date type="Anticipated">July 13, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parental stress</measure>
    <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</time_frame>
    <description>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).</description>
  </primary_outcome>
  <enrollment type="Anticipated">1440</enrollment>
  <condition>Parenting</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Anger</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The participants are parents in the general population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants are all adults with at least one child, including those of 18&#xD;
             years and above&#xD;
&#xD;
          -  Who are currently living in Norway and thus experiencing identical NPIs, and&#xD;
&#xD;
          -  Who had provided digital consent to partake in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents (individuals below 18) Adults not residing in Norway during&#xD;
             the measurement period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miriam S Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo Metropolitan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nora Paulsen Skjerdingstad</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omid Ebrahimi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo &amp; Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asle Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo &amp; Modum Bad</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>+47-22845295</phone>
    <email>s.u.johnson@psykologi.uio.no</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Sverre Urnes Johnson</investigator_full_name>
    <investigator_title>Associate Professer Sverre Urnes Johnson</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442308
org study id: REK125510 (6)
nct id: NCT04442308
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
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
description: 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).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miriam S Johnson, PhD
role: Principal Investigator
affiliation: Oslo Metropolitan University
last name: Nora Paulsen Skjerdingstad
role: Principal Investigator
affiliation: University of Bergen
last name: Omid Ebrahimi
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Sverre Urnes Johnson, PhD
phone: +47-22845295
email: s.u.johnson@psykologi.uio.no
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Sverre Urnes Johnson
investigator title: Associate Professer Sverre Urnes Johnson
mesh term: COVID-19
sharing ipd: No