<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/NCT04431856</url>
  </required_header>
  <id_info>
    <org_study_id>20200484</org_study_id>
    <nct_id>NCT04431856</nct_id>
  </id_info>
  <brief_title>CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment</brief_title>
  <acronym>Co-PARENT</acronym>
  <official_title>CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this research study is to collect information to better understand caregiver&#xD;
      responses to COVID-19 stress and to help caregivers cope with these stressors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">November 17, 2020</completion_date>
  <primary_completion_date type="Actual">November 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of Anxiety as assessed by the OASIS</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of Depression as assessed by the ODSIS</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of PTSD as assessed by the PCL-5</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>The Egna Minnen Betraffande Uppfostran - Short Form (S-EMBU) is a 9-item measure that assesses parents' perception of their overprotection/control. Total scores ranging from 9 (low overcontrol) to 36 (high overcontrol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Parenting Rejection as assessed by the S-EMBU</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>The Egna Minnen Betraffande Uppfostran - Short Form is a 7-item measure that assesses parents' perception of their rejection. Total score ranging from 7 (low rejection) to 28 (high rejection).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Parenting Emotional Warmth as assessed by the S-EMBU</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>The Egna Minnen Betraffande Uppfostran - Short Form is a 6-item measure that assesses parents' perception of their emotional warmth. Total scores ranging from 6 (low warmth) to 24 (high warmth).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Parent Accommodation for Child Anxiety as assessed by the FASA</measure>
    <time_frame>week 6 and week 12</time_frame>
    <description>The Family Accommodation Scale - Anxiety (FASA) is a 13-item measure that assesses parent's accommodation of their child's anxiety related behaviors. Total scores range from 0 (low accommodation) to 52 (high accommodation).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Immediate Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the Delayed Condition group will receive the Self Help Guide (SHG) by the National Child Traumatic Stress Network (NCTSN). They will then receive the UP-COVID intervention following their week 6 assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unified Protocol for COVID-19 Parenting Stress (UP-COVID)</intervention_name>
    <description>UP-COVID is a group therapy session with each session lasting approximately 60-90 minutes. The sessions will focus on cognitive and behavioral strategies for managing their own distress, anxiety and sadness related to COVID-19, as well as, strategies related to parenting in the midst of the crisis.</description>
    <arm_group_label>Delayed Condition</arm_group_label>
    <arm_group_label>Immediate Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SHG</intervention_name>
    <description>Brochure that details techniques for coping with stress.</description>
    <arm_group_label>Delayed Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consent to participate via RedCap&#xD;
&#xD;
          -  indicate a mild or greater elevation on screening measures of anxiety, depression&#xD;
             and/or traumatic stress&#xD;
&#xD;
          -  have a child between 6 and 13 years&#xD;
&#xD;
          -  speak/read English or Spanish fluently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  reported severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual&#xD;
             disability, psychosis, alcohol use disorder, substance use disorder) or&#xD;
             hospitalization for mental health concerns or suicide attempt.&#xD;
&#xD;
          -  reported prior arrest for child endangerment, child abuse or child neglect, or prior&#xD;
             investigation by the Florida Department of Children and Families (DCF)&#xD;
&#xD;
          -  may be excluded if the severity of current mental illness is such that outpatient,&#xD;
             weekly group treatment would be considered inappropriate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill Ehrenreich-May, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Jill May Ehrenreich</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</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/NCT04431856
org study id: 20200484
nct id: NCT04431856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to collect information to better understand caregiver
      responses to COVID-19 stress and to help caregivers cope with these stressors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measure of Anxiety as assessed by the OASIS
time frame: week 6 and week 12
description: The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).
measure: Measure of Depression as assessed by the ODSIS
time frame: week 6 and week 12
description: Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.
measure: Measure of PTSD as assessed by the PCL-5
time frame: week 6 and week 12
description: PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.
measure: Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
time frame: week 6 and week 12
description: The Egna Minnen Betraffande Uppfostran - Short Form (S-EMBU) is a 9-item measure that assesses parents' perception of their overprotection/control. Total scores ranging from 9 (low overcontrol) to 36 (high overcontrol).
measure: Measure of Parenting Rejection as assessed by the S-EMBU
time frame: week 6 and week 12
description: The Egna Minnen Betraffande Uppfostran - Short Form is a 7-item measure that assesses parents' perception of their rejection. Total score ranging from 7 (low rejection) to 28 (high rejection).
measure: Measure of Parenting Emotional Warmth as assessed by the S-EMBU
time frame: week 6 and week 12
description: The Egna Minnen Betraffande Uppfostran - Short Form is a 6-item measure that assesses parents' perception of their emotional warmth. Total scores ranging from 6 (low warmth) to 24 (high warmth).
measure: Measure of Parent Accommodation for Child Anxiety as assessed by the FASA
time frame: week 6 and week 12
description: The Family Accommodation Scale - Anxiety (FASA) is a 13-item measure that assesses parent's accommodation of their child's anxiety related behaviors. Total scores range from 0 (low accommodation) to 52 (high accommodation).
arm group label: Immediate Condition
arm group type: Experimental
description: Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention
arm group label: Delayed Condition
arm group type: Active Comparator
description: Participants in the Delayed Condition group will receive the Self Help Guide (SHG) by the National Child Traumatic Stress Network (NCTSN). They will then receive the UP-COVID intervention following their week 6 assessment
intervention type: Behavioral
intervention name: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
description: UP-COVID is a group therapy session with each session lasting approximately 60-90 minutes. The sessions will focus on cognitive and behavioral strategies for managing their own distress, anxiety and sadness related to COVID-19, as well as, strategies related to parenting in the midst of the crisis.
arm group label: Delayed Condition
arm group label: Immediate Condition
intervention type: Behavioral
intervention name: SHG
description: Brochure that details techniques for coping with stress.
arm group label: Delayed Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jill Ehrenreich-May, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Jill May Ehrenreich
investigator title: Professor
mesh term: COVID-19
mesh term: Stress Disorders, Traumatic
sharing ipd: No