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CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment (Co-PARENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431856
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jill May Ehrenreich, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Traumatic Stress Disorder Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID) Behavioral: SHG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : November 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Parenting

Arm Intervention/treatment
Experimental: Immediate Condition
Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention
Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
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.

Active Comparator: Delayed Condition
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
Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
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.

Behavioral: SHG
Brochure that details techniques for coping with stress.




Primary Outcome Measures :
  1. Measure of Anxiety as assessed by the OASIS [ Time Frame: week 6 and week 12 ]
    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).

  2. Measure of Depression as assessed by the ODSIS [ Time Frame: week 6 and week 12 ]
    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.

  3. Measure of PTSD as assessed by the PCL-5 [ Time Frame: week 6 and week 12 ]
    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.


Secondary Outcome Measures :
  1. Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU [ Time Frame: week 6 and week 12 ]
    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).

  2. Measure of Parenting Rejection as assessed by the S-EMBU [ Time Frame: week 6 and week 12 ]
    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).

  3. Measure of Parenting Emotional Warmth as assessed by the S-EMBU [ Time Frame: week 6 and week 12 ]
    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).

  4. Measure of Parent Accommodation for Child Anxiety as assessed by the FASA [ Time Frame: week 6 and week 12 ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consent to participate via RedCap
  • indicate a mild or greater elevation on screening measures of anxiety, depression and/or traumatic stress
  • have a child between 6 and 13 years
  • speak/read English or Spanish fluently

Exclusion Criteria:

  • reported severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt.
  • reported prior arrest for child endangerment, child abuse or child neglect, or prior investigation by the Florida Department of Children and Families (DCF)
  • may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431856


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Jill Ehrenreich-May, Ph.D. University of Miami
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Responsible Party: Jill May Ehrenreich, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04431856    
Other Study ID Numbers: 20200484
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill May Ehrenreich, University of Miami:
COVID-19
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders