Back to resultsCO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment (Co-PARENT)
Primary Purpose
Anxiety, Depression, Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
SHG
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring COVID-19
Eligibility 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Condition
Delayed Condition
Arm 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
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
Outcomes
Primary Outcome Measures
Measure of Anxiety as assessed by the OASIS
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 of Depression as assessed by the ODSIS
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 of PTSD as assessed by the PCL-5
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
Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
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 of Parenting Rejection as assessed by the S-EMBU
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 of Parenting Emotional Warmth as assessed by the S-EMBU
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 of Parent Accommodation for Child Anxiety as assessed by the FASA
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04431856
Brief Title
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Acronym
Co-PARENT
Official Title
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Traumatic Stress Disorder
Keywords
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Condition
Arm Type
Experimental
Arm 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 Title
Delayed Condition
Arm Type
Active Comparator
Arm 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(s)
Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
SHG
Intervention Description
Brochure that details techniques for coping with stress.
Primary Outcome Measure Information:
Title
Measure of Anxiety as assessed by the OASIS
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).
Time Frame
week 6 and week 12
Title
Measure of Depression as assessed by the ODSIS
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.
Time Frame
week 6 and week 12
Title
Measure of PTSD as assessed by the PCL-5
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.
Time Frame
week 6 and week 12
Secondary Outcome Measure Information:
Title
Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU
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).
Time Frame
week 6 and week 12
Title
Measure of Parenting Rejection as assessed by the S-EMBU
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).
Time Frame
week 6 and week 12
Title
Measure of Parenting Emotional Warmth as assessed by the S-EMBU
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).
Time Frame
week 6 and week 12
Title
Measure of Parent Accommodation for Child Anxiety as assessed by the FASA
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).
Time Frame
week 6 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CO-PARENT: COVID-19 - Parent Action in Response to Emotions and Needs for Treatment
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