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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID); Behavioral: SHG

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	week 6 and week 12
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.	week 6 and week 12
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.	week 6 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	week 6 and week 12
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).	week 6 and week 12
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).	week 6 and week 12
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).	week 6 and week 12

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Jill Ehrenreich-May, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): November 17, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; COVID-19; Stress Disorders, Traumatic
• Other Study ID Numbers: 20200484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No