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Clinical Trials/NCT04431856
NCT04431856
Completed
Not Applicable

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

University of Miami1 site in 1 country80 target enrollmentMay 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Miami
Enrollment
80
Locations
1
Primary Endpoint
Measure of Anxiety as assessed by the OASIS
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
November 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jill May Ehrenreich

Professor

University of Miami

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

Outcomes

Primary Outcomes

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).

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.

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 Outcomes

  • Measure of Parenting Emotional Warmth as assessed by the S-EMBU(week 6 and week 12)
  • Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU(week 6 and week 12)
  • Measure of Parenting Rejection as assessed by the S-EMBU(week 6 and week 12)
  • Measure of Parent Accommodation for Child Anxiety as assessed by the FASA(week 6 and week 12)

Study Sites (1)

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