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

Depression Clinical Trial

— Co-PARENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431856
• Other study ID #: 20200484
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: November 17, 2020

Study information

• Verified date: November 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Traumatic
• Traumatic Stress Disorder

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.
• SHG
Brochure that details techniques for coping with stress.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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