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

Not Applicable

Completed

• Conditions: Anxiety; Depression; Traumatic Stress Disorder

• Registration Number: NCT04431856
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2020-11
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure of Anxiety as assessed by the OASIS	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	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	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

Name	Time	Method
Measure of Parenting Emotional Warmth as assessed by the S-EMBU	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).
Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU	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).
Measure of Parenting Rejection as assessed by the S-EMBU	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).
Measure of Parent Accommodation for Child Anxiety as assessed by the FASA	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).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States