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

Not Applicable

Completed

• Conditions: Anxiety; Depression; Traumatic Stress Disorder
• Interventions: Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID); Behavioral: SHG

• 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

Arm && Interventions

Group	Intervention	Description
Delayed Condition	Unified Protocol for COVID-19 Parenting Stress (UP-COVID)	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
Delayed Condition	SHG	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
Immediate Condition	Unified Protocol for COVID-19 Parenting Stress (UP-COVID)	Participants in the Immediate Condition group will receive a total of 4 sessions of Unified Protocol for COVID-19 Parenting Stress (UP-COVID) intervention

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