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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Depression, Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Unified Protocol for COVID-19 Parenting Stress (UP-COVID)
* Behavioral: SHG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Condition<br>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)<br>* 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.<br>|
| Active Comparator: Delayed Condition<br>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)<br>* 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.<br>Behavioral: SHG<br>* Brochure that details techniques for coping with stress.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19