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

NCT04431856 | Completed

• 1 other identifier: 20200484
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Traumatic Stress Disorder

Keywords

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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 Parenting Emotional Warmth 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 Arms (2)

Immediate Condition

EXPERIMENTAL

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)

Delayed Condition

ACTIVE COMPARATOR

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); Behavioral: SHG

Interventions

Unified Protocol for COVID-19 Parenting Stress (UP-COVID) BEHAVIORAL

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.

Delayed Condition; Immediate Condition

SHG BEHAVIORAL

Brochure that details techniques for coping with stress.

Delayed Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Traumatic; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jill Ehrenreich-May, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: May 15, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)