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Completed

NCT Number: NCT04431856

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Traumatic Trauma and Stressor Related Disorders Traumatic Stress Disorder Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

SHG

Behavioral

Brochure that details techniques for coping with stress.

Primary outcomes

  1. Measure of Anxiety as assessed by the OASIS

    Time frame: 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).

  2. Measure of Depression as assessed by the ODSIS

    Time frame: 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.

  3. Measure of PTSD as assessed by the PCL-5

    Time frame: 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 outcomes

  1. Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU

    Time frame: 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).

  2. Measure of Parenting Rejection as assessed by the S-EMBU

    Time frame: 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).

  3. Measure of Parenting Emotional Warmth as assessed by the S-EMBU

    Time frame: 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).

  4. Measure of Parent Accommodation for Child Anxiety as assessed by the FASA

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: Co-PARENT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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