跳至主要内容
临床试验/NCT04431856
NCT04431856已完成不适用

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

University of Miami1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Measure of Anxiety as assessed by the OASIS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: Unified Protocol for COVID-19 Parenting Stress (UP-COVID) (Behavioral)

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

干预措施: Unified Protocol for COVID-19 Parenting Stress (UP-COVID) (Behavioral)

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

干预措施: SHG (Behavioral)

结局指标

主要结局

Measure of Anxiety as assessed by the OASIS

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Measure of Parenting Emotional Warmth as assessed by the S-EMBU(week 6 and week 12)
  • 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 Parent Accommodation for Child Anxiety as assessed by the FASA(week 6 and week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill May Ehrenreich

Professor

University of Miami

研究点 (1)

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