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临床试验/NCT04715906
NCT04715906已完成不适用

Coping Options for Parent Empowerment

University of Miami2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in depressive symptoms as measured by the PHQ

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 of children with Autism Spectrum Disorder (ASD) cope with these stressors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Must be willing to consent to participate via RedCap
  • Indicate a mild or greater elevation on screening measures of anxiety and/or depression
  • Not meet any exclusion criteria.
  • Lives in Florida
  • Has a child between the ages of 4-13 years who has been diagnosed with ASD
  • Speaks either English or Spanish primarily
  • Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer

排除标准

  • 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. Parents may receive concurrent psychiatric or psychological intervention services but may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate.
  • Parents who report any prior arrest for child endangerment, child abuse or child neglect may also be excluded.
  • Parents who have Moderate or greater risk of suicidal ideation.

结局指标

主要结局

Change in depressive symptoms as measured by the PHQ

时间窗: Baseline, 6 Weeks

Parent Psychopathology levels will be reported as the change in the Patient Health Questionnaire (PHQ) scores. PHQ is a 9-item measure assessing the severity of depressive symptoms. It has a total score ranging from 0 to 27 with the higher scores indicating greater depressive symptoms.

Change in Anxiety levels as measured by GAD-7

时间窗: Baseline, 6 Weeks

Parent Psychopathology levels will be reported as the change in the Generalized Anxiety Disorder 7-item (GAD-7) scores. GAD-7 is a 7-item measure assessing the presence and severity of symptoms of anxiety. The Scale has a total score ranging from 0 to 21 with the higher scores indicating greater anxiety.

次要结局

  • Change in Hope as measured by the State Hope Scale(Baseline, 6 Weeks)
  • Change in parenting beliefs as measured by the PSOC Scale(Baseline, 6 Weeks)
  • Acceptability of Intervention as measured by the Program Feedback Scale(6 Weeks)

研究者

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

Jill May Ehrenreich

Professor, Assistant Chair for Academic Affairs and Research

University of Miami

研究点 (2)

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