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临床试验/NCT04460677
NCT04460677已完成不适用

ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年8月12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
26
试验地点
2
主要终点
Decreased distress on Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Decreased distress on Patient Health Questionnaire (PHQ-9)

时间窗: 8 week study period

The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.

Decreased distress on EMA reports

时间窗: 8 week study period

EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.

Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

时间窗: 8 week study period

The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.

次要结局

  • Adult Self Report (ASR)(8 week study period)

研究者

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

Vanessa H. Bal, PhD

Assistant Professor

Rutgers, The State University of New Jersey

研究点 (2)

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