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临床试验/NCT04926090
NCT04926090已完成不适用

Developing Supports to Address Mental Health Needs of Autistic Students in Postsecondary Education

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年7月26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
19
试验地点
2
主要终点
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

研究概览

简要总结

The present study aims to expand the availability of emotional supports in order to promote successful transitions and longer-term outcomes for autistic students in PSE.

详细描述

This study has three specific aims:

Aim 1: Identify mental health needs of autistic students to inform supports. Focus groups engaging key stakeholders will be used to understand the mental health needs of autistic college students and inform adaptation of two individualized mental health supports: 1) the ESP intervention and 2) protocols for monitoring mood and psychological distress.

Aim 2: Develop resources to inform and guide mental health care of autistic students. Focus group information will inform 1) adaptation of clinician (ESP-C) and self-guided (ESP-S) emotional support plans and monitoring protocols and 2) develop a "College Student Mental Health Guide" to aide autistic college students, their families and mental health professionals in proactive planning for mental health supports during PSE.

Aim 3: Assess the feasibility, acceptability and initial efficacy of the ESP-C and ESP-S.

The study will yield preliminary data to apply for additional funding to conduct a large-scale trial to validate these methods to monitor and support mental health of autistic adults. Information gathered from the study will also be used to inform development of a mental health guide for autistic students.

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
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous ASD diagnosis,
  • Has smartphone (to access the ESP app)
  • At least 6th grade Reading Comprehension on the WRAT-
  • The WRAT-5 may not be required if a student has other evidence of age-appropriate reading level.
  • Be currently enrolled in a Postsecondary Education (PSE) institution.

排除标准

  • Not a students in a PSE Institution or do not have diagnosis of ASD
  • Score below a 6th grade Reading Comprehension on the WRAT-5
  • Unable to understand English
  • No access to a compatible iOS and Android smartphone
  • the PI's clinical judgment that it would not be in the adult's best interest to be enrolled

结局指标

主要结局

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

时间窗: 15 week monitoring 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.

Change in distress on Patient Health Questionnaire (PHQ-9)

时间窗: 15 week monitoring period

The PHQ-9, assessed weekly for first 6 weeks and biweekly for remaining 9 weeks, 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.

Change in distress on Ecological Momentary Assessment (EMA) reports

时间窗: 15 week monitoring period

EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring groups only). Scores range from 0(not at all) to 5 (very much). Higher scores on the item equal higher levels of distress.

次要结局

  • Change Young Adult Coping Orientation for Problem Experience (YA-COPE)(15 week monitoring period)
  • Change in Adult Self Report(15 week monitoring period)
  • Change in Adult Behavior Checklist(15 week monitoring period)
  • Change in Emotion Dysregulation Inventory(15 week monitoring period)

研究者

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

Vanessa H. Bal, PhD

Associate Professor

Rutgers, The State University of New Jersey

研究点 (2)

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