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临床试验/NCT06064422
NCT06064422已完成不适用

Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年11月1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
9
试验地点
2
主要终点
Glasgow Depression Scale for Intellectual Disability (GDS)

研究概览

简要总结

The present study aims to adapt and evaluate the feasibility of the BeatIt-2 behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with minimally verbal autistic individuals.

详细描述

Aim 1. The first phase of the project will focus on adapting the BeatIt-2 manual to consider specific needs of MV autistic adults. This procedure includes an intervention development group (IDG), for which MV autistic adults and their supporters (i.e., someone identified as a source of support they can work with) will be recruited. Aim 2. During the following phase of the project, a feasibility trial will be conducted. Using the treatment manual and study procedures adapted and refined in phase 1, the trial will examine the feasibility and acceptability of BeatIt-MV.

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

  • Minimally verbal
  • Aged 18 years or older
  • Diagnosis of Autism Spectrum Disorder and clinically significant depression based on clinical best estimate diagnosis using DSM-5 or Diagnostic Manual - Intellectual Disability criteria
  • Have a support person willing to participate
  • Live in New Jersey or New York, or be within travel distance to Rutgers University

排除标准

  • Not able to engage in treatment in English
  • current engagement in other treatment for depression
  • conditions that may preclude engagement in treatment sessions (e.g., active psychosis, unmanaged seizures)
  • high suicide risk (i.e., with a clear plan, expressed intent or recent documented attempts)

研究组 & 干预措施

BeatIt-MV Treatment Group

Experimental

Participants, along with support persons, will complete 12 weekly sessions of the BeatIt-MV intervention. The support person will complete an initial session before commencement of the 12 weekly sessions.

干预措施: BeatIt-MV (Behavioral)

结局指标

主要结局

Glasgow Depression Scale for Intellectual Disability (GDS)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

The GDS is a 20-item self- and caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. Scores range from 0-32. The expected change is a decrease in the score.

Anxiety Depression and Mood Scale (ADAMS)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

The ADAMS is a 20-item caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. Total scores range from 0-84. The expected change is a decrease in the score.

Mood, Interest, & Pleasure Questionnaire (MIPQ)

时间窗: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)

The MIPQ is a 25-item caregiver-reported questionnaire of behaviors over the past week with all items on a "0" (Never) to 4 (All the time) scale. Higher scores equal more distress. Total scores range from 0-100. The expected change is a decrease in the score.

次要结局

  • Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)(Week 1 (initial assessment) to week 22 (follow-up))
  • Shalock Quality of Life Questionnaire(Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up))

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; Karmazin & Lillard Chair in Adult Autism, Rutgers, The State University of New Jersey

Rutgers, The State University of New Jersey

研究点 (2)

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