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临床试验/NCT05018169
NCT05018169已完成不适用

Behavioral Activation for Treatment of Depression in Adolescents With Autism Spectrum Disorder: A Pilot Study

University of Virginia2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年8月1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
18
试验地点
2
主要终点
Children's Depression Inventory, Second Edition, Parent Report

研究概览

简要总结

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A).

详细描述

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A). BA-A is a 12-session manualized treatment that utilizes established behavioral activation strategies and incorporates common mental health treatment adaptations for young people with ASD. For this project, the investigators will pilot BA-A with 23 adolescents (12-17 years of age) with ASD and clinically significant depression symptoms. To investigate BA-A feasibility, the investigators will examine treatment session attendance and therapist treatment fidelity. To investigate BA-A acceptability, the investigators will utilize a mixed methods approach, inclusive of surveys and qualitative interviews, to inform BA-A protocol refinement. To investigate BA-A preliminary efficacy, the investigators will examine depression symptoms, as well as secondary outcome measures, at pre-treatment, post-treatment, and one-month follow-up.

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
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Previous diagnosis of ASD by a qualified health care provider
  • Children's Depression Inventory, Second Edition (CDI2) parent-report and/or self-report T- score ≥ 65
  • Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) Full Scale IQ, Two-Subtest Form (FSIQ-2) ≥ 85
  • Participation of a parent or legal guardian living in the same home who can read and write in English at or above the fifth grade level
  • Teens must have been on a stable dose of medications for mood, anxiety, or behavior for at least three months prior to enrollment and have no planned medication changes during study period
  • Not actively participating in another psychotherapy during study period

排除标准

  • High suicide risk
  • Physical aggression
  • Psychotic and/or manic symptoms

结局指标

主要结局

Children's Depression Inventory, Second Edition, Parent Report

时间窗: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Children's Depression Inventory, Second Edition, Self Report

时间窗: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

Children's Depression Rating Scale, Revised

时间窗: Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment

次要结局

  • Social Skills Improvement System, Parent Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)
  • Spence Children's Anxiety Scale, Self Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)
  • Spence Children's Anxiety Scale, Parent Report(Change from pre-treatment to post-treatment (i.e., within one week of finishing 12-week treatment) and one-month following treatment)

研究者

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

Micah Mazurek

Novartis U.S. Foundation Professor of Education

University of Virginia

研究点 (2)

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