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Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series (AMPOCD)

2017年1月13日 更新者:Susanna Chang, PhD、University of California, Los Angeles

Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth. Although empirically supported psychosocial and pharmacological treatments for OCD exist, many children and their families are not able to adequately access these treatments or derive only partial benefit from them. Such findings highlight the importance of developing more effective treatment options which have the potential to be widely accessible to OCD youth.

The investigators are proposing to test a computerized attention modification program, AMP, in six youth with OCD in an open case series to gather information regarding protocol acceptability, feasibility and preliminary efficacy. This phase includes the development and refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP parameters for use with children.

Following ascertainment of study eligibility, participants will undergo a baseline assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention bias assessment, and self report questionnaires. Study participants will then receive 12 sessions of AMP treatment over the course of three weeks. All youngsters and their families will be reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours over the course of six weeks. Participants who are treatment responders may be asked to return approximately 3 months after completing treatment for a follow-up assessment.

Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom severity.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

6

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90024
        • University of California Los Angeles

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Youth ages 8 - 17
  • Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule (ADIS-IV) Child/Parent version
  • Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score > 15
  • Medication free or on stable medication for six weeks prior to study entry
  • Informed parental consent and child assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.

Exclusion Criteria:

  • DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
  • Concurrent psychosocial treatment for OCD
  • IQ < 80
  • Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate treatment initiation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Attention Modification Program
Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
其他名称:
  • 安培

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment
大体时间:pre-treatment (week 0) and post-treatment (week 5)
pre-treatment (week 0) and post-treatment (week 5)

次要结果测量

结果测量
措施说明
大体时间
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment
大体时间:pre-treatment (week 0) and post-treatment (week 5)
pre-treatment (week 0) and post-treatment (week 5)
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment
大体时间:pre-treatment (week 0) and post-treatment (week 5)
Computerized assessment of attention bias
pre-treatment (week 0) and post-treatment (week 5)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Susanna Chang, PhD、University of California, Los Angeles
  • 首席研究员:John Piacentini, PhD、University of California, Los Angeles
  • 首席研究员:James McCraken, MD、University of California, Los Angeles

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年11月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2012年10月11日

首先提交符合 QC 标准的

2012年10月15日

首次发布 (估计)

2012年10月16日

研究记录更新

最后更新发布 (估计)

2017年1月16日

上次提交的符合 QC 标准的更新

2017年1月13日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB12-001459
  • 1R34MH095885-01A1 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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