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临床试验/NCT01708226
NCT01708226已完成1 期

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

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
6
试验地点
2
主要终点
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment

研究概览

简要总结

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

入选标准

  • 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.

排除标准

  • DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
  • Concurrent psychosocial treatment for OCD
  • 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.

结局指标

主要结局

Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment

时间窗: pre-treatment (week 0) and post-treatment (week 5)

次要结局

  • Attention Bias Assessment Change from Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))
  • Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment(pre-treatment (week 0) and post-treatment (week 5))

研究者

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

Susanna Chang, PhD

Assistant Professor

University of California, Los Angeles

研究点 (2)

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