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临床试验/NCT00445471
NCT00445471终止不适用

A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
45
试验地点
1
主要终点
ADOS scores at 3 and 6 months after commencement of treatment

研究概览

简要总结

The current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as usual. A child and adolescent psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental psychologist will make the developmental and psychological assessments using the Vineland Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before the child enters the study. Each child will be reassessed following completion of the Mifne intervention, at three and at six months after commencement of treatment. The control child will also be reassessed at three and at six months after commencement of a therapeutic intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children between the ages of 2-5 years who meet diagnostic criteria for Autism or Pervasive Developmental Disorder by DSM IV criteria who are referred for treatment at Mifne for the treatment group.
  • The control group will consist of children meeting the same criteria who are referred to Schneider Children's Medical Center of Israel (SCMCI). Matching will be for age, sex, ethnicity, socioeconomic status, IQ, language development and diagnosis.
  • Exclusion criteria:
  • All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.

排除标准

  • 未提供

结局指标

主要结局

ADOS scores at 3 and 6 months after commencement of treatment

时间窗: 2.5 years

次要结局

  • CGI-I score after 3 and 6 months(2.5 years)

研究者

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

alan apter

Director, Feinberg Child Study Center and Department of Psychiatry, Schneider's Children's Medical Center of Israel

Rabin Medical Center

研究点 (1)

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