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临床试验/NCT04440852
NCT04440852已完成不适用

Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial

Wuhan Mental Health Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)

研究概览

简要总结

This study is design to evaluate the efficacy of the Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with autism spectrum disorders (ASD) in China.A case-randomized controlled study was conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly assigned to the a TEACCH intervention group or a control group.The control group was subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation training.

详细描述

Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
36 Months 至 90 Months(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosed by two children's psychiatrists above the level of the attending physician, in accordance with the diagnostic criteria of DSM-V (Diagnostic and Statistical Manual of Mental Disorder, fifth revised) children's autism spectrum disorder issued by the United States in
  • Diagnostic screening scales include Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), and Modified Checklist for Autism in Toddlers (M-CHAT) (for under 4 years old), Social Communication Questionnaire (SCQ) (for over 4 years old), all children' scores above the scale suggest ASD performance;
  • able to cooperate with clinical evaluation and related examinations, and the guardian signs the informed consent to agree to participate in the study.

排除标准

  • combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
  • serious self-harm.

结局指标

主要结局

Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)

时间窗: 6 months follow-up : 1 year to pretest

a validated assessment tool that comprehensively measures the development of Chinese children with ASD

次要结局

未报告次要终点

研究者

发起方
Wuhan Mental Health Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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