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Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism

2015年3月31日 更新者:Jair Mari、Federal University of São Paulo

Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training

This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.

Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.

研究概览

地位

完全的

详细说明

Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.

Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.

研究类型

介入性

注册 (实际的)

67

阶段

  • 第四阶段

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

      • São Paulo、巴西、04038-030
        • Federal University of São Paulo Department of Psychiatry

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

3年 至 7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:

  • Clinical Diagnosis of Autism Spectrum Disorders
  • Diagnosis of Autism Spectrum Disorders by means of ADI
  • IQ equal or lower than 70 by means of SON
  • Main caregiver's level of education > primary education

Exclusion Criteria:

  • IQ lower than 50 by means of SON
  • Child who is receiving ABA therapy at least 10 hours per week
  • Main caregiver diagnosed with Autism Spectrum Disorders

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:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
其他名称:
  • Applied Behavior Analysis parent training using videomodeling
无干预:ABA parent training control

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Acquisition from baseline of new behaviors at 8 weeks
大体时间:baseline assessment to 8 weeks of therapy
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline assessment to 8 weeks of therapy
Acquisition from baseline of new behaviors at 16 weeks
大体时间:baseline assessment to 16 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline assessment to 16 weeks
Acquisition from baseline of new behaviors at 21 weeks
大体时间:baseline to 21 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline to 21 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Eye-tracking at 21 weeks
大体时间:baseline assessment to 21 weeks
Latency, duration, and sequence of visual fixations measured with eye-tracking
baseline assessment to 21 weeks
Change from baseline in Vineland Scale at 21 weeks
大体时间:baseline assessment to 21 weeks
Adaptative behavior using Vineland Scale
baseline assessment to 21 weeks
Change from baseline in SON-R 2½-7 at 21 weeks
大体时间:baseline assessment to 21 weeks
Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
baseline assessment to 21 weeks
Change from baseline in Zaritt Burden Interview at 21 weeks
大体时间:baseline assessment to 21 weeks
The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
baseline assessment to 21 weeks
Change from baseline in OERA at 21 weeks
大体时间:baseline assessment to 21 weeks
OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
baseline assessment to 21 weeks

其他结果措施

结果测量
措施说明
大体时间
Change from baseline in KAP at 21 weeks
大体时间:baseline assessment to 21 weeks
Improvement on the knowledge, attitude and practice (KAP) questionnaire
baseline assessment to 21 weeks
Change from baseline in Hamilton scalels and at 21 weeks
大体时间:baseline assessment to 21 weeks
Improvement on the Hamilton Depression and Anxiety scales of the caregiver
baseline assessment to 21 weeks

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

  • 研究主任:Sheila C Caetano, MD, PhD、Federal University of São Paulo, São Paulo, Brazil

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

2014年2月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2014年9月5日

首先提交符合 QC 标准的

2014年9月5日

首次发布 (估计)

2014年9月10日

研究记录更新

最后更新发布 (估计)

2015年4月2日

上次提交的符合 QC 标准的更新

2015年3月31日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • U1111-1157-8984
  • 2012/51584-0 (其他赠款/资助编号:FAPESP)

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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